Multimedia-delivered cognitive behavioural therapy

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Cochrane Database of Systematic Reviews

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Multimedia-delivered cognitive behavioural therapy versus face-to-face cognitive behavioural therapy for depression in adults (Protocol)

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Davies SR, Caldwell DM, Dawson S, Sampson SJ, Welton NJ, Wiles N, Kessler D, Miljanovi M, Milunovic V, Peters T, Lewis G, Lopez-Lopez JA, Churchill R

Davies SR, Caldwell DM, Dawson S, Sampson SJ, Welton NJ, Wiles N, Kessler D, Miljanovi M, Milunovic V, Peters T, Lewis G, Lopez-Lopez JA, Churchill R. Multimedia-delivered cognitive behavioural therapy versus face-to-face cognitive behavioural therapy for depression in adults. Cochrane Database of Systematic Reviews 2018, Issue 11. Art. No.: CD013184. DOI: 10.1002/14651858.CD013184.

www.cochranelibrary.com

Multimedia-delivered cognitive behavioural therapy versus face-to-face cognitive behavioural therapy for depression in adults (Protocol) Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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HEADER . . . . . . . . . . ABSTRACT . . . . . . . . . BACKGROUND . . . . . . . OBJECTIVES . . . . . . . . METHODS . . . . . . . . . ACKNOWLEDGEMENTS . . . REFERENCES . . . . . . . . APPENDICES . . . . . . . . CONTRIBUTIONS OF AUTHORS DECLARATIONS OF INTEREST . SOURCES OF SUPPORT . . . .


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[Intervention Protocol]

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Multimedia-delivered cognitive behavioural therapy versus face-to-face cognitive behavioural therapy for depression in adults

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Sarah R Davies1 , Deborah M Caldwell1 , Sarah Dawson1 , Stephanie J Sampson2 , Nicky J Welton1 , Nicola Wiles1 , David Kessler1, Maja Miljanovi 3 , Vibor Milunovic4 , Tim Peters5 , Glyn Lewis6 , Jose A Lopez-Lopez1 , Rachel Churchill2,7 1 Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK. 2 Centre for Reviews and Dissemination, University of York, York, UK. 3 Agency for Quality and Accreditation in Health Care and Social Welfare, Zagreb, Croatia. 4 Division of Hematology, Clinical Hospital Merkur, Zagreb, Croatia. 5 Academic Unit of Primary Health Care, Department of Community Based Medicine, University of Bristol, Bristol, UK. 6 UCL Division of Psychiatry, UCL, London, UK. 7 Cochrane Common Mental Disorders Group, University of York, York, UK

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Contact address: Sarah R Davies, Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK. [email protected].

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Editorial group: Cochrane Common Mental Disorders Group. Publication status and date: New, published in Issue 11, 2018.

Citation: Davies SR, Caldwell DM, Dawson S, Sampson SJ, Welton NJ, Wiles N, Kessler D, Miljanovi M, Milunovic V, Peters T, Lewis G, Lopez-Lopez JA, Churchill R. Multimedia-delivered cognitive behavioural therapy versus face-to-face cognitive behavioural therapy for depression in adults. Cochrane Database of Systematic Reviews 2018, Issue 11. Art. No.: CD013184. DOI: 10.1002/14651858.CD013184.

ABSTRACT

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Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:

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To assess the efficacy and acceptability of multimedia-delivered cognitive behavioural therapy compared with face-to-face CBT for adults with depression.

BACKGROUND

Description of the condition Major depressive disorder (also known as ’major depression’ or ’depression’) is a commonly occurring, often recurrent disorder that is characterised by low mood and diminished interest in pleasurable activities. Individuals can experience a range of symptoms including weight loss or weight gain, a decrease or increase in appetite, insomnia or hypersomnia, psychomotor agitation or impairment, fatigue, loss of energy, diminished concentration or ability to think,

feelings of worthlessness or of inappropriate guilt, disruptions in decision-making, and morbid thoughts of death (APA 2013). Depression is a global health concern that has a large impact, both on the individual affected and on society as a whole. The global burden of depression has risen greatly over the past few decades, and it is now estimated that 350 million people worldwide are affected by the disorder (World Health Organization 2016). As the leading cause of disability worldwide (World Health Organization 2016), depression is associated with marked personal, social, and economic morbidity; loss of functioning and productivity; and high levels of service use (NICE 2010a; NICE 2010b).


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Level of therapist interaction Multimedia-delivered CBT programmes include varying levels of therapist interaction. Broadly speaking, they can be categorised as self-help, guided self-help, or blended treatments. In self-help programmes, a therapeutic intervention - designed to be conducted predominantly independently of professional contact - is administered through written materials, audio, video, smartphone, computer, or Internet (Bower 2001), with only technical support provided. With guided self-help, individuals independently work through set procedures delivered via multimedia platforms while therapists provide support such as encouragement and feedback on homework (Cuijpers 2010). More recently, blended treatments have been developed with the aim of preserving the personal contact and therapeutic relationship that occur in traditional faceto-face therapy while maintaining the benefits of enhanced accessibility that come with multimedia-delivered therapies (Kenter 2015; Kooistra 2016). Blended programmes combine real-time therapist interaction - conducted either face-to-face or remotely - with multimedia-delivered material to form a single treatment (Hoifodt 2013; Kessler 2009; Mansson 2013).

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Treatment options for depression include antidepressant medication, psychological therapies, or a combination of the two (Markowitz 2005; Schramm 2007). Psychological therapy approaches include cognitive behavioural, interpersonal, behavioural, psychodynamic, humanistic, and others. Traditionally, psychological therapies have been delivered in a face-to-face setting with a trained practitioner; however certain barriers (e.g. time constraints, transportation problems, stigma, long waiting lists, lack of qualified practitioners) may impede access to face-to-face therapy (Coppens 2013). One approach that has been used increasingly to enhance accessibility to therapy is self-help psychological therapy delivered via various media platforms. Multimedia-delivered psychological therapy can be defined as any standardised therapeutic approach that is delivered via one, or a combination, of the following multimedia platforms: selfhelp books, audio or video recordings, telephone, computer programmes (both online and desktop), apps (for mobile devices such as smartphones and tablets), e-mail, or text messages. These therapies can be provided with varying amounts of therapist interaction. Psychodynamic therapy (Johansson 2012), interpersonal psychotherapy (Donker 2013), and cognitive behavioural therapy (CBT) have all been adapted for multimedia delivery on a variety of platforms, including books (Bilich 2008; Cuijpers 1997), audio tapes (Blenkiron 2001), videos/DVDs (Mall 2011), CD-ROMs (Levin 2011), interactive desktop computer programmes (Beating the Blues, Proudfoot 2003), online computer programmes (MoodGYM, Christensen 2004; Beating the Blues, Proudfoot 2004; Colour Your Life, de Graaf 2009; Overcoming Depression on the Internet, Clarke 2002), mobile technologies (myCompass, Harrison 2011), interactive voice response systems accessed via telephone (COPE, Osgood-Hynes 1998), and text messages (short message service - SMS), as well as other mobile phone technology (MEMO, Whittaker 2012). Diversity in process (e.g. method of delivery, access to therapists) and in content is apparent in multimedia-delivered CBT programmes.

As technology has advanced, computer self-help programmes have increased in number and now incorporate interactive elements, with many including pictures, streamed videos, audio files, and features such as quizzes and secure online video chat facilities ( Carlbring 2018), therapies are also being developed that utilise an avatar therapist to deliver parts of a therapy (SPARX, Merry 2012; Pinto 2016). With the development of new mobile technologies, multimedia CBT packages are being developed that allow patients to gain access through smartphones, making treatments even more accessible (Ly 2015).

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Description of the intervention

Therapy content

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Multimedia-delivered CBT programmes generally reflect the same principles as standard face-to-face CBT and often are based on self-help manuals. These programmes therefore tend to have a common focus on behavioural activation, cognitive restructuring, and relapse prevention. Programmes often start with modules focussed on psychoeducation and finish with modules about relapse prevention, but details of the content can differ, as can the order in which the modules are presented to individuals.

Mode of treatment delivery Early versions of multimedia-delivered CBT consisted largely of text-based modules with few interactive elements (Marks 2007).

How the intervention might work Cognitive behavioural therapy is based on Beck’s cognitive model of depression (Beck 1976), which proposes that problematic experiences in early life can make an individual vulnerable to depression through development of negative core beliefs about the self, others, and the world. These core beliefs can be triggered later in life by stressful events. During episodes of depression, information processing is affected, leading to biased and negative interpretation of interpersonal experiences, with an increased sense of isolation and reduced levels of activity (Grant 2004). The aim of multimedia-delivered CBT is to enhance an individual’s understanding of the link between thoughts, feelings, and behaviour. During CBT, an individual learns how to identify, monitor, and counteract thoughts, beliefs, and interpretations related to particular situations. With self-help CBT approaches, this process can begin at an early stage, and some evidence suggests that multimedia-delivered self-help can empower individuals to feel in


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control of managing their own condition in a manner that is not reliant upon the availability of practitioners (Lucock 2007).

METHODS

Criteria for considering studies for this review Why it is important to do this review

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Types of studies

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We will include randomised controlled trials (RCTs); cluster-randomised trials; and cross-over trials, although the latter study design is unlikely to be used in this area of study. For cross-over trials, we will include in our analysis only results of the first active treatment phase. Types of participants

Participant characteristics

We will include adults between 18 and 74 years of age. We have chosen a broad age range to reflect the age group likely to be offered CBT for depression. To ensure that older patients are appropriately represented in the review (Bayer 2000; McMurdo 2005), we will use an upper age cutoff of 75 years (when a study may have included individuals ≥ 75, we will include it, so long as the average age is < 75). The increasing prevalence of memory decline reported in Ivnik 1992, cognitive impairment discussed in Rait 2005, and multiple comorbid physical disorders/polypharmacy described in Chen 2001 among individuals over 74 years of age may differentially influence the process and effects of psychological therapy interventions, especially those delivered via a multimedia format.

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Several systematic reviews have been conducted to assess the efficacy of self-help and guided self-help CBT for depression and other common mental disorders (Andersson 2016; Carlbring 2018; Cuijpers 2010; Johansson 2012a; Kaltenthaler 2004; Pasarelu 2017; van Ballegooijen 2014), including a meta-review of systematic reviews carried out on this topic (Foroushani 2011). Only three of these reviews compared self-help with face-to-face therapy; two focussed purely on computerised delivery platforms, with both concluding that the approaches were comparable (Carlbring 2018; van Ballegooijen 2014). A third systematic review compared self-help (not restricted to CBT) delivered via a variety of media platforms versus face-to-face therapy for depression and anxiety (Cuijpers 2010), and review authors concluded that these treatments have comparable effects. A recent priority setting partnership (PSP) in digital mental health involving over 1200 UK participants (including people with lived experience, carers, and practitioners) highlighted a ’top ten’ list of research priorities, one priority broadly asks whether therapies including CBT delivered via digital technology are as effective as those delivered face-toface (Hollis 2018). As yet, no comprehensive systematic review has compared all self-help, guided self-help, and blended mediadelivered CBT approaches versus traditional face-to-face therapy for treatment of depression. Given the potential benefits of increased accessibility and lower costs of multimedia-delivered CBT for depression in adults, an up-to-date synthesis of these developments will provide valuable information for clinicians. Because we will include therapies with all levels of therapist contact, delivered in a manner of different formats, we will need to be be considerate of the content of the therapies alongside the mode of delivery when we interpret findings from this comparison. We will do this by extracting relevant information regarding the content, process and delivery of the interventions using the TIDieR guidelines as a framework (Hoffman 2014), and using this context in our discussions. This dataset will contribute to a network meta-analysis comparing the efficacy and acceptability of different process and content components of CBT for depression in adults (Davies 2018).

OBJECTIVES To assess the efficacy and acceptability of multimedia-delivered cognitive behavioural therapy compared with face-to-face CBT for adults with depression.

Diagnosis

We will include studies of participants receiving treatment during an active depressive illness. 1. These include studies adopting any standardised diagnostic criteria to define participants suffering from an acute phase unipolar depressive disorder. Accepted diagnostic criteria include Feighner criteria; Research Diagnostic Criteria; criteria provided in the Diagnostic and Statistical Manual of Mental Disorders Third Edition (DSM-III; APA 1980), Revised Third Edition (DSM-III-R; APA 1987), Fourth Edition (DSM-IV; APA 1994), Fourth Edition Text Revision (DSM-IV-TR; APA 2000), and Fifth Edition (DSM-5; APA 2013), as well as criteria identified by the International Statistical Classification of Diseases and Related Health Problems Tenth Edition (ICD-10; WHO 1992). 2. Mild, moderate, and severe depressive disorders are all found in primary care (Mitchell 2009; Rait 2009; Roca 2009). To fully represent the broad spectrum of severity of depressive symptoms encountered by healthcare professionals in primary care, we will include studies that used non-operationalised diagnostic criteria or a validated clinician or self-report


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Studies involving participants with comorbid physical or common mental disorders will be eligible for inclusion as long as the comorbidity is not the focus of the study. In other words, for example, we will exclude studies that focus on depression among patients with Parkinson’s disease or after acute myocardial infarction, but we will accept studies on depression that may have included some participants with Parkinson’s disease or acute myocardial infarction.

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Comorbidities

1. Self-help CBT: individuals work through the CBT programme entirely independently, or with only minimal help provided when necessary regarding technical aspects such as navigating the programme. These treatments are most likely to be delivered via self-help books, audio or video recordings, or computer programmes. 2. Guided self-help CBT: individuals receive some level of guidance from clinical practitioners. This guidance can be seen in the form of e-mail or text message reminders, assessment of homework via e-mail, or scheduled telephone calls. 3. Blended CBT: integrated delivery of CBT through a mixture of real-time therapist contact and multimedia-delivered materials. Real-time therapist contact can be conducted face-toface or remotely (e.g. via Skype, instant messaging).

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depression symptom questionnaire, such as Hamilton Rating Scale for Depression - from Hamilton 1960 - or the Beck Depression Inventory - presented in Beck 1961 - to identify depression caseness based on a recognised threshold. However, we will perform a sensitivity analysis to examine the influence of including this category of studies.

Comparator interventions

We will include studies that compare multimedia-delivered CBT versus traditional CBT delivered on a face-to-face basis in group or individual format.

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Setting

Multimedia-delivered CBT

Types of outcome measures

Face-to-face CBT

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We will include studies in which individuals received multimediadelivered CBT at a location outside of a clinical and/or research setting with or without remote or face-to-face access to therapists located in primary care settings, on university premises, or in community mental health clinics or private practice clinics.

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We will include studies with face-to-face CBT as the comparator when therapy was conducted in primary care and communitybased settings, or in secondary or specialist settings. We will exclude studies involving inpatients. Participants may have been referred to the study by healthcare professionals, or they could have volunteered for enrolment by responding to advertisements about study participation.

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Types of interventions

Experimental intervention

We define multimedia-delivered psychological therapy as any standardised CBT approach that is delivered via one or more of the following multimedia platforms: self-help books, audio or video recordings, telephone, computer programmes (both online and desktop), apps, e-mail, or text messages. Multimedia-delivered therapies can be provided with varying extent of real-life or avatar therapist interaction and are broadly defined as self-help, guided self-help, and blended treatment.

Primary outcomes

1. Treatment efficacy: the number of participants who respond to treatment, based on changes on the Beck Depression Inventory (BDI) (Beck 1961), BDI-II (Beck 1996), the Hamilton Rating Scale for Depression (HAM-D) (Hamilton 1960), the Montgomery-Asberg Depression Rating Scale (MADRS) (Montgomery 1979), or any other validated depression scale. Many studies define response as 50% or greater reduction on BDI, HAM-D, etc., but some studies define response by using Jacobson’s Reliable Change Index (RCI). The RCI is calculated to determine whether the magnitude of change is statistically reliable. The post-treatment score is subtracted from the pre-treatment score and divided by the standard error of the differences. If the absolute value of t is greater than 1.96, then change is considered statistically reliable. If statistically reliable change is established, a second criterion is suggested for determining clinical significance: the post-treatment score must fall within the range of scores for a ’normal’ population (Jacobson 1991). We will accept the study authors’ original definition. If the original study authors report several outcomes corresponding with our definition of response, we will give preference to BDI for the self-rating scale and HAM-D for the observer-rating scale 2. Treatment acceptability: the number of participants who drop out of treatment for any reason

Secondary outcomes


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When researchers report several possible outcome measures for the same outcome, we will use the primary outcome according to the original study.

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Search methods for identification of studies

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Cochrane Common Mental Disorders Controlled Trials Register (CCMD-CTR) The Cochrane Common Mental Disorders Group maintains a specialised register of randomised controlled trials - the CCMDCTR. This register contains over 39,000 reference records (reports of RCTs) for anxiety disorders, depression, bipolar disorder, eating disorders, self-harm, and other mental disorders within the scope of this Group. The CCMD-CTR is a partially studies-based register with > 50% of reference records tagged to c12,500 individually PICO-coded study records. Reports of trials for inclusion in the register are collated through (weekly) generic searches of MEDLINE (1950 onward), Embase (1974 onward), and PsycINFO (1967 onward); quarterly searches of the Cochrane Central Register of Controlled Trials (CENTRAL), in the Cochrane Library; and review-specific searches of additional databases. Reports of trials are also sourced from international trials registries and drug companies, and through handsearching of key journals, conference proceedings, and other (non-Cochrane) systematic reviews and meta-analyses. Details of CCMD’s core search strategies (used to identify RCTs) can be found on the Group’s website; we have provided an example of the core MEDLINE search in Appendix 1. The Group’s Specialised Register (CCMD-CTR) is up to-date to June 2016.

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3. Number of participants who achieve remission. We will assess remission status using the endpoint status of participants, as measured on the Beck Depression Inventory (BDI; Beck 1961), BDIII (Beck 1996), the Hamilton Rating Scale for Depression (HAMD; Hamilton 1960), the Montgomery-Asberg Depression Rating Scale (MADRS; Montgomery 1979), or any other validated depression scale. Examples of definitions of remission include scores of 10 or less on the BDI and BDI-II, 7 or less on HAM-D, or 10 or less on the MADRS; we will accept the study authors’ definition 4. Improvement in depression symptoms as measured by validated instruments, for example, HAM-D (Hamilton 1980), BDI (Beck 1961) and BDI-II (Beck 1996), the Hospital Anxiety and Depression Scale (HADS) (Zigmond 1983), or the Geriatric Depression Scale (GDS) (Sheikh 1986) 5. Improvement in overall symptoms via the Clinical Global Impressions Scale (CGI) (Guy 1976) 6. Improvement in anxiety symptoms as measured on a validated continuous scale, either assessor-rated, such as the Hamilton Anxiety Scale (HAM-A) (Hamilton 1959), or self-report, including the Trait Subscale of the Spielberger State-Trait Anxiety Inventory (STAI-T), as described in Spielberger 1983, and the Beck Anxiety Inventory (BAI), as reported in Beck 1988 7. Adverse events as reported by study authors, including incidences of self-harming behaviour, completed suicide, attempted suicide, and worsening of behaviour 8. Social adjustment and social functioning, including Global Assessment of Function scores (Luborsky 1962), which we will summarise in narrative form when reported 9. Quality of life as measured via validated measures such as Short Form (SF)-36 (Ware 1993), SF-12, European Quality of Life 5 Dimensions (EQ-5D), Health of the Nation Outcome Scale (HoNOS) (Wing 1994), and the World Health Organization Quality of Life Questionnaire (WHO QOL) (WHO QOL 1998) 10. Economic outcomes (e.g. days of work absence/ability to return to work, number of appointments with primary care physician, number of referrals to secondary services, use of additional treatments), which we will summarise in narrative form, when reported

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Timing of outcome assessment

We will extract outcomes measured post-treatment and at followup. We will categorise outcomes as short term (up to six months post treatment), medium term (7 to 12 months post treatment), and long term (longer than 12 months post treatment). When study authors measure outcomes at multiple time points within a pre-defined period, we will include only the measure obtained at the longest time point after randomisation.

Hierarchy of outcome measures

Electronic searches The Information Specialist with the Common Mental Disorders Group will search the following databases using relevant subject headings (controlled vocabularies) and search syntax appropriate to each resource. 1. Cochrane Common Mental Disorders Controlled Trials Register (CCMD-CTR) (all years to 2016) (Appendix 2). 2. Cochrane Library Trials Database (current issue). 3. Ovid MEDLINE databases (1946 onwards) (Appendix 3). 4. Ovid PsycINFO (all available years). 5. Ovid Embase (1974 onwards). We will apply to the searches no restrictions on date nor language or publication status. We will search International trials registries via the World Health Organization trials portal - ICTRP - and ClinicalTrials.gov to identify unpublished or ongoing studies. We will also search for retraction statements and errata to any of the included studies.


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We will search the following databases to identify relevant PhD theses. 1. ProQuest Dissertations & Theses Global. 2. Digital Access to Research Theses (DART)-Europe E-theses Portal ( www.dart-europe.eu/). 3. EThOS - the British Libraries e-theses online service ( ethos.bl.uk/). 4. Open Access Theses and Dissertations ( oatd.org).

Reference lists

Correspondence

Data collection and analysis

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We will use Review Manager 2014 software for data synthesis and analysis.

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At least two review authors will independently assess titles and abstracts for relevance. We will code abstracts as ’retrieve’ or ’do not retrieve’. We will then find the full-text papers for all abstracts coded ’retrieve’. Two authors will independently assess full-text papers for inclusion. We will resolve conflicts through discussion or consultation with another review author. We will provide reasons for exclusion. We will tag together multiple reports of the same study. We will record study selection in sufficient detail to produce a PRISMA flow diagram.

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The main comparison will examine multimedia-delivered CBT versus CBT delivered face-to-face. If possible, we will stratify comparisons by category of multimediadelivered CBT as presented in the Types of interventions section of the protocol.

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We will contact trialists and experts for information on unpublished or ongoing studies, or to request additional trial data.

Selection of studies

Main comparison

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We will check the reference lists of all included studies and relevant systematic reviews to identify additional studies missed during the original electronic searches (e.g. unpublished citations, in-press citations).

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Grey literature

1. Methods: study design, location, study setting, total duration of study, and recruitment methods. 2. Participants: N, mean age, age range, gender, severity of condition, diagnostic criteria, inclusion criteria, and exclusion criteria. 3. Interventions: multimedia intervention characteristics including package, comparator, and intervention characteristics inline with TIDieR guidelines. 4. Outcomes: primary and secondary outcomes and time points reported. 5. Notes: funding source and conflicts of interest of trial authors. 6. Information needed to complete risk of bias assessments. 7. Information on treatment fidelity. We will include relevant information in the description of studies and in the ’Characteristics of included studies’ tables.

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Searching other resources

Data extraction and management Two review authors will use a data extraction sheet designed specifically for this review to independently extract data regarding study methods and outcomes. If necessary, we will resolve discrepancies through discussion and via consultation with another review author. When more than two intervention arms are included in the same trial, we will describe all arms. For all trial arms, we will collect the following data.

Assessment of risk of bias in included studies Two review authors will independently assess the risk of bias of included trials using the approach described in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2017). We will resolve disagreements through discussion or by consultation with a third review author. We will assess risk of bias according to the following domains. 1. Random sequence generation. 2. Allocation concealment. 3. Blinding of participants and personnel. 4. Blinding of outcome assessment (with separate assessments carried out for self-administered scales and observer-rated scales). 5. Incomplete outcome data. 6. Selective outcome reporting. 7. Other bias. We will judge each potential source of bias as high, low, or unclear, and will provide a supporting quotation from the study report together with a justification for our judgement in the ’Risk of bias’ table. Measures of treatment effect

Dichotomous data

We will analyse outcomes reporting dichotomous data by calculating a pooled odds ratio (OR) and 95% confidence intervals (CIs).


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When studies have used the same outcome measure, we will pool data by calculating the mean difference (MD). When researchers have used different measures to assess the same outcome, we will pool data using the standardised mean difference (SMD) and effect sizes interpreted using Cohen’s rule of thumb i.e. 0.2 represents a small effect, 0.5 a moderate effect, and 0.8 a large effect (Cohen 1988). We will calculate 95% confidence intervals for each analysis.

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Unit of analysis issues

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Continuous data

We will manage missing dichotomous data through intention-totreat (ITT) analysis, in which we will assume that participants who dropped out after randomisation had a negative outcome. We will also calculate best/worse-case scenarios for the clinical response outcome, in which we will assume that dropouts in the active treatment group had positive outcomes and those in the control group had negative outcomes (best-case scenario), and that dropouts in the active treatment group had negative outcomes and those in the control group had positive outcomes (worst-case scenario), thus providing boundaries for the observed treatment effect. If we encounter a large amount of missing information, we will give greater emphasis to these best/worst-case scenarios in the presentation of study results. We will analyse missing continuous data either on an endpoint basis, including only participants with a final assessment, or by using last observation carried forward (LOCF) to the final assessment if trial authors reported LOCF data. When standard deviations (SDs) are missing, we will attempt to obtain these data by contacting trial authors. When SDs are not available from trial authors, we will calculate them from P values, t values, confidence intervals, or standard errors, when reported in the articles (Deeks 1997). When a vast majority of actual SDs are available and only a minority of SDs are unavailable or unobtainable, we will use the pooled SDs from all the other available RCTs in the same metaanalysis to impute SDs and calculate the percentage of responders (Furukawa 2005; Furukawa 2006). When we use this method, we will interpret data with caution, taking into account the degree of heterogeneity observed. We will also undertake a sensitivity analysis to examine the effect of the decision to use imputed data. When additional figures are not available or obtainable, and it is not deemed appropriate to use the Furukawa method described above, we will not include the study data in the comparison of interest.

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Because ORs can be difficult to interpret, we will convert these pooled ORs to risk ratios (RRs) using the formula provided in the Cochrane Handbook for Systematic Reviews of Interventions (Deeks 2011), and we will present data in this form for ease of interpretation.

Cluster-randomised trials

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We will include cluster-randomised trials only if researchers report the intracluster correlation coefficient (ICC), or if we can borrow this from similar trials. We will estimate the effect size in clusterrandomised trials using the ICC to adjust for cluster effects, as described in Section 16.4.3, in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011).

Cross-over trials

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We will include cross-over trials in the calculation of summary statistics only when it is possible to extract intervention and comparator data obtained during the first treatment period.

Assessment of heterogeneity

For trials with multiple arms, we will combine arms as long as they can be regarded as providing subtypes of the same treatment. If this is not the case, we will treat each arm as a separate group and will subdivide the sample size of the common comparator arm for pairwise meta-analysis.

We will assess heterogeneity by two methods. First, we will assess face value clinical heterogeneity (obvious differences between participants, interventions, and outcomes). In the case of obvious face value clinical heterogeneity, we will not pool the data and will describe the clinical diversity of the studies (Deeks 2005; Egger 1997; Sterne 2001). Second, we will use the Chi² test and the I² statistic to explore the presence of statistical heterogeneity. We will consider a Chi² test P value < 0.10 as showing statistically significant heterogeneity. We will use strategies in addressing heterogeneity as outlined in the Cochrane Handbook for Systematic Reviews of Interventions (Deeks 2011), which offers the following guidance for interpretation of the I² statistic. 1. 0% to 40%: might not be important. 2. 30% to 60%: may represent moderate heterogeneity.

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Studies with multiple treatment groups

Dealing with missing data In the case of missing outcome data, we will contact the primary author of each included study to request any unreported missing data (e.g. group means and standard deviations (SDs), details of dropouts, details of interventions received by the control group). We will document in the review details regarding the primary contact, the respondent, and reasons given (if any) for missing data.


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As far as possible, we will minimise the impact of reporting biases by undertaking comprehensive searches, including a search of trial registries. Should we identify a sufficient number of studies (10 or more) using our search methods, we will check for publication bias by preparing a funnel plot. We will inspect funnel plots visually for asymmetry. If we identify evidence of small-study effects, we will investigate possible reasons for funnel plot asymmetry, including publication bias.

Individuals receive some level of guidance from clinical practitioners. This guidance can be seen in the form of email or text message reminders, assessment of homework via email, or scheduled telephone calls.

2.3 Blended CBT

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Assessment of reporting biases

2.2 Guided self-help CBT

Integrated delivery of CBT through a mixture of real-time therapist contact and multimedia-delivered materials. Real-time therapist contact can be conducted face-to-face or remotely (e.g. via Skype, instant messaging).

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3. 50% to 90%: may represent substantial heterogeneity. 4. 75% to 100%: shows considerable heterogeneity.

Sensitivity analysis Data synthesis

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Given the potential heterogeneity of psychological therapy approaches for inclusion, together with the likelihood of differing secondary comorbid mental disorders in the population of interest, we will use a random-effects model in all analyses.

We will perform sensitivity analyses to test the impact of methodological decisions made throughout the review process regarding the overall estimate of effect. We will analyse the impact of the following. 1. Risk of bias: we will remove studies that have been assessed as having high or unclear risk of bias in the domains of allocation concealment and blinding of outcome assessors. 2. Treatment fidelity: we will remove studies that have not examined fidelity to the treatment models by assessing video or audio tapes of sessions. 3. Imputation of missing data: Trials that provide results only when missing data were imputed will be removed. 4. Diagnostic criteria: studies that used non-operationalised diagnostic criteria or used a validated clinician or self-report depression symptom questionnaire, such as the Hamilton Rating Scale for Depression (Hamilton 1960) and the Beck Depression Inventory (Beck 1961) to identify depression caseness based on a recognised threshold will be removed.

Subgroup analysis and investigation of heterogeneity

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We expect to perform the following subgroup analyses:

1. Baseline severity of depression

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Severity of depression at the point of randomisation to treatment arms is likely to have an impact on outcomes. When possible, we will categorise baseline severity as mild, moderate, or severe using standard cutoff scores for the scales.

2. Level of therapist involvement

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This is likely to vary between interventions and may impact trial results. We will categorise level of therapist involvement in the following way:

2.1 Self-help CBT

Individuals work through the CBT programme entirely independently, or with only minimal help provided when necessary regarding technical aspects such as navigating the programme. These treatments are most likely to be delivered via self-help books, audio or video recordings, or computer programmes.

’Summary of findings’ table We will prepare a ’Summary of findings’ table using GRADEproGDT software (GRADEproGDT 2015). We will include a ’Summary of findings’ table for the main comparison and will include the following outcomes measured post treatment: treatment response, number of dropouts, remission, improvement in depressive symptoms, improvement in overall symptoms, adverse events, and quality of life. We will assess the quality of evidence for all outcomes using the GRADE approach (GRADE Working Group 2004). In doing this, we will consider within-study risk of bias (methodological quality), directness of evidence, heterogeneity, precision of effect estimates, and risk of publication bias. When assessing the quality of the evidence using GRADE, we will adhere to guidance provided in the Cochrane Handbook for Systematic Reviews of Interventions, which details the ways in which authors can make reasoned decisions when assessing the overall quality of


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the evidence across studies by balancing risk of bias, indirectness of the evidence, levels of heterogeneity, imprecision of the results, and probability of publication bias (Schünemann 2017).

CRG funding acknowledgement The National Institute for Health Research (NIHR) is the largest funder of the Cochrane Common Mental Disorders Group.

Disclaimer

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The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the NIHR, the NHS, or the Department of Health and Social Care. This report is independent research funded by the National Institute for Health Research

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ACKNOWLEDGEMENTS

(Programme Grants for Applied Research - Integrated therapist and online CBT for depression in primary care, RP-PG-051420012). The views expressed in this publication are those of the author(s) and not necessarily those of the NHS, the National Institute for Health Research, or the Department of Health. This study was also supported by The Centre for the Development and Evaluation of Complex Interventions for Public Health Improvement (DECIPHer), a UKCRC Public Health Research Centre of Excellence. Joint funding (MR/KO232331/1) from the British Heart Foundation, Cancer Research UK, Economic and Social Research Council, Medical Research Council, the Welsh Government, and the Wellcome Trust, under the auspices of the UK Clinical Research Collaboration, is gratefully acknowledged. This study was also supported by the NIHR Biomedical Research Centre at the University Hospitals Bristol NHS Foundation Trust and the University of Bristol. The study was additionally supported by the MRC ConDuCT-II Hub for Trials Methodology Research. This study was conducted in collaboration with the Bristol Randomised Trials Collaboration (BRTC), a UKCRC Registered Clinical Trials Unit (CTU), in receipt of National Institute for Health Research CTU support funding.

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APPENDICES

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Appendix 1. CCMDCTR core MEDLINE search

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The search strategy listed below is the weekly OVID Medline search that was used to inform the Group’s Specialised Register (to June 2016). It was based on a list of terms for all conditions within the scope of the Cochrane Common Mental Disorders Group plus a sensitive RCT filter. 1. [MeSH Headings]: eating disorders/ or anorexia nervosa/ or binge-eating disorder/ or bulimia nervosa/ or female athlete triad syndrome/ or pica/ or hyperphagia/ or bulimia/ or self-injurious behavior/ or self mutilation/ or suicide/ or suicidal ideation/ or suicide, attempted/ or mood disorders/ or affective disorders, psychotic/ or bipolar disorder/ or cyclothymic disorder/ or depressive disorder/ or depression, postpartum/ or depressive disorder, major/ or depressive disorder, treatment-resistant/ or dysthymic disorder/ or seasonal affective disorder/ or neurotic disorders/ or depression/ or adjustment disorders/ or exp antidepressive agents/ or anxiety disorders/ or agoraphobia/ or neurocirculatory asthenia/ or obsessive-compulsive disorder/ or obsessive hoarding/ or panic disorder/ or phobic disorders/ or stress disorders, traumatic/ or combat disorders/ or stress disorders, post-traumatic/ or stress disorders, traumatic, acute/ or anxiety/ or anxiety, castration/ or koro/ or anxiety, separation/ or panic/ or exp anti-anxiety agents/ or somatoform disorders/ or body dysmorphic disorders/ or conversion disorder/ or hypochondriasis/ or neurasthenia/ or hysteria/ or munchausen syndrome by proxy/ or munchausen syndrome/ or fatigue syndrome, chronic/ or obsessive behavior/ or compulsive behavior/ or behavior, addictive/ or impulse control disorders/ Multimedia-delivered cognitive behavioural therapy versus face-to-face cognitive behavioural therapy for depression in adults (Protocol) Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Appendix 2. Review search - CCMDCTR

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or firesetting behavior/ or gambling/ or trichotillomania/ or stress, psychological/ or burnout, professional/ or sexual dysfunctions, psychological/ or vaginismus/ or Anhedonia/ or Affective Symptoms/ or *Mental Disorders/ 2. [Title/ Author Keywords]: (eating disorder* or anorexia nervosa or bulimi* or binge eat* or (self adj (injur* or mutilat*)) or suicide* or suicidal or parasuicid* or mood disorder* or affective disorder* or bipolar i or bipolar ii or (bipolar and (affective or disorder*)) or mania or manic or cyclothymic* or depression or depressive or dysthymi* or neurotic or neurosis or adjustment disorder* or antidepress* or anxiety disorder* or agoraphobia or obsess* or compulsi* or panic or phobi* or ptsd or posttrauma* or post trauma* or combat or somatoform or somati# ation or medical* unexplained or body dysmorphi* or conversion disorder or hypochondria* or neurastheni* or hysteria or munchausen or chronic fatigue* or gambling or trichotillomania or vaginismus or anhedoni* or affective symptoms or mental disorder* or mental health).ti,kf. 3. [RCT filter]: (controlled clinical trial.pt. or randomised controlled trial.pt. or (randomi#ed or randomi#ation).ab,ti. or randomly.ab. or (random* adj3 (administ* or allocat* or assign* or class* or control* or determine* or divide* or distribut* or expose* or fashion or number* or place* or recruit* or subsitut* or treat*)).ab. or placebo*.ab,ti. or drug therapy.fs. or trial.ab,ti. or groups.ab. or (control* adj3 (trial* or study or studies)).ab,ti. or ((singl* or doubl* or tripl* or trebl*) adj3 (blind* or mask* or dummy*)).mp. or clinical trial, phase ii/ or clinical trial, phase iii/ or clinical trial, phase iv/ or randomised controlled trial/ or pragmatic clinical trial/ or (quasi adj (experimental or random*)).ti,ab. or ((waitlist* or wait* list* or treatment as usual or TAU) adj3 (control or group)).ab.) 4. (1 and 2 and 3) Records were screened for reports of RCTs within the scope of the Cochrane Common Mental Disorders Group. Secondary reports of RCTs are tagged to the appropriate study record.

Cochrane Common Mental Disorders Controlled Trials Register (CCMDCTR)

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The CCMDCTR will be searched using the following terms. #1 (“chat room*” or distance* or etherap* or e-therap* or “instant messag*” or messaging or iCBT* or i-CBT or cCBT or c-CBT or internet* or web* or www or online* or on-line* or DVD or CD-ROM or CDROM or eHealth or e- health or electronic health or e-Portal or ePortal or ePsych* or e-Psych* or mHealth or m-Health or multmedia* or multi-media* or mobile or email* or e-mail* or remote or texting or “text message” or SMS or telecomm* or telehealth* or tele-health* or telemed* or tele-med* or telemonitor* or tele-monitor* or telepsych* or tele-psych* or teletherap* or tele-therap* or videogam* or “video game*” or videoconferenc* or “video conferenc*” or virtual):ti,ab,kw,ky,mh,mc,emt [REFERENCE] [STANDARD] #2 (android or app or apps or avatar* or blog* or cellphone* or “cell phone*” or cyber* or ”digital device*“ or ”digital medi*“ or ”digital technolog*“ or emediated or e-mediated or ”information technolog*“ or iphone* or i-phone* or ipad* or i-pad* or ipod or i-pod or ”personal digital assistant“ or PDA or podcast or ”mobile phone“ or smartphone or ”smart phone” or smartwatch* or “social network* site*” or “social medi*” or forum or Facebook or YouTube):ti,ab,kw,ky,mh,mc,emt [REFERENCE] [STANDARD] #3 (asynchronous or synchronous or (electronic adj2 deliver*)):ti,ab,kw,ky #4 (MoodGym* or “Mood Gym” or “Beat* the Blues” or “Blues Begone” or BluesBegone or eSmart* or “Glasgow Steps” or GlasgowSteps or GripOpJeDip or “Grip Op Je Dip” or Help4Mood or Interapy or MasterYourMoodOnline or “Master Your Mood” or “MobileType” or Mobilyze or Moodhelper or “Mood Helper “or Pratenonline or “Praten Online” or StudentBodies or “Student Bodies” or ThisWayUp or This-Way-Up):ti,ab,kw,ky [REFERENCE] [STANDARD] #5 ((computer* or software) near (*CBT* or cognitive or psychotherap*)):ti,ab [REFERENCE] [STANDARD] #6 (eLearning or ecompared or e-compared or emediated or e-mediated):ti,ab,kw,ky [REFERENCE] [STANDARD] #7 (blended or bCBT or b-CBT):ti,ab [REFERENCE] [STANDARD] #8 (asynchronous or synchronous or (electronic adj2 deliver*)):ti,ab [REFERENCE] [STANDARD] #9 ((manual or book or booklet or leaflet or pamphlet) and (*face* or *self* or CBT* or cognitive behavi* or therapist* or psychotherap*)): ti,ab,kw,ky,mh,mc,emt [REFERENCE] [STANDARD] #10 ((selfhelp or “self help”) adj3 depress*):ti,ab #11 (#1 or #2 or #3 or #4 or #5 or #6 or #7 or #8 or #9) [REFERENCE] [STANDARD] #12 (depress* or mood or dysthymi* or “affective disorder*” or “affective symptom*”):ti,ab,kw,ky,mh,mc,emt [REFERENCE] [STANDARD] Multimedia-delivered cognitive behavioural therapy versus face-to-face cognitive behavioural therapy for depression in adults (Protocol) Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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#13 (#11 and #12) [REFERENCE] [STANDARD] #14 telephone:ti,ab,kw,ky,mh,mc,emt [REFERENCE] [STANDARD] #15 #14 and #12 [REFERENCE] [STANDARD] #16 #10 or #13 or #15 [REFERENCE] [STANDARD] #17 (#16) AND (INREGISTER) [REFERENCE] [STANDARD] [Key to field tags. ti:title; ab:abstract; kw:keywords; ky:other keywords; mh:MeSH headings; mc:MeSH check words; emt:EMTREE headings]

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Appendix 3. Review search - MEDLINE

Ovid MEDLINE databases

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Ovid MEDLINE(R) and Epub Ahead of Print, In-Process & Other Non-Indexed Citations and Daily Search Strategy: -------------------------------------------------------------------------------1 ((selfhelp or self help) adj3 depress*).ti,ab,kf. 2 (Beat* the Blues or Blues Begone or BluesBegone or eSmart* or Glasgow Steps or GlasgowSteps or GripOpJeDip or Grip Op Je Dip or Help4Mood or Interapy or MasterYourMoodOnline or Master Your Mood or MobileType or Mobilyze or MoodGym or Mood Gym or Moodhelper or Mood Helper or NetCope or Net Cope or Pratenonline or Praten Online or StudentBodies or Student Bodies or ThisWayUp or This-Way- Up).ti,ab,kf. 3 ((computer* or digital or internet or software or multimedi* or web based) adj3 (CBT* or cognitive* or psychotherap*)).ti,ab,kf. 4 (tele* adj2 (CBT* or cognitive or psychotherap* or therap*)).ti,ab,kf. 5 (cCBT* or c-CBT*).ti,ab,kf. 6 ((selfhelp or self help) adj3 (CBT* or cognitive*)).ti,ab,kf. 7 ((blended adj3 (CBT* or cognitive*)) or bCBT or b-CBT).ti,ab,kf. 8 or/2-7 9 MULTIMEDIA/ 10 TELEMEDICINE/ 11 COMPUTER COMMUNICATION NETWORKS/ or INTERNET/ or BLOGGING/ or SOCIAL MEDIA/ 12 CELL PHONES/ or SMARTPHONES/ or TEXT MESSAGING/ or VIDEOCONFERENCING/ or WEBCASTS as TOPIC/ or WIRELESS TECHNOLOGY/ 13 (android or app or apps or avatar* or blog* or CD-ROM or cell phone or cellphone or chat room or cyber* or digital technolog* or digital media* or digital device* or DVD or eHealth or e-health or electronic health or e-mail* or email* or e-Portal or ePortal or ePsych* or e-Psych* or eTherap* or e-therap* or forum* or gaming or iCBT or i-CBT or information technolog* or instant messag* or messaging or internet* or ipad or i-pad or iphone or i-phone or ipod or i-pod or podcast or smart phone or smartphone or social network* site* or social networking or mHealth or m-health or mobile phone or multi-media or multimedia or online* or on-line or personal digital assistant or PDA or SMS or social medi* or telecomm* or telehealth* or tele-health* or telemed* or tele-med* or telemonitor* or tele-monitor* or telepsych* or tele-psych* or teletherap* or tele-therap* or text messag* or texting or virtual* or web or Facebook or YouTube).ti,ab,kf. 14 (technology based or ((technology or technologies) adj5 (deliver* or wearable or information or communication? or mood or mental or psychiatr*))).ti,ab,kf. 15 (digital or computer* of software or tele*).ti,kf. 16 (eLearning or ecompared or e-compared or blended learning).ti,ab,kf. 17 (gaming or gamification or smartwatch* or wearable device? or wearables or videogame or video game or videoconferenc* or video conferenc*).ti,ab,kf. 18 (asynchronous or synchronous or ((electronic or digital) adj2 deliver*)).ti,ab,kf. 19 ((manual or book or booklet or leaflet or pamphlet) adj3 (self* or guided or unguided)).ti,ab,kf. 20 or/9-19 21 PSYCHOTHERAPY/ or PSYCHOTHERAPY, GROUP/ or BEHAVIOR THERAPY/ or exp COGNITIVE THERAPY/ 22 (CBT* or (cognitive* adj2 (behavi* or diffusion or restructur* or therap* or psychotherap* or training)) or metacogniti* or metacogniti*).ti,ab,kf. Multimedia-delivered cognitive behavioural therapy versus face-to-face cognitive behavioural therapy for depression in adults (Protocol) Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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23 ((acceptance* or commitment) adj2 (psychotherap* or therap*)).ti,ab,kf. 24 ACT intervention.ti,ab,kf. 25 BEHAVIOR MODIFICATION/ 26 (behavi* adj2 (activat* or dialectic* or modif* or therap* or psychotherap*)).ti,ab,kf. 27 (compassion* adj2 (focus* or intervention* or therap* or psychotherap* or train*)).ti,ab,kf. 28 ((experiential or functional analy*) adj3 (psychotherap* or therap*)).ti,ab,kf. 29 (psychoeducat* or psycho educat* or (problem*1 adj (sol* or focus*))).ti,id. 30 (problem*1 adj (sol* or focus*)).ti,ab,kf. 31 PSYCHOTHERAPY, RATIONAL-EMOTIVER/ 32 (rational emotive adj (therap* or psychotherap*)).ti,ab,kf. 33 SELF CONTROL/ or SELF REGULATION/ or SELF MANAGEMENT/ 34 (self adj (control or efficacy or help or instruct* or manag* or regulat* or schema*)).ti,ab,id. 35 MINDFULNESS/ 36 (mindful* or mind train*).ti,ab,kf. 37 (competitive memory train* or COMET).ti,ab,kf. 38 or/21-37 39 20 and 38 40 DEPRESSION/ 41 DEPRESSIVE DISORDER/ 42 DEPRESSIVE DISORDER, MAJOR/ 43 (depress* adj3 (acute or clinical* or diagnos* or disorder* or major or unipolar or illness or scale* or score* or adult* or patient* or participant* or people or inpatient* or in-patient* or outpatient* or out-patient*)).ab. 44 (depress* and (Beck* or BDI* or DSM* or (Statistical Manual adj2 Mental Disorders) or Hamilton or HAM-D or HAMD or MADRS or (International Classification adj2 Disease?) or ICD-10 or ICD-9)).ab. 45 “with depressi*”.ab. 46 (depress* or mood or mental health).ti,kf. 47 or/40-46 48 (8 or 39) and 47 49 controlled clinical trial.pt. 50 randomized controlled trial.pt. 51 (randomi#ed or randomi#ation or randomi#ing).ti,ab,kf. 52 (RCT or “at random” or (random* adj3 (administ* or allocat* or assign* or class* or cluster or control* or determine* or divide* or division or distribut* or expose* or fashion or number* or place* or pragmatic or quasi or recruit* or split or subsitut* or treat*))).ti,ab,kf. 53 placebo*.ab,ti,kf. 54 trial.ab,ti,kf. 55 (control* and (trial or study or group*) and (placebo or waitlist* or wait* list* or ((treatment or care) adj2 usual))).ti,ab,kf,hw. 56 ((single or double or triple or treble) adj2 (blind* or mask* or dummy)).ti,ab,kf. 57 double-blind method/ or random allocation/ or single-blind method/ 58 or/49-57 59 (1 and 58) 60 (48 and 58) 61 (59 or 60) ***************************


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CONTRIBUTIONS OF AUTHORS NW, DSK, DMC, NJW, and RC conceived the project and wrote the application for funding. SRD drafted the initial protocol and data extraction forms, with input from DMC, JALL, SD, SJS, NJW, NW, DSK, and RC. All review authors have contributed to the protocol design and content, for example, at team meetings and through formal protocol review at various times since the study was funded.

The authors of this protocol have no financial interest in its outcome.

SOURCES OF SUPPORT

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All review authors have approved this version for publication.

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External sources

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• No sources of support supplied

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• National Institute for Health Research, UK. This report is independent research funded by a Programme Grant for Applied Research - Integrated therapist and online CBT for depression in primary care (RP-PG-0514-20012). The views expressed in this publication are those of the review author(s) and are not necessarily those of the NHS, the National Institute for Health Research, or the Department of Health and Social Care.


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