Acceptance and Commitment Therapy vs. Medical Treatment as Usual Waitlist Control Group for Primary Headache Sufferers: The ALGEA Study .
Vasilis S. Vasiliou, Ph.D Candidate Maria Karekla, Ph.D.
Clinical Psychology & Behavioral Medicine Laboratory
Presentation Outline
Why ACT for Headache Management Aims of this study Methods Preliminary Results from an ACT RCT study Discussion Limitations/future directions
Two major coping responses with HAs: Key factors in headache-related disability
Behavioral Avoidance (BA)
Experiential (emotional) Avoidance (EA)
Behavioral Avoidance (BA) is problematic for coping with headaches • Avoidance of HA triggers – visual stimuli, stress, noise, certain food or restricting activities
• Few studies support that avoiding HA triggers can actual effectively reduce HA episodes. • Avoidance of HA triggers is counterproductive when it is inflexibly or excessively applied to HA triggers. • Despite immediate relief, BA in the long-run: reduces tolerance for triggers (Martin, 2010), increases trigger sensitivity (Martin & McLeod, 2009), diminishes quality of life (Ford et al., 2008; Hassinger et al., 1999).
Experiential Avoidance (EA) is problematic for coping with headaches
• EA is a process of : – Deliberate control, avoidance or unwillingness to experience private events and the context in which they occur (Hayes et al., 1999; Hayes & Wilson, 1994; Karekla et al., 2004).
• Repeated attempts at avoiding internal unwanted experiences, paradoxically, result in an increase in the experience one is trying to avoid (Hayes et al., 1996). • EA becomes pathogenic when applied universally and inflexibly to “unwanted” internal events:
greater suffering and disability (Asmundson et al., 1999; Geiser, 1992; McCracken et al., 1996), heightened distress, more pain (McCracken et al., 2005), lower pain tolerance (Gutierrez et al., 2004; Feldner et al., 2006; Zettle et al., 2005), poorer quality of life (Koleck et al., 2006).
The Alternative to BA & EA: Acceptance
• Pain acceptance – open and without defense engagement in personally meaningful activities – even in the presence of unwanted experiences (e.g., pain; McCracken et al., 1999).
• Acceptance is associated with: less avoidance coping responses in dealing with headaches higher levels of activity engagement better control over the influence that headache plays in one's life (Chiros & O’Brien, 2011). lower migraine-related disability (Foote et al., 2015)
A shift in what constitutes a successful behavioral intervention for headache
FROM: reduce head pain (e.g., intensity and severity) via AVOIDANCE
TO: reduce disability and achieve better life functioning via ACCEPTANCE
The vicious cycle of reducing head pain via avoidance CBT emphasizes prevention of HA episodes via avoidance (Penzien et al., 2002)
An inflexibly and irrespective of the context use of avoidance, creates more problems
CBT teach HA sufferers to identify and avoid HA triggers or other ambiguous events that activate a HA episode (e.g., stress, emotions; odors) (Friedman & De Ver Dye, 2009; Lipchik & Nash, 2002)
Preventive Headache = is an avoidance way of coping
The alternative of avoidance : ACT for Headache Management
ACT for headaches aims at improving functioning and quality of life, by reducing the influence that EA and BA exert over behaviors
HOW? via the use of acceptance and mindfulness processes: increase flexible responses to head pain
via the use of values clarification and committed actions: promote vital behavioral changes and reduce BA and EA
Preliminary evidence support ACT for Headache management
Three small-scale Randomized Controlled Trials (RCT) of ACT for HAs :
significant reduction in HA-related disability; emotional functioning; emotional distress; quality of life (Mo’tamedi, Rezaiemaram, & Tavallaie, 2012; Dindo, Recober, Marchman, Turvey, & O’Hara, 2012; Dindo et al., 2015)
Two cross-sectional studies: Acceptance and values-based actions are significantly related with : lower headache- related disability; diminished headache- related interference; improved headache sufferers functioning (Chiros & O’Brien, 2011; Foote et al., 2015)
Aims of the present study
1. Examine an ACT+MTAU vs. WL-MTAU for headache management effectiveness in a pilot RCT 2. ACT+MTAU group would show significant improvement on physical and psychological functioning, disability, quality of life and reductions in headache intensity, psychological distress and headache-related medical utilization.
Methods Design: participants were randomly assigned to either Acceptance Commitment Therapy with medical treatment as usual (ACT+MTAU) or wait-list control group with MTAU (WL-MTAU).
Participants: 94 Headache sufferers diagnosed with primary headaches referred from Neurology practitioners, hospitals department or via self- referral (newsletter adverts, fliers, articles published in local newspapers) from Cyprus.
Inclusion criteria assessed via two structured-clinical interviews (one medical and one psychological): a) meeting Primary Headache disorder criteria as defined in International Classification of Headache Disorders-II (ICHD-II, HIS, 2004); b) being aged 18 years or older; c) Greek-speaking; d) stable pharmacotherapy (i.e., remained unchanged for at least 4 weeks before treatment and remained unchanged over the course of treatment)
CONSORT flow diagram
Measures: Primary Outcomes Henry Ford Hospital Headache Disability Inventory (HDI) 25 items, two dimensions: (a) Functional (13 items;a =.88); (b) Emotional (12 items; a= .87) (b-HDI; Jacobsons et al., , 1994) Migraine-Specific Quality of Life Questionnaire (MSQ) 14-items assessing quality of life in three dimensions: (a) Role Restrictive (7 items; a= .93); (b) Role Preventive (4 items ;a=.87); (c) Emotional Function (3 items; a= .83) (MSQ v 2.1; Martin et al., 2000; permission of GlaxoSmithKline; USMA health outcome group)
Greek Brief Pain Inventory (GBPI) 11-item measure of: (a) pain severity (4 items; a= .88); (b) pain interference (7 items; a = .89) (G-BPI; Mystakidou et al., 2001; Original version: Cleeland, 1994)
Measures: Secondary Outcomes Medical Utilization 4 items assessing number of visits (#) due to headaches to: (a) Physicians, (b) Primary care provider, (c) Emergency Room, (d) hospitalization (adapted by permission by Vowles & McCracken, 2008)
The Hospital Anxiety and Depression Scale (HADS)- Greek 14-item questionnaire assessing levels of : (a) depression (7-items; a = .84), (b) anxiety (7-items; a = .75) (HADS; Mitsopoulos et al., 2007; Original version: Zigmond & Snaith, 1983)
Measures: Process Greek Chronic Pain Acceptance Questionnaire (G-CPAQ) 8-items assess pain acceptance via two sub-factors: (a) activity engagement (4 items; a = .83), (b) pain willingness (4 items; a = .63). (Vasiliou et al., under review; Original: McCracken et al.,2006)
Greek Psychological Inflexibility in Pain Scale (G-PIPS-II) 12 items assessing psychological inflexibility via two subscales: (a) avoidance of pain (8 items; a = .90), (b) cognitive fusion (4 items; a = 71.). (Vasiliou et al., in preparation; Original version: Wicksell et al., 2010)
Valuing Questionnaire (VQ) 10-items assessing personal values actions in two dimensions: (a) progress in identified values (5 items, a = .87), (b) obstruction of valued living (5 items; a = .62) (Smout et al., 2014)
Committed Action Questionnaire (CAQ) 8-item scale (a = .80) assessing goal- directed behaviors (McCracken, 2014). Cognitive Affective Mindfulness Scale Revised (CAMS-R) 12-item self-report questionnaire assessing affective and cognitive components of mindfulness (a=-.87) in a total score of a general mindfulness (Feldman et al., 2007)
Phase 4 An open response style
Phase 3 A centered response style
Phase 2 An engaged response style
Phase 1 Setting the premises for a change
The Algea Protocol for Headache Management 1) Introduction to the treatment program 2) Building awareness of the futile efforts and the cost of controlling head pain 3) mindfulness practice
4) Building a value compass and values incongruent actions 5) Values vs. goals, shaping behaviors with value-based actions 6) The dominance of verbal processes and the way impact behaviors 7) Healthy behavioral patterns (e.g., sleep hygiene, balanced diet, exercise, activity pacing)
8) Discovering the self-as-context and the observing self 9) Observing self and pain behaviors 10) Turning pain-avoidant behaviors into head pain willingness 11) Cultivating willingness and committed actions I, II & III parts 12) Mindfulness practice 13) Long-term maintenance of the skills and further enhancement of flexible responses to head pain
Data Analyses Plan
• G* power analysis, 130 individuals (65 in each condition) for reliable effect size estimates • Repeated Measures ANOVA (Time: pre, post, and 3 months follow-up assessments X two groups: ACT+MTAU and WL-MTAU)
Note 1: All analyses are presented in a Intent-to-treat analysis (ITT) following the last-value-carried- forward procedure (LCFP). Note 2: T-tests for independent samples with bonferroni corrections showed that the 2 groups were equivalent on all measures at the beginning of the study
Patients Characteristics Variable
Age (Mean/SD) Gender (female %) Educational level % High or vocational school (12 years) College/ University degree (16 years) Postgraduate degree (>16 years) Family Status % Married Monthly income % < 1000 euros 1000-1500 euros 1500-2000 euros Occupation Professionals Teachers and Market Positions Community service & Independent working positions Clerical and Public Administration Positions Sales Workers, Cleaners, General Assistance Positions Students Years since Headache suffering onset (Mean/ SD) General measure index of headache rating Pain Severity (GBPI) HDI-Func (0-48) Average headache frequency/month (Mean/ SD) Currently taking medication for headache Yes Headache Diagnosis (HIS Criteria) Migraine Tension-type headache
Groups ACT+MTAU (N= 47) 42.89 (10.27)
WL-MTAU (N = 47)1 44.92 (10.43)
pvalue2 .78
74.5%
92.5%
34.8% 26.1% 34.8%
34.6% 34.6% 17.3%
85.1%
60.4%
25.6% 27.9% 11.6%
55.3% 21.3% 12.8%
6.7% 15.6% 15.6%
8.5% 6.4% 27.7%
28.9% 24.4%
8.5% 17%
2.2%
23.4%
18.09 (10.71)
18.72 (10.99)
.78
4.20 (1.91) 26.34 (10.46) 7.87 (5.73)
5.08 (2.05) 28.08 (11.61) 10.55 (8.25)
.52 .19 .06 .96
82.2%
85%
.17
.13 .03
.01**
.46 90.9% 9.1%
83.3% 16.7%
Decreases in Headache General Disability Levels (HDI)
Variables
General Disability (HDI; 0100)
Groups
Mean (SD)1 Pre
Post
FUP-3
Effects Between Groups (ANOVAs across time; pre, post, fup3) Post: F (df)2 FUP- 3 (df)
ACT+MTAU
51.36 (21.28)
34.13 (21.20)
31.29 (21.32)
7.43 ** (1,59) 9.92 **(1,59)
WL-MTAU
58.13 (22.95)
51.93 (29.30)
50.87 (26.01)
Effect sizes Between Groups Post ηp2,3 FUP-3 ηp2
.11
.14
Decreases in emotional disability (HDI-Em)
Variables
Emotional Disability (HDIEm; 0-52)
Groups
Mean (SD)1 Pre
Post
FUP-3
Effects Between Groups (ANOVAs across time; pre, post, fup3) Post: F (df)2 FUP- 3 (df)
ACT+MTAU
24.06 (11.59)
15.48 (10.68)
14.97 (11.30)
5.84** (1,59)
WL-MTAU
28.53 (12.55)
23.33 (14.46)
24.87 (13.91)
9.33** (1,59)
Effect sizes Between Groups Post ηp2,3 FUP-3 ηp2
.09
.14
Decreases in Functional Disability Levels (HDI-Func)
Variables
Functional Disability (HDIFunc; 0-48)
Groups
Mean (SD)1 Pre
Post
FUP-3
Effects Between Groups (ANOVAs across time; pre, post, fup3) Post: F (df)2 FUP- 3 (df)
ACT+MTAU
27.29 (10.84)
17.42 (11.40)
16.32 (11.39)
8.00** (1,59)
WL-MTAU
29.60 (11.81)
26.73 (14.20)
26.00 (13.72)
9.01** (1,59)
Effect sizes Between Groups Post ηp2,3 FUP-3 ηp2
.12
.13
Increases in performance of daily activities (Quality of LifeMSQ-RR) Levels
Variables
Role Functional Restrictive (MSQ-RR;0-100)
Groups
Mean (SD)1 FUP-3
Effects Between Groups (ANOVAs Effect sizes Between across time; pre, post, fup3) Groups 2 Post: F (df) FUP- 3 (df) Post ηp2,3 FUP-3 ηp2
Pre
Post
ACT+MTAU
57.14 (17.30)
74.56 (16.74) 77.51 (14.95) 12.53*** (1,59)
WL-MTAU
49.14 (18.95)
56.10 (23.54) 57.90 (20.87)
17.88*** (1,59)
.17
.23
Increases in the amount of activities that have been interrupted by headache (Quality of Life-MSQ-RP)
Variables
Role Functional Preventive (MSQ-RP;0-100)
Groups
Mean (SD)1 Pre
Post
FUP-3
Effects Between Groups (ANOVAs across time; pre, post, fup3) Post: F (df)2 FUP- 3 (df)
ACT+MTAU
73.23 (19.52)
85.97 (16.90)
89.03 (13.25)
11.68*** (1,59)
WL-MTAU
65.17 (20.74)
68.17 (23.36)
69.00 (26.27)
14.27*** (1,59)
Effect sizes Between Groups Post ηp2,3 FUP-3 ηp2 .16
.19
Increases in emotional functioning (Quality of Life-MSQ-EF)
Variables
Role Functional Emotional (MSQ-EF ;0-100)
Groups
Mean (SD)1 Pre
Post
FUP-3
Effects Between Groups (ANOVAs across time; pre, post, fup3) Post: F (df)2 FUP- 3 (df)
ACT+MTAU
71.83 (20.20)
83.01 (18.60)
86.45 (15.82)
8.48** (1,59)
WL-MTAU
61.78 (23.61)
66.44 (25.40)
69.11 (29.16)
8.41** (1,59)
Effect sizes Between Groups Post ηp2,3 FUP-3 ηp2
.13
.12
Discussion Immediately following treatment and at 3-months follow-up, ACT+MTAU reported significantly lower disability, increase in functioning and QoL in comparison to the WL-MTAU group (ITT analyses).
All effect sizes were medium and in some cases (e.g., QoL) were large at the 3 months follow-up. Treatment did not reduce pain severity, consistent with the ACT theoretical framework. - The present data support the contention that effective daily functioning is possible in the context of continuing pain.
First findings supporting ACT for a mixed headache population that add to the limited empirical findings of ACT for headache management (Dindo et al., 2012; Dindo et al., 2015; Mo’tamedi et al., 2012)
Limitations/ Future directions Limitations: Self-report assessment methods Small sample size (preliminary findings) Mixed Headache sample from a Mediterranean region of Europe (limits generalizability)
Future directions: Investigate reliable and clinical significant changes (Jacobson criteria, 1999) Replicate and extend findings in larger-scale RCTs
Examine treatment mechanism & predictors of treatment success for ACT (process mediators) Examine moderators of change in ACT (e.g., demographic variables, headache intensity, co-existing clinical problems) will lead to a more personalized and adequately tailor interventions
Thank you, www.algea.com.cy
[email protected] Funding Sources:
Funded by The E.U. Structural Funding: Cross Border Cooperation (CBC) Programme “Greece- Cyprus” 2007-2013; ALGEA»| Κ3_01_06 (3 years) A Ph.D Scholarship given to VS.Vasiliou (by UCY Graduate council committee at 04/11/2015) for the academic year 2016-2017
