Effects of Progressive Muscle Relaxation Training on ...

Regular Article Psychother Psychosom 2008;77:119–125 DOI: 10.1159/000112889

Published online: January 25, 2008

Effects of Progressive Muscle Relaxation Training on Anxiety and Depression in Patients Enrolled in an Outpatient Pulmonary Rehabilitation Program Sermsak Lolak a, d Gerilynn L. Connors b Michael J. Sheridan a, c Thomas N. Wise a Departments of a Psychiatry, b Respiratory Care Services, and c Medicine, Inova Fairfax Hospital, Falls Church, Va., USA; d Department of Psychiatry, Faculty of Medicine, Chulalongkorn University, Bangkok , Thailand

Key Words Anxiety Depression Relaxation Pulmonary rehabilitation Chronic obstructive pulmonary disease

Abstract Background: This prospective, randomized controlled trial examined the effect of progressive muscle relaxation (PMR) training on anxiety and depression in patients with chronic breathing disorders receiving pulmonary rehabilitation (PR). Methods: Eighty-three subjects with chronic breathing disorders entering the 8-week PR program were randomly assigned to a standard care or intervention group. The standard program included 2 days per week of exercise, education and psychosocial support delivered by a multidisciplinary team. The intervention group received additional sessions of PMR training using a prerecorded tape for 25 min/week during weeks 2–8. Primary outcome measures were levels of anxiety and depression evaluated by the Hospital Anxiety and Depression Scale. Results: For anxiety, there was an overall significant improvement within each group over time (p ! 0.0001). There was no statistically significant grouptime interaction (p = 0.17) and no statistically significant difference between the groups (p = 0.22), despite lower scores for every time point in the PMR group. For depression, there was an overall significant improvement within each group over time (p ! 0.0001). Although the difference between the groups (p = 0.09) and group-time interaction (p = 0.07) did

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not reach statistical significance, the results again favored the PMR group for weeks 5–8. Depression scores were lower for the PMR throughout weeks 1–8. Conclusions: PR is effective in reducing anxiety and depressive level in chronic lung patients. Our findings suggest that adding structured PMR training to a well-established PR program may not confer additional benefit in the further reduction of anxiety and depression in patients receiving PR. Copyright © 2008 S. Karger AG, Basel

Introduction

The association between chronic breathing disorders, particularly chronic obstructive pulmonary disease (COPD), and psychiatric disorders, particularly anxiety and depression, has been recognized for many years, but the exact prevalence of psychiatric comorbidity in these patients is uncertain. The incidence of all anxiety symptoms in COPD varies from 2 to 150% [1–3] and that of generalized anxiety disorder from 10 to 15.8% [4]. The prevalence of depressive symptoms in similar cohorts has been estimated to be between 7 and 57% [5–7]. Depression and anxiety can negatively affect both the quality of life and functional status of COPD patients [4, 8–10]. Increased anxiety has been linked with worse dyspnea [11], while depression can negatively impact on a patient’s self-management skills [12] and treatment deciSermsak Lolak, MD Department of Psychiatry, Faculty of Medicine Chulalongkorn University, 873 Rama IV Rd., Patumwan Bangkok 10330 (Thailand) Tel./Fax +66 2 256 4298, E-Mail [email protected]

sions for cardiopulmonary resuscitation [13]. Anxiety and depression in COPD patients are associated with treatment failure and increased mortality risk [14, 15]. Compared to patients with congestive heart failure, arthritis, angina or diabetes, COPD patients have worse psychological functioning [16]. Although pharmacotherapy can successfully treat anxiety and depression, there are limitations to using these medications in medically ill patients. Psychiatric medications alone or through their interaction with other drugs can produce side effects, and some patients are unwilling to be on psychiatric medications. Some patients may be reluctant to take any additional drugs, perceiving it as a sign of loss of control and personal weakness in the handling of their illness [17]. Psychotherapeutic interventions for anxiety and depression in COPD patients have been studied as an alternative or an adjunct to pharmacotherapy. Evidence suggests that psychotherapy may decrease depression and anxiety in this patient population [18]. One small randomized controlled trial [19] demonstrated that including 1 psychotherapy session per week in a pulmonary rehabilitation (PR) program for COPD reduced anxiety and depression levels. Most studies, however, used inadequate sample sizes and posed other methodological problems. Relaxation techniques have been considered as an adjunctive therapy for anxiety and can provide patients with self-maintenance coping skills to reduce anxiety symptoms. Such techniques, including hypnosis, meditation and progressive muscle relaxation (PMR), have been shown to reduce anxiety, and to a lesser degree depressive symptoms, in a variety of medical and psychiatric illnesses [20–24]. There is evidence suggesting that COPD patients who utilize relaxation techniques have decreased anxiety and dyspnea compared to a routine outpatient care control group [25, 26]. PMR is one systematic technique that can be used to achieve a deep state of relaxation. It has several advantages for patients with COPD compared to other stress reduction techniques [25]. PMR was originally developed by Edmund Jacobson [27] in 1938. The original Jacobson method required dozens of sessions where the subject was taught to relax 30 different muscle groups. Bernstein and Borkovec [28] later shortened this technique to 16 muscle groups and found it to be equally effective [29]. PMR has been applied to a variety of conditions including insomnia, headache and psychological distress as well as chemotherapy-induced nausea in cancer patients [20, 30, 31]. A randomized clinical trial of PMR versus alprazolam in 120

Psychother Psychosom 2008;77:119–125

147 cancer patients showed both treatments to be effective in reducing anxiety and depression levels [17]. PR aims to improve functional capacity, exercise tolerance and overall quality of life in patients with chronic lung diseases. Comprehensive PR programs generally have 4 major components: exercise training, education, psychosocial/behavioral intervention and outcome assessment provided by a multidisciplinary team [32]. The physical and psychosocial benefits of PR are widely accepted [32], yet evidence of specific efficacy regarding improvement of anxiety and/or depression remains inconclusive. PR has been shown to improve levels of anxiety and depression among patients with COPD in some studies [2, 33, 34] but not in others [35, 36]. A recent study showed PR could decrease psychosocial morbidity even when no specific psychological intervention is performed [37]. The main aim of this study was to examine in a randomized fashion whether the addition of PMR training to a well-established outpatient PR program could further reduce anxiety and/or depression levels in this patient population. We believe this is the first study of its kind.

Methods Study Population Following approval from the Inova Institutional Review Board, subjects were recruited from all adult patients entering the Inova Fairfax Hospital outpatient PR program between January 2004 and December 2004. Inclusion criteria for the outpatient PR program were: (1) referral by a physician (i.e. primary care physician or pulmonologist); (2) chronic lung disease that was relatively stable under medical management, and (3) ability to meet one of the following parameters in the past year: FEV1 (forced expiratory volume) !65%, forced vital capacity !65% or diffuse capacity of carbon monoxide !65%. Exclusion criteria for the outpatient PR program were: (1) any unstable medical condition (e.g. acute heart failure or acute exacerbation of COPD); (2) diagnosis of dementia, and (3) physical inability to participate in the program (i.e. unable to join the exercise training). PMR + PR was the experimental program compared to the standard PR program for the COPD patients. Only 12 rehabilitation sessions were offered annually, and each 2-day per week, 8week PR rehabilitation took place in a group session in the hospital. Since we could not combine PR + PMR and PR subjects in the same session, the rehabilitation session starting date and not the individual patient was chosen as the unit of randomization. A block randomization technique was used to insure an equal number of sessions in each study arm after every nth allocation. With 12 rehabilitation sessions, the result was that every 4 random allocations produced 2 sessions assigned to PR and 2 sessions assigned to PR + PMR. Therefore, the total randomization pro-

Lolak /Connors /Sheridan /Wise

duced 6 sessions each for PR and PR + PMR. Patients were then serially assigned to 1 session. When allocating by program starting date, it was not possible to ensure equal numbers of patients per session, since the number of patients available for each session varied. However, statistical power was not predicated on equal numbers of patients per rehabilitation group but only on 40 patients per group. Potential subjects were approached by one of the investigators on the first day of the program. All patients signed an informed consent, which made it clear that the patients would receive the standard PR program whether or not they chose to participate in the study. Intervention The standard PR program included 2 days per week of supervised exercise training, education and psychosocial support delivered by a multidisciplinary team. The intervention group received the standard program plus additional weekly sessions of PMR training during weeks 2–8 of the PR program. For the intervention, the subjects listened to a 25-min prerecorded tape of PMR, using Bernstein’s technique [28, 29] in a group setting supervised by respiratory therapists from the PR program. It was not possible to blind the PMR therapy. The respiratory therapists who supervised the PMR therapy were the same as those responsible for the PR program, as would be the case in a real-world setting. Outcome Measures Anxiety and depression were assessed using the Hospital Anxiety and Depression Scale (HADS), a 14-item self-report scale consisting of two 7-item subscales, 1 for anxiety (HADS-A) and 1 for depression (HADS-D) [38]. The HADS is designed to measure anxiety and depression in medical patients. It is commonly used to evaluate depression and anxiety in pulmonary patients [32], both in- and outpatient settings. Each item is scored on a scale of 0 to 3. The HADS has been found to have good internal consistency, reliability and validity in a variety of medical populations [39, 40], including those with COPD. It also allows longitudinal assessment with repeated testing at intervals of 1 week or more and is sensitive to changes in a patient’s emotional state [39]. In studies of noncancer medical patients, the mean optimal cutoff scores for caseness in both anxiety disorders and depression were approximately 8+ with a mean sensitivity of 0.83–0.90 and a mean specificity of 0.78–0.79 [40]. In this study, we defined clinically important anxiety or depression as a HADS-A or HADS-D score 18. Data Collection At baseline, the following data were collected for each patient: age, sex, referring pulmonary diagnosis, duration of pulmonary symptoms (in months), FEV1 as an indicator of COPD severity, 6-min walk distance (in feet) as a measure of physical functioning, current diagnosis or treatment of depressive or anxiety disorder, HADS-A and HADS-D. Anxiety and depression (using HADS) were measured at the beginning of the study during the initial assessment and weekly at weeks 2–8. Statistical Analysis The dependent variable for this study was level of anxiety and depression as measured by the HADS. For the sample size estimate, we assumed a baseline HADS-A score of 8, the threshold

Progressive Muscle Relaxation Training in Anxiety and Depression

value for clinically important anxiety. To detect a 20% reduction from a baseline anxiety score of 8.0, a sample size of 40 per group was required for a 2-group test with a 0.05 two-sided level of significance. To measure equivalence at baseline, an independent ttest for continuous variables and a 2 test for categorical variables were used. To determine change in anxiety and depression scores over time both within and between the groups, a 2-factor repeated measures analysis of variance test was used. All comparisons at p ^ 0.05 were considered statistically significant.

Results

During the 12-month recruitment period, 103 subjects were found to meet the eligibility criteria and were invited to participate in the study. Of these subjects, 20 declined to do so and 83 were enrolled. Thirty-seven were assigned to the intervention group and 46 to the standard group at random. Of the 83 enrolled subjects, 66 (79.5%) completed the study. Thirteen subjects (15.7%) dropped out of the study, 6 from the intervention group and 7 from the standard group. Reasons for dropping out included: transfer to another facility (1 subject), too sick to participate (4), inpatient admission due to exacerbation of illness (2), family issues (1), transplantation (1), no reason given (3) and withdrawal from the program because of behavioral problems (1). Four additional subjects (4.8%), all from the intervention group, withdrew from the study but remained in the PR program. They also refused to participate in follow-up assessments. Reasons for withdrawing included: did not like the relaxation tape (1 subject), intervention did not work (2) and no reason given (1). Between completers and dropouts, there were no statistically significant differences in baseline characteristics, which included age (p = 0.84), duration of symptoms (p = 0.88), percentage of FEV predicted (p = 0.84), pre-6min walk (p = 0.37), week 1 HADS-A (p = 0.38), week 1 HADS-D (p = 0.44) and percent with a mood or anxiety disorder (p = 0.75). Primary diagnoses of subjects enrolled in the study included: COPD (54 subjects), pulmonary fibrosis (14), asthma (5), pulmonary embolism (3), pneumonia (1), cystic fibrosis (1), tuberous sclerosis (1), restrictive lung disease secondary to neuromuscular disease (1), bronchiolitis obliterans with organizing pneumonia (1), postlung-volume-reduction surgery (1) and reactive airway disease (1). At baseline, 32.5% (27/83) of the subjects had clinically important anxiety (HADS-A 18), 10 from the intervention group and 17 from the standard group. Also at Psychother Psychosom 2008;77:119–125

121

8

6

6

HADS-D score

HADS-A score

8

4

2

4

2 Intervention (n = 37) Standard (n = 46)

Intervention (n = 37) Standard (n = 46)

0

0 1

2

3

4 5 Time (weeks)

6

7

8

Table 1. Baseline characteristics of study

2

3

4 5 Time (weeks)

6

7

8

Fig. 2. HADS-D scores (means 8 95% CIs).

Fig. 1. HADS-A scores (means 8 95% CIs).

groups

1

Variable

Intervention (n = 37)

Age, years Duration of symptoms, months FEV1 predicted, % Six-minute walk (pre-) HAD-A (week 1) HAD-D (week 1) Mood disorder, %

64 (59–68) 80 (51–110) 46 (40–53) 1,161 (1,021–1,301) 5.5 (4.2–6.8) 4.9 (3.8–5.9) 0.35 [13/37]

Standard (n = 46) 67 (64–70) 60 (40–79) 45 (39–50) 975 (847–1,102) 7.0 (5.8–8.2) 5.9 (4.9–7.0) 0.37 [17/46]

p value 0.34 0.38 0.83 0.04 0.10 0.18 1.00

Values are means with 95% CI in parentheses and numbers of patients in square brackets.

baseline, 20.5% (17/83) of the subjects had clinically important depression (HADS-D 18), 5 from the intervention group and 12 the from standard group. The baseline characteristics of the 2 study groups are shown in table 1. There were no statistically significant differences between the groups for age, duration of pulmonary symptoms, FEV1 percentage predicted, percentage of subjects with diagnosis or treatment of mood or anxiety disorders, baseline HADS-A or baseline HADSD. The standard intervention had a 16% lower 6-min walking distance at baseline than the intervention group (p = 0.04). When the baseline characteristics for the sub122


jects only with clinically important anxiety or depression (HADS-A or HADS-D 18) were compared, no statistically significant differences were found between the study groups. The HADS-A scores over time are shown in figure 1. For anxiety, there was an overall significant improvement within each group over time (F7, 7, 448 = 7.94, p ! 0.0001). There was 36% reduction in the HADS-A scores in the intervention group and 39% in the standard group. There was no statistically significant group-time interaction (F7, 58 = 1.86, p = 0.17) and no statistically significant difference between the groups (F1, 64 = 2.69, p = 0.22), deLolak /Connors /Sheridan /Wise

spite lower scores for weeks 1–8 in the PMR group (lower at every time point). The HADS-D scores over time are shown in figure 2. For depression, there was an overall significant improvement within each group over time (F7, 7, 448 = 6.99, p ! 0.0001). There was a 36% reduction in the HADS-D scores in the intervention group and 23% reduction in the standard group. Although the difference between the groups (F1, 64 = 4.26, p = 0.09) and group-time interaction (F7, 58 = 2.31, p = 0.07) did not reach statistical significance, the results again favored the PMR group for weeks 5–8. The depression scores were lower for the PMR throughout weeks 1–8. These results remained unchanged when only subjects with clinically important anxiety or depression (HADS-A or HADS-D scores 18) were analyzed.

Discussion

The results of this study add to the body of evidence that PR is effective not only physically but also psychologically, specifically in reducing patients’ depression and anxiety. This study did not attempt to assess the effectiveness of PMR alone in treating depression. Rather, it was the first of its kind to evaluate the benefit of adding structured PMR training to an existing PR program. Several studies evaluating the effectiveness of PMR alone in reducing depressive symptoms have yielded mixed results [21, 41, 42] and may not be applicable to this patient population as PR becomes more and more widely used in chronic lung patients. Several limitations should be noted. First, this study may have been underpowered to detect the hypothesized differences because of sample size and subject dropout for medical and other reasons. Due to the nature of patient enrollment into the PR program, it was not possible for block randomization to produce the required 40 subjects per group. Also, 13 subjects (15.7%) dropped out of the study, 6 from the intervention group and 7 from the standard group. This resulted in 13% of missing data, 6% from the intervention group and 7% from the standard group, mostly for week 5 and beyond. Second, to preserve intention-to-treat, multiple imputation and the substitution of baseline scores were compared as methods of replacing these missing data. Substitution of baseline scores proved to be the more conservative approach and was chosen to replace all missing values, possibly resulting in an underestimation of the beneficial effect of the intervention. Third, although the randomization did produce Progressive Muscle Relaxation Training in Anxiety and Depression

well-matched groups at baseline for the most part, baseline 6-min walk values were higher in the intervention group, possibly indicating a potential confounder not reflected in the other equivalent baseline measures. Fourth, the baseline HADS scores for both depression and anxiety in this chronic disease cohort were lower than we had expected. Overestimating these anticipated baseline HADS scores no doubt reduced the statistical power of the study, making it more difficult to demonstrate significant differences between the groups. Fifth, it is common for patients with chronic breathing problems to interrupt or drop out of rehabilitation programs due to physical illness or rehospitalization. Therefore, the uninterrupted weekly monitoring of HADS scores may not be feasible in some patients. Finally, these results reflect a short-term intervention of only 8 weeks and it is unclear whether a longer duration would have produced statistically significant benefits for the intervention arm. Consistent with prior reports, our data confirm that an 8-week outpatient PR program was effective in reducing participants’ anxiety and depression by 23–39% in HADS-A and HADS-D levels. Because the PR program itself was so effective for reducing depression and anxiety, it may have been more difficult for the PMR arm to demonstrate further clinically significant improvement. The effects of PMR were somewhat greater for depression. The HADS-D scores were lower for the PMR group throughout weeks 1–8. For both anxiety and depression, it is possible that more subjects and less proxy data would have produced more statistically significant differences between the groups. Also, a greater frequency of PMR (e.g. 3–5 sessions per week) might have increased its effectiveness. Further studies with appropriate sample sizes, more frequent sessions of PMR and attention to cost issues are warranted. In patients with COPD, depression is thought to result from a complex interplay between physiological and psychological response and underlying brain dysfunction from chronic respiratory insufficiency and/or smoking [6]. The mechanism of PMR for improving depression is unclear. It is hypothesized that PMR may help in depression because of its effectiveness in reducing anxiety, which frequently co-occurs with depression [22]. These effects may not be unique to PMR but also apply in general to psychotherapies that use relaxation techniques. Both groups demonstrated statistically significant reductions in anxiety and depression over an 8-week period, but the differences between the groups were not statistically significant. These findings suggest that adding structured PMR training to a well-established PR proPsychother Psychosom 2008;77:119–125

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gram may not confer additional clinical benefit to patients receiving PR and may indirectly support a growing body of evidence showing the effectiveness of PR alone in reducing the depression and anxiety so commonly associated with these patients. In light of these findings, future randomized designs may have to specify a larger clinically meaningful difference (1 40%) and to examine the cost-effectiveness of adding PMR to an established PR program.

Acknowledgments The authors wish to thank Susan Farrell, Sidnie Hess and Judith Shumway of the Department of Respiratory Care Services, Inova Fairfax Hospital, for their invaluable help and contribution to this project.

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