Managing Chronic Pain Through Self-Help

Study Overview
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Brief Summary
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Chronic pain has a significant impact on the physical and emotional functioning of those living with this condition. It is now recognized that Acceptance and Commitment Therapy (ACT) is an effective treatment in managing chronic pain; however, several barriers limit its accessibility. Therefore, self-help versions of ACT are promising because they offer a cost-effective treatment option that usually require little support from a therapist, and can be widely accessed. The current study aims to evaluate the effectiveness of predominantly self-help ACT interventions (web-based and bibliotherapy programs) in comparison to an education intervention among adults living with chronic pain. The current study was a randomized controlled trial (RCT) with two experimental groups and an active control group. The first experimental group received access to an internet platform with videos, interactive content and exercises based on ACT. The second experimental group received a copy of a self-help book based on ACT for chronic pain and had access to this book's website which includes audio mindfulness exercises. The third group consisted of an active control group, in which participants received pamphlet style pdf documents of education for pain (without any ACT components) as well as related practical exercises.

Detailed Description
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This study aimed to evaluate the effectiveness of a web-based ACT intervention program with minimal therapeutic contact, compared to an ACT-based bibliotherapy and a pain education program (active control group) among adults with chronic pain. Participants were randomly assigned to each group. We hypothesized that: both ACT interventions would lead to significant reductions in pain-related disability (primary variable), greater than the control group (education), and that the web-based program would lead to greater reductions in disability than the bibliotherapy group; both ACT interventions would lead to significant improvements in quality of life (secondary variable), greater than the control group (education), and that the web-based program would lead to greater improvements in quality of life than the bibliotherapy group; both ACT interventions would lead to significant reductions in anxiety and depressive symptoms (secondary variables), greater than the control group (education), and that the web-based program would lead to greater reductions in anxiety and depressive symptoms than the bibliotherapy group; Improvements on primary (pain-related disability) and secondary variables (quality of life, anxiety/depressive symptoms) for the ACT groups will be maintained at 3 and 6 months and will remain superior to the control group (education); Participants from both ACT groups would have a positive impressions of change following the intervention (as measured by the PGIC scale). Some of the questionnaires described in the following section were administered and will be subject to subsequent analyses examining patient trajectories of change and profiles of patients who respond well or not to these treatment modalities.

Official Title
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Managing Chronic Pain Through Self-Help: A Randomized Controlled Trial Comparing Guided Self-Help Programs Based on Acceptance and Commitment Therapy (ACT) to Education

Conditions
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Chronic Pain

Intervention / Treatment
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* Behavioral: Self-help Acceptance and commitment therapy (Web-based)
* Behavioral: Self-help Acceptance and commitment therapy (bibliotherapy)
* Other: Self-help Education pamphlets on pain (active control group)


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Being 18 years or older; Residing in Canada; Having daily pain for at least 6 months; Having a reading and writing ability equivalent or superior to grade 8; Having access to internet at home and a valid e-mail address; Not having previously engaged in an ACT-based psychotherapy and/or regularly meditated and/or read Libérez-vous de la douleur by Frédérick Dionne; Not being in an unstable psychological situation (severe suicidal thoughts or severe/persistent mental health disorder); Having an average level of pain of at least 4/10 within the past week; Having non-cancer related pain; Having stable medication for at least one month. Participants were excluded if they did not meet any of the above criteria.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Web-based<br>Self-help Acceptance and commitment therapy (Web-based) | Behavioral: Self-help Acceptance and commitment therapy (Web-based)<br>* 9 week program with minimal contact with therapist (predominantly self-help)<br>|
| Experimental: Bibliotherapy<br>Self-help Acceptance and commitment therapy (bibliotherapy) | Behavioral: Self-help Acceptance and commitment therapy (bibliotherapy)<br>* 9 week program with contact with therapist (predominantly self-help)<br>|
| Active Comparator: Education pamphlets on pain<br>Self-help Education on Chronic pain (pamphlet style pdf documents) | Other: Self-help Education pamphlets on pain (active control group)<br>* 9 week program with contact with therapist (predominantly self-help)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain interference | The Brief Pain Inventory (BPI) evaluates the severity and interference of pain in daily activities (Cleeland & Ryan, 1994; Tyler et al., 2002; French version: Poundja et al., 2007). The instrument consists of 10 items rated on a Likert scale ranging from 0 = does not interfere to 10 = interferes completely, and participants are asked to rate the degree to which pain interfered with various activities in the past week (e.g., social activities, work, mood, etc.). Higher scores represent higher levels of pain interference. This questionnaire has shown good reliability across a variety of populations (e.g. French speaking fibromyalgia patients; Bourgault et al., 2015). The BPI is extensively used in chronic pain research, has strong psychometric properties and is recommended as an outcome in clinical trials of patients with chronic pain (Dworkin et al., 2005). The French version has shown to have good internal consistency (Poundja et al., 2007). | Change from week start of treatment (week 0) to end of treatment (week 9), 3-month follow-up (week 22) and 6-month follow-up (week 35) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Anxiety and Depression symptoms | The Hospital Anxiety Depression Scale (HADS; Zigmond & Snaith, 1983; French version: Bocéréan & Dupret, 2014) is a 14-item questionnaire which evaluates psychological distress according to two 7-item subscales measuring anxiety and depressive symptoms in non-psychiatric hospital contexts. Items are scored on a 4-point Likert scale ranging from 0 to 3. An example of items is I feel tense or wound up. A higher score reflects a higher level of anxiety or depression. | Change from week start of treatment (week 0) to end of treatment (week 9), 3-month follow-up (week 22) and 6-month follow-up (week 35) | 
| Change in Quality of life measure | The World Health Organization Quality of Life-Brief (WHOQOL-BRIEF; WHOQOL; Group, 1998) is a self-reported measure of 26 items assessing quality of life in terms of physical and psychological health, social relationships and social functioning. Items are rated from 1 = very poor to 5 = very good, with higher scores reflect higher quality of life. This instrument has demonstrated good levels of internal consistency for its subscales (α = .66 to α = .80) and adequate test-retest reliability (r = .75). The French version of the instrument offers high internal consistency (Baumann, Erpelding, Régat, Collin, & Briançon, 2010). | Change from week start of treatment (week 0) to end of treatment (week 9), 3-month follow-up (week 22) and 6-month follow-up (week 35) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic pain, Self-help, Bibliotherapy, Web-based interventions, Acceptance and commitment therapy, Psychological flexibility