Managing Chronic Pain Through Self-Help

NCT03711851 | Completed

• 1 other identifier: CDERS-17-11-06.05
• Study Type: interventional
• Target: 297
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Pain

Keywords

Chronic pain; Self-help; Bibliotherapy; Web-based interventions; Acceptance and commitment therapy; Psychological flexibility

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Anxiety and Depression symptoms

  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

  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)

Other Outcomes (5)

• Psychological In/Flexibility

  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)

• Chronic Pain Acceptance

  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)

• Chronic Pain Self-Efficacy

  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)

Study Arms (3)

Web-based

EXPERIMENTAL

Self-help Acceptance and commitment therapy (Web-based)

Behavioral: Self-help Acceptance and commitment therapy (Web-based)

Bibliotherapy

EXPERIMENTAL

Self-help Acceptance and commitment therapy (bibliotherapy)

Behavioral: Self-help Acceptance and commitment therapy (bibliotherapy)

Education pamphlets on pain

ACTIVE COMPARATOR

Self-help Education on Chronic pain (pamphlet style pdf documents)

Other: Self-help Education pamphlets on pain (active control group)

Interventions

Self-help Acceptance and commitment therapy (Web-based) BEHAVIORAL

9 week program with minimal contact with therapist (predominantly self-help)

Web-based

Self-help Acceptance and commitment therapy (bibliotherapy) BEHAVIORAL

9 week program with contact with therapist (predominantly self-help)

Bibliotherapy

Self-help Education pamphlets on pain (active control group) OTHER

9 week program with contact with therapist (predominantly self-help)

Education pamphlets on pain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Université du Québec à Trois-Rivières: lead
• Quebec Pain Research Network: collaborator
• Fonds de la Recherche en Santé du Québec: collaborator

Study Sites (1)

Université du Québec à Trois-Rivières

Trois-Rivières, Quebec, G8Z 4M3, Canada

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Bibliotherapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Frederick Dionne, Ph.D.

  Université du Québec à Trois-Rivières

  STUDY DIRECTOR

• Marie-Eve Martel, Psy.D.

  Université du Québec à Trois-Rivières

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 9, 2018
• First Posted: October 19, 2018
• Study Start: October 1, 2018
• Primary Completion: June 27, 2019
• Study Completion: June 28, 2019
• Last Updated: July 11, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)