Managing Chronic Pain Through Self-Help

NCT ID: NCT03711851

Last Updated: 2019-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 297 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2019-06-28

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.

Detailed Description

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:

1. 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;

2. 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;

3. 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;

4. 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);

5. 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.

Conditions

Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Web-based

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

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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

Bibliotherapy

Self-help Acceptance and commitment therapy (bibliotherapy)

Group Type: EXPERIMENTAL

Self-help Acceptance and commitment therapy (bibliotherapy)

Intervention Type: BEHAVIORAL

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

Education pamphlets on pain

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: OTHER

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

Interventions

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

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

Intervention Type: BEHAVIORAL

Self-help Acceptance and commitment therapy (bibliotherapy)

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

Intervention Type: BEHAVIORAL

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

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Being 18 years or older;

2. Residing in Canada;

3. Having daily pain for at least 6 months;

4. Having a reading and writing ability equivalent or superior to grade 8;

5. Having access to internet at home and a valid e-mail address;

6. Not having previously engaged in an ACT-based psychotherapy and/or regularly meditated and/or read "Libérez-vous de la douleur" by Frédérick Dionne;

7. Not being in an unstable psychological situation (severe suicidal thoughts or severe/persistent mental health disorder);

8. Having an average level of pain of at least 4/10 within the past week;

9. Having non-cancer related pain;

10. Having stable medication for at least one month.

Participants were excluded if they did not meet any of the above criteria.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Quebec Pain Research Network

OTHER

Sponsor Role: collaborator

Fonds de la Recherche en Santé du Québec

OTHER_GOV

Sponsor Role: collaborator

Université du Québec à Trois-Rivières

OTHER

Sponsor Role: lead

Responsible Party

Dr. Frédérick Dionne, Ph.D.

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Frederick Dionne, Ph.D.

Role: STUDY_DIRECTOR

Université du Québec à Trois-Rivières

Marie-Eve Martel, Psy.D.

Role: PRINCIPAL_INVESTIGATOR

Université du Québec à Trois-Rivières

Locations

Université du Québec à Trois-Rivières

Trois-Rivières, Quebec, Canada

Countries

Canada

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CDERS-17-11-06.05

Identifier Type: -

Identifier Source: org_study_id