A Randomized Controlled Trial Evaluating the Effectiveness of an Acceptance and Commitment Therapy-Based Bibliotherapy Intervention Among Adults Living With Chronic Pain

Evaluating the Effectiveness of an ACT-Based Bibliotherapy Intervention Among Adults Living With Chronic Pain

Sponsors

Lead sponsor: Université du Québec à Trois-Rivières

Source Université du Québec à Trois-Rivières
Brief Summary

Chronic pain has a significant impact on the physical and psychological functioning of those living with this condition. It is now recognized that Acceptance and Commitment Therapy (ACT) is an effective intervention in managing chronic pain; however, several barriers limit its accessibility.

The current study aims to evaluate the effectiveness of an eight-week bibliotherapy-type self-administered psychological intervention with minimal therapeutic contact, based on ACT, in the management of chronic pain.

This study is a randomized controlled trial with two groups (one experimental group and one wait-list control group). Participants will be randomly assigned to each condition and measures will be taken at pretest, posttest and three months following the intervention.

Detailed Description

The purpose of this randomized controlled trial was to assess the effectiveness of an eight-week self-administered intervention program (bibliotherapy) based on Acceptance and Commitment Therapy with minimal therapeutic support in the management of chronic pain.

This study was based on the following hypotheses. In comparison to the control group, from pre to post, the self-help program will:

1. significantly reduce pain-related disability (primary variable);

2. improve depressive symptoms related to CP (secondary variable);

3. increase the level of pain acceptance;

4. reduce psychological inflexibility linked to painful symptoms (process variables).

It was also expected that:

5. the improvements would be maintained at three-month follow-up;

6. participants would have an overall impression of a positive change following the intervention.

Overall Status Completed
Start Date March 28, 2016
Completion Date August 2016
Primary Completion Date August 2016
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in Pain-related disability Change from week 1 to week 9
Change in Pain-related disability Change from week 9 and week 21 (ACT group only)
Secondary Outcome
Measure Time Frame
Change in Depressive symptoms Change from week 1 to week 9
Change in Depressive symptoms Change from week 9 and week 21 (ACT group only)
Change in Pain acceptance Change from week 1 to week 9
Change in Pain acceptance Change from week 9 and week 21 (ACT group only)
Change in Psychological inflexibility Change from week 1 to week 9
Change in Psychological inflexibility Change from week 9 and week 21 (ACT group only)
Participants' impression of change week 21
Enrollment 140
Condition
Intervention

Intervention type: Behavioral

Intervention name: Acceptance and Commitment Therapy (ACT) bibliotherapy for chronic pain

Description: The intervention consisted of the book "Libérez-vous de la douleur par la méditation et l'ACT" (Dionne, 2014) and a participant workbook, along with two phone calls of approximately 15 minutes each and weekly e-mails presenting the week's content. Participants also had access to audio meditation exercises on the book's website (http://liberezvousdeladouleur.com/meditations/).

Arm group label: ACT group

Eligibility

Criteria:

Inclusion Criteria:

- being 18 years of age or older

- having suffered from daily pain for more than three months

- having reading and writing abilities in French equivalent or superior to grade 8

- having access to Internet at home and having a valid e-mail address

- not having previously completed an ACT-type psychotherapy, not having practiced mindfulness meditation regularly and not having read a bibliotherapy on ACT for pain

- having stable medication for at least one month, if applicable.

Exclusion Criteria:

-

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Verification Date

April 2019

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Université du Québec à Trois-Rivières

Investigator full name: Dr. Frédérick Dionne, Ph.D.

Investigator title: Associate Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: ACT group

Arm group type: Experimental

Description: ACT group: participants receiving the 8-week bibliotherapy intervention based on Acceptance and Commitment Therapy

Arm group label: control group

Arm group type: No Intervention

Description: Wait-list control condition: participants placed on a wait-list (and receiving the intervention following the 9 week duration of the intervention)

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov