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

Not Applicable

Completed

• Conditions: Chronic Pain
• Interventions: Behavioral: Acceptance and Commitment Therapy (ACT) bibliotherapy for chronic pain

• Registration Number: NCT03924687
• Lead Sponsor: 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.

Study Timeline

• Study Start: 2016-03-28
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2019-04
• Study First Submitted: 2019-04-08
• Study First Submitted QC: 2019-04-19
• Last Update Submitted: 2019-04-19
• Study First Posted: 2019-04-23
• Last Update Posted: 2019-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ACT group	Acceptance and Commitment Therapy (ACT) bibliotherapy for chronic pain	ACT group: participants receiving the 8-week bibliotherapy intervention based on Acceptance and Commitment Therapy

Primary Outcome Measures

Name	Time	Method
Change in Pain-related disability	Change from week 9 and week 21 (ACT group only)	Brief Pain Inventory (BPI; Interference subscale; Cleeland \& Ryan 1994; Poundja, Fikretoglu, Guay, \& Brunet 2007; Tyler, Jensen, Engel, \& Schwartz 2002)

Secondary Outcome Measures

Name	Time	Method
Change in Pain acceptance	Change from week 9 and week 21 (ACT group only)	Chronic Pain Acceptance Questionnaire (CPAQ-8: Fish, McGuire, Hogan, Morrison, \& Stewart 2010). The CPAQ-8 is an 8-item measure that evaluates acceptance of pain according to two sub-scales: activity engagement and pain willingness. Items are rated on a Likert scale from 0 = never true to 6 = always true. Total scores range from 0 to 48 and higher scores reflect greater acceptance of pain.
Change in Psychological inflexibility	Change from week 9 and week 21 (ACT group only)	Psychological Inflexibility in Pain Scale (PIPS; Wicksell, Lekander, et al. 2010). The PIPS is composed of 12 items that evaluate two dimensions: avoidance and cognitive fusion. Items are rated on a Likert scale from 1 = never true to 7 = always true, to evaluate the level of inflexibility associated to pain. Scores range from 12 to 84, with higher scores revealing greater psychological inflexibility.
Change in Depressive symptoms	Change from week 9 and week 21 (ACT group only)	The Beck Depression Inventory (BDI - Short Form: Beck, Rial, \& Rickels 1974)
Participants' impression of change	week 21	Patient Global Impression of Change (PGIC: Guy et al. 1976)