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

Sponsor
Université du Québec à Trois-Rivières (Other)
Overall Status
Completed
CT.gov ID
NCT03924687
Collaborator
(none)
140
2
4.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Acceptance and Commitment Therapy (ACT) bibliotherapy for chronic pain
N/A

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

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

Study Design

Study Type:
Interventional
Actual Enrollment :
140 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Controlled Trial Evaluating the Effectiveness of an Acceptance and Commitment Therapy-Based Bibliotherapy Intervention Among Adults Living With Chronic Pain
Actual Study Start Date :
Mar 28, 2016
Actual Primary Completion Date :
Aug 1, 2016
Actual Study Completion Date :
Aug 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: ACT group

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

Behavioral: Acceptance and Commitment Therapy (ACT) bibliotherapy for chronic pain
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/).

No Intervention: control group

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

Outcome Measures

Primary Outcome Measures

  1. Change in Pain-related disability [Change from week 1 to week 9]

    Brief Pain Inventory (BPI; Interference subscale; Cleeland & Ryan 1994; Poundja, Fikretoglu, Guay, & Brunet 2007; Tyler, Jensen, Engel, & Schwartz 2002)

  2. 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

  1. Change in Depressive symptoms [Change from week 1 to week 9]

    The Beck Depression Inventory (BDI - Short Form: Beck, Rial, & Rickels 1974)

  2. 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)

  3. Change in Pain acceptance [Change from week 1 to week 9]

    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.

  4. 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.

  5. Change in Psychological inflexibility [Change from week 1 to week 9]

    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.

  6. 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.

  7. Participants' impression of change [week 21]

    Patient Global Impression of Change (PGIC: Guy et al. 1976)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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:

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Université du Québec à Trois-Rivières

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Dr. Frédérick Dionne, Ph.D., Associate Professor, Université du Québec à Trois-Rivières
ClinicalTrials.gov Identifier:
NCT03924687
Other Study ID Numbers:
  • CER-15-215-07.23
First Posted:
Apr 23, 2019
Last Update Posted:
Apr 23, 2019
Last Verified:
Apr 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dr. Frédérick Dionne, Ph.D., Associate Professor, Université du Québec à Trois-Rivières
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 23, 2019