Clinical trial NCT03924687: Evaluating the Effectiveness of an ACT-Based Bibliotherapy Intervention Among Adults Living With Chronic Pain
Official title: A Randomized Controlled Trial Evaluating the Effectiveness of an Acceptance and Commitment Therapy-Based Bibliotherapy Intervention Among Adults Living With Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: chronic pain
Acceptance or Commitment Therapy (ACT)
self-help
pain-related disability
psychological inflexibility
depression
pain acceptance
bibliotherapy
Lead sponsor: Université du Québec à Trois-Rivières
Sponsor class: OTHER
First posted: 2019-04-23
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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:

-

Primary outcomes:
measure: Change in Pain-related disability
timeFrame: Change from week 1 to week 9
measure: Change in Pain-related disability
timeFrame: Change from week 9 and week 21 (ACT group only)
Secondary outcomes:
measure: Change in Depressive symptoms
timeFrame: Change from week 1 to week 9
measure: Change in Depressive symptoms
timeFrame: Change from week 9 and week 21 (ACT group only)
measure: Change in Pain acceptance
timeFrame: Change from week 1 to week 9
measure: Change in Pain acceptance
timeFrame: Change from week 9 and week 21 (ACT group only)
measure: Change in Psychological inflexibility
timeFrame: Change from week 1 to week 9
measure: Change in Psychological inflexibility
timeFrame: Change from week 9 and week 21 (ACT group only)
measure: Participants' impression of change
timeFrame: week 21
Other outcomes:
Locations:
Study officials:
References:
citation: Hann, K. E. J., & McCracken, L. M. (2014). A systematic review of randomized controlled trials of Acceptance and Commitment Therapy for adults with chronic pain: Outcome domains, design quality, and efficacy. Journal of Contextual Behavioral Science, 3(4), 217-227. http://dx.doi.org/http://dx.doi.org/10.1016/j.jcbs.2014.10.001
citation: Hughes LS, Clark J, Colclough JA, Dale E, McMillan D. Acceptance and Commitment Therapy (ACT) for Chronic Pain: A Systematic Review and Meta-Analyses. Clin J Pain. 2017 Jun;33(6):552-568. doi: 10.1097/AJP.0000000000000425.
citation: Boulanger, A., Charbonneau, C., Choinière, M., Laliberté, J., & St-Hilaire, F. (2015). Renforcer les services de première ligne, développer les connaissances et les compétences des patients et des professionnels de la santé afin de mieux prévenir et traiter la douleur chronique.
citation: Hogg MN, Gibson S, Helou A, DeGabriele J, Farrell MJ. Waiting in pain: a systematic investigation into the provision of persistent pain services in Australia. Med J Aust. 2012 Apr 2;196(6):386-90. doi: 10.5694/mja12.10140.
citation: Jamison RN, Gintner L, Rogers JF, Fairchild DG. Disease management for chronic pain: barriers of program implementation with primary care physicians. Pain Med. 2002 Jun;3(2):92-101. doi: 10.1046/j.1526-4637.2002.02022.x.
citation: Hayes, S. C., Strosahl, K. D., & Wilson, K., G. (2012). Acceptance and commitment therapy : the process and practice of mindful change (2nd ed.). New York: Guilford Press.
citation: Veillette J, Martel ME, Dionne F. A randomized controlled trial evaluating the effectiveness of an acceptance and commitment therapy-based bibliotherapy intervention among adults living with chronic pain. Can J Pain. 2019 Nov 26;3(1):209-225. doi: 10.1080/24740527.2019.1678113. eCollection 2019.