NCT03924687

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P75+ for not_applicable chronic-pain

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable chronic-pain

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 28, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

April 8, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 23, 2019

Completed
Last Updated

April 23, 2019

Status Verified

April 1, 2019

Enrollment Period

4 months

First QC Date

April 8, 2019

Last Update Submit

April 19, 2019

Conditions

Keywords

chronic painAcceptance or Commitment Therapy (ACT)self-helppain-related disabilitypsychological inflexibilitydepressionpain acceptancebibliotherapy

Outcome Measures

Primary Outcomes (2)

  • Change in Pain-related disability

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

    Change from week 1 to week 9

  • Change in Pain-related disability

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

    Change from week 9 and week 21 (ACT group only)

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (2)

ACT group

EXPERIMENTAL

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

control group

NO INTERVENTION

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

Interventions

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/).

ACT group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • 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

    BACKGROUND
  • 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.

    PMID: 27479642BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 22471539BACKGROUND
  • 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.

    PMID: 15102155BACKGROUND
  • 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.

    BACKGROUND
  • 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.

MeSH Terms

Conditions

Chronic PainDepression

Interventions

Bibliotherapy

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 8, 2019

First Posted

April 23, 2019

Study Start

March 28, 2016

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

April 23, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share