Evaluating the Effectiveness of an ACT-Based Bibliotherapy Intervention Among Adults Living With Chronic Pain
Primary Purpose
Chronic Pain
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Acceptance and Commitment Therapy (ACT) bibliotherapy for chronic pain
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring chronic pain, Acceptance or Commitment Therapy (ACT), self-help, pain-related disability, psychological inflexibility, depression, pain acceptance, bibliotherapy
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:
-
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
ACT group
control group
Arm Description
ACT group: participants receiving the 8-week bibliotherapy intervention based on Acceptance and Commitment Therapy
Wait-list control condition: participants placed on a wait-list (and receiving the intervention following the 9 week duration of the intervention)
Outcomes
Primary Outcome Measures
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 in Pain-related disability
Brief Pain Inventory (BPI; Interference subscale; Cleeland & Ryan 1994; Poundja, Fikretoglu, Guay, & Brunet 2007; Tyler, Jensen, Engel, & Schwartz 2002)
Secondary Outcome Measures
Change in Depressive symptoms
The Beck Depression Inventory (BDI - Short Form: Beck, Rial, & Rickels 1974)
Change in Depressive symptoms
The Beck Depression Inventory (BDI - Short Form: Beck, Rial, & Rickels 1974)
Change in Pain acceptance
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 Pain acceptance
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
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 Psychological inflexibility
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.
Participants' impression of change
Patient Global Impression of Change (PGIC: Guy et al. 1976)
Full Information
NCT ID
NCT03924687
First Posted
April 8, 2019
Last Updated
April 19, 2019
Sponsor
Université du Québec à Trois-Rivières
1. Study Identification
Unique Protocol Identification Number
NCT03924687
Brief Title
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
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
March 28, 2016 (Actual)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université du Québec à Trois-Rivières
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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:
significantly reduce pain-related disability (primary variable);
improve depressive symptoms related to CP (secondary variable);
increase the level of pain acceptance;
reduce psychological inflexibility linked to painful symptoms (process variables).
It was also expected that:
the improvements would be maintained at three-month follow-up;
participants would have an overall impression of a positive change following the intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
chronic pain, Acceptance or Commitment Therapy (ACT), self-help, pain-related disability, psychological inflexibility, depression, pain acceptance, bibliotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ACT group
Arm Type
Experimental
Arm Description
ACT group: participants receiving the 8-week bibliotherapy intervention based on Acceptance and Commitment Therapy
Arm Title
control group
Arm Type
No Intervention
Arm Description
Wait-list control condition: participants placed on a wait-list (and receiving the intervention following the 9 week duration of the intervention)
Intervention Type
Behavioral
Intervention Name(s)
Acceptance and Commitment Therapy (ACT) bibliotherapy for chronic pain
Intervention 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/).
Primary Outcome Measure Information:
Title
Change in Pain-related disability
Description
Brief Pain Inventory (BPI; Interference subscale; Cleeland & Ryan 1994; Poundja, Fikretoglu, Guay, & Brunet 2007; Tyler, Jensen, Engel, & Schwartz 2002)
Time Frame
Change from week 1 to week 9
Title
Change in Pain-related disability
Description
Brief Pain Inventory (BPI; Interference subscale; Cleeland & Ryan 1994; Poundja, Fikretoglu, Guay, & Brunet 2007; Tyler, Jensen, Engel, & Schwartz 2002)
Time Frame
Change from week 9 and week 21 (ACT group only)
Secondary Outcome Measure Information:
Title
Change in Depressive symptoms
Description
The Beck Depression Inventory (BDI - Short Form: Beck, Rial, & Rickels 1974)
Time Frame
Change from week 1 to week 9
Title
Change in Depressive symptoms
Description
The Beck Depression Inventory (BDI - Short Form: Beck, Rial, & Rickels 1974)
Time Frame
Change from week 9 and week 21 (ACT group only)
Title
Change in Pain acceptance
Description
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.
Time Frame
Change from week 1 to week 9
Title
Change in Pain acceptance
Description
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.
Time Frame
Change from week 9 and week 21 (ACT group only)
Title
Change in Psychological inflexibility
Description
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.
Time Frame
Change from week 1 to week 9
Title
Change in Psychological inflexibility
Description
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.
Time Frame
Change from week 9 and week 21 (ACT group only)
Title
Participants' impression of change
Description
Patient Global Impression of Change (PGIC: Guy et al. 1976)
Time Frame
week 21
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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:
-
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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
Results Reference
background
PubMed Identifier
27479642
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.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
22471539
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.
Results Reference
background
PubMed Identifier
15102155
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.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
35005411
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.
Results Reference
derived
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Evaluating the Effectiveness of an ACT-Based Bibliotherapy Intervention Among Adults Living With Chronic Pain
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