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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/23/2021.

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

Clinicaltrials.gov identifier NCT03924687

Recruitment Status Completed

First Posted April 23, 2019

Last update posted April 23, 2019

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:Chronic Pain
  • Intervention/Treatment: Behavioral: Acceptance and Commitment Therapy (ACT) bibliotherapy for chronic pain
  • Phase: 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: 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 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: March 2016
  • Actual Primary Completion Date: August 2016
  • Actual Study Completion Date: August 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/).
Outcome Measures
  • Primary Outcome Measures: 1. Change in Pain-related disability [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Change from week 1 to week 9 ]
    The Beck Depression Inventory (BDI — Short Form: Beck, Rial, & Rickels 1974)
  • 2. Change in Depressive symptoms [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: week 21 ]
    Patient Global Impression of Change (PGIC: Guy et al. 1976)
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
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:

-

Contacts and Locations
Contacts
Locations
Sponsors and Collaborators

Université du Québec à Trois-Rivières

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