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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
Université du Québec à Trois-Rivières
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    April 8, 2019
    Last Updated
    April 19, 2019
    Sponsor
    Université du Québec à Trois-Rivières
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    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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