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NCT Number: NCT03924687

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

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.

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Key information

Conditions

Chronic Pain Behavior Behavioral Symptoms Depression Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Acceptance and Commitment Therapy (ACT) bibliotherapy for chronic pain

Behavioral

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 outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Université du Québec à Trois-Rivières

Other

Registry information

Official study title

A Randomized Controlled Trial Evaluating the Effectiveness of an Acceptance and Commitment Therapy-Based Bibliotherapy Intervention Among Adults Living With Chronic Pain

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 23, 2019
Registry last updated
Apr 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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