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

Study Overview
=================
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.

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

Conditions
-----------------
Chronic Pain

Intervention / Treatment
-----------------
* Behavioral: Acceptance and Commitment Therapy (ACT) bibliotherapy for chronic pain


Participation Criteria
=================
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: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACT group<br>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<br>* 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/).<br>|
| No Intervention: control group<br>Wait-list control condition: participants placed on a wait-list (and receiving the intervention following the 9 week duration of the intervention) | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Depressive symptoms | The Beck Depression Inventory (BDI - Short Form: Beck, Rial, & Rickels 1974) | Change from week 1 to week 9 | 
| Change in Depressive symptoms | The Beck Depression Inventory (BDI - Short Form: Beck, Rial, & Rickels 1974) | Change from week 9 and week 21 (ACT group only) | 
| 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 from week 1 to week 9 | 
| 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 from week 9 and week 21 (ACT group only) | 
| 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 from week 1 to week 9 | 
| 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 from week 9 and week 21 (ACT group only) | 
| Participants' impression of change | Patient Global Impression of Change (PGIC: Guy et al. 1976) | week 21 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
depression, chronic pain, Acceptance or Commitment Therapy (ACT), self-help, pain-related disability, psychological inflexibility, pain acceptance, bibliotherapy