Clinical trial NCT03711851: Managing Chronic Pain Through Self-Help
Official title: Managing Chronic Pain Through Self-Help: A Randomized Controlled Trial Comparing Guided Self-Help Programs Based on Acceptance and Commitment Therapy (ACT) to Education
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: Chronic pain
Self-help
Bibliotherapy
Web-based interventions
Acceptance and commitment therapy
Psychological flexibility
Lead sponsor: Université du Québec à Trois-Rivières
Sponsor class: OTHER
Collaborators: name: Quebec Pain Research Network
name: Fonds de la Recherche en Santé du Québec
First posted: 2018-10-19
Enrollment: 297
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic pain has a significant impact on the physical and emotional functioning of those living with this condition. It is now recognized that Acceptance and Commitment Therapy (ACT) is an effective treatment in managing chronic pain; however, several barriers limit its accessibility. Therefore, self-help versions of ACT are promising because they offer a cost-effective treatment option that usually require little support from a therapist, and can be widely accessed.

The current study aims to evaluate the effectiveness of predominantly self-help ACT interventions (web-based and bibliotherapy programs) in comparison to an education intervention among adults living with chronic pain.

The current study was a randomized controlled trial (RCT) with two experimental groups and an active control group. The first experimental group received access to an internet platform with videos, interactive content and exercises based on ACT. The second experimental group received a copy of a self-help book based on ACT for chronic pain and had access to this book's website which includes audio mindfulness exercises. The third group consisted of an active control group, in which participants received pamphlet style pdf documents of education for pain (without any ACT components) as well as related practical exercises.

Detailed description: This study aimed to evaluate the effectiveness of a web-based ACT intervention program with minimal therapeutic contact, compared to an ACT-based bibliotherapy and a pain education program (active control group) among adults with chronic pain. Participants were randomly assigned to each group. We hypothesized that:

1. both ACT interventions would lead to significant reductions in pain-related disability (primary variable), greater than the control group (education), and that the web-based program would lead to greater reductions in disability than the bibliotherapy group;
2. both ACT interventions would lead to significant improvements in quality of life (secondary variable), greater than the control group (education), and that the web-based program would lead to greater improvements in quality of life than the bibliotherapy group;
3. both ACT interventions would lead to significant reductions in anxiety and depressive symptoms (secondary variables), greater than the control group (education), and that the web-based program would lead to greater reductions in anxiety and depressive symptoms than the bibliotherapy group;
4. Improvements on primary (pain-related disability) and secondary variables (quality of life, anxiety/depressive symptoms) for the ACT groups will be maintained at 3 and 6 months and will remain superior to the control group (education);
5. Participants from both ACT groups would have a positive impressions of change following the intervention (as measured by the PGIC scale).

   * Some of the questionnaires described in the following section were administered and will be subject to subsequent analyses examining patient trajectories of change and profiles of patients who respond well or not to these treatment modalities.

Eligibility criteria: Inclusion criteria:

1. Being 18 years or older;
2. Residing in Canada;
3. Having daily pain for at least 6 months;
4. Having a reading and writing ability equivalent or superior to grade 8;
5. Having access to internet at home and a valid e-mail address;
6. Not having previously engaged in an ACT-based psychotherapy and/or regularly meditated and/or read "Libérez-vous de la douleur" by Frédérick Dionne;
7. Not being in an unstable psychological situation (severe suicidal thoughts or severe/persistent mental health disorder);
8. Having an average level of pain of at least 4/10 within the past week;
9. Having non-cancer related pain;
10. Having stable medication for at least one month.

Participants were excluded if they did not meet any of the above criteria.

Primary outcomes:
measure: Change in Pain interference
timeFrame: Change from week start of treatment (week 0) to end of treatment (week 9), 3-month follow-up (week 22) and 6-month follow-up (week 35)
Secondary outcomes:
measure: Change in Anxiety and Depression symptoms
timeFrame: Change from week start of treatment (week 0) to end of treatment (week 9), 3-month follow-up (week 22) and 6-month follow-up (week 35)
measure: Change in Quality of life measure
timeFrame: Change from week start of treatment (week 0) to end of treatment (week 9), 3-month follow-up (week 22) and 6-month follow-up (week 35)
Other outcomes:
measure: Psychological In/Flexibility
timeFrame: Change from week start of treatment (week 0) to end of treatment (week 9), 3-month follow-up (week 22) and 6-month follow-up (week 35)
measure: Chronic Pain Acceptance
timeFrame: Change from week start of treatment (week 0) to end of treatment (week 9), 3-month follow-up (week 22) and 6-month follow-up (week 35)
measure: Chronic Pain Self-Efficacy
timeFrame: Change from week start of treatment (week 0) to end of treatment (week 9), 3-month follow-up (week 22) and 6-month follow-up (week 35)
measure: Patient's Impression of Change
timeFrame: 3-month follow-up (week 22) and 6-month follow-up (week 35)
measure: Diary items
timeFrame: Weekly changes from baseline (week 0), throughout treatment (Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9), and after treatment (week 10)
Locations:
city: Trois-Rivières
country: Canada
facility: Université du Québec à Trois-Rivières
state: Quebec
Study officials:
affiliation: Université du Québec à Trois-Rivières
name: Frederick Dionne, Ph.D.
role: STUDY_DIRECTOR
affiliation: Université du Québec à Trois-Rivières
name: Marie-Eve Martel, Psy.D.
role: PRINCIPAL_INVESTIGATOR
References: