Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-25 @ 9:47 PM
Study NCT ID:
NCT03711851
Status:
COMPLETED
Last Update Posted:
2019-07-11
First Post:
2018-10-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Managing Chronic Pain Through Self-Help
Sponsor:
Université du Québec à Trois-Rivières
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: