Dual-Language Brief Mindfulness-Oriented Recovery Enhancement (B-MORE) vs Brief Cognitive-Behavioral Therapy (B-CBT) for Chronic Pain
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Florida State University
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Program Feasibility
Study Overview
Brief Summary
This randomized controlled trial aims to test both English and Spanish versions of two, benign behavioral interventions for adults with chronic pain -- 1) Brief Mindfulness-Oriented Recovery Enhancement (B-MORE), and 2) Brief Cognitive- Behavioral Therapy (B-CBT).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Having a chronic pain condition
- •Average pain of > 3 in the last week
- •Willingness to engage with study assessments and interventions
- •Understanding English or Spanish instructions fluently
- •Age 18 and above.
Exclusion Criteria
- •Unable to consent because of physical or mental incapacity
- •Have previous, formal mindfulness or CBT training (e.g., MBSR)
- •Have pain from a current cancer diagnosis
- •Unstable illness that may interfere with treatment
- •Had surgery within the previous three months
- •Had pain relieving injections, such as cortisone or hyaluronate, within the previous three months.
Arms & Interventions
Brief Behavioral Intervention #1
Brief Mindfulness Oriented Recovery Enhancement (B-MORE)
Intervention: Brief Mindfulness Oriented Recovery Enhancement (Behavioral)
Brief Behavioral Intervention #2
Brief Cognitive-Behavioral Therapy (B-CBT)
Intervention: Brief Cognitive-Behavioral Therapy (Behavioral)
Outcomes
Primary Outcomes
Program Feasibility
Time Frame: At the first treatment session [1 hour] and the final treatment session [1 hour]
Feasibility will be assessed by intervention adherence rates (percentage of treatment sessions completed).
Treatment Acceptability
Time Frame: Upon completion of the final treatment session [1 hour]
Treatment acceptability will be assessed by an adaptation of the Theoretical Framework of Acceptability scale (TFA).
Secondary Outcomes
- Pain Catastrophizing(Baseline and 2, 6, and 12-week post-treatment follow-ups)
- Wellbeing(Baseline and 2, 6, and 12-week post-treatment follow-ups)
- Chronic Pain Symptoms(Baseline and 2, 6, and 12-week post-treatment follow-ups)
- Depressive Symptoms(Baseline and 2, 6, and 12-week post-treatment follow-ups)
- Anxiety Symptoms(Baseline and 2, 6, and 12-week post-treatment follow-ups)
Investigators
Adam Hanley
Assistant Professor
Florida State University