Brief Mindfulness-Oriented Recovery Enhancement vs Brief Cognitive-Behavioral Therapy for Chronic Pain

Not Applicable

Not yet recruiting

• Conditions: Chronic Pain

• Registration Number: NCT07207174
• Lead Sponsor: Florida State University

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-09-17
• Study Start: 2025-09-22
• Status Verified: 2025-10
• Study First Submitted QC: 2025-10-02
• Last Update Submitted: 2025-10-02
• Study First Posted: 2025-10-03
• Last Update Posted: 2025-10-03
• Primary Completion: 2027-09-22
• Study Completion: 2027-09-22

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Program Feasibility	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	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 Outcome Measures

Name	Time	Method
Chronic Pain Symptoms	Baseline and 2, 6, and 12-week post-treatment follow-ups	Chronic Pain Symptoms will be measured via the Pain, Enjoyment, and General Activity scale (PEG-3).
Depressive Symptoms	Baseline and 2, 6, and 12-week post-treatment follow-ups	Depressive Symptoms will be measured with the Patient Health Questionnaire (PHQ-2).
Anxiety Symptoms	Baseline and 2, 6, and 12-week post-treatment follow-ups	Anxiety Symptoms will be measured with the Generalized Anxiety Disorder questionnaire (GAD-2).
Wellbeing	Baseline and 2, 6, and 12-week post-treatment follow-ups	Wellbeing will be measured with the World Health Organization Wellbeing Index (WHO-5).
Pain Catastrophizing	Baseline and 2, 6, and 12-week post-treatment follow-ups	Pain Catastrophizing will be measured with a validated 4-item adaptation of the Pain Catastrophizing scale (PCS-4).

Trial Locations

Locations (1)

Research Building B; 🇺🇸 Tallahassee, Florida, United States