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

NCT07207174 | Recruiting

• 1 other identifier: 00006512
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Pain

Keywords

Chronic pain; Spanish-language intervention; Mindfulness; Cognitive-behavioral Therapy; Brief intervention

Outcome Measures

Primary Outcomes (2)

• Program Feasibility

  Feasibility will be assessed by intervention adherence rates (percentage of treatment sessions completed).

  At the first treatment session [1 hour] and the final treatment session [1 hour]

• Treatment Acceptability

  Treatment acceptability will be assessed by an adaptation of the Theoretical Framework of Acceptability scale (TFA).

  Upon completion of the final treatment session [1 hour]

Secondary Outcomes (5)

• 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

• Wellbeing

  Baseline and 2, 6, and 12-week post-treatment follow-ups

• Pain Catastrophizing

  Baseline and 2, 6, and 12-week post-treatment follow-ups

Other Outcomes (11)

• Credibility/Expectancy

  Immediately upon completion of the first treatment session

• Mindful Reappraisal of Pain Sensations

  Baseline and 2, 6, and 12-week post-treatment follow-ups

• Trait Decentering

  Baseline and 2, 6, and 12-week post-treatment follow-ups

Study Arms (2)

Brief Behavioral Intervention #1

EXPERIMENTAL

Brief Mindfulness Oriented Recovery Enhancement (B-MORE)

Behavioral: Brief Mindfulness Oriented Recovery Enhancement

Brief Behavioral Intervention #2

EXPERIMENTAL

Brief Cognitive-Behavioral Therapy (B-CBT)

Behavioral: Brief Cognitive-Behavioral Therapy

Interventions

Brief Mindfulness Oriented Recovery Enhancement BEHAVIORAL

B-MORE is a 2-hour adaptation of the traditional MORE program.

Brief Behavioral Intervention #1

Brief Cognitive-Behavioral Therapy BEHAVIORAL

B-CBT is a 2-hour adaptation of a traditional 8-week CBT for Chronic Pain manual.

Brief Behavioral Intervention #2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Florida State University: lead

Study Sites (1)

Research Building B

Tallahassee, Florida, 32310, United States

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Adam Hanley, PhD

CONTACT

850-270-7844; adam.hanley@fsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: October 3, 2025
• Study Start: September 26, 2025
• Primary Completion (Estimated): September 22, 2027
• Study Completion (Estimated): September 22, 2027
• Last Updated: November 3, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: It will be available from study end up to 5 years afterwards.
• Access Criteria: Any qualified individual may request the above-mentioned IPD and supporting information from the research team. Research team will provide the above via secure individual correspondence.

Locations

US (1)