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NCT Number: NCT07207174

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

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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Research Building B

Tallahassee, Florida, 32310, United States

Location status: Recruiting

Location contact

Adam Hanley, PhD

CONTACT

[email protected]

850-270-7844

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Brief Mindfulness Oriented Recovery Enhancement

Behavioral

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

Brief Cognitive-Behavioral Therapy

Behavioral

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

Primary outcomes

  1. 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).

  2. 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

  1. Chronic Pain Symptoms

    Time frame: 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).

  2. Depressive Symptoms

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

    Depressive Symptoms will be measured with the Patient Health Questionnaire (PHQ-2).

  3. Anxiety Symptoms

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

    Anxiety Symptoms will be measured with the Generalized Anxiety Disorder questionnaire (GAD-2).

  4. Wellbeing

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

    Wellbeing will be measured with the World Health Organization Wellbeing Index (WHO-5).

  5. Pain Catastrophizing

    Time frame: 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).

Other outcomes

  1. Credibility/Expectancy

    Time frame: Immediately upon completion of the first treatment session

    Treatment Credibility/Expectancy will be measured with an adaptation of the Credibility and Expectancy Questionnaire (CEQ).

  2. Mindful Reappraisal of Pain Sensations

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

    Mindful Reappraisal of Pain Sensations will be measured with the Mindful Reappraisal of Pain Sensations scale (MRPS-9).

  3. Trait Decentering

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

    Trait Decentering will be measured with the 3-item Metacognitive Processes of Decentering Scale

  4. Trait Self-Transcendence

    Time frame: Baseline, and at 2, 6, and 12-week post-treatment follow-ups

    Trait Self-Transcendence will be measured with the 3-item Nondual Awareness Dimensional Scale

  5. Acute Pain Intensity/Unpleasantness

    Time frame: Immediately before and after treatment sessions #1 (first) and #2 (last)

    Acute Pain Intensity/Unpleasantness will be assessed with a 0-10 Numeric Rating Scale before and after each treatment session.

  6. Acute Anxiety

    Time frame: Immediately before and after treatment sessions #1 (first) and #2 (last)

    Acute Anxiety will be assessed with a 0-10 numeric rating scale before and after each treatment session.

  7. State Decentering

    Time frame: Immediately before and after treatment sessions #1 (first) and #2 (last)

    State Decentering will be measured with the 3-item questionnaire - Metacognitive Processes of Decentering Scale (MPoDS)

  8. State Self-Transcendence

    Time frame: Immediately before and after treatment sessions #1 (first) and #2 (last)

    State Self-Transcendence will be measured with the 3-item Nondual Awareness Dimensional Assessment (NADA).

  9. Optional Neuroimaging Session: EEG

    Time frame: After study completion at the 12-week post-treatment follow-up.

    Spanish-speaking participants will be invited to participate in an optional neuroimaging session. EEG will be collected and analyzed during a baseline period and a mindfulness meditation task.

  10. Optional Neuroimaging Session: fNIRS

    Time frame: After study completion at the 12-week post-treatment follow-up.

    Spanish-speaking participants will be invited to participate in an optional neuroimaging session. Functional Near-Infrared Spectroscopy (fNIRS) will be collected and analyzed during a baseline period and a mindfulness meditation task.

  11. Acute Pain Medication Desire

    Time frame: Treatment session #1 [1 hour] and treatment session #2 [1 hour]

    Acute Pain Medication Desire will be assessed via a 0-10 numeric rating scale.

Study contacts

Contact information is provided by the study sponsor or research team.

Adam Hanley, PhD

CONTACT

[email protected]

850-270-7844

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Registry information

Official study title

Dual-Language Brief Mindfulness-Oriented Recovery Enhancement (B-MORE) vs Brief Cognitive-Behavioral Therapy (B-CBT) for Chronic Pain

Acronym: B-MORE v B-CBT

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 3, 2025
Registry last updated
Nov 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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