Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brief Behavioral Intervention #1 | Experimental | Brief Mindfulness Oriented Recovery Enhancement (B-MORE) |
|
| Brief Behavioral Intervention #2 | Experimental | Brief Cognitive-Behavioral Therapy (B-CBT) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief Mindfulness Oriented Recovery Enhancement | Behavioral | B-MORE is a 2-hour adaptation of the traditional MORE program. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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] |
| Measure | Description | Time Frame |
|---|---|---|
| Chronic Pain Symptoms | Chronic Pain Symptoms will be measured via the Pain, Enjoyment, and General Activity scale (PEG-3). | Baseline and 2, 6, and 12-week post-treatment follow-ups |
| Depressive Symptoms |
| Measure | Description | Time Frame |
|---|---|---|
| Credibility/Expectancy | Treatment Credibility/Expectancy will be measured with an adaptation of the Credibility and Expectancy Questionnaire (CEQ). | Immediately upon completion of the first treatment session |
| Mindful Reappraisal of Pain Sensations |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adam Hanley, PhD | Contact | 850-270-7844 | adam.hanley@fsu.edu |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Building B | Recruiting | Tallahassee | Florida | 32310 | United States |
The study protocol, SAP, ICF, and de-identified IPD will be shared with qualified individuals upon request.
It will be available from study end up to 5 years afterwards.
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.
Not provided
Not provided
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Brief Cognitive-Behavioral Therapy | Behavioral | B-CBT is a 2-hour adaptation of a traditional 8-week CBT for Chronic Pain manual. |
|
Depressive Symptoms will be measured with the Patient Health Questionnaire (PHQ-2).
| Baseline and 2, 6, and 12-week post-treatment follow-ups |
| Anxiety Symptoms | Anxiety Symptoms will be measured with the Generalized Anxiety Disorder questionnaire (GAD-2). | Baseline and 2, 6, and 12-week post-treatment follow-ups |
| Wellbeing | Wellbeing will be measured with the World Health Organization Wellbeing Index (WHO-5). | Baseline and 2, 6, and 12-week post-treatment follow-ups |
| Pain Catastrophizing | Pain Catastrophizing will be measured with a validated 4-item adaptation of the Pain Catastrophizing scale (PCS-4). | 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).
| Baseline and 2, 6, and 12-week post-treatment follow-ups |
| Trait Decentering | Trait Decentering will be measured with the 3-item Metacognitive Processes of Decentering Scale | Baseline and 2, 6, and 12-week post-treatment follow-ups |
| Trait Self-Transcendence | Trait Self-Transcendence will be measured with the 3-item Nondual Awareness Dimensional Scale | Baseline, and at 2, 6, and 12-week post-treatment follow-ups |
| Acute Pain Intensity/Unpleasantness | Acute Pain Intensity/Unpleasantness will be assessed with a 0-10 Numeric Rating Scale before and after each treatment session. | Immediately before and after treatment sessions #1 (first) and #2 (last) |
| Acute Anxiety | Acute Anxiety will be assessed with a 0-10 numeric rating scale before and after each treatment session. | Immediately before and after treatment sessions #1 (first) and #2 (last) |
| State Decentering | State Decentering will be measured with the 3-item questionnaire - Metacognitive Processes of Decentering Scale (MPoDS) | Immediately before and after treatment sessions #1 (first) and #2 (last) |
| State Self-Transcendence | State Self-Transcendence will be measured with the 3-item Nondual Awareness Dimensional Assessment (NADA). | Immediately before and after treatment sessions #1 (first) and #2 (last) |
| Optional Neuroimaging Session: EEG | 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. | After study completion at the 12-week post-treatment follow-up. |
| Optional Neuroimaging Session: fNIRS | 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. | After study completion at the 12-week post-treatment follow-up. |
| Acute Pain Medication Desire | Acute Pain Medication Desire will be assessed via a 0-10 numeric rating scale. | Treatment session #1 [1 hour] and treatment session #2 [1 hour] |