Chronic Pain
Conditions
Keywords
Chronic pain, Spanish-language intervention, Mindfulness, Cognitive-behavioral Therapy, Brief intervention
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).
Interventions
B-MORE is a 2-hour adaptation of the traditional MORE program.
BEHAVIORALBrief Cognitive-Behavioral Therapy
B-CBT is a 2-hour adaptation of a traditional 8-week CBT for Chronic Pain manual.
Sponsors
Florida State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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). |
| 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). |
| 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). |
| 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| State Self-Transcendence | 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). |
| Optional Neuroimaging Session: EEG | 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. |
| Credibility/Expectancy | Immediately upon completion of the first treatment session | Treatment Credibility/Expectancy will be measured with an adaptation of the Credibility and Expectancy Questionnaire (CEQ). |
| Acute Pain Medication Desire | 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. |
| Optional Neuroimaging Session: fNIRS | 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. |
| Mindful Reappraisal of Pain Sensations | 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). |
| Trait Decentering | 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 |
| Trait Self-Transcendence | 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 |
| Acute Pain Intensity/Unpleasantness | 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. |
| Acute Anxiety | 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. |
| State Decentering | 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) |
Countries
United States
Contacts
Primary ContactAdam Hanley, PhD
Outcome results
None listed