Pain Disengagement Training (open Pilot)

Not Applicable

Not yet recruiting

• Conditions: Chronic Musculoskeletal Pain

• Registration Number: NCT06870162
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

The investigators aim to conduct an open pilot trial to determine the initial feasibility of a self-directed writing-based intervention in individuals with chronic musculoskeletal pain and elevated pain catastrophizing. The investigators will assess the feasibility of recruitment, acceptability of the treatment, credibility and participant satisfaction, treatment adherence, and feasibility of assessments following pre-specified benchmarks.

Detailed Description

Mind-body interventions are some of the most effective treatments for chronic pain, yet due to lack of resources, many are inaccessible to the patients who need them. The investigators seek to fill this gap by developing and testing Pain Disengagement Training (PDT) for the treatment of chronic pain catastrophizing, a key risk factor for pain interference. The investigators will administer the PDT treatment in a small number (approximately 10) of participants to evaluate initial benchmarks (the feasibility of recruitment, acceptability of the treatment, credibility and participant satisfaction, treatment adherence, and feasibility of assessments) and to assess participants' experience with the intervention using qualitative exit interviews. Results will inform the refinement of the intervention for a future larger trial.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-05
• Study First Submitted QC: 2025-03-05
• Last Update Submitted: 2025-03-13
• Study First Posted: 2025-03-25
• Last Update Posted: 2025-03-25
• Study Start: 2025-06
• Primary Completion: 2025-12
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Outpatient adults (i.e., greater than or equal to 18)
2. Has self reported chronic musculoskeletal pain (i.e., pain persisting for at least 3 months)
3. Pain score greater than or equal to 4 (moderate) on the Numerical Rating Scale
4. Pain catastrophizing score greater than or equal to 20 on Pain Catastrophizing Scale
5. Willingness to engage in a writing-based intervention and self-reported ability to write or type for at least 30 minutes in a sitting
6. Received care at Massachusetts General Hospital
7. English verbal and writing fluency

Exclusion Criteria

1. Clinically significant change in therapy or medication in the past 3 months
2. Severe untreated mental health condition (e.g., psychosis)
3. Active suicidality with history of plan or current intent
4. Serious illness expected to worsen in the next 6 months (e.g., cancer)
5. Untreated substance use problem that, per patient's self-report, would interfere with the ability to complete the intervention.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility of recruitment	Baseline, post-test (6 weeks)	\>70% participants approached agree to participate in the intervention
Feasibility of assessments	Baseline, post-test (6 weeks)	\>70% of participants have no measures fully missing
Acceptability of treatment	Baseline, post-test (6 weeks)	\>70% of participants attend at least 6 out of 8 sessions
Client Satisfaction Questionnaire	Post-test (6 weeks)	Measure of client satisfaction with a program or intervention. 8-item scale measured from 1 to 4 with greater scores indicating greater satisfaction.
Credibility and Expectancy Questionnaire	Baseline	Measures perception that the treatment is credible and will offer improvements. Credibility (4 items) is rated from 1-9 with higher scores indicating more credibility. Expectancy is rated from 0-10 with higher scores indicating greater expectancy of improvement.
Adherence to intervention	Mid-intervention	Percent of writing sections demonstrate correct themes (e.g., anxiety words in imaginal exposure writing)

Secondary Outcome Measures

Name	Time	Method
Numerical Rating Scale	Baseline, post-test (6 weeks)	Rating of pain intensity on a 0-10 1-item scale with greater scores indicating greater pain intensity
Graded Chronic Pain Scale	Baseline, post-test (6 weeks)	Measure of pain severity. 3-item scale rated from 0 to 10 with greater scores indicating greater pain severity.
PROMIS Pain Interference scale	Baseline, post-test (6 weeks)	Assesses pain interference in the past 7 days in activities, work, chores, etc. 8-item scale (1 - not at all to 5 - very much) with greater scores indicating greater pain interference.
Patient Health Questionnaire - 9	Baseline, post-test (6 weeks)	Measure of depressive symptoms. 9-item scale rated from 0 to 3 with greater scores indicating greater depressive symptoms.
Brief Pain Inventory	Baseline, post-test (6 weeks)	Assesses pain intensity (4 items) and interference (7 items) on a 0 to 10 scale with greater scores indicating worse pain intensity and interference.
Penn State Worry Questionnaire - abbreviated	Baseline, post-test (6 weeks)	8-item measure of worry rated from 1 to 5 with greater scores indicating greater worry.
Pain Catastrophizing Scale	Baseline, post-test (6 weeks)	Assesses magnification, helplessness, and rumination in response to pain. 13-item scale rated 0 to 4 with greater scores indicating greater pain catastrophizing.
Pain Anxiety Symptom Scale - Short Form (PASS-20)	Baseline, post-test (6 weeks)	Assesses fear and anxiety in response to pain. 20-item scale rated 0 to 5 with greater scores indicating greater pain anxiety.
Worry Disengagement Questionnaire	Baseline, post-test (6 weeks)	Measures ability to shift attention from worry. 4-item scale rated from 0 to 10 with greater scores indicating greater ability to shift attention away from worry.
Behavioral Activation for Depression Scale - Short Form	Baseline, post-test (6 weeks)	Assesses engagement in meaningful activities. 9-item measure rated from 0 to 6 with greater scores indicating greater activity engagement.
PROMIS depression scale-8	Baseline, post-test (6 weeks)	Measure of depressive symptoms. 8-item scale rated from 1 to 5 with greater scores indicating greater depressive symptoms.
Positive and Negative Affect Schedule - Short Form	Mid-intervention	Assesses level of emotional intensity. Investigators are using a 5-item subset of items rated on a scale from 1 to 5 with greater scores indicating more positive emotionality.
Contrast Avoidance Questionnaire-General Emotion	Baseline, post-test (6 weeks)	Measures ability to sustain negative emotionality to protect against sudden shifts in emotion. 25-item scale rated from 1 to 5 with greater scores indicating greater avoidance of contrasting emotional states.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States