Clinical trial NCT06870162: Pain Disengagement Training (Open Pilot)
Official title: Pain Disengagement Training: A Self-directed Intervention for Pain Catastrophizing (Open Pilot)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Musculoskeletal Pain
Keywords: pain catastrophizing
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2025-03-11
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility of recruitment
timeFrame: Baseline, post-test (6 weeks)
measure: Acceptability of treatment
timeFrame: Baseline, post-test (6 weeks)
measure: Credibility and Expectancy Questionnaire
timeFrame: Baseline
measure: Client Satisfaction Questionnaire
timeFrame: Post-test (6 weeks)
measure: Adherence to intervention
timeFrame: Mid-intervention
measure: Feasibility of assessments
timeFrame: Baseline, post-test (6 weeks)
Secondary outcomes:
measure: Numerical Rating Scale
timeFrame: Baseline, post-test (6 weeks)
measure: Graded Chronic Pain Scale
timeFrame: Baseline, post-test (6 weeks)
measure: PROMIS Pain Interference scale
timeFrame: Baseline, post-test (6 weeks)
measure: Brief Pain Inventory
timeFrame: Baseline, post-test (6 weeks)
measure: Patient Health Questionnaire - 9
timeFrame: Baseline, post-test (6 weeks)
measure: PROMIS depression scale-8
timeFrame: Baseline, post-test (6 weeks)
measure: Penn State Worry Questionnaire - abbreviated
timeFrame: Baseline, post-test (6 weeks)
measure: Pain Catastrophizing Scale
timeFrame: Baseline, post-test (6 weeks)
measure: Pain Anxiety Symptom Scale - Short Form (PASS-20)
timeFrame: Baseline, post-test (6 weeks)
measure: Worry Disengagement Questionnaire
timeFrame: Baseline, post-test (6 weeks)
measure: Behavioral Activation for Depression Scale - Short Form
timeFrame: Baseline, post-test (6 weeks)
measure: Positive and Negative Affect Schedule - Short Form
timeFrame: Mid-intervention
measure: Contrast Avoidance Questionnaire-General Emotion
timeFrame: Baseline, post-test (6 weeks)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Katherine McDermott, PhD
role: PRINCIPAL_INVESTIGATOR
References: