An interventional study of Pain Disengagement Training in Chronic Musculoskeletal Pain, sponsored by Massachusetts General Hospital. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment
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.
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.
Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
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Exclusion Criteria:
The intervention involves approximately 8 sessions. The first session will involve a psychoeducation component describing the association between negative emotions and pain and the rationale for the intervention strategies. The intervention sessions will consist of approximately 30 minutes of writing alternating between imaginal exposure writing and positive writing periods alternating back and forth (e.g., 3-5 minutes of imaginal exposure writing followed by 3-5 minutes of positive writing before returning to imaginal exposure writing, etc.). Exposure writing will involve writing about a pain-related catastrophic worry repeatedly until it becomes less anxiety-provoking. The positive writing topics will change with each prompt and will be structured by session theme (e.g., values/goals, meaningful activities). They will also complete between session practice by setting aside a time for worrying and then completing a meaningful activity.
Behavioral: Pain Disengagement Training
The intervention involves approximately 8 sessions. The first session will involve a psychoeducation component describing the association between negative emotions and pain and the rationale for the intervention strategies. The intervention sessions will consist of approximately 30 minutes of writing alternating between imaginal exposure writing and positive writing periods alternating back and forth (e.g., 3-5 minutes of imaginal exposure writing followed by 3-5 minutes of positive writing before returning to imaginal exposure writing, etc.). Exposure writing will involve writing about a pain-related catastrophic worry repeatedly until it becomes less anxiety-provoking. The positive writing topics will change with each prompt and will be structured by session theme (e.g., values/goals, meaningful activities). They will also complete between session practice by setting aside a time for worrying and then completing a meaningful activity.
Feasibility of recruitment
\>70% participants approached agree to participate in the intervention
Time frame: Baseline, post-test (6 weeks)
Acceptability of treatment
\>70% of participants attend at least 6 out of 8 sessions
Time frame: Baseline, post-test (6 weeks)
Credibility and Expectancy Questionnaire
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.
Time frame: Baseline
Client Satisfaction Questionnaire
Measure of client satisfaction with a program or intervention. 8-item scale measured from 1 to 4 with greater scores indicating greater satisfaction.
Time frame: Post-test (6 weeks)
Adherence to intervention
Percent of writing sections demonstrate correct themes (e.g., anxiety words in imaginal exposure writing)
Time frame: Mid-intervention
Feasibility of assessments
\>70% of participants have no measures fully missing
Time frame: Baseline, post-test (6 weeks)
Numerical Rating Scale
Rating of pain intensity on a 0-10 1-item scale with greater scores indicating greater pain intensity
Time frame: Baseline, post-test (6 weeks)
Graded Chronic Pain Scale
Measure of pain severity. 3-item scale rated from 0 to 10 with greater scores indicating greater pain severity and interference
Time frame: Baseline, post-test (6 weeks)
PROMIS Pain Interference scale
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.
Time frame: Baseline, post-test (6 weeks)
Brief Pain Inventory
Assesses pain intensity (4 items) on a 0 to 10 scale with greater scores indicating worse pain intensity and interference.
Time frame: Baseline, post-test (6 weeks)
Patient Health Questionnaire - 9
Measure of depressive symptoms. 9-item scale rated from 0 to 3 with greater scores indicating greater depressive symptoms.
Time frame: Baseline, post-test (6 weeks)
PROMIS depression scale-8
Measure of depressive symptoms. 8-item scale rated from 1 to 5 with greater scores indicating greater depressive symptoms.
Time frame: Baseline, post-test (6 weeks)
Penn State Worry Questionnaire - abbreviated
8-item measure of worry rated from 1 to 5 with greater scores indicating greater worry.
Time frame: Baseline, post-test (6 weeks)
Pain Catastrophizing Scale
Assesses magnification, helplessness, and rumination in response to pain. 13-item scale rated 0 to 4 with greater scores indicating greater pain catastrophizing.
Time frame: Baseline, post-test (6 weeks)
Pain Anxiety Symptom Scale - Short Form (PASS-20)
Assesses fear and anxiety in response to pain. 20-item scale rated 0 to 5 with greater scores indicating greater pain anxiety.
Time frame: Baseline, post-test (6 weeks)
Worry Disengagement Questionnaire
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.
Time frame: Baseline, post-test (6 weeks)
Behavioral Activation for Depression Scale - Short Form
Assesses engagement in meaningful activities. 9-item measure rated from 0 to 6 with greater scores indicating greater activity engagement.
Time frame: Baseline, post-test (6 weeks)
Positive emotion rating scale
Assesses level of emotional intensity on a 4-item scale from 1 to 5 with greater scores indicating more positive emotionality.
Time frame: Mid-intervention
Contrast Avoidance Questionnaire-General Emotion and Worry subscales
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.
Time frame: Baseline, post-test (6 weeks)
PROMIS meaning and purpose scale short form 4a
4 item scale assessing meaning and fulfillment in life (1 to 5 rating scale)
Time frame: Baseline, post-test (6-weeks)
Self-Compassion Scale
12 item 1 to 5 scale measuring self-compassion
Time frame: Baseline, Post-test (6 weeks)
Plan to share: Yes — De-identified data will include feasibility assessments, intervention measures (i.e., peak emotion during writing periods) and pre and post intervention self-report questionnaires in the open pilot.
Supporting information: Sap, Analytic code
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