Pain Disengagement Training (Open Pilot)

NCT06870162 | Recruiting DMC

• 2 other identifiers: 2025p0003481K23AT012789-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Musculoskeletal Pain

Keywords

pain catastrophizing

Outcome Measures

Primary Outcomes (6)

• Feasibility of recruitment

  \>70% participants approached agree to participate in the intervention

  Baseline, post-test (6 weeks)

• Acceptability of treatment

  \>70% of participants attend at least 6 out of 8 sessions

  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.

  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.

  Post-test (6 weeks)

• Adherence to intervention

  Percent of writing sections demonstrate correct themes (e.g., anxiety words in imaginal exposure writing)

  Mid-intervention

• Feasibility of assessments

  \>70% of participants have no measures fully missing

  Baseline, post-test (6 weeks)

Secondary Outcomes (15)

• Numerical Rating Scale

  Baseline, post-test (6 weeks)

• Graded Chronic Pain Scale

  Baseline, post-test (6 weeks)

• PROMIS Pain Interference scale

  Baseline, post-test (6 weeks)

• Brief Pain Inventory

  Baseline, post-test (6 weeks)

• Patient Health Questionnaire - 9

  Baseline, post-test (6 weeks)

Study Arms (1)

Pain Disengagement Training

EXPERIMENTAL

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

Interventions

Pain Disengagement Training BEHAVIORAL

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.

Pain Disengagement Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Study Officials

• Katherine McDermott, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katherine McDermott, PhD

CONTACT

(617) 643-4208; kmcdermott@mgh.harvard.edu

Ana-Maria Vranceanu, PhD

CONTACT

avranceanu@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff psychologist

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 11, 2025
• Study Start: October 14, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ANALYTIC CODE
• Time Frame: Data from this study will be deposited into the repositories no later than the end of the funded project period. Data will be available indefinitely and will only be removed from the repository if requested by NIH or other relevant institution policy.
• Access Criteria: Data will be stored in the Vivli repository, an NIH-approved independent, generalist global data-sharing and analytics platform. Researchers will be able to access the data by request. Investigators will need to provide evidence of their institution's IRB approval for planned analyses of the data and upon the contingency that data only be used for research and secured by electronic safeguards. Further, this agreement will state that data will be destroyed once data analysis is complete.

Locations

US (1)