Brief Intervention for Chronic Pain and History of Stressful Experiences

Not Applicable

Recruiting

• Conditions: Chronic Pain; Trauma; Adverse Childhood Experiences

• Registration Number: NCT06983327
• Lead Sponsor: Brigham and Women's Hospital

Brief Summary

The goal of this study is to understand whether a brief, three session program can be helpful in reducing symptoms related to both chronic pain and stressful experiences/trauma.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-12-06
• Study First Submitted: 2025-04-14
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-13
• Last Update Submitted: 2025-05-13
• Study First Posted: 2025-05-21
• Last Update Posted: 2025-05-21
• Primary Completion: 2026-04
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Presence of a chronic pain condition (pain for at least 3 months or more)
• History of psychosocial trauma or stressful experience (Adverse Childhood Events questionnaire [ACEs] score of ≥ 3 OR Trauma History Questionnaire Score [THQ] of ≥ 2)
• English fluency
• Access to a smartphone, laptop, or computer
• Able to participate in the intervention via a virtual platform

Exclusion Criteria

• Unable to participate in 3 weekly sessions
• Unable to complete study procedures due to the presence of delirium, dementia, psychosis, or other cognitive impairment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility of Recruitment	At screening	Feasibility of recruitment: ≥70% of the patients who are identified as eligible for the study will agree to participate and enroll.
Treatment Completion	From enrollment to end of treatment at 4 weeks	≥70% of participants who start the intervention will complete at least 2 of the 3 sessions.
Feasibility of Data Collection	At end of treatment at (~4 weeks post-enrollment), and at 1-month follow-up (~8 weeks post-enrollment)	≥70% of participants will complete the survey at end of treatment and at 1-month follow-up.
Treatment Credibility	At end of treatment at (~4 weeks post-enrollment), and at 1-month follow-up (~8 weeks post-enrollment)	≥70% of participants will report average credibility and expectancy scores greater than the scale's midpoint.
Treatment Helpfulness	At end of treatment at (~4 weeks post-enrollment), and at 1-month follow-up (~8 weeks post-enrollment)	≥70% participants will report average treatment helpfulness scores greater than the scale's midpoint.

Secondary Outcome Measures

Name	Time	Method
Pain Interference	At end of treatment at (~4 weeks post-enrollment), and at 1-month follow-up (~8 weeks post-enrollment)	Pain interference Sub-scale of the Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29)
Pain Catastrophizing	At end of treatment at (~4 weeks post-enrollment), and at 1-month follow-up (~8 weeks post-enrollment)	Pain Catastrophizing Scale (PCS)
Anxiety	At end of treatment at (~4 weeks post-enrollment), and at 1-month follow-up (~8 weeks post-enrollment)	Anxiety Sub-scale of the Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29)
Kinesiophobia	At end of treatment at (~4 weeks post-enrollment), and at 1-month follow-up (~8 weeks post-enrollment)	Tampa Scale of Kinesiophobia (TSK)

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Chestnut Hill, Massachusetts, United States