Brief Intervention for Chronic Pain and History of Stressful Experiences

NCT06983327 | Completed

• 1 other identifier: 2024P001483
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Trauma; Adverse Childhood Experiences

Outcome Measures

Primary Outcomes (5)

• Feasibility of Recruitment

  Feasibility of recruitment: Rate of ≥70% of the patients who are identified as eligible for the study will agree to participate and enroll.

  At screening

• Treatment Completion

  Rate of ≥70% of participants who start the intervention will complete at least 2 of the 3 sessions.

  From enrollment to end of treatment at 4 weeks

• Feasibility of Data Collection

  Rate of ≥70% of participants will complete the survey at end of treatment and at 1-month follow-up.

  At end of treatment at (~4 weeks post-enrollment), and at 1-month follow-up (~8 weeks post-enrollment)

• Treatment Credibility

  Rate of ≥70% of participants will report average credibility and expectancy scores greater than the scale's midpoint.

  At end of treatment at (~4 weeks post-enrollment), and at 1-month follow-up (~8 weeks post-enrollment)

• Treatment Helpfulness

  Rate of ≥70% participants will report average treatment helpfulness scores greater than the scale's midpoint.

  At end of treatment at (~4 weeks post-enrollment), and at 1-month follow-up (~8 weeks post-enrollment)

Secondary Outcomes (4)

• Pain Interference

  At end of treatment at (~4 weeks post-enrollment), and at 1-month follow-up (~8 weeks post-enrollment)

• Pain Catastrophizing

  At end of treatment at (~4 weeks post-enrollment), and at 1-month follow-up (~8 weeks post-enrollment)

• Posttraumtic Stress Disorder (PTSD) Symptoms

  At end of treatment at (~4 weeks post-enrollment), and at 1-month follow-up (~8 weeks post-enrollment)

• Kinesiophobia

  At end of treatment at (~4 weeks post-enrollment), and at 1-month follow-up (~8 weeks post-enrollment)

Study Arms (1)

Brief Intervention

EXPERIMENTAL

Behavioral: Trauma Focused Emotional Awareness and Expression Therapy (EAET)

Interventions

Trauma Focused Emotional Awareness and Expression Therapy (EAET) BEHAVIORAL

The intervention is three-session program which includes pain neuroscience education, education on the relationship between trauma and chronic pain, and skills training to reduce pain- and stress-related symptoms.

Brief Intervention

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Chestnut Hill, Massachusetts, 02467, United States

Location

MeSH Terms

Conditions

Chronic Pain; Wounds and Injuries

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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: Clinical Psychologist

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: May 21, 2025
• Study Start: April 14, 2025
• Primary Completion: November 28, 2025
• Study Completion: November 30, 2025
• Last Updated: March 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)