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Completed

NCT Number: NCT06983327

Brief Intervention for Chronic Pain and History of Stressful Experiences

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.

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Key information

Conditions

Chronic Pain Adverse Childhood Experiences Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Trauma Wounds and Injuries

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Chestnut Hill, Massachusetts, 02467, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Feasibility of Recruitment

    Time frame: At screening

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

  2. Treatment Completion

    Time frame: From enrollment to end of treatment at 4 weeks

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

  3. Feasibility of Data Collection

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

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

  4. Treatment Credibility

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

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

  5. Treatment Helpfulness

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

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

Secondary outcomes

  1. Pain Interference

    Time frame: 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). Range 4-20; higher scores indicate worse pain interference.

  2. Pain Catastrophizing

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

    Pain Catastrophizing Scale (PCS); Range 0-52; higher scores indicate worse pain catastrophizing.

  3. Posttraumtic Stress Disorder (PTSD) Symptoms

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

    PTSD Checklist for DSM-5 (PCL-5); Range 0-80; higher scores indicate worse PTSD symptoms.

  4. Kinesiophobia

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

    Tampa Scale of Kinesiophobia (TSK); Range 17-68; higher scores indicate worse kinesiophobia.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 21, 2025
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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