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Brief Intervention for Chronic Pain and History of Stressful Experiences

Brief Intervention for Chronic Pain and History of Stressful Experiences

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06983327
Enrollment
50
Registered
2025-05-21
Start date
2025-04-14
Completion date
2025-11-30
Last updated
2026-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adverse Childhood Experiences, Chronic Pain, Trauma

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.

Interventions

BEHAVIORALTrauma Focused Emotional Awareness and Expression Therapy (EAET)

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.

Sponsors

Brigham and Women's Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of RecruitmentAt screeningFeasibility of recruitment: Rate of ≥70% of the patients who are identified as eligible for the study will agree to participate and enroll.
Treatment CompletionFrom enrollment to end of treatment at 4 weeksRate of ≥70% of participants who start the intervention will complete at least 2 of the 3 sessions.
Feasibility of Data CollectionAt 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.
Treatment CredibilityAt 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.
Treatment HelpfulnessAt 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

MeasureTime frameDescription
Pain InterferenceAt 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.
Pain CatastrophizingAt 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.
Posttraumtic Stress Disorder (PTSD) SymptomsAt 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.
KinesiophobiaAt 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026