Chronic PainNCT06983327
Brief Intervention for Chronic Pain and History of Stressful Experiences
A study testing Trauma Focused Emotional Awareness and Expression Therapy (EAET) in people with Chronic Pain and Trauma, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Chronic Pain, Trauma, Adverse Childhood Experiences
- What is being tested?
- Trauma Focused Emotional Awareness and Expression Therapy (EAET)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2025to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unable to participate in 3 weekly sessions
- Unable to complete study procedures due to the presence of delirium, dementia, psychosis, or other cognitive impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Chestnut Hill, Massachusetts, 02467
About this study
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
- Being tested
- Trauma Focused Emotional Awareness and Expression Therapy (EAET)
- Medical subject headings
- Chronic Pain, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trauma Focused Emotional Awareness and Expression Therapy (EAET)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Brief Intervention | Experimental | Not described Receives: Behavioral: Trauma Focused Emotional Awareness and Expression Therapy (EAET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At screening
Treatment Completion
Rate of ≥70% of participants who start the intervention will complete at least 2 of the 3 sessions.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At end of treatment at (~4 weeks post-enrollment), and at 1-month follow-up (~8 weeks post-enrollment)
Secondary outcomes (4)
Pain Interference
Pain interference Sub-scale of the Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29). Range 4-20; higher scores indicate worse pain interference.
Measured: At end of treatment at (~4 weeks post-enrollment), and at 1-month follow-up (~8 weeks post-enrollment)
Pain Catastrophizing
Pain Catastrophizing Scale (PCS); Range 0-52; higher scores indicate worse pain catastrophizing.
Measured: At end of treatment at (~4 weeks post-enrollment), and at 1-month follow-up (~8 weeks post-enrollment)
Posttraumtic Stress Disorder (PTSD) Symptoms
PTSD Checklist for DSM-5 (PCL-5); Range 0-80; higher scores indicate worse PTSD symptoms.
Measured: At end of treatment at (~4 weeks post-enrollment), and at 1-month follow-up (~8 weeks post-enrollment)
Kinesiophobia
Tampa Scale of Kinesiophobia (TSK); Range 17-68; higher scores indicate worse kinesiophobia.
Measured: At end of treatment at (~4 weeks post-enrollment), and at 1-month follow-up (~8 weeks post-enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start14 Apr 2025
- Primary completion28 Nov 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Edwards, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06983327
- Sponsor's protocol ID
- 2024P001483
- Status last verified
- Feb 2026
- First submitted
- 14 Apr 2025
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Intervention for Chronic Pain and History of Stressful Experiences
- ClinicalTrials.gov ID
- NCT06983327
- Acronym / sponsor ID
- 2024P001483
- Conditions
- Chronic Pain, Trauma, Adverse Childhood Experiences
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 14 Apr 2025 (actual)
- Primary completion
- 28 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 21 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brief Intervention | Experimental | Behavioral: Trauma Focused Emotional Awareness and Expression Therapy (EAET) |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Unable to participate in 3 weekly sessions
- Unable to complete study procedures due to the presence of delirium, dementia, psychosis, or other cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trauma 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. | Behavioural | Brief Intervention |
Primary outcome
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.
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.
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.
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.
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.
4 secondary outcomes
Pain Interference
Time frame: At end of treatment at (~4 weeks post-enrollment), and at 1-month follow-up (~8 weeks post-enrollment)
Pain Catastrophizing
Time frame: At end of treatment at (~4 weeks post-enrollment), and at 1-month follow-up (~8 weeks post-enrollment)
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)
Kinesiophobia
Time frame: At end of treatment at (~4 weeks post-enrollment), and at 1-month follow-up (~8 weeks post-enrollment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trauma Focused Emotional Awareness and Expression Therapy (EAET) in people with Chronic Pain and Trauma, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Recruitment (time frame: At screening). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.