Not Yet RecruitingNot Applicable

Mechanisms of Written Exposure Therapy in Residential SUD Treatment

108 participantsStarted 2026-06

Plain-language summary

The goal of this clinical trial is to learn how Written Exposure Therapy (WET), a brief treatment for PTSD, works among individuals with substance use disorders (SUD) engaged in residential SUD treatment and how biology may influence treatment. The main questions it aims to answer are: * Does WET improve PTSD and substance use outcomes among individuals with SUD+PTSD? * Does WET improve physiological responses and craving to trauma cues? * Do sex hormones influence changes physiological responses and craving during treatment among women? Participants will: * Complete WET or a neutral writing in addition to their residential SUD treatment * Complete two laboratory sessions before and after treatment * Complete follow-up surveys and interviews at 1- and 3-months post-treatment

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. ability to understand and sign informed consent
. ability to write in English;
. age between 18-55 (average age of menopause in the US)
. \[women only\] naturally cycling (i.e., regular cycles, not on gonadal-related hormones)
. current diagnosis of a moderate or severe DSM-5 SUD
. current diagnosis of DSM-5 PTSD
. sufficient memory of the trauma to write about the event
. at least 5 business days left in their residential treatment episode (to allow for 5 treatment sessions).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

PTSD Symptom Severity

Timeframe: Baseline, Immediately after intervention, 1- and 3-Month Post-Discharge

Days of Substance Use

Timeframe: Baseline, 1- and 3-Month Post-Discharge

Heart Rate (HR)

Timeframe: Baseline, Intervention Sessions, Immediately after intervention

Skin Conductance Response (SCR)

Timeframe: Baseline, Intervention Sessions, Immediately after intervention

High-Frequency Heart Rate Variability (HF-HRV)

Timeframe: Baseline, Intervention Sessions, Immediately after intervention

Trauma-Reactive Craving

Timeframe: Baseline, Intervention Sessions, Immediately after intervention, 1- and 3-Month Post-Discharge Follow-ups

Trial details

NCT IDNCT07397507

SponsorMclean Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-12

View on ClinicalTrials.gov More PTSD - Post Traumatic Stress Disorder trials

Plain-language summary

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. ability to understand and sign informed consent
. ability to write in English;
. age between 18-55 (average age of menopause in the US)
. \[women only\] naturally cycling (i.e., regular cycles, not on gonadal-related hormones)
. current diagnosis of a moderate or severe DSM-5 SUD
. current diagnosis of DSM-5 PTSD
. sufficient memory of the trauma to write about the event
. at least 5 business days left in their residential treatment episode (to allow for 5 treatment sessions).

What they're measuring

PTSD Symptom Severity

Timeframe: Baseline, Immediately after intervention, 1- and 3-Month Post-Discharge

Days of Substance Use

Timeframe: Baseline, 1- and 3-Month Post-Discharge

Heart Rate (HR)

Timeframe: Baseline, Intervention Sessions, Immediately after intervention

Skin Conductance Response (SCR)

Timeframe: Baseline, Intervention Sessions, Immediately after intervention

High-Frequency Heart Rate Variability (HF-HRV)

Timeframe: Baseline, Intervention Sessions, Immediately after intervention

Trauma-Reactive Craving

Timeframe: Baseline, Intervention Sessions, Immediately after intervention, 1- and 3-Month Post-Discharge Follow-ups

Mechanisms of Written Exposure Therapy in Residential SUD Treatment

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Mechanisms of Written Exposure Therapy in Residential SUD Treatment

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria