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Not yet recruiting NCT07397507

Mechanisms of Written Exposure Therapy in Residential SUD Treatment

No phase Interventional PTSD - Post Traumatic Stress Disorder Substance Use Disorder (SUD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Written Exposure Therapy, Neutral Writing.
Who it may be relevant to
Registry conditions: PTSD - Post Traumatic Stress Disorder, Substance Use Disorder (SUD). Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

  • Behavioral Written Exposure Therapy
    Written Exposure Therapy (WET) is a five-session manualized treatment for PTSD. At the first session, psychoeducation about common reactions to trauma and PTSD are presented followed by a 30-minute written exposure. Following the exposure, a 10-minute check-in is completed, and individuals are instructed not to avoid any thoughts/feelings/ images related to the trauma between sessions. All subsequent sessions follow this structure: check-in on avoidance and feedback on writing, written exposure,
  • Behavioral Neutral Writing
    Participants will complete five writing prompts that are not intended to provoke emotional responses. Examples of these prompts include writing about the food they ate the day prior or what they did yesterday. Participants will be instructed to not discuss their thoughts and feelings regarding these topics. Neutral writing will provide control for time and clinician contact.

Primary outcome measures

  • PTSD Symptom Severity [Time frame: Baseline, Immediately after intervention, 1- and 3-Month Post-Discharge]
  • Days of Substance Use [Time frame: Baseline, 1- and 3-Month Post-Discharge]
  • Heart Rate (HR) [Time frame: Baseline, Intervention Sessions, Immediately after intervention]
  • Skin Conductance Response (SCR) [Time frame: Baseline, Intervention Sessions, Immediately after intervention]
  • High-Frequency Heart Rate Variability (HF-HRV) [Time frame: Baseline, Intervention Sessions, Immediately after intervention]
  • Trauma-Reactive Craving [Time frame: Baseline, Intervention Sessions, Immediately after intervention, 1- and 3-Month Post-Discharge Follow-ups]
Secondary outcome measures (1)
  • Consequences of Substance Use [Time frame: Baseline, Immediately after intervention, 1- and 3-Month Post-Discharge]

Eligibility criteria

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).

Exclusion criteria

  • presence of a psychiatric or medical condition that would interfere with participation (e.g., severe, uncontrolled psychosis)
  • prescription of a PRN benzodiazepine
  • current PTSD treatment

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07397507 · 2025P003371

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗