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NCT Number: NCT07782268

Written Exposure in Substance Treatment (WEST 3.0): Randomized Controlled Trial

The purpose of the current research study is to evaluate the efficacy of the refined Written Exposure in Substance Treatment (WEST) for PTSD among residential SUD patients through a randomized controlled trial. All participants meet criteria for PTSD and are in a short term residential SUD treatment program (target residential treatment duration = 28 days) regardless of the research. Participants will be randomly assigned to WEST + treatment as usual (TAU) or TAU only. The primary outcome is change in PTSD symptoms from pre-intervention to post-intervention. The secondary outcome will be change in SUD outcomes (e.g., treatment completion, reduced opioid and other drug use) and change in non-PTSD mental health outcomes (e.g., depression) from pre-intervention to post-intervention.

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Key information

Conditions

Posttraumatic Stress Disorder (PTSD) Chemically-Induced Disorders Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Substance Use Disorder (SUD) Substance-Related Disorders Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • be enrolled in residential SUD treatment at MTC
  • meet criteria for PTSD based on the Clinician-Administered PTSD Scale for DSM-5
  • be 18 years of age or older
  • have sufficient memory of the index trauma to write about it
  • be sufficiently able to speak, read, and write in the English language to complete WEST therapy and study assessments.

Exclusion criteria

  • Inability to give informed consent for any reason (e.g., cognitive impairment)
  • Presence of acute psychosis that would interfere with study participation
  • Suicide attempt within the past 3 months
  • History of psychiatric hospitalization within the past month
  • Presence of any other psychiatric instability or suicidality that would interfere with study participation
  • Planning to leave residential treatment before WEST could realistically be completed as determined by the investigator
  • Lack of access to a mobile phone after treatment discharge

Treatment and study plan

Written Exposure Therapy

Behavioral

Written Exposure Therapy is a brief, evidenced based intervention for PTSD. WET is generally delivered individually across 5 sessions in which the therapist guides the patient through writing exercises. Across exposure sessions, participants experience habituation so that their symptoms decrease by the end of treatment. WET has an established evidence base in general outpatient psychotherapy for PTSD, but has not been adapted or tested in residential SUD treatment settings. Further, the investigators have adapted WET for this setting based on stakeholder and expert feedback.

Treatment as Usual

Behavioral

Treatment as Usual will include a variety of standard care services offered in short term residential treatment. For example, participants receiving TAU will participate in individual case management/general counseling sessions focused on substance use disorder and its consequences, group based psychoeducation sessions, group based counseling sessions (e.g., relapse prevention planning), individual services with a medical provider and pharmacotherapy (e.g., for withdrawal, relapse prevention, or co-occurring conditions)

Primary outcomes

  1. PTSD symptom reduction

    Time frame: Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.

    PTSD symptom reduction pre/post intervention by treatment arm as measured by he PTSD Checklist for DSM-5 (PCL-5) and the Clinician-Administered PTSD Scale for DSM-5 (CAPS). The PCL-5 is a 20-item self-report questionnaire that yields a total symptom scores ranging from 0-80 with higher scores indicating greater symptomology. The CAPS is a 30-item structured interview that yields a diagnosis of PTSD, a total PTSD symptom severity score, and a severity score for each symptom cluster.

Secondary outcomes

  1. Days of Substance Use

    Time frame: Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.

    Timeline Follow-back (TLFB) will assess opioid and other substance use in the 30 days prior to residential treatment admission and at all follow-ups. Participants will be shown a reference sheet that describes standard drinks (see attached) to help them more easily recall how many standard drinks they have consumed in the past month.

  2. Substance Use Exposure

    Time frame: Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.

    Kreek-McHugh-Schuluger-Kellogg scale (KMSK) will assess participants' lifetime and past 30-day exposure to specific substances. The KMSK items assessing past 30-day usage will be administered during all follow up appointments.

  3. Anxiety Symptoms

    Time frame: Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.

    General Anxiety Disorder (GAD-7) will assess symptoms of anxiety.

  4. Depressive Symptoms

    Time frame: Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.

    Patient Health Questionnaire-9 (PHQ-9) will assess depressive symptoms.

  5. Recovery Capital

    Time frame: Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.

    Brief Assessment of Recovery Capital (BARC-10) will assess participant-reported areas of recovery capital.

    Multidimensional Inventory of Recovery Capital (MIRC): designed to assess the resources a person uses to resolve alcohol or drug problems.

  6. Treatment Outcomes

    Time frame: Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.

    Treatment Utilization Self-Report Form: an investigator-created form will collect data on ongoing engagement in SUD treatment, mental health, and hospital services.

    Medication Continuity assessment (see participant information document): will track adherence with medications prescribed during treatment, including addiction-related and other psychotropic medications.

  7. Moral Injury

    Time frame: Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.

    Moral Injury and Distress Scale (MIDS) will assess exposure to potentially morally injurious events and the possible impacts of moral injury.

  8. Emotion Regulation

    Time frame: Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.

    Difficulties in Emotion Regulation Scale-Short Form (DERS-SF) will assess emotion regulation and distress tolerance skills

  9. Self Efficacy

    Time frame: Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.

    Trauma Coping Self Efficacy (CSE-T) will assess participants' perceptions of their ability to cope with trauma related distress

  10. Discharge related outcomes

    Time frame: Completed during the 4-week follow-up appointment once after the participant discharges from the inpatient unit. If participant is still in inpatient, will be completed at the next follow up appointment after discharge (either 8 or 12-week appointments)

    Discharge Chart Abstraction (see attached): An investigator-created form will gather information on inpatient treatment completion status, successful initiation on relapse prevention medications for opioid use disorder and alcohol use disorder, and continuing care referrals made by the inpatient treatment team.

  11. Barriers to Treatment

    Time frame: This will be administered during the 4-week follow-up appointment. If this measure was not completed during the 4-week follow-up, participants will complete the measure during the 8 or 12-week appointment.

    Barriers to Treatment Participation Scale (BTPS): A WEST specific version of the measure will assess barriers to patient engagement in WEST.

  12. Adverse Events

    Time frame: 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.

    Adverse Events Reporting Form (see participant information document): An investigator- created form used to solicit reporting of any adverse events, additional traumatic exposures, and drug/alcohol overdoses since the last research contact; the traumatic exposure item is taken from the Primary Care PTSD Screen for DSM-5 (PC-PTSD-5).

  13. Physical Pain

    Time frame: Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.

    Short-Form Health Survey (SF-12): two items from this measure will assess participant-reported physical pain.

Study contacts

Contact information is provided by the study sponsor or research team.

Kevin Wenzel, PhD

CONTACT

[email protected]

410-233-1400

Rebecca Schacht, PhD

CONTACT

[email protected]

410-455-5626

Sponsors and collaborators

Lead sponsor

Potomac Health Foundations

Other

Collaborators

  • University of Maryland, Baltimore County

Registry information

Official study title

Treating OUD/PTSD in Residential Care: Written Exposure in Substance Treatment (WEST)

Acronym: WEST

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Aug 24, 2026
Registry last updated
Aug 24, 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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