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

ConditionsPosttraumatic Stress Disorder (PTSD)Substance Use Disorder (SUD)

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorPotomac Health Foundations

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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)

Treatment groups

400 Participants

are divided into 2 treatment groups

Group A: TAU + Adapted Written Exposure Therapy (WET)Experimental treatment 1 intervention

Group B: TAUActive comparator 1 intervention

Trial outcomes

Primary outcomes

PTSD symptom reduction

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.

Time frame