Written Exposure Therapy for Veterans With SUD and PTSD

NCT ID: NCT05327504

Last Updated: 2025-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-26

Study Completion Date

2027-06-30

Brief Summary

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The proposed project will evaluate the efficacy of written exposure therapy (WET) among Veterans engaged in substance use disorder (SUD) treatment, who present with co-occurring posttraumatic stress disorder (PTSD). While SUD treatment programs traditionally do not address PTSD, effective trauma treatments have been used successfully among those with substance use comorbidities. WET is a brief trauma-focused intervention shown to effectively treat PTSD. In a recent acceptability and feasibility pilot study among Veterans with co-occurring SUD and PTSD, results showed a decrease in PTSD symptoms among participants receiving WET. The goal of the present study is to improve outcomes for Veterans who present for SUD treatment with comorbid SUD/PTSD.

Detailed Description

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This study is a randomized clinical trial within a Substance Use Disorder (SUD) specialty clinic to evaluate whether treatment as usual (TAU) plus Written Exposure Therapy (WET) is superior to TAU augmented by a neutral topic writing condition on both PTSD and addiction outcomes for Veterans in SUD treatment. Veterans with a current diagnosis of SUD and comorbid PTSD will be randomized to either WET plus TAU or TAU augmented by a neutral topic writing condition. During the first writing session, participants will be asked to write about either a personal traumatic experience (WET) or a neutral topic (control). In sessions 2 through 5, participants will again meet with the study therapist for 45 minutes (maintaining the same writing condition as assigned in session one). Measures of trauma symptoms, distress, and mood will be collected at each writing session, with additional assessments at baseline, at post-treatment (following 5 writing sessions), 8-weeks, and 12-weeks post-baseline assessment. The primary aim of this study is to examine whether WET augmentation of TAU improves trauma symptoms for Veterans with SUD and PTSD who are receiving outpatient SUD treatment compared to TAU with a neutral writing control. The secondary aim will examine whether WET improves SUD outcomes for Veterans with comorbid PTSD compared to TAU with a neutral writing control. If results prove promising, they will support WET as an effective brief, cost efficient, easy to disseminate, adjunct to current SUD treatment for Veterans with comorbid PTSD.

Conditions

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Substance Use Disorders Posttraumatic Stress Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized clinical trial within a Substance Use Disorder (SUD) clinic to evaluate whether treatment as usual (TAU) plus Written Exposure Therapy (WET) is superior to TAU augmented by a neutral topic writing on both PTSD and addiction outcomes for Veterans who present to SUD treatment with comorbid SUD/PTSD.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Assessors will be blind to randomization status.

Study Groups

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Written Exposure Therapy

Written Exposure Therapy (WET) plus Treatment As Usual (TAU). WET is a 5 session, evidence-based trauma-focused written narrative exposure treatment. At each session, patients are instructed to write about the same trauma event and therapists provide feedback about adherence and offer suggestions. The first session includes psychoeducation about PTSD and a treatment rationale prior to general trauma narrative writing instructions, and specific instructions for completing the first writing session, before completing the first writing (30 minutes) session. Participants are instructed to write about the same trauma event at each following session, with an emphasis on delving into their deepest emotions and thoughts, in as much detail as possible, about the event. All writing sessions begin with specific instructions from the therapist followed by 30 minutes of writing by the participant.

Group Type EXPERIMENTAL

Written Exposure Therapy

Intervention Type BEHAVIORAL

Written Exposure Therapy is a 5 session treatment in which individuals write about their trauma event in a specified manner.

Neutral Topic Writing

Treatment As Usual (TAU) augmented by a neutral topic writing condition. The neutral topic writing condition involves writing about an assigned topic during each of the five writing sessions. As opposed to writing about trauma, the specific focus of this condition is on writing for 30 minutes about topics related to their life without writing about emotions or opinions. Rather, they are asked to write about specific objects or events in detail, as accurately as possible, and with as much description as possible. All writing sessions begin with specific instructions from the therapist followed by 30 minutes of writing by the participant.

Group Type ACTIVE_COMPARATOR

Neutral Topic Writing

Intervention Type BEHAVIORAL

Treatment as Usual augmented by 5 sessions of Neutral Topic Writing which involves writing about specific objects (e.g., what they have eaten over the past week) or events (e.g., what they did since yesterday) in detail without discussing thoughts or feelings.

Interventions

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Written Exposure Therapy

Written Exposure Therapy is a 5 session treatment in which individuals write about their trauma event in a specified manner.

Intervention Type BEHAVIORAL

Neutral Topic Writing

Treatment as Usual augmented by 5 sessions of Neutral Topic Writing which involves writing about specific objects (e.g., what they have eaten over the past week) or events (e.g., what they did since yesterday) in detail without discussing thoughts or feelings.

Intervention Type BEHAVIORAL

Other Intervention Names

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Trauma-focused Treatment Control Writing

Eligibility Criteria

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Inclusion Criteria

* Veterans ages 18 years old or older;
* Meets DSM-5 criteria for at least one substance use disorder (SUD);
* Meets DSM-5 criteria for PTSD;
* Approved for SUD treatment at VA Connecticut Healthcare System.

Exclusion Criteria

* Veterans who meet current criteria for schizophrenia, schizophrenia-type disorders, or unmedicated mania or bipolar disorder as determined by QuickSCID-5;
* current suicidal or homicidal risks necessitating a higher level of care;
* Veterans who have received an Evidence-Based Psychotherapy for PTSD protocol within the past 6 months;
* Problems that would prevent a participant from completing the writing intervention or study assessments (e.g., illiteracy). To assess for literacy, participants will read parts of the consent out loud.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sarah Meshberg-Cohen, PhD MS BS

Role: PRINCIPAL_INVESTIGATOR

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

Locations

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VA Connecticut Healthcare System West Haven Campus, West Haven, CT

West Haven, Connecticut, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Michael Merritt

Role: CONTACT

(352) 548-6000 ext. 6476

Jenelle Newcomb, BA

Role: CONTACT

(203) 932-5711 ext. 2874

Facility Contacts

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Amanda O'Brien, MA

Role: primary

203-932-5711 ext. 1-4841

Diana DeNegre

Role: backup

(203) 932-5711 ext. 5217

References

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Meshberg-Cohen S, Cook JM, Bin-Mahfouz A, Petrakis IL. Written exposure therapy for veterans with co-occurring substance use disorders and PTSD: Study design of a randomized clinical trial. Contemp Clin Trials. 2024 Apr;139:107475. doi: 10.1016/j.cct.2024.107475. Epub 2024 Feb 15.

Reference Type DERIVED
PMID: 38365173 (View on PubMed)

Other Identifiers

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MHBP-010-21F

Identifier Type: -

Identifier Source: org_study_id

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