Behavioral Health Technician Delivered Written Exposure Therapy

NCT ID: NCT06789887

Last Updated: 2025-01-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2028-09-30

Brief Summary

This study has two main goals. First, it aims to test a treatment called written exposure therapy to see if it can help military service members who have posttraumatic stress disorder (PTSD). Second, it aims to test a new way of making this therapy more accessible in military clinics by utilizing task-sharing with Behavioral Health Technicians (BHTs). PTSD is a common and serious issue among service members. Written exposure therapy (WET) has been proven to be effective for improving PTSD that requires five therapy sessions delivered weekly. This study aims to determine:

1. How well does written exposure therapy help to reduce symptoms of posttraumatic stress for service members with PTSD?

2. Is sharing the therapy tasks with behavioral health technicians is a helpful approach for managing behavioral health clinic patient volume and improving patient outcomes?

We plan to recruit a total of 40-59 staff participants, as well as 150 active-duty patient participants with PTSD. We will randomize patient participants to one of two treatment conditions: 1) treatment-as-usual (TAU) or 2) TAU and 5 sessions of WET. Staff and participants will be recruited from two military treatment facilities: 1) Fort Sam Houston in San Antonio (Brooke Army Medical Center) and 2) Camp Pendleton (Naval Hospital at Camp Pendleton).

Consented patient participants will:

• Complete a PTSD interview via telehealth with a study team member to determine if you are eligible for the study
• Be randomly assigned to one of the following conditions: 1) TAU + WET or 2) TAU
• Complete up to 8 weeks of behavioral health treatment (either TAU + WET or TAU)
• Complete self-report measures before, during, and after treatment, and at a 3- and 6-month follow up assessment after the treatment period
• Complete a posttreatment PTSD interview via telehealth with a study team member
• A subset of participants will be asked to complete a brief treatment experience interview posttreatment

Consented staff participants will:

• Participate in an interview about your perceptions of and experiences supporting BHT-delivered WET with a study team member at the VAPAHCS
• A subset of participants will also be asked to participate in a brief staff feedback interview approximately 6 months after their first interview

Conditions

Post Traumatic Stress Disorder; Written Exposure Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Treatment As Usual (TAU)

Participants in this arm will receive usually prescribed behavioral health treatment.

Group Type: ACTIVE_COMPARATOR

Treatment as Usual (TAU)

Intervention Type: BEHAVIORAL

Treatment as usual (TAU) will be available to all patient participants. Treatment as usual may include various forms of psychotherapy and or medication management.

Treatment As Usual (TAU) and Written Exposure Therapy (WET)

Participants in this arm will receive the usually prescribed behavioral health treatment as well as 5 total sessions of Written Exposure Therapy with a Behavioral Health Technician.

Group Type: EXPERIMENTAL

Written Exposure Therapy

Intervention Type: BEHAVIORAL

Written Exposure Therapy (WET) is a 5-session, trauma-focused intervention in which individuals write about their traumatic experience following scripted instructions.

Treatment as Usual (TAU)

Intervention Type: BEHAVIORAL

Treatment as usual (TAU) will be available to all patient participants. Treatment as usual may include various forms of psychotherapy and or medication management.

Interventions

Written Exposure Therapy

Written Exposure Therapy (WET) is a 5-session, trauma-focused intervention in which individuals write about their traumatic experience following scripted instructions.

Intervention Type: BEHAVIORAL

Treatment as Usual (TAU)

Treatment as usual (TAU) will be available to all patient participants. Treatment as usual may include various forms of psychotherapy and or medication management.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

Patient participants:

1. Adult active duty personnel ages ≥18

2. Clinically significant PTSD symptoms (CAPS-5 ≥ 25).

Clinic staff participants: Individuals working as BHTs, clinic providers, and clinic leaders working at the behavioral health clinics participating in the study

Exclusion Criteria

Patient participants:

1. Current suicide or homicide risk meriting crisis intervention

2. Serious mental health symptoms, such as mania, psychosis, alcohol or substance use disorders warranting immediate attention

3. Inability to comprehend the baseline screening questionnaires

4. Definite plans to leave the military within 10 weeks

Clinic staff participants:

None

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Uniformed Services University of the Health Sciences

FED

Sponsor Role: collaborator

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role: collaborator

Brooke Army Medical Center

FED

Sponsor Role: collaborator

Naval Hospital Camp Pendleton

FED

Sponsor Role: collaborator

NDRI-USA, Inc.

OTHER

Sponsor Role: collaborator

Palo Alto Veterans Institute for Research

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Carmen McLean, PhD

Role: CONTACT

carmen.mclean4@va.gov

(650) 519-5974

Meghan Bell, MS

Role: CONTACT

meghan.bell@va.gov

(650) 519-5974

Other Identifiers

MCA0011

Identifier Type: -

Identifier Source: org_study_id