Behavioral Health Technician Delivered Written Exposure Therapy

NCT06789887 | Not Yet Recruiting

• 1 other identifier: MCA0011
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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:

• 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

Keywords

PTSD; Post Traumatic Stress Disorder; Behavioral Health Technician; Written Exposure Therapy

Outcome Measures

Primary Outcomes (1)

• Clinician Administered PTSD Scale (CAPS-5)

  The CAPS-5 is a 30-item structured clinical interview that assesses the presence and severity of 20 PTSD symptoms as defined by the DSM-5. It also assess the impact of these symptoms on daily functioning and will be used to evaluate if there is a response to the experimental treatment in this study.

  Change from baseline to immediately post treatment

Secondary Outcomes (15)

• Posttraumatic Stress Disorder Checklist (PCL-5)

  Change from baseline through 6 months post treatment

• Insomnia Severity Index (ISI)

  Change from baseline through 6 months post treatment

• Generalized Anxiety Disorder 7-Item (GAD-7) Scale

  Change from baseline through 6 months post treatment

• Patient Health Questionnaire-9 (PHQ-9)

  Change from baseline through 6 months post treatment

• Life Events Checklist for DSM-5 (LEC-5)

  Baseline

Study Arms (2)

Treatment As Usual (TAU)

ACTIVE COMPARATOR

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

Behavioral: Treatment as Usual (TAU)

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

EXPERIMENTAL

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.

Behavioral: Written Exposure Therapy; Behavioral: Treatment as Usual (TAU)

Interventions

Written Exposure Therapy 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) and Written Exposure Therapy (WET)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient participants:
• Adult active duty personnel ages ≥18
• 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

You may not qualify if:

• Patient participants:
• Current suicide or homicide risk meriting crisis intervention
• Serious mental health symptoms, such as mania, psychosis, alcohol or substance use disorders warranting immediate attention
• Inability to comprehend the baseline screening questionnaires
• Definite plans to leave the military within 10 weeks
• Clinic staff participants:
• None

Sponsors & Collaborators

• Palo Alto Veterans Institute for Research: lead
• Uniformed Services University of the Health Sciences: collaborator
• The University of Texas Health Science Center at San Antonio: collaborator
• Brooke Army Medical Center: collaborator
• Naval Hospital Camp Pendleton: collaborator
• NDRI-USA, Inc.: collaborator

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Central Study Contacts

Carmen McLean, PhD

CONTACT

(650) 519-5974; carmen.mclean4@va.gov

Meghan Bell, MS

CONTACT

(650) 519-5974; meghan.bell@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: January 23, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: January 23, 2025

Record last verified: 2025-01