Clinical trial NCT06789887: Behavioral Health Technician Delivered Written Exposure Therapy
Official title: Increasing Access to Evidenced-Based PTSD Treatment in the Military: Behavioral Health Technician Delivered Written Exposure Therapy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Post Traumatic Stress Disorder
Written Exposure Therapy
Keywords: PTSD
Post Traumatic Stress Disorder
Behavioral Health Technician
Written Exposure Therapy
Lead sponsor: Palo Alto Veterans Institute for Research
Sponsor class: OTHER
Collaborators: name: Uniformed Services University of the Health Sciences
name: The University of Texas Health Science Center at San Antonio
name: Brooke Army Medical Center
name: Naval Hospital Camp Pendleton
name: NDRI-USA, Inc.
First posted: 2025-01-23
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Clinician Administered PTSD Scale (CAPS-5)
timeFrame: Change from baseline to immediately post treatment
Secondary outcomes:
measure: Posttraumatic Stress Disorder Checklist (PCL-5)
timeFrame: Change from baseline through 6 months post treatment
measure: Insomnia Severity Index (ISI)
timeFrame: Change from baseline through 6 months post treatment
measure: Generalized Anxiety Disorder 7-Item (GAD-7) Scale
timeFrame: Change from baseline through 6 months post treatment
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Change from baseline through 6 months post treatment
measure: Life Events Checklist for DSM-5 (LEC-5)
timeFrame: Baseline
measure: Depressive Symptoms Index-Suicidality Subscale (DSI-SS).
timeFrame: Change from baseline through 6 months post treatment
measure: History of Head Injuries
timeFrame: Baseline
measure: Brief Inventory of Psychosocial Functioning (B-IPF).
timeFrame: Changes from baseline through 6 months post treatment
measure: Credibility/Expectancy Questionnaire (CEQ)
timeFrame: Immediately after the first treatment session, and immediately after the final treatment session
measure: Net Prompter Score
timeFrame: Post treatment (~6 months post baseline)
measure: Patient Satisfaction Survey
timeFrame: Post treatment (~6 months post baseline)
measure: Treatment Engagement
timeFrame: Through study completion, an average of 2 years
measure: WET Adoption
timeFrame: Through study completion, an average of 2 years
measure: WET Fidelity
timeFrame: Through study completion, an average of 2 years
measure: Demographics and Military Service Characteristics Form
timeFrame: Baseline.
Other outcomes:
Locations:
Study officials:
References: