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Behavioral Health Technician Delivered Written Exposure Therapy

ConditionsPost Traumatic Stress DisorderWritten Exposure Therapy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPalo Alto Veterans Institute for Research

About this trial

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

This trial accepts healthy volunteers

Qualifiers

Adult active duty personnel ages ≥18

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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)

    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 groups

150 Participants
are divided into 2 treatment groups
Group A: Treatment As Usual (TAU)Active comparator 1 intervention
Group B: Treatment As Usual (TAU) and Written Exposure Therapy (WET)Experimental treatment 2 interventions

Trial outcomes

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.

Time frame
Change from baseline to immediately post treatment

Secondary outcomes

1

Posttraumatic Stress Disorder Checklist (PCL-5)

The PCL-5 is a 20-item self-report questionnaire designed to assess PTSD symptoms as defined by the DSM-5. This questionnaire will be used to monitor changes before and after treatment, as well as screening patients for PTSD.

Time frame
Change from baseline through 6 months post treatment
2

Insomnia Severity Index (ISI)

The ISI is a seven-item questionnaire that is designed as a screening tool to assess the severity of a patient's insomnia using a Likert-type scale.

Time frame
Change from baseline through 6 months post treatment
3

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

The GAD-7 is a 7-item self-report measure of the severity from mild to severe of symptoms related to generalized anxiety; items correspond to the diagnostic criteria for generalized anxiety disorder.

Time frame
Change from baseline through 6 months post treatment
4

Patient Health Questionnaire-9 (PHQ-9)

The PHQ-9 is a 9-item questionnaire that assesses the severity of affective and somatic symptoms related to depression; items correspond to the diagnostic criteria for major depression disorder.

Time frame
Change from baseline through 6 months post treatment

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Palo Alto Veterans Institute for Research

Lead sponsor

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

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: