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NCT Number: NCT06789887

Behavioral Health Technician Delivered Written Exposure Therapy

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. Clinician Administered PTSD Scale (CAPS-5)

    Time frame: Change from baseline to immediately post treatment

    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.

Secondary outcomes

  1. Posttraumatic Stress Disorder Checklist (PCL-5)

    Time frame: Change from baseline through 6 months post treatment

    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.

  2. Insomnia Severity Index (ISI)

    Time frame: Change from baseline through 6 months post treatment

    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.

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

    Time frame: Change from baseline through 6 months post treatment

    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.

  4. Patient Health Questionnaire-9 (PHQ-9)

    Time frame: Change from baseline through 6 months post treatment

    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.

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

    Time frame: Baseline

    The LEC-5 includes a list of 16 different potentially traumatic life events that that are commonly associated with PTSD symptoms and was designed to facilitate the diagnosis of PTSD. Therefore, it is used as a self-report measure designed to screen for potentially traumatic events in a respondent's lifetime and is typically administered before the CAP-5.

  6. Depressive Symptoms Index-Suicidality Subscale (DSI-SS).

    Time frame: Change from baseline through 6 months post treatment

    The DSI-SS is a 4-item self-report measure of suicidal ideation that focuses on ideation, plans, perceived control over ideation, and impulses for suicide.

    Scores on each item range from 0 to 3, with higher scores reflecting greater severity of suicidal ideation.

  7. History of Head Injuries

    Time frame: Baseline

    The History of Head Injuries form is a 3-item screening questionnaire that assesses a participant's history of a head injuries and altered consciousness to determine the worst head injury sustained while deployed. The form captures the total number of injuries during and outside of deployment.

  8. Brief Inventory of Psychosocial Functioning (B-IPF).

    Time frame: Changes from baseline through 6 months post treatment

    The B-IPF is a 7-item measure of functioning in seven life domains: romantic relationship, relationship with children, family relationships, friendships and socializing, work, training and education, and activities of daily living. The B-IPF is an abridged version of the 80-item Inventory of Psychosocial Functioning, a survey that assesses psychosocial functioning but that would be too time-intensive to administer.

  9. Credibility/Expectancy Questionnaire (CEQ)

    Time frame: Immediately after the first treatment session, and immediately after the final treatment session

    The CEQ is a 6-item measure that was designed to assess treatment expectancy and rationale credibility for use of an experimental treatment in clinical outcomes studies.

  10. Net Prompter Score

    Time frame: Post treatment (~6 months post baseline)

    The Net Prompter Score is a single item measures of treatment acceptability that asks respondents to rate the likelihood that they would recommend the efficient treatment to a friend or colleague on a scale from 0-10.

  11. Patient Satisfaction Survey

    Time frame: Post treatment (~6 months post baseline)

    The Patient Satisfaction Survey is an adapted version of the Therapeutic Alliance and Patient Satisfaction survey. For this study, adaptations were made in order to assess satisfaction with the care received by the BHT (5 items; among patient participants assigned to WET + TAU) and providers separately (5 items; among all patient participants).

  12. Treatment Engagement

    Time frame: Through study completion, an average of 2 years

    Treatment engagement will be assessed by the BHTs' supervisor at the clinic who will review administrative data to determine the number of behavioral health appointments completed by each enrolled patient participant. Engagement in TAU for patient participant who receive care in the network will be assessed at posttreatment via participant self-report.

  13. WET Adoption

    Time frame: Through study completion, an average of 2 years

    Adoption will be assessed by examining the proportion of available BHTs who participate in the WET training and who deliver WET to study participants.

  14. WET Fidelity

    Time frame: Through study completion, an average of 2 years

    To assess fidelity to the WET protocol, BHTs will audio record treatment sessions and submit a copy of the written trauma narratives. A random subset of 20% of the WET sessions will be reviewed rated for fidelity. Sessions will be rated using the WET Therapist Adherence and Competence Protocol. Clinicians are rated (yes/no) whether each session task was completed (e.g., "Therapist presented the treatment rationale for writing about traumatic event," "Therapist checked in with participant after writing and inquired how writing session went") and how well the therapist delivered each task (1 = poor to 7 = excellent). An overall competence score is also provided for each session.

  15. Demographics and Military Service Characteristics Form

    Time frame: Baseline.

    This form will be administered to participants to measure standard demographics (race, gender, age) and military service information (e.g., deployment history, rank).

Study contacts

Contact information is provided by the study sponsor or research team.

Carmen McLean, PhD

CONTACT

[email protected]

(650) 519-5974

Meghan Bell, MS

CONTACT

[email protected]

(650) 519-5974

Sponsors and collaborators

Lead sponsor

Palo Alto Veterans Institute for Research

Other

Collaborators

  • Brooke Army Medical Center
  • NDRI-USA, Inc.
  • Naval Hospital Camp Pendleton
  • The University of Texas Health Science Center at San Antonio
  • Uniformed Services University of the Health Sciences

Registry information

Official study title

Increasing Access to Evidenced-Based PTSD Treatment in the Military: Behavioral Health Technician Delivered Written Exposure Therapy

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jan 23, 2025
Registry last updated
Jan 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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