Post Traumatic Stress DisorderNCT06789887
Behavioral Health Technician Delivered Written Exposure Therapy
A study testing Written Exposure Therapy and Treatment as Usual (TAU) in people with Post Traumatic Stress Disorder and Written Exposure Therapy, run by Palo Alto Veterans Institute for Research.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post Traumatic Stress Disorder, Written Exposure Therapy
- What is being tested?
- Written Exposure Therapy and Treatment as Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2025to 30 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Increasing Access to Evidenced-Based PTSD Treatment in the Military: 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:
- How well does written exposure therapy help to reduce symptoms of posttraumatic stress for service members with PTSD?
- Is sharing the therapy tasks with behavioral health technicians is a helpful approach for managing behavioral health clinic patient volume and improving patient outcomes?
Read more
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
- Being tested
- Written Exposure Therapy, Treatment as Usual (TAU)
- Keywords
- PTSD, Post Traumatic Stress Disorder, Behavioral Health Technician, Written Exposure Therapy
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Written Exposure TherapyBehavioural
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)Behavioural
Treatment as usual (TAU) will be available to all patient participants. Treatment as usual may include various forms of psychotherapy and or medication management.
| Study group | Role | What they receive |
|---|---|---|
| Treatment As Usual (TAU) | Active comparator | Participants in this arm will receive usually prescribed behavioral health treatment. Receives: 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. Receives: Behavioral: Written Exposure Therapy; Behavioral: Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to immediately post treatment
Secondary outcomes (15)
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.
Measured: Change from baseline through 6 months post treatment
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.
Measured: Change from baseline through 6 months post treatment
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.
Measured: Change from baseline through 6 months post treatment
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.
Measured: Change from baseline through 6 months post treatment
Life Events Checklist for DSM-5 (LEC-5)
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.
Measured: Baseline
Depressive Symptoms Index-Suicidality Subscale (DSI-SS).
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.
Measured: Change from baseline through 6 months post treatment
History of Head Injuries
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.
Measured: Baseline
Brief Inventory of Psychosocial Functioning (B-IPF).
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.
Measured: Changes from baseline through 6 months post treatment
Credibility/Expectancy Questionnaire (CEQ)
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.
Measured: Immediately after the first treatment session, and immediately after the final treatment session
Net Prompter Score
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.
Measured: Post treatment (~6 months post baseline)
Patient Satisfaction Survey
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).
Measured: Post treatment (~6 months post baseline)
Treatment Engagement
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.
Measured: Through study completion, an average of 2 years
WET Adoption
Adoption will be assessed by examining the proportion of available BHTs who participate in the WET training and who deliver WET to study participants.
Measured: Through study completion, an average of 2 years
WET Fidelity
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.
Measured: Through study completion, an average of 2 years
Demographics and Military Service Characteristics Form
This form will be administered to participants to measure standard demographics (race, gender, age) and military service information (e.g., deployment history, rank).
Measured: Baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start1 Feb 2025 (estimated)
- Primary completionJan 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Palo Alto Veterans Institute for Research
- Sponsor type
- University, hospital or other
- Collaborators
- Uniformed Services University of the Health Sciences, The University of Texas Health Science Center at San Antonio, Brooke Army Medical Center, Naval Hospital Camp Pendleton, NDRI-USA, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06789887
- Sponsor's protocol ID
- MCA0011
- Status last verified
- Jan 2025
- First submitted
- 6 Jan 2025
- Last updated
- 23 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Access to Evidenced-Based PTSD Treatment in the Military: Behavioral Health Technician Delivered Written Exposure Therapy
- ClinicalTrials.gov ID
- NCT06789887
- Acronym / sponsor ID
- MCA0011
- Keywords
- PTSD, Post Traumatic Stress Disorder, Behavioral Health Technician, Written Exposure Therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Palo Alto Veterans Institute for ResearchUniversity, hospital or other
- Collaborators
- Uniformed Services University of the Health Sciences, The University of Texas Health Science Center at San Antonio, Brooke Army Medical Center, Naval Hospital Camp Pendleton, NDRI-USA, Inc.
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 23 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- How well does written exposure therapy help to reduce symptoms of posttraumatic stress for service members with PTSD?
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment As Usual (TAU) | Active comparator | Behavioral: Treatment as Usual (TAU)Participants in this arm will receive usually prescribed behavioral health treatment. |
| Treatment As Usual (TAU) and Written Exposure Therapy (WET) | Experimental | Behavioral: Written Exposure Therapy, Behavioral: Treatment as Usual (TAU)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Written Exposure TherapyWritten Exposure Therapy (WET) is a 5-session, trauma-focused intervention in which individuals write about their traumatic experience following scripted instructions. | Behavioural | Treatment As Usual (TAU) and Written Exposure Therapy (WET) |
| 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. | Behavioural | Treatment As Usual (TAU), Treatment As Usual (TAU) and Written Exposure Therapy (WET) |
Primary outcome
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.
15 secondary outcomes
Posttraumatic Stress Disorder Checklist (PCL-5)
Time frame: Change from baseline through 6 months post treatment
Insomnia Severity Index (ISI)
Time frame: Change from baseline through 6 months post treatment
Generalized Anxiety Disorder 7-Item (GAD-7) Scale
Time frame: Change from baseline through 6 months post treatment
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Change from baseline through 6 months post treatment
Life Events Checklist for DSM-5 (LEC-5)
Time frame: Baseline
Depressive Symptoms Index-Suicidality Subscale (DSI-SS).
Time frame: Change from baseline through 6 months post treatment
History of Head Injuries
Time frame: Baseline
Brief Inventory of Psychosocial Functioning (B-IPF).
Time frame: Changes from baseline through 6 months post treatment
Credibility/Expectancy Questionnaire (CEQ)
Time frame: Immediately after the first treatment session, and immediately after the final treatment session
Net Prompter Score
Time frame: Post treatment (~6 months post baseline)
Patient Satisfaction Survey
Time frame: Post treatment (~6 months post baseline)
Treatment Engagement
Time frame: Through study completion, an average of 2 years
WET Adoption
Time frame: Through study completion, an average of 2 years
WET Fidelity
Time frame: Through study completion, an average of 2 years
Demographics and Military Service Characteristics Form
Time frame: Baseline.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Written Exposure Therapy and Treatment as Usual (TAU) in people with Post Traumatic Stress Disorder and Written Exposure Therapy, run by Palo Alto Veterans Institute for Research.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carmen McLean, PhD ((650) 519-5974, carmen.mclean4@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician Administered PTSD Scale (CAPS-5) (time frame: Change from baseline to immediately post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2025.