SuicideNCT04225130
Decreasing Suicide Risk Among Service Members With Posttraumatic Stress
A study testing Written Exposure Therapy -for Suicide and Treatment as Usual in people with Suicide and Posttraumatic Stress Disorder, run by Boston VA Research Institute, Inc. at 1 site in United States.
Trial summary
In this study, the investigators will conduct a randomized controlled trial (RCT) to evaluate the efficacy of the WET-S + treatment as usual (TAU) compared with TAU among high-risk, suicidal service members with PTSD or posttraumatic stress (PTS) admitted to the Carl R. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide, Posttraumatic Stress Disorder
- What is being tested?
- Written Exposure Therapy -for Suicide and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (18 years or older) service members hospitalized at Carl R Darnall Army Medical Center for SI/suicide plan or attempt.
- Symptoms of posttraumatic stress (PTS) of at least moderate severity (total scores > 20) confirmed by assessor using the CAPS-5.
- Speak, read, and write English.
Who cannot join
- Active psychosis.
- The presence of moderate to severe cognitive impairment (as determined by the inability to comprehend the baseline screening questionnaires).
- The presence of any factor that may impair an individual's ability to comprehend and effectively participate in the study, including the presence of extreme agitation or violent behavior.
Trial locations and contacts
1 site in 1 country.
United States1 site
Carl R Darnell Army Medical Center
Fort Hood, Texas, 76544
About this study
Official title: Decreasing Suicide Risk Among Service Members With Posttraumatic Stress Using Written Exposure Therapy
In this study, the investigators will conduct a randomized controlled trial (RCT) to evaluate the efficacy of the WET-S + treatment as usual (TAU) compared with TAU among high-risk, suicidal service members with PTSD or posttraumatic stress (PTS) admitted to the Carl R. Darnall Army Medical Center (CRDAMC) acute inpatient psychiatry unit at Fort Hood, Texas. Suicide risk and PTS symptom severity are the primary outcomes. Secondary outcomes include subsequent hospitalizations for suicidal thoughts and behaviors and suicide attempts. Investigators will conduct a needs assessment with stakeholders during the RCT to develop a tool kit for WET implementation in other DoD inpatient psychiatry units.
Read the detailed description
This study aims to compare a new formulation of WET referred to as WET-for suicide (WET-S) that includes crisis response planning + treatment as usual (TAU) compared with TAU among high-risk, suicidal service members with PTS admitted to the Carl R. Darnall Army Medical Center (CRDAMC) acute inpatient psychiatry unit at Fort Hood, Texas.
Aim 1: Determine if WET-S reduces the presence, frequency, and severity of suicidal ideation, suicide plans, suicide gestures, suicide attempts, non-suicidal self-injurious behaviors, and rehospitalization for suicidality.
Aim 2: Determine if WET-S + TAU reduces PTS symptom severity among service members admitted to an acute psychiatric inpatient unit for SI and/or attempt compared with TAU.
Aim 3: Determine if reductions in PTS symptoms mediate the association between treatment condition and suicide-related outcomes (suicidal ideation, plans, gestures, attempts, non-suicidal self-injurious behaviors, and rehospitalizations).
Aim 4: Develop a tool kit for WET-S implementation through a needs assessment with key stakeholders and evaluation of contextual factors among DoD inpatient facilities to determine readiness for successful implementation of WET-S.
Study investigators will conduct a randomized controlled trial (RCT) to evaluate the efficacy of the WET-S + treatment as usual (TAU) compared with TAU among high-risk, suicidal service members with PTSD or posttraumatic stress (PTS) admitted to the Carl R. Darnall Army Medical Center (CRDAMC) acute inpatient psychiatry unit at Fort Hood, Texas. Investigators will conduct a needs assessment with stakeholders during the RCT to develop a tool kit for WET implementation in other DoD inpatient psychiatry units.
Data will be collected in Texas. Investigators conservatively anticipate enrollment of approximately 140 service members to achieve a final sample size of 124 (n = 62 per condition) after accounting for 15% attrition. CRDAMC receives approximately 4500 admissions each year for SI/attempt. TAU on the inpatient unit consists of crisis management and stabilization. Suicide risk and PTS symptom severity are the primary outcomes. Secondary outcomes include subsequent hospitalizations for suicidal thoughts and behaviors and suicide attempts.
- Conditions
- Suicide, Posttraumatic Stress Disorder
- Being tested
- Written Exposure Therapy -for Suicide, Treatment as Usual
- Medical subject headings
- Suicide, 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 Therapy -for SuicideBehavioural
Also called WET-S
The first session will consist of the therapist educating the participant about common reactions to trauma and providing information regarding the rationale of WET-S as a treatment for PTSD. The participant will then be given general instructions for completing the trauma narratives, specific instructions for completing the first session, and will then complete the first (30 minutes) narrative writing session. Participants will be instructed to write about the same trauma experience during each session. The importance of delving into their deepest emotions surrounding the trauma event is emphasized. All WET-S sessions will take place in a private room and begin with the therapist reading the specific writing instructions for that session and then leaving the instructions with the participant while 30-minute writing session is completed.
Treatment as UsualBehavioural
Also called TAU
The TAU condition consists of daily contact and patient centered care by the acute psychiatric inpatient unit provider team (e.g., psychiatrists, therapists, case managers, behavioral health techs). TAU includes initial stabilization, nurse case management, medication management, psychoeducation groups, and discharge planning. Patients engage with the provider team daily.
| Study group | Role | What they receive |
|---|---|---|
| Written Exposure Therapy -for Suicide | Experimental | Written Exposure Therapy-for Suicide (WET-S) consists of 5 treatment sessions. Each session includes a written exposure exercise. It also includes CRP. Participants assigned to WET-S will complete the CRP prior to beginning their writing in session 1. Patient use of the CRP since the previous session will be briefly reviewed at the start of each WET-S session to manage safety and problem solve fluctuations in risk during treatment. Receives: Behavioral: Written Exposure Therapy -for Suicide |
| Treatment as Usual | Active comparator | The TAU condition consists of daily contact and patient centered care by the acute psychiatric inpatient unit provider team. TAU includes initial stabilization, nurse case management, medication management, psychoeducation groups, and discharge planning. Patients engage with the provider team daily. Receives: Behavioral: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Clinician Administered PTSD Scale Scores
The CAPS-5 is a structured diagnostic interview and gold standard for assessing PTSD. It provides a dichotomous PTSD diagnosis and overall symptom severity score. Scores range from 0 to 80, with greater scores signifying more severe PTSD symptoms.
Measured: baseline, 1-month, 4-month follow-up
Change in Self-Injurious Thoughts and Behaviors Interview Scores
The SITBI is a structured interview that assesses the presence (lifetime, past year, past month), frequency, severity, and characteristics of five types of SITB: (a) suicidal ideation, (b) suicide plans, (c) suicide gestures, (d) suicide attempts, and (e) non-suicidal self-injury. The SITBI assesses the frequency of each type of thought or behavior in the respondent's lifetime, past year, and past month, as well as the age of onset of each thought or behavior endorsed. The SITBI also assesses the severity of each thought or behavior endorsed on a scale from 0 (low/little) to 4 (very much/severe) scale, on average and at the worst point at each of those time frames.
Measured: Baseline, 1-month, 4-month follow-up
Change in medical record outcomes
At baseline and each follow-up assessment, study staff will access participants' medical record to obtain information about current and past mental health treatment, current and past psychiatric diagnoses, current and past psychiatric medication, and history of suicidal thoughts and behaviors. If applicable, date of admission(s) to inpatient psychiatric unit, chief complaint at the time of admission(s), details of psychiatric stay(s), and length of stay(s) will also be obtained. Changes in any of these variables from baseline to follow-up will be recorded.
Measured: Baseline, 1-month, 4-month follow-up
Change physical and mental health assessed by Military Suicide Research Consortium Common Data Elements
Participants will provide self-report information about their physical and mental health and behaviors at each time point.
Measured: Baseline, 1-month, 4-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start9 Jan 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SuicideStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston VA Research Institute, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Marx, PH.D., Boston VA Research Institute, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04225130
- Sponsor's protocol ID
- W81XWH-16-2-0003
- Status last verified
- Oct 2023
- First submitted
- 6 Jan 2020
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data from study participants will be prepared and stored in the Military Suicide Research Consortium data repository, where it can then be accessed by interested researchers.
Publications
Kearns JC, Straud CL, Stanley IH, Sloan DM, Fina BA, Young-McCaughan S, Tyler HC, Kaplan AM, Blankenship AE, Schrader CC, Green VR, Bryan CJ, Peterson AL, Marx BP; STRONG STAR Consortium. Written Exposure Therapy for Posttraumatic Stress Symptoms and Suicide Risk: A Randomized Controlled Trial With High-Risk Patients Admitted to a Military Inpatient Psychiatric Unit. Suicide Life Threat Behav. 2025 Apr;55(2):e70008. doi: 10.1111/sltb.70008.
PubMed 40052305
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decreasing Suicide Risk Among Service Members With Posttraumatic Stress Using Written Exposure Therapy
- ClinicalTrials.gov ID
- NCT04225130
- Acronym / sponsor ID
- W81XWH-16-2-0003
- Conditions
- Suicide, Posttraumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Boston VA Research Institute, Inc.University, hospital or other
- Collaborators
- The University of Texas Health Science Center at San Antonio
- Study start
- 9 Jan 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 13 Jan 2020 (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.
In this study, the investigators will conduct a randomized controlled trial (RCT) to evaluate the efficacy of the WET-S + treatment as usual (TAU) compared with TAU among high-risk, suicidal service members with PTSD or posttraumatic stress (PTS) admitted to the Carl R. Darnall Army Medical Center (CRDAMC) acute inpatient psychiatry unit at Fort Hood, Texas. Suicide risk and PTS symptom severity are the primary outcomes. Secondary outcomes include subsequent hospitalizations for suicidal thoughts and behaviors and suicide attempts. Investigators will conduct a needs assessment with stakeholders during the RCT to develop a tool kit for WET implementation in other DoD inpatient psychiatry units.
Detailed description
This study aims to compare a new formulation of WET referred to as WET-for suicide (WET-S) that includes crisis response planning + treatment as usual (TAU) compared with TAU among high-risk, suicidal service members with PTS admitted to the Carl R. Darnall Army Medical Center (CRDAMC) acute inpatient psychiatry unit at Fort Hood, Texas.
Aim 1: Determine if WET-S reduces the presence, frequency, and severity of suicidal ideation, suicide plans, suicide gestures, suicide attempts, non-suicidal self-injurious behaviors, and rehospitalization for suicidality.
Aim 2: Determine if WET-S + TAU reduces PTS symptom severity among service members admitted to an acute psychiatric inpatient unit for SI and/or attempt compared with TAU.
Aim 3: Determine if reductions in PTS symptoms mediate the association between treatment condition and suicide-related outcomes (suicidal ideation, plans, gestures, attempts, non-suicidal self-injurious behaviors, and rehospitalizations).
Aim 4: Develop a tool kit for WET-S implementation through a needs assessment with key stakeholders and evaluation of contextual factors among DoD inpatient facilities to determine readiness for successful implementation of WET-S.
Study investigators will conduct a randomized controlled trial (RCT) to evaluate the efficacy of the WET-S + treatment as usual (TAU) compared with TAU among high-risk, suicidal service members with PTSD or posttraumatic stress (PTS) admitted to the Carl R. Darnall Army Medical Center (CRDAMC) acute inpatient psychiatry unit at Fort Hood, Texas. Investigators will conduct a needs assessment with stakeholders during the RCT to develop a tool kit for WET implementation in other DoD inpatient psychiatry units.
Data will be collected in Texas. Investigators conservatively anticipate enrollment of approximately 140 service members to achieve a final sample size of 124 (n = 62 per condition) after accounting for 15% attrition. CRDAMC receives approximately 4500 admissions each year for SI/attempt. TAU on the inpatient unit consists of crisis management and stabilization. Suicide risk and PTS symptom severity are the primary outcomes. Secondary outcomes include subsequent hospitalizations for suicidal thoughts and behaviors and suicide attempts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Written Exposure Therapy -for Suicide | Experimental | Behavioral: Written Exposure Therapy -for SuicideWritten Exposure Therapy-for Suicide (WET-S) consists of 5 treatment sessions. Each session includes a written exposure exercise. It also includes CRP. Participants assigned to WET-S will complete the CRP prior to beginning their writing in session 1. Patient use of the CRP since the previous session will be briefly reviewed at the start of each WET-S session to manage safety and problem solve fluctuations in risk during treatment. |
| Treatment as Usual | Active comparator | Behavioral: Treatment as UsualThe TAU condition consists of daily contact and patient centered care by the acute psychiatric inpatient unit provider team. TAU includes initial stabilization, nurse case management, medication management, psychoeducation groups, and discharge planning. Patients engage with the provider team daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult (18 years or older) service members hospitalized at Carl R Darnall Army Medical Center for SI/suicide plan or attempt.
- Symptoms of posttraumatic stress (PTS) of at least moderate severity (total scores > 20) confirmed by assessor using the CAPS-5.
- Speak, read, and write English.
Key exclusion criteria (3 listed)
- Active psychosis.
- The presence of moderate to severe cognitive impairment (as determined by the inability to comprehend the baseline screening questionnaires).
- The presence of any factor that may impair an individual's ability to comprehend and effectively participate in the study, including the presence of extreme agitation or violent behavior.
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 Therapy -for SuicideAlso: WET-SThe first session will consist of the therapist educating the participant about common reactions to trauma and providing information regarding the rationale of WET-S as a treatment for PTSD. The participant will then be given general instructions for completing the trauma narratives, specific instructions for completing the first session, and will then complete the first (30 minutes) narrative writing session. Participants will be instructed to write about the same trauma experience during each session. The importance of delving into their deepest emotions surrounding the trauma event is emphasized. All WET-S sessions will take place in a private room and begin with the therapist reading the specific writing instructions for that session and then leaving the instructions with the participant while 30-minute writing session is completed. | Behavioural | Written Exposure Therapy -for Suicide |
| Treatment as UsualAlso: TAUThe TAU condition consists of daily contact and patient centered care by the acute psychiatric inpatient unit provider team (e.g., psychiatrists, therapists, case managers, behavioral health techs). TAU includes initial stabilization, nurse case management, medication management, psychoeducation groups, and discharge planning. Patients engage with the provider team daily. | Behavioural | Treatment as Usual |
Primary outcome
Change in Clinician Administered PTSD Scale Scores
Time frame: baseline, 1-month, 4-month follow-up
The CAPS-5 is a structured diagnostic interview and gold standard for assessing PTSD. It provides a dichotomous PTSD diagnosis and overall symptom severity score. Scores range from 0 to 80, with greater scores signifying more severe PTSD symptoms.
Change in Self-Injurious Thoughts and Behaviors Interview Scores
Time frame: Baseline, 1-month, 4-month follow-up
The SITBI is a structured interview that assesses the presence (lifetime, past year, past month), frequency, severity, and characteristics of five types of SITB: (a) suicidal ideation, (b) suicide plans, (c) suicide gestures, (d) suicide attempts, and (e) non-suicidal self-injury. The SITBI assesses the frequency of each type of thought or behavior in the respondent's lifetime, past year, and past month, as well as the age of onset of each thought or behavior endorsed. The SITBI also assesses the severity of each thought or behavior endorsed on a scale from 0 (low/little) to 4 (very much/severe) scale, on average and at the worst point at each of those time frames.
Change in medical record outcomes
Time frame: Baseline, 1-month, 4-month follow-up
At baseline and each follow-up assessment, study staff will access participants' medical record to obtain information about current and past mental health treatment, current and past psychiatric diagnoses, current and past psychiatric medication, and history of suicidal thoughts and behaviors. If applicable, date of admission(s) to inpatient psychiatric unit, chief complaint at the time of admission(s), details of psychiatric stay(s), and length of stay(s) will also be obtained. Changes in any of these variables from baseline to follow-up will be recorded.
Change physical and mental health assessed by Military Suicide Research Consortium Common Data Elements
Time frame: Baseline, 1-month, 4-month follow-up
Participants will provide self-report information about their physical and mental health and behaviors at each time point.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Derived from this study: PubMed 40052305Kearns JC, Straud CL, Stanley IH, Sloan DM, Fina BA, Young-McCaughan S, Tyler HC, Kaplan AM, Blankenship AE, Schrader CC, Green VR, Bryan CJ, Peterson AL, Marx BP; STRONG STAR Consortium. Written Exposure Therapy for Posttraumatic Stress Symptoms and Suicide Risk: A Randomized Controlled Trial With High-Risk Patients Admitted to a Military Inpatient Psychiatric Unit. Suicide Life Threat Behav. 2025 Apr;55(2):e70008. doi: 10.1111/sltb.70008.
- Individual participant dataSharing planned: Yes. De-identified data from study participants will be prepared and stored in the Military Suicide Research Consortium data repository, where it can then be accessed by interested researchers.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Written Exposure Therapy -for Suicide and Treatment as Usual in people with Suicide and Posttraumatic Stress Disorder, run by Boston VA Research Institute, Inc. at 1 site in United States.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Clinician Administered PTSD Scale Scores (time frame: baseline, 1-month, 4-month follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04225130, which also lists 1 linked publication.
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 31 Oct 2023.