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SuicideNCT07404787

Evaluation of a Telehealth Case Management Intervention to Prevent Suicide Among Soldiers Discharged From Psychiatric Hospitalization

A study testing Pathfinding and Treatment As Usual (TAU) in people with Suicide and Suicide Attempt, run by Uniformed Services University of the Health Sciences at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study evaluates the effectiveness of Pathfinding, a 6-month, remotely-delivered case management intervention designed to decrease suicidal behavior among active-duty Regular Army soldiers recently discharged from inpatient psychiatric treatment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Suicide, Suicide Attempt
What is being tested?
Pathfinding and Treatment As Usual (TAU)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,500 participants
Where
1 siteUnited States
Study dates
24 Feb 2026to 31 Aug 2029
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Active duty Regular Army soldiers recently discharged from inpatient psychiatric care at a military treatment facility in the US
  • Access to telephone and computer (including smartphone)

Who cannot join

  • Impaired ability to provide informed consent
  • Terminal illness
  • Failure to complete baseline survey within 30 days of discharge
  • Positive screen for post-discharge suicide-related behaviors

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting
  • Uniformed Services University of the Health Sciences

    Bethesda, Maryland, 20814

    Pathfinding Study, 301-295-3409, pathfinding-study@usuhs.edu

    Recruiting

Other trials in United States

About this study

Official title: SAFEGUARD Phase 2 Pathfinding Study

This study evaluates the effectiveness of Pathfinding, a 6-month, remotely-delivered case management intervention designed to decrease suicidal behavior among active-duty Regular Army soldiers recently discharged from inpatient psychiatric treatment. Soldiers discharged from military treatment facilities across the U.S. will be identified and recruited to participate. Those who consent will be randomly assigned to receive either Treatment As Usual (TAU), which is the Army's standard post-discharge care, or TAU plus Pathfinding. Participants will complete a baseline assessment and follow-up assessments 6 months and 12 months later. The 6- and 12-month follow-up periods will also include examination of participants' electronic healthcare data and Army administrative data. The overall goals of the study are: (1) to evaluate whether Pathfinding decreases suicidal behaviors among soldiers transitioning from psychiatric hospitalization back to the community; and (2) to determine which discharged soldiers are most likely to benefit from the Pathfinding intervention versus TAU alone.

Read the detailed description

Discharge from psychiatric hospitalization is the highest risk period for death by suicide. Intensive case management programs have been effective in reducing post-discharge suicidal behavior, but such programs are too resource-intensive to implement for all psychiatric inpatients. It would be more scalable to target the intervention to those most likely to benefit and implement it remotely with centralized training \& management. This study evaluates the effectiveness of Pathfinding, a 6-month, adjunctive, telehealth case management intervention, in decreasing suicide-related behaviors among active-duty Regular Army soldiers over the 12 months following discharge from inpatient psychiatric treatment. The Pathfinding intervention combines elements from two case management programs that have been found to reduce suicidal behavior and other negative outcomes among individuals transitioning out of the hospital and back to the community-Coping with Long-Term Active Suicide Program (CLASP) and Critical Time Intervention (CTI)-and adapts them for the unique needs of an active-duty military population. The intervention is delivered remotely by "Guides," masters-level mental health professionals who are centrally trained and supervised.

Soldiers hospitalized for inpatient psychiatric care at military treatment facilities (MTFs) across the U.S. will be identified in the electronic health record (EHR) as soon as possible after being discharged. A previously developed machine learning model based on EHR and Army administrative data will be used to stratify discharged soldiers based on their predicted probability of suicidal behavior. Soldiers will be recruited from across the distribution of predicted risk via emails, text messages, and phone calls. Consenting soldiers will complete a baseline assessment of their health, experiences, and characteristics. They will then be randomized to receive either Treatment As Usual (TAU), which is the Army's standard post-discharge care, or TAU plus the 6-month Pathfinding case management intervention. All participants will be administered follow-up assessments 6 and 12 months after baseline to identify self-reported suicide-related events and other outcomes. Outcomes will also be tracked through EHR data.

The study will examine: (1) whether Pathfinding decreases suicide-related behaviors among soldiers transitioning from psychiatric hospitalization back to the community; and (2) whether certain soldiers are more likely than others to benefit from the Pathfinding intervention versus TAU alone.

Being tested
Pathfinding, Treatment As Usual (TAU)
Keywords
suicide, suicide attempt, hospital discharge, military, intervention, case management
Medical subject headings
Suicide, Suicide, Attempted

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PathfindingBehavioural

    The Pathfinding intervention consists of remote (videoconference or phone) interactions between participants and masters-level Guides over the 6 months following study enrollment. Participants have the option of involving a support person (SP) in the intervention (e.g., family member, friend). First 4 sessions (45 min. each) occur as soon as possible following hospital discharge and focus on orientation to Pathfinding, identifying a SP, and identifying and prioritizing values/needs, values-consistent goals, corresponding actions, and relevant resources. Participants subsequently receive up to 10 brief (15-30 min. each) contacts to monitor risk and progress. Frequency of contacts is front-loaded and diminishes over time as participants take more control over managing their transition. SPs are contacted for up to 5 sessions (10-15 min. each) to help with monitoring and support. Sessions, risk assessments, and any crisis response actions are documented in the electronic health record.

  • Treatment As Usual (TAU)Behavioural

    TAU is standard post-discharge care based on Defense Health Agency policy (DHA Administrative Instruction 6025.06): Discharge plans must consist of referral with plans for outpatient or partial hospitalization follow-up within 7 days (optimally within 72 hours). Discharged patients are placed on a High-Risk (HR) list for at least 30 days. During this period, patients are seen weekly for follow-up appointments or attendance of the HR group if individual psychotherapy is not available. If, after 4 weeks, the patient is assessed as no longer acutely suicidal, they are removed from the HR list. After removal from the HR list, patients are seen either weekly or every other week, depending on clinical need. Initial care coordination is handled by the discharge nurse. Ongoing care coordination is managed by the outpatient mental health team. Safety planning is conducted at discharge and every few sessions thereafter using the DHA safety plan. Safety assessments are conducted at each visit.

Study groups in NCT07404787
Study groupRoleWhat they receive
Pathfinding intervention plus Treatment As Usual (TAU)ExperimentalPathfinding is a 6-month, adjunctive, telehealth intervention that integrates 2 evidence-based case management programs and adapts them for active duty soldiers: Coping Long Term with Active Suicide Program (CLASP), a case management intervention for suicidal patients transitioning out of psychiatric hospitals; and Critical Time Intervention (CTI), a more general case management intervention for high-risk transitions out restrictive environments. Administered remotely by a centrally trained \& supervised team of "Guides." Focuses on key suicide risk factors (e.g., treatment engagement, social connection, problem-solving) and unmet needs across life domains (e.g., legal, financial, housing, and relationships). Participants receive Pathfinding in addition to standard post-discharge care (see TAU intervention description for details).
Receives: Behavioral: Pathfinding
Treatment As Usual (TAU)Active comparatorTreatment As Usual (TAU) is the Army's standard care for soldiers discharged from inpatient psychiatric treatment. It involves discharge planning, risk assessment, and referrals (as detailed in the TAU intervention description).
Receives: Behavioral: Treatment As Usual (TAU)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Suicide-related behaviors

    Suicide-related behaviors are defined as: suicide death (administratively documented or informant reported), nonfatal suicide attempt (self-reported or administratively documented), and interrupted suicide attempt, aborted suicide attempt, and preparatory behaviors for suicide (the latter 3 are all self-reported).

    Measured: Within the 12 months following completion of the baseline assessment

Secondary outcomes (6)
  1. Number of suicide attempts

    A count of nonfatal suicide attempts (self-reported or administratively documented) that occurred during the follow-up period.

    Measured: Within the 12 months following completion of the baseline assessment

  2. Rehospitalization

    Psychiatric hospitalization (self-reported, informant reported, or administratively documented) during the follow-up period.

    Measured: Within the 12 months following completion of the baseline assessment

  3. Non-suicide death

    Any manner of death other than suicide (informant reported or administratively documented) during the follow-up period.

    Measured: Within the 12 months following completion of the baseline assessment

  4. Risky behaviors

    Risky behaviors (self-reported) related to driving or riding in a vehicle, sexual encounters, and aggression (bullying, sexual harassment, intimate partner violence) during the follow-up period.

    Measured: Within the 12 months following completion of the baseline assessment

  5. Suicide ideation

    Worst-week frequency, severity, and controllability of suicide ideation during the follow-up period.

    Measured: Within the 12 months following completion of the baseline assessment

  6. Low psychological resilience

    Perceived increase or decrease in ability to manage stressful experiences (self-reported) during the follow-up period.

    Measured: Within the 12 months following completion of the baseline assessment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2026
  2. Study start24 Feb 2026
  3. Primary completion31 Aug 2028 (estimated)
  4. Study completion31 Aug 2029 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07404787
Sponsor's protocol ID
USUHS.2025-156
Other IDs
Federal Award # HU00012520025
Status last verified
Jan 2026
First submitted
4 Feb 2026
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Herman, D. B., Susser, E. S., & Conover, S. (2024). Critical Time Intervention: Mobilizing Supports for People During Perilous Transitions. Oxford University Press.

  • Miller, I., Gaudiano, B., & Weinstock, L. (2022). The Coping Long Term with Active Suicide Program (CLASP): A multi-modal intervention for suicide prevention. Oxford University Press.

  • Miller IW, Gaudiano BA, Weinstock LM. The Coping Long Term with Active Suicide Program: Description and Pilot Data. Suicide Life Threat Behav. 2016 Dec;46(6):752-761. doi: 10.1111/sltb.12247. Epub 2016 Apr 2.

    PubMed 27038050
  • Weinstock LM, Bishop TM, Bauer MS, Benware J, Bossarte RM, Bradley J, Dobscha SK, Gibbs J, Gildea SM, Graves H, Haas G, House S, Kennedy CJ, Landes SJ, Liu H, Luedtke A, Marx BP, Miller A, Nock MK, Owen RR, Pigeon WR, Sampson NA, Santiago-Colon A, Shivakumar G, Urosevic S, Kessler RC. Design of a multicenter randomized controlled trial of a post-discharge suicide prevention intervention for high-risk psychiatric inpatients: The Veterans Coordinated Community Care Study. Int J Methods Psychiatr Res. 2024 Dec;33(4):e70003. doi: 10.1002/mpr.70003.

    PubMed 39352173
  • Kessler RC, Warner CH, Ivany C, Petukhova MV, Rose S, Bromet EJ, Brown M 3rd, Cai T, Colpe LJ, Cox KL, Fullerton CS, Gilman SE, Gruber MJ, Heeringa SG, Lewandowski-Romps L, Li J, Millikan-Bell AM, Naifeh JA, Nock MK, Rosellini AJ, Sampson NA, Schoenbaum M, Stein MB, Wessely S, Zaslavsky AM, Ursano RJ; Army STARRS Collaborators. Predicting suicides after psychiatric hospitalization in US Army soldiers: the Army Study To Assess Risk and rEsilience in Servicemembers (Army STARRS). JAMA Psychiatry. 2015 Jan;72(1):49-57. doi: 10.1001/jamapsychiatry.2014.1754.

    PubMed 25390793
  • Kessler RC, Bauer MS, Bishop TM, Bossarte RM, Castro VM, Demler OV, Gildea SM, Goulet JL, King AJ, Kennedy CJ, Landes SJ, Liu H, Luedtke A, Mair P, Marx BP, Nock MK, Petukhova MV, Pigeon WR, Sampson NA, Smoller JW, Miller A, Haas G, Benware J, Bradley J, Owen RR, House S, Urosevic S, Weinstock LM. Evaluation of a Model to Target High-risk Psychiatric Inpatients for an Intensive Postdischarge Suicide Prevention Intervention. JAMA Psychiatry. 2023 Mar 1;80(3):230-240. doi: 10.1001/jamapsychiatry.2022.4634.

    PubMed 36652267

Questions about this trial

What is this clinical trial studying?

A study testing Pathfinding and Treatment As Usual (TAU) in people with Suicide and Suicide Attempt, run by Uniformed Services University of the Health Sciences 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 2 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 11 Sep 2026. 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?

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 Pathfinding Study (301-295-3409, pathfinding-study@usuhs.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Suicide-related behaviors (time frame: Within the 12 months following completion of the baseline assessment). 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 NCT07404787, which also lists 6 linked publications.

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 11 Sep 2026.

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