Development of a Treatment Prognosis Calculator for the Prevention of Suicide

StatusRecruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 2 years 2 months later Aug 31, 2026 → Oct 31, 2028
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Record History

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  1. Notable Primary completion pushed from Aug 31, 2026 to Oct 31, 2028
    • Start date: Oct 31, 2023 to Oct 31, 2026
    • Study completion pushed from Aug 31, 2027 to Aug 31, 2029
    • Eligibility criteria expanded, about 6 words
  2. Notable Primary completion date: Aug 31, 2025 to Aug 31, 2026
    • Study completion date: Aug 31, 2026 to Aug 31, 2027
    v6
  3. Minor Eligibility criteria expanded, about 15 wordsv5
  4. Minor 2 versions Re-verified since Oct 23, 2024, no change to tracked fieldsv3-v4
  5. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Oct 17, 2023 to Oct 31, 2023
    v2
  6. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this interventional study is to develop and test a treatment prognosis calculator to identify which service members with suicidal ideation or behavior are likely to respond well to the current standard of care treatment and which should instead receive Brief Cognitive Behavioral Therapy (BCBT) as a first-line treatment. The main aims of the study are: * Aim 1: To develop a novel treatment prognostic calculator to predict response to treatment as usual (TAU) and identify treatment-seeking military personnel who are unlikely to respond adequately to TAU for the reduction of suicidal ideation. * Aim 2: To evaluate the performance of the treatment prognosis calculator in a new sample of treatment-seeking military personnel and determine whether BCBT is more effective than TAU for those patients who are predicted not to respond adequately to TAU. Participants will receive mental health treatment as it is typically administered by their mental healthcare treatment team. Members of their mental healthcare treatment team may receive intensive training in BCBT. After their provider has received this training, they may use this treatment as part of standard of care treatment. The timing of this training will be determined randomly. Participants will complete self-report assessments at the beginning of the study (baseline) as well as 3, 6, 9 and 12 months after their participant begins. These assessments will include questions about feelings, thoughts, moods, impulses, substance use, and behavior.
Trial Details
NCT Number NCT06094218
Lead Sponsor Ohio State University
Collaborators: United States Department of Defense
Conditions
(from sponsor)
Suicidal Ideation
Related terms Suicidal Ideation
Enrollment 1,200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov