Health TrialsbyHealthPanel

Development of a Treatment Prognosis Calculator for the Prevention of Suicide

ConditionSuicidal Ideation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOhio State University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

female and male active duty service members;

=> 18 years old;

engaged in mental health treatment at one of the sites at study enrollment;

score >0 on the Columbia Suicide Severity Rating Scale (CSSRS) Screener-Recent, or indicated suicidal ideation on questions 4 or 5 of the Scale for Suicidal Ideation, indicating suicidal ideation within the last month;

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Brief Cognitive Behavioral Therapy (BCBT)

    Behavioral

    BCBT was developed to provide patients with the skills they need to better manage the cognitive, emotional, physiological, and behavioral components of acute suicidal crises.

  • Treatment as usual (TAU)

    Behavioral

    Behavioral health treatment as it is typically provided at the treatment site.

Treatment groups

1,200 Participants
are divided into 2 treatment groups
Group A: Treatment as Usual (TAU)Active comparator 1 intervention
Group B: Brief Cognitive Behavioral Therapy (BCBT)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Suicidal Ideation

Assess severity of suicidal ideation at 6 months with the Scale for Suicide Ideation (SSI)

Time frame
6 Months

Secondary outcomes

1

Suicide Attempts

Suicide attempts will be assessed with the Self-Injurious Thoughts and Behaviors Interview-Revised (SITBI-R)

Time frame
12 Months
2

Depression

Depression will be assessed with the PROMIS-Depression Computer Adaptive Test (CAT)

Time frame
12 Months
3

Hopelessness

Hopelessness will be assessed with the abbreviated Beck Hopelessness Scale (BHS)

Time frame
12 Months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ohio State University

Lead sponsor

United States Department of Defense

Collaborator

Source ClinicalTrials.gov
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