Clinical trial NCT06094218: Development of a Treatment Prognosis Calculator for the Prevention of Suicide
Official title: Development of a Treatment Prognosis Calculator for the Prevention of Suicide
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Suicidal Ideation
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2023-10-23
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a two phase, stepped-wedge design. In Phase I, all participants receive TAU. In Phase II, sites are randomized to receive training in BCBT. Prior to the training, participants receive TAU. Following the training, participants may receive BCBT.
Primary purpose: PREVENTION

Brief summary: 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: Inclusion Criteria:

1. female and male active duty service members;
2. =\> 18 years old;
3. engaged in mental health treatment at one of the sites at study enrollment;
4. 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;
5. able to understand and speak English;
6. able to provide consent.

Exclusion Criteria:

(1) participants with a psychiatric or medical condition that prevents them from providing informed consent or from participating in the treatments (e.g., psychosis, mania, acute intoxication).

Primary outcomes:
measure: Suicidal Ideation
timeFrame: 6 Months
Secondary outcomes:
measure: Suicide Attempts
timeFrame: 12 Months
measure: Depression
timeFrame: 12 Months
measure: Hopelessness
timeFrame: 12 Months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Harding Hospital
state: Ohio
Study officials:
References: