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Development of a Treatment Prognosis Calculator for the Prevention of Suicide

Primary Purpose

Suicidal Ideation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Brief Cognitive Behavioral Therapy (BCBT)
Treatment as usual (TAU)
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Suicidal Ideation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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, indicating suicidal ideation within the last month; able to understand and speak English; 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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Treatment as Usual (TAU)

    Brief Cognitive Behavioral Therapy (BCBT)

    Arm Description

    TAU may include (1) routine suicide risk screening and assessment; (2) safety planning with means restriction; and (3) the Collaborative Assessment and Management of Suicidality (CAMS), an evidence-based approach to managing and treating suicidal patients.

    BCBT consists of 12 outpatient individual psychotherapy sessions scheduled weekly or biweekly. The first session is 90 minutes and subsequent sessions are 60 minutes. BCBT is divided into three phases. In phase 1 (5 sessions), the therapist conducts a detailed assessment of the patient's most recent suicidal episode or suicide attempt, identifies patient-specific factors that contribute to and maintain suicidal behaviors, provides a cognitive-behavioral conceptualization, collaboratively develops a crisis response plan, and teaches basic emotion regulation skills. In phase 2 (5 sessions), the therapist teaches cognitive restructuring skills to build cognitive flexibility. In phase 3 (2 sessions), a relapse prevention task is conducted, and participants must demonstrate the ability to successfully complete this task in order to terminate the treatment. Additional sessions are conducted until participants demonstrate the ability to successfully complete this task.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Suicide Attempts
    Suicide attempts will be assessed with the Self-Injurious Thoughts and Behaviors Interview-Revised (SITBI-R)
    Depression
    Depression will be assessed with the PROMIS-Depression Computer Adaptive Test (CAT)
    Hopelessness
    Hopelessness will be assessed with the abbreviated Beck Hopelessness Scale (BHS)

    Full Information

    First Posted
    October 3, 2023
    Last Updated
    October 16, 2023
    Sponsor
    Ohio State University
    Collaborators
    United States Department of Defense
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06094218
    Brief Title
    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

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 17, 2023 (Anticipated)
    Primary Completion Date
    August 31, 2025 (Anticipated)
    Study Completion Date
    August 31, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ohio State University
    Collaborators
    United States Department of Defense

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Suicidal Ideation

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Sequential Assignment
    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.
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    1200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment as Usual (TAU)
    Arm Type
    Active Comparator
    Arm Description
    TAU may include (1) routine suicide risk screening and assessment; (2) safety planning with means restriction; and (3) the Collaborative Assessment and Management of Suicidality (CAMS), an evidence-based approach to managing and treating suicidal patients.
    Arm Title
    Brief Cognitive Behavioral Therapy (BCBT)
    Arm Type
    Experimental
    Arm Description
    BCBT consists of 12 outpatient individual psychotherapy sessions scheduled weekly or biweekly. The first session is 90 minutes and subsequent sessions are 60 minutes. BCBT is divided into three phases. In phase 1 (5 sessions), the therapist conducts a detailed assessment of the patient's most recent suicidal episode or suicide attempt, identifies patient-specific factors that contribute to and maintain suicidal behaviors, provides a cognitive-behavioral conceptualization, collaboratively develops a crisis response plan, and teaches basic emotion regulation skills. In phase 2 (5 sessions), the therapist teaches cognitive restructuring skills to build cognitive flexibility. In phase 3 (2 sessions), a relapse prevention task is conducted, and participants must demonstrate the ability to successfully complete this task in order to terminate the treatment. Additional sessions are conducted until participants demonstrate the ability to successfully complete this task.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Brief Cognitive Behavioral Therapy (BCBT)
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Treatment as usual (TAU)
    Intervention Description
    Behavioral health treatment as it is typically provided at the treatment site.
    Primary Outcome Measure Information:
    Title
    Suicidal Ideation
    Description
    Assess severity of suicidal ideation at 6 months with the Scale for Suicide Ideation (SSI)
    Time Frame
    6 Months
    Secondary Outcome Measure Information:
    Title
    Suicide Attempts
    Description
    Suicide attempts will be assessed with the Self-Injurious Thoughts and Behaviors Interview-Revised (SITBI-R)
    Time Frame
    12 Months
    Title
    Depression
    Description
    Depression will be assessed with the PROMIS-Depression Computer Adaptive Test (CAT)
    Time Frame
    12 Months
    Title
    Hopelessness
    Description
    Hopelessness will be assessed with the abbreviated Beck Hopelessness Scale (BHS)
    Time Frame
    12 Months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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, indicating suicidal ideation within the last month; able to understand and speak English; 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).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jay Fournier, PhD
    Phone
    614-293-9889
    Email
    jay.fournier@osumc.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Development of a Treatment Prognosis Calculator for the Prevention of Suicide

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