Study to Refine the Effectiveness of New Generation Therapies for Suicide

Purpose

The purpose of this research study is to improve the effectiveness of a well-established therapy for suicidal thoughts and behaviors called Brief Cognitive Behavioral Therapy (BCBT) for Suicide Prevention.

Conditions

  • Suicide Risk
  • Suicide Attempt
  • Treatment Response

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 18 years of age or older; suicidal ideation (assessed with the SSI) and/or suicidal behavior within the past month (assessed with the SITBI-R), psychiatric hospitalization for elevated suicide risk within the past month, and/or SCS-R total score >21; eligibility to understand and speak the English language; ability to complete the informed consent process

Exclusion Criteria

  • impaired mental status that precludes the ability to provide informed consent (e.g., intoxication, psychosis, mania) and/or a medical or psychiatric condition that precludes the ability to engage in outpatient therapy

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Other
Reasons for Living 		Participants will complete reasons for living in session 2, physiological regulation in session 3, and sleep in session 4.
  • Behavioral: Brief Cognitive Behavioral Therapy
    In this study, BCBT skills will be introduced in various randomly determined sequence. During the first stage, around half of participants will complete reasons for living in session 2, physiological regulation in session 3, and sleep in session 4. The other half of participants will complete these components in the reverse order: sleep in session 2, physiological regulation in session 3, and reasons for living in session 4. Treatment non-responders will continue attending BCBT sessions during Stage 2 following their 4 completed sessions in Stage 1, up to a maximum of 6 additional sessions (i.e., 10 therapy sessions total across both stages). The specific sequence of the BCBT skills used in Stage 2 will be randomly assigned.
Other
Sleep 		Sleep in session 2, physiological regulation in session 3, and reasons for living in session 4.
  • Behavioral: Brief Cognitive Behavioral Therapy
    In this study, BCBT skills will be introduced in various randomly determined sequence. During the first stage, around half of participants will complete reasons for living in session 2, physiological regulation in session 3, and sleep in session 4. The other half of participants will complete these components in the reverse order: sleep in session 2, physiological regulation in session 3, and reasons for living in session 4. Treatment non-responders will continue attending BCBT sessions during Stage 2 following their 4 completed sessions in Stage 1, up to a maximum of 6 additional sessions (i.e., 10 therapy sessions total across both stages). The specific sequence of the BCBT skills used in Stage 2 will be randomly assigned.
Other
Cognitive Reappraisal 		Beginning at week 4, participants will be classified as treatment responders if they (1) have not engaged in any preparatory behavior or made any suicide attempts (aborted, interrupted, or actual) and (2) have an SCS-R total score ≤21. Participants who do not meet these criteria will continue BCBT and be randomized a second time to determine if cognitive reappraisal or behavioral activation components are delivered next (sessions 5-9).
  • Behavioral: Brief Cognitive Behavioral Therapy
    In this study, BCBT skills will be introduced in various randomly determined sequence. During the first stage, around half of participants will complete reasons for living in session 2, physiological regulation in session 3, and sleep in session 4. The other half of participants will complete these components in the reverse order: sleep in session 2, physiological regulation in session 3, and reasons for living in session 4. Treatment non-responders will continue attending BCBT sessions during Stage 2 following their 4 completed sessions in Stage 1, up to a maximum of 6 additional sessions (i.e., 10 therapy sessions total across both stages). The specific sequence of the BCBT skills used in Stage 2 will be randomly assigned.
Other
Behavioral Activation 		Beginning at week 4, participants will be classified as treatment responders if they (1) have not engaged in any preparatory behavior or made any suicide attempts (aborted, interrupted, or actual) and (2) have an SCS-R total score ≤21. Participants who do not meet these criteria will continue BCBT and be randomized a second time to determine if cognitive reappraisal or behavioral activation components are delivered next (sessions 5-9).
  • Behavioral: Brief Cognitive Behavioral Therapy
    In this study, BCBT skills will be introduced in various randomly determined sequence. During the first stage, around half of participants will complete reasons for living in session 2, physiological regulation in session 3, and sleep in session 4. The other half of participants will complete these components in the reverse order: sleep in session 2, physiological regulation in session 3, and reasons for living in session 4. Treatment non-responders will continue attending BCBT sessions during Stage 2 following their 4 completed sessions in Stage 1, up to a maximum of 6 additional sessions (i.e., 10 therapy sessions total across both stages). The specific sequence of the BCBT skills used in Stage 2 will be randomly assigned.

Recruiting Locations

Department of Psychiatry and Behavioral Health
Columbus, Ohio 43210

More Details

Status
Recruiting
Sponsor
Ohio State University

Study Contact

Anna Crouser, MSW, LSW
614-293-2554
anna.crouser@osumc.edu

Detailed Description

Funded by The Jordan Elizabeth Harris Foundation, this study uses a Sequential Multiple Assignment Randomized Trial (SMART) design to evaluate how various sequences and doses of BCBT components differentially impact suicide risk. In this two-stage clinical trial, all participants will initially receive 4 sessions of BCBT and complete weekly assessments. They will also complete 4 weeks of ecological momentary assessment (EMA) and digital phenotyping procedures during the first month of treatment.