Suicide Attempt, Suicide Risk, Treatment Response
Conditions
Keywords
suicide risk, suicide attempt, suicidality
Brief summary
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.
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.
Interventions
BEHAVIORALBrief 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.
Sponsors
Ohio State University
The Jordan Elizabeth Harris Foundation
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Suicide attempts during follow-up | From enrollment to the end of study completion at one year. | The primary outcome is suicide attempts during follow-up, assessed with the Self-Injurious Thoughts and Behaviors Interview-Revised (SITBI-R). SITBI-R responses will be used to determine the rate of participants making a follow-up suicide attempt (binary) and the rate of follow-up suicide attempts per participant-year across treatment arms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Suicidal Cognitions and Suicidal Ideation | From enrollment to the end of study completion at one year. | Suicidal beliefs will be assessed using the SCS-R.15 SCS-R scores assess future risk for attempting suicide. Severity of suicidal ideation will be assessed using the Scale for Suicide Ideation (SSI),16 a 19-item self-report scale that measures the intensity of suicide-related thoughts, urges, and behaviors. |
Countries
United States
Contacts
CONTACTAnna Crouser, MSW, LSW
PRINCIPAL_INVESTIGATORMelanie Bozzay, PhD
Ohio State University
Outcome results
None listed