Study to Refine the Effectiveness of New Generation Therapies for Suicide
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOhio State University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Sequential
Treatments tested in this trial
Brief Cognitive Behavioral Therapy
BehavioralIn 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.
Treatment groups
50 Participants
are divided into 4 treatment groupsGroup A: Reasons for LivingOther 1 intervention
Group B: SleepOther 1 intervention
Group C: Cognitive ReappraisalOther 1 intervention
Group D: Behavioral ActivationOther 1 intervention
Trial outcomes
Primary outcomes
1
Suicide attempts during follow-up
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.
Time frame
From enrollment to the end of study completion at one year.Secondary outcomes
1
Suicidal Cognitions and Suicidal Ideation
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.
Time frame
From enrollment to the end of study completion at one year.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Ohio State University
Lead sponsor
The Jordan Elizabeth Harris Foundation
Collaborator
Source ClinicalTrials.gov