Inpatient Cognitive-Behavioral Therapy to Reduce Suicide Risk Post-Discharge

Study Overview
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Brief Summary
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The goal of this randomized-controlled trial is to determine whether adding brief cognitive-behavioral therapy for suicide prevention (BCBT) to inpatient treatment improves suicide-related outcomes after the person leaves the hospital. The study will also determine whether being diagnosed with a substance use disorder impacts these outcomes. Participants will either receive treatment as usual or treatment as usual plus up to four sessions of BCBT during their inpatient stay. They will complete monthly follow-up assessments for six months after leaving the hospital.

Detailed Description
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Although inpatient treatment provides immediate stabilization and crisis management for suicidal patients, the risk of suicide post-discharge is substantial, with approximately one third of all suicides by individuals with mental disorders occurring in the 90 days following hospitalization. These data highlight the importance of establishing an empirically-supported inpatient treatment for suicide prevention. Cognitive behavioral therapy (CBT) is a strong candidate, given that CBT reduces risk in suicidal outpatients. In addition, an open trial was completed that 1) adapted the strongest outpatient CBT protocol for an inpatient setting, 2) demonstrated high levels of feasibility and acceptability, and 3) obtained preliminary estimates of efficacy. The objective here is to conduct a largescale randomized controlled trial (RCT) comparing brief cognitive-behavioral therapy for suicide prevention (BCBT) (n = 100) to treatment as usual (TAU, n = 100) to firmly establish efficacy and collect pilot data on treatment implementation metrics. This study aims to determine the efficacy of inpatient BCBT on suicidal behavior, suicidal ideation/intent, and readmission post-treatment and over a 6-month follow-up period. The central hypothesis, based on strong outpatient data, is that inpatient BCBT will reduce suicidal behavior, suicidal ideation/intent, and inpatient readmission over 6 months post-discharge, compared to TAU. Participants will be recruited after inpatient admission following a suicide attempt or with suicidal ideation and plan with suicide attempt within the previous two years. Participants assigned to the BCBT condition will receive four BCBT sessions in addition to treatment as usual. Assessments will occur at intake, discharge, and monthly for six months post-discharge. The proposed study will inform best practices treatment for hospitalized suicidal patients by establishing for the first time, and ultimately disseminating, an empirically-validated inpatient treatment for suicide prevention.

Official Title
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Inpatient Cognitive-Behavioral Therapy to Reduce Suicide Risk Post-Discharge

Conditions
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Suicide, Attempted

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any Gender Age 18-65 inclusive Fluent in English (speaking, reading, and writing) Having made a suicide attempt within one week preceding admission or suicidal ideation and plan on admissions along with suicide attempt within previous two years. Admission will be defined as admission to either the medical floor (in cases where medical stabilization is required prior to transfer to psychiatric inpatient facility) or to psychiatric inpatient facility (in cases where medical stabilization is not required). A suicide attempt will be defined as behavior that is self-directed and deliberately results in injury or the potential for injury to oneself for which there is evidence, whether explicit or implicit, of intent to die. Exclusion Criteria: Age <18 or ≥66 years old History of schizophrenia or schizoaffective disorder History of intellectual disability or organic brain illness Active mania or other psychiatric or medical condition that would preclude informed consent or participation in the trial, in the investigator's opinion ECT included on patient's inpatient treatment plan. Patients who are referred for ECT after starting the study will be withdrawn from the study. Discharge expected within four business days of attending approval.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomly assigned (using a computer-generated randomization schedule) to either BCBT or TAU using stratified block randomization on Substance Use Disorder (SUD). We expect, based on pilot data analyses, that approximately two-thirds of patients in each group will be diagnosed with SUD.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Presence of SUD with BCBT<br>Patients diagnosed with SUD who are randomly assigned to receive BCBT will participate in all aspects of their prescribed treatment plan (i.e., TAU) and will receive up to 4 sessions of CBT (depending on length of stay), lasting 1.5 hours for the first session and 1 hour for the remaining sessions. | Behavioral: Cognitive Behavioral Therapy<br>* Up to 4 sessions of BCBT (depending on length of stay) will be provided. The first session lasts 1.5 hours and subsequent sessions are 1 hour.<br>|
| No Intervention: Presence of SUD with TAU<br>Patients diagnosed with SUD who are randomly assigned to receive TAU will participate in all aspects of the prescribed treatment plan given by the inpatient unit. | |
| Experimental: Absence of SUD with BCBT<br>Patients without SUD who are randomly assigned to receive BCBT will participate in all aspects of their prescribed treatment plan (i.e., TAU) and will receive up to 4 sessions of BCBT (depending on length of stay), lasting 1.5 hours for the first session and 1 hour for the remaining sessions. | Behavioral: Cognitive Behavioral Therapy<br>* Up to 4 sessions of BCBT (depending on length of stay) will be provided. The first session lasts 1.5 hours and subsequent sessions are 1 hour.<br>|
| No Intervention: Absence of SUD with TAU<br>Patients without SUD who are randomly assigned to receive TAU will participate in all aspects of the prescribed treatment plan given by the inpatient unit. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Suicidal Behavior | Suicidal behavior will be assessed using the Columbia Suicide Severity Rating Scale (C-SSRS), a widely used suicide assessment measure. Several suicidal behaviors are assessed on the C-SSRS including the presence or absence of each of the following: suicide attempt, interrupted attempt, aborted attempt, and preparatory acts or behaviors. Scores on this scale will be the number of each behavior. | Assessed at baseline, at completion of inpatient treatment (average of 16 days), and on a monthly basis for 6 months follow-up. | 
| Change in Suicidal Ideation/Intent | Suicidal ideation and intent will also be assessed using the same Columbia Suicide Severity Rating Scale (C-SSRS). Two subscales as described by Posner and colleagues will be extracted: severity and intensity. The severity subscale is a single score rated from 1-5, with 5 being the most severe type of ideation/intent that the participant has endorsed. The intensity subscale contains 5 questions to be rated from 1-5, with 5 representing more severe intensity. | Assessed at baseline, at completion of inpatient treatment (average of 16 days), and on a monthly basis for 6 months follow-up. | 
| Change in Number of Readmissions | Readmission is determined using the participant's electronic medical record along with a self-report measure. | Assessed on a monthly basis for 6 months follow-up. |