Clinical trial NCT04168645: Inpatient Cognitive-Behavioral Therapy to Reduce Suicide Risk Post-Discharge
Official title: Inpatient Cognitive-Behavioral Therapy to Reduce Suicide Risk Post-Discharge
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide, Attempted
Lead sponsor: Hartford Hospital
Sponsor class: OTHER
Collaborators: name: American Foundation for Suicide Prevention
First posted: 2019-11-19
Enrollment: 213
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Columbia Suicide Severity Rating Scale Number of Participants Reporting Presence of Suicidal Behaviors
timeFrame: Assessed at completion of inpatient treatment (average of 12 days), and on a monthly basis for 6 months follow-up.
measure: Columbia Suicide Severity Rating Scale Number of Suicidal Behaviors
timeFrame: Assessed at completion of inpatient treatment (average of 12 days), and on a monthly basis for 6 months follow-up.
measure: The Number of Participants Reporting Columbia Suicide Severity Rating Scale Suicidal Ideation Categories as Most Severe
timeFrame: Assessed at completion of inpatient treatment (average of 12 days), and on a monthly basis for 6 months follow-up.
measure: Columbia Suicide Severity Rating Scale Suicidal Ideation Intensity Scale Total Score
timeFrame: Assessed at completion of inpatient treatment (average of 12 days), and on a monthly basis for 6 months follow-up.
measure: Number of Participants With Readmissions
timeFrame: Assessed on a monthly basis for 6 months follow-up.
Secondary outcomes:
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Institute of Living/Hartford Hospital
state: Connecticut
Study officials:
affiliation: Institute of Living/Hartford Hospital
name: David F Tolin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.