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

Primary Purpose

Suicide, Attempted

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy
Sponsored by
Hartford Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicide, Attempted

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Males and females
  • Age 18-65 inclusive
  • Fluent in English (speaking, reading, and writing)
  • Having made a suicide attempt within one week preceding admission. 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 spectrum disorder
  • History of mental retardation 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 Patients who are referred for ECT after starting the study will be withdrawn from the study.

Sites / Locations

  • Institute of Living/Hartford Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Experimental

No Intervention

Arm Label

Presence of SUD with BCBT

Presence of SUD with TAU

Absence of SUD with BCBT

Absence of SUD with TAU

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
Change in Number of Readmissions
Readmission is determined using the participant's electronic medical record along with a self-report measure.

Secondary Outcome Measures

Full Information

First Posted
November 9, 2019
Last Updated
June 30, 2023
Sponsor
Hartford Hospital
Collaborators
American Foundation for Suicide Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT04168645
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 20, 2020 (Actual)
Primary Completion Date
August 15, 2023 (Anticipated)
Study Completion Date
August 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hartford Hospital
Collaborators
American Foundation for Suicide Prevention

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Attempted

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Allocation
Randomized
Enrollment
213 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Presence of SUD with BCBT
Arm Type
Experimental
Arm Description
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.
Arm Title
Presence of SUD with TAU
Arm Type
No Intervention
Arm Description
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.
Arm Title
Absence of SUD with BCBT
Arm Type
Experimental
Arm Description
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.
Arm Title
Absence of SUD with TAU
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Suicidal Behavior
Description
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.
Time Frame
Assessed at baseline, at completion of inpatient treatment (average of 16 days), and on a monthly basis for 6 months follow-up.
Title
Change in Suicidal Ideation/Intent
Description
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.
Time Frame
Assessed at baseline, at completion of inpatient treatment (average of 16 days), and on a monthly basis for 6 months follow-up.
Title
Change in Number of Readmissions
Description
Readmission is determined using the participant's electronic medical record along with a self-report measure.
Time Frame
Assessed on a monthly basis for 6 months follow-up.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David F Tolin, Ph.D.
Organizational Affiliation
Institute of Living/Hartford Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Living/Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33884617
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.
Results Reference
derived

Learn more about this trial

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

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