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Completed

NCT Number: NCT04168645

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

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.

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Key information

Conditions

Suicide, Attempted Behavior Behavioral Symptoms Self-Injurious Behavior Suicide

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Living/Hartford Hospital

Hartford, Connecticut, 06106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive behavioral therapy

Behavioral

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 outcomes

  1. Columbia Suicide Severity Rating Scale Number of Participants Reporting Presence of Suicidal Behaviors

    Time frame: Assessed at completion of inpatient treatment (average of 12 days), and on a monthly basis for 6 months follow-up.

    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 reflect the number of participants with the presence of the suicide behavior.

  2. Columbia Suicide Severity Rating Scale Number of Suicidal Behaviors

    Time frame: Assessed at completion of inpatient treatment (average of 12 days), and on a monthly basis for 6 months follow-up.

    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 reflect the median number of each behavior.

  3. The Number of Participants Reporting Columbia Suicide Severity Rating Scale Suicidal Ideation Categories as Most Severe

    Time frame: Assessed at completion of inpatient treatment (average of 12 days), and on a monthly basis for 6 months follow-up.

    The number of participants endorsing each category as the highest (most severe) suicidal ideation category on the Columbia Suicide Severity Rating Scale (C-SSRS) ranging from 1-5, with 5 being the most severe type of suicidal ideation.

  4. Columbia Suicide Severity Rating Scale Suicidal Ideation Intensity Scale Total Score

    Time frame: Assessed at completion of inpatient treatment (average of 12 days), and on a monthly basis for 6 months follow-up.

    The Columbia Suicide Severity Rating Scale (C-SSRS) intensity subscale is the sum of 5 questions (frequency, duration, controllability, deterrents, and reasons for ideation) rated from 1-5, with 5 representing more severe intensity. Zero is entered if no suicidal ideation is reported. Total scores range from 0 to 25 with higher scores indicating more intense suicidal ideation.

  5. Number of Participants With Readmissions

    Time frame: Assessed on a monthly basis for 6 months follow-up.

    Readmission is determined using the participant's electronic medical record along with a self-report measure.

Sponsors and collaborators

Lead sponsor

Hartford Hospital

Other

Collaborators

  • American Foundation for Suicide Prevention

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Nov 19, 2019
Registry last updated
Apr 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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