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

NCT04168645 | Completed Results

• 1 other identifier: HHC-2019-0163
• Study Type: interventional
• Target: 213
• Locations: 1 country
• Sites: 1

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.

Conditions

Suicide, Attempted

Outcome Measures

Primary Outcomes (5)

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

  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.

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

• Columbia Suicide Severity Rating Scale Number of Suicidal Behaviors

  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.

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

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

  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.

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

• Columbia Suicide Severity Rating Scale Suicidal Ideation Intensity Scale Total Score

  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.

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

• Number of Participants With 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.

Study Arms (4)

Presence of SUD with BCBT

EXPERIMENTAL

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

Presence of SUD with TAU

NO INTERVENTION

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.

Absence of SUD with BCBT

EXPERIMENTAL

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

Absence of SUD with TAU

NO INTERVENTION

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.

Interventions

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.

Absence of SUD with BCBT; Presence of SUD with BCBT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hartford Hospital: lead
• American Foundation for Suicide Prevention: collaborator

Study Sites (1)

Institute of Living/Hartford Hospital

Hartford, Connecticut, 06106, United States

Location

Related Publications (4)

• Diefenbach GJ, Lord KA, Stubbing J, Rudd MD, Levy HC, Worden B, Sain KS, Bimstein JG, Rice TB, Everhardt K, Gueorguieva R, Tolin DF. Brief Cognitive Behavioral Therapy for Suicidal Inpatients: A Randomized Clinical Trial. JAMA Psychiatry. 2024 Dec 1;81(12):1177-1186. doi: 10.1001/jamapsychiatry.2024.2349.

  PMID: 39259550 DERIVED

• Stubbing J, Tolin DF, Sain KS, Everhardt K, Rudd MD, Diefenbach GJ. Borderline Personality Traits Do Not Moderate the Relationship Between Depression, Beliefs, and Suicidal Thoughts and Behaviors. Arch Suicide Res. 2025 Jan-Mar;29(1):223-237. doi: 10.1080/13811118.2024.2345168. Epub 2024 Apr 29.

  PMID: 38683542 DERIVED

• Diefenbach GJ, Stubbing J, Rice TB, Lord KA, Rudd MD, Tolin DF. Uncovering the role of substance use in suicide attempts using a mixed-methods approach. Suicide Life Threat Behav. 2024 Feb;54(1):70-82. doi: 10.1111/sltb.13019. Epub 2023 Nov 21.

  PMID: 37987548 DERIVED

• 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.

  PMID: 33884617 DERIVED

MeSH Terms

Conditions

Suicide, Attempted

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: David Tolin
• Organization: Hartford Hospital

david.tolin@hhchealth.org

860-545-7685

Study Officials

• David F Tolin, Ph.D.

  Institute of Living/Hartford Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Anxiety Disorders Center

Model Details: 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.

Study Record Dates

• First Submitted: November 9, 2019
• First Posted: November 19, 2019
• Study Start: January 20, 2020
• Primary Completion: August 15, 2023
• Study Completion: August 15, 2023
• Last Updated: April 16, 2025
• Results First Posted: April 16, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)