An Initial Feasibility Study of Brief Cognitive Behavioral Therapy for Suicidal Inpatients

NCT03442699 | Completed Results

• 1 other identifier: HHC-2017-0218
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Suicide is a major public health problem. Although inpatient treatment provides immediate stabilization and crisis management, the risk of suicide post-discharge is substantial. Approximately one third of all suicides by individuals with mental disorders occur in the 90 days following hospitalization. Cognitive behavioral therapy (CBT) has been shown to reduce both suicidal ideation and behavior in outpatients. However, to date, the efficacy of inpatient CBT for suicide prevention is not clear. This study aims to 1) develop and implement a brief CBT treatment for suicide prevention for inpatients, 2) conduct a brief feasibility test and collect initial pilot data on efficacy, and 3) collect preliminary data on the effects of CBT on implicit cognitive suicide associations. In Phase 1, the investigators will work with an expert in CBT for suicide prevention to modify his treatment protocol for use with inpatients, and meet with this expert for a 2-day protocol training. In Phase 2, the investigators will conduct an initial feasibility trial with 5-10 inpatients recruited from the Institute of Living inpatient units. Participants will be recruited within 24 hrs of admission or later and will provide written informed consent prior to any study procedures. Enrolled participants will undergo a clinical assessment by an independent evaluator (IE) that will include diagnostic/symptom assessments, assessment of suicide risk using the Columbia-Suicide Rating Scale, and an implicit association test (IAT). Participants will receive up to 10 daily sessions of CBT (depending on length of stay), lasting 1 hour, following the manualized protocol developed in Phase 1. Participants will then meet with the IE again for reassessment after the 10th session or within 24 hr prior to discharge, whichever comes first. After discharge, participants will have a telephone interview at 1 month, 2 month, and 3 month follow-up. The IE will administer the C-SSRS during these calls. The proposed study will yield feasibility and initial efficacy data that will be used to inform a grant proposal to the American Foundation for Suicide Prevention. That proposal will fund a randomized controlled trial of CBT vs. treatment as usual. Concurrently, the investigators will develop an in-house program to train other staff in the protocol, and will submit a second grant to investigate the efficacy of the training program as well as the efficacy of CBT by those clinicians.

Conditions

Suicide, Attempted

Keywords

cognitive behavioral therapy; suicidal ideology; suicidal behavior

Outcome Measures

Primary Outcomes (1)

• Suicidal Ideation Intensity as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS) Intensity Subscale.

  The CSSRS intensity subscale measures frequency, duration, controllability, deterrents, and reasons for suicidal ideation. The scale ranges from 2-25 with higher scores indicating more severe suicidal ideation.

  Pre-treatment, after treatment which was an average of 16 days, and through follow up, an average of 3 months post-treatment

Secondary Outcomes (1)

• Structured Interview Guide for the Hamilton Rating Scale for Depression (SIGH-D)

  Pre-treatment through post-treatment up to 24 days, 16 days on average

Study Arms (1)

Cognitive Behavioral Therapy

EXPERIMENTAL

Participants will receive up to 10 daily sessions of cognitive behavioral therapy (depending on length of stay), for about an hour each day. During this time the therapist will work to develop a crisis response plan and build coping skills to prevent future suicidal thoughts and behaviors.

Behavioral: Cognitive Behavioral Therapy

Interventions

Cognitive Behavioral Therapy BEHAVIORAL

Up to 10 daily sessions of brief cognitive behavioral therapy for suicidal inpatients for about an hour each day.

Cognitive Behavioral Therapy

Eligibility Criteria

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

You may qualify if:

• 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 Hartford Hospital medical floor (in cases where medical stabilization is required prior to transfer to IOL) or to IOL (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 spectrum disorder
• history of mental retardation or organic brain illness
• current substance use disorder
• 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.

Sponsors & Collaborators

• Hartford Hospital: lead

Study Sites (1)

Institute of Living

Hartford, Connecticut, 06106, United States

Location

Related Publications (18)

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  BACKGROUND

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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, Ph.D.
• Organization: Hartford Hospital/Institute of Living

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: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Anxiety Disorders Center

Model Details: Participants will receive up to 10 daily sessions of CBT (depending on length of stay), for about an hour each day. During this time the therapist will work with participants to develop a crisis response plan and build coping skills to prevent future suicidal thoughts and behaviors.

Study Record Dates

• First Submitted: January 30, 2018
• First Posted: February 22, 2018
• Study Start: February 1, 2018
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: January 2, 2020
• Results First Posted: December 30, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)