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

NCT03442699 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2020-01-02

Study results available
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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

Interventions

BEHAVIORAL

Cognitive Behavioral Therapy

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

Sponsors & Collaborators

  • Hartford Hospital

    lead OTHER

Principal Investigators

  • David F Tolin, Ph.D. · Institute of Living/Hartford Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-01
Primary Completion
2018-11-01
Completion
2018-11-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03442699 on ClinicalTrials.gov