N/A
N=6
An Initial Feasibility Study of Brief Cognitive Behavioral Therapy for Suicidal Inpatients
Suicide, Attempted
Bottom Line
View on ClinicalTrials.gov: NCT03442699 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcome: Primary: Suicidal Ideation Intensity as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS) Intensity Subscale. — 13.0; 2.50; 2.60 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cognitive Behavioral Therapy (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hartford Hospital
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Suicidal Ideation Intensity as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS) Intensity Subscale. |
13.0; 2.50; 2.60 | — |
| SECONDARY Structured Interview Guide for the Hamilton Rating Scale for Depression (SIGH-D) |
15.0; 6.17 | — |
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.
Eligibility Criteria
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 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03442699). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.