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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03442699
Recruitment Status : Completed
First Posted : February 22, 2018
Last Update Posted : February 22, 2019
Sponsor:
Information provided by (Responsible Party):
David Tolin, Hartford Hospital

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.

Condition or disease Intervention/treatment Phase
Suicide, Attempted Behavioral: Cognitive Behavioral Therapy Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Initial Feasibility Study of Brief Cognitive Behavioral Therapy for Suicidal Inpatients
Actual Study Start Date : February 1, 2018
Actual Primary Completion Date : November 1, 2018
Actual Study Completion Date : November 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arm Intervention/treatment
Experimental: Cognitive Behavioral Therapy
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
Up to 10 daily sessions of brief cognitive behavioral therapy for suicidal inpatients for about an hour each day.




Primary Outcome Measures :
  1. Change in Suicidal Behavior as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Pre-treatment through follow up, an average of 3 months post-treatment ]
    Mean change in suicidal behavior (minimum total score 0, maximum total score 5; higher total scores indicate more suicidal behavior)


Secondary Outcome Measures :
  1. Hamilton Rating Scale for Depression (SIGH-D) [ Time Frame: Pre-treatment through post-treatment, after 10 days or prior to discharge (whichever occurs first) ]
    Mean change in depression symptoms (minimum total score 0, maximum total score 52; higher total scores indicate greater depression severity)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03442699


Locations
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United States, Connecticut
Institute of Living
Hartford, Connecticut, United States, 06106
Sponsors and Collaborators
Hartford Hospital
Investigators
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Principal Investigator: David F Tolin, Ph.D. Institute of Living/Hartford Hospital

Publications:
Rudd MD, Joiner TE, Rajab MH. Treating suicidal behavior: An effective, time-limited approach. New York: Guilford Press; 2001.
Borkovec TD, Nau SD. Credibility of analogue therapy rationales. J. Behav. Ther. Exp. Psychiatry. 1972;3:257-260

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Responsible Party: David Tolin, Director, Anxiety Disorders Center, Hartford Hospital
ClinicalTrials.gov Identifier: NCT03442699     History of Changes
Other Study ID Numbers: HHC-2017-0218
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by David Tolin, Hartford Hospital:
cognitive behavioral therapy
suicidal ideology
suicidal behavior

Additional relevant MeSH terms:
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Suicide
Suicide, Attempted
Self-Injurious Behavior
Behavioral Symptoms