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Clinical Trials/NCT05486091
NCT05486091
Completed
Not Applicable

A Feasibility Open Trial of App-Enhanced Brief CBT for Suicidal Inpatients

Hartford Hospital1 site in 1 country4 target enrollmentOctober 3, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Suicidal and Self-injurious Behavior
Sponsor
Hartford Hospital
Enrollment
4
Locations
1
Primary Endpoint
Suicidal Ideation 2 Months
Status
Completed
Last Updated
last year

Overview

Brief Summary

The purpose of this study is to evaluate the feasibility of integrating Brief Cognitive-Behavioral Therapy (BCBT) counseling with a software application (app) to prevent future suicidal thoughts and behaviors.

Detailed Description

Participants will provide written informed consent. Participants will complete up to 4 sessions of BCBT (depending on length of stay) incorporating the use of a SmartPhone app. This study treatment will be completed in addition to usual care in an open trial design. Assessments will be completed at intake, discharge, and 1-, 2-, and 3-month follow-up.

Registry
clinicaltrials.gov
Start Date
October 3, 2022
End Date
February 15, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • History of suicide attempt (lifetime) AND active ideation (with or without plan or intent) on admission
  • Own and have access to their phone (iPhone or Android with capability to download apps) during their inpatient stay
  • Ability to understand the nature of the study and provide written informed consent
  • Willing and able to provide at least two verifiable contacts for emergency or tracking purposes
  • Expected length of stay long enough to complete the entire treatment protocol

Exclusion Criteria

  • Not fluent in English
  • Experiencing current mania or psychosis
  • Have lifetime history of schizophrenia spectrum disorder, intellectual disability, or organic brain illness
  • Inpatient treatment plan includes detox protocol or electroconvulsive therapy
  • Any other psychiatric or medical condition that in the investigator's opinion would preclude informed consent or participation in the trial

Outcomes

Primary Outcomes

Suicidal Ideation 2 Months

Time Frame: 2 months after discharge

The Adult Suicidal Ideation Questionnaire (ASIQ) assesses the frequency of suicidal ideation. The ASIQ contains 25 items rated on a 0-6 scale. Items are added together for a total score ranging from 0 to 150. Higher scores indicate more frequent suicidal ideation. Means and standard deviations of the total score will be reported utilizing all available data.

Suicidal Ideation 3 Months

Time Frame: 3 months after discharge

The Adult Suicidal Ideation Questionnaire (ASIQ) assesses the frequency of suicidal ideation. The ASIQ contains 25 items rated on a 0-6 scale. Items are added together for a total score ranging from 0 to 150. Higher scores indicate more frequent suicidal ideation. Means and standard deviations of the total score will be reported utilizing all available data.

App Usability at Discharge

Time Frame: Assessed at completion of inpatient treatment (average of 16 days from admission)

The System Usability Scale (SUS) contains 10 items assessing the usability of digital technology. Items are rated from 1 to 5, with higher numbers representing stronger agreement with usability statements. Scores can range from 0 to 100, with higher scores reflecting better outcomes, meaning increased usability of the technology. The mean and standard deviation for the SUS will be reported utilizing all available data.

Suicidal Ideation Baseline

Time Frame: Baseline (before receiving BCBT intervention)

The Adult Suicidal Ideation Questionnaire (ASIQ) assesses the frequency of suicidal ideation. The ASIQ contains 25 items rated on a 0-6 scale. Items are added together for a total score ranging from 0 to 150. Higher scores indicate more frequent suicidal ideation. Means and standard deviations of the total score will be reported utilizing all available data.

Frequency of Suicide Attempts

Time Frame: 3 months post-discharge from inpatient unit

Frequency (percentage) of participants who made a suicide attempt over the entire follow-up period

Client Satisfaction at Discharge

Time Frame: Assessed at completion of inpatient treatment (average of 16 days from admission)

The Client Satisfaction Questionnaire (CSQ) contains 8 multiple choice items and assesses the acceptability and satisfaction of the study treatment. Items are rated from 1 to 4. Items are added together for a total score ranging from 8 to 32 with higher numbers representing greater satisfaction with the treatment. The mean and standard deviation for the CSQ total score will be reported utilizing all available data.

Suicidal Ideation at Discharge

Time Frame: Assessed at completion of inpatient treatment (average of 16 days from admission)

The Adult Suicidal Ideation Questionnaire (ASIQ) assesses the frequency of suicidal ideation. The ASIQ contains 25 items rated on a 0-6 scale. Items are added together for a total score ranging from 0 to 150. Higher scores indicate more frequent suicidal ideation. Means and standard deviations of the total score will be reported utilizing all available data.

Suicidal Ideation 1 Month

Time Frame: 1 month after discharge

The Adult Suicidal Ideation Questionnaire (ASIQ) assesses the frequency of suicidal ideation. The ASIQ contains 25 items rated on a 0-6 scale. Items are added together for a total score ranging from 0 to 150. Higher scores indicate more frequent suicidal ideation. Means and standard deviations of the total score will be reported utilizing all available data.

Study Sites (1)

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