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Clinical Trials/NCT05486091
NCT05486091CompletedNot Applicable

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

Hartford Hospital1 site in 1 country4 target enrollmentStarted: October 3, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
4
Locations
1
Primary Endpoint
Suicidal Ideation 2 Months

Study 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 24 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

App-Enhanced Brief Cognitive-Behavioral Therapy

Experimental

Up to 4 in-person sessions

Intervention: App-Enhanced Brief Cognitive-Behavioral Therapy (Behavioral)

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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