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

Suicidal and Self-injurious Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05486091
• Other study ID #: HHC-2022-0057
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2022
• Est. completion date: February 2023

Study information

• Verified date: July 2022
• Source: Hartford Hospital
• Contact: Gretchen Diefenbach, PhD
• Phone: 860-545-7396
• Email: Gretchen.Diefenbach[@]hhchealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 4
• Est. completion date: February 2023
• Est. primary completion date: February 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• Self-Injurious Behavior
• Suicidal and Self-injurious Behavior

Intervention

Behavioral:
• App-Enhanced Brief Cognitive-Behavioral Therapy
BCBT is a cognitive-behavioral intervention designed to target core skills deficits among suicidal individuals. App-enhanced BCBT incorporates the use of a SmartPhone app during the therapy sessions.

Locations

Country	Name	City	State
United States	Anxiety Disorders Center, Institute of Living	Hartford	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Hartford Hospital	Oui Therapeutics, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Client Satisfaction at Discharge	The Client Satisfaction Questionnaire (CSQ) contains 8 multiple choice items and 1 open response item for Comments, and assesses the acceptability and satisfaction of the study treatment. Items are rated from 1 to 4, with higher numbers representing greater satisfaction with the treatment. The mean and standard deviation for the CSQ will be reported utilizing all available data.	Assessed at completion of inpatient treatment (average of 16 days from admission)
Primary	App Usability at Discharge	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. The mean and standard deviation for the SUS will be reported utilizing all available data.	Assessed at completion of inpatient treatment (average of 16 days from admission)
Primary	Frequency of suicide attempts	Frequency (percentage) of participants who made a suicide attempt over the entire follow-up period	3 months post-discharge from inpatient unit
Primary	Suicidal Ideation Baseline	The Adult Suicide Ideation Questionnaire (ASIQ) is a 25-item self-report scale that assesses suicidal ideation on a 7-point scale, with possible total scores ranging from 0 to 150. Higher scores indicate more severe suicidal ideation. Means and standard deviations will be reported utilizing all available data.	Baseline (before receiving BCBT intervention)
Primary	Suicidal Ideation at Discharge	The Adult Suicide Ideation Questionnaire (ASIQ) is a 25-item self-report scale that assesses suicidal ideation on a 7-point scale, with possible total scores ranging from 0 to 150. Higher scores indicate more severe suicidal ideation. Means and standard deviations will be reported utilizing all available data.	Assessed at completion of inpatient treatment (average of 16 days from admission)
Primary	Suicidal Ideation 1 month	The Adult Suicide Ideation Questionnaire (ASIQ) is a 25-item self-report scale that assesses suicidal ideation on a 7-point scale, with possible total scores ranging from 0 to 150. Higher scores indicate more severe suicidal ideation. Means and standard deviations will be reported utilizing all available data.	1 month after discharge
Primary	Suicidal Ideation 2 months	The Adult Suicide Ideation Questionnaire (ASIQ) is a 25-item self-report scale that assesses suicidal ideation on a 7-point scale, with possible total scores ranging from 0 to 150. Higher scores indicate more severe suicidal ideation. Means and standard deviations will be reported utilizing all available data.	2 months after discharge
Primary	Suicidal Ideation 3 months	The Adult Suicide Ideation Questionnaire (ASIQ) is a 25-item self-report scale that assesses suicidal ideation on a 7-point scale, with possible total scores ranging from 0 to 150. Higher scores indicate more severe suicidal ideation. Means and standard deviations will be reported utilizing all available data.	3 months after discharge