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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Suicidal and Self-injurious Behavior
• Intervention / Treatment: Behavioral: App-Enhanced Brief Cognitive-Behavioral Therapy

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 Type: Interventional
• Enrollment (Anticipated): 4
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gretchen Diefenbach, PhD; Phone Number: 860-545-7396; Email: Gretchen.Diefenbach@hhchealth.org
• Study Contact Backup: Name: David Tolin, PhD; Phone Number: 860-545-7709; Email: David.Tolin@hhchealth.org

Study Locations

• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Anxiety Disorders Center, Institute of Living
      • Contact: Gretchen Diefenbach, PhD; Phone Number: 57396 860-545-7396; Email: gretchen.diefenbach@hhchealth.org
      • Principal Investigator: Gretchen Diefenbach, PhD
      • Principal Investigator: David Tolin, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 24 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: App-Enhanced Brief Cognitive-Behavioral Therapy; Up to 4 in-person sessions	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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
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)
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)
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
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
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

Collaborators and Investigators

• Sponsor: Hartford Hospital
• Collaborators: Oui Therapeutics, LLC
• Investigators: Principal Investigator: Gretchen Diefenbach, PhD, Anxiety Disorders Center, Institute of Living; Principal Investigator: David Tolin, PhD, Anxiety Disorders Center, Institute of Living

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2022
• Primary Completion (Anticipated): February 1, 2023
• Study Completion (Anticipated): February 1, 2023

Study Registration Dates

• First Submitted: July 25, 2022
• First Submitted That Met QC Criteria: August 1, 2022
• First Posted (Actual): August 3, 2022

Study Record Updates

• Last Update Posted (Actual): August 3, 2022
• Last Update Submitted That Met QC Criteria: August 1, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior
• Other Study ID Numbers: HHC-2022-0057

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No