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

Primary Purpose

Suicidal and Self-injurious Behavior

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
App-Enhanced Brief Cognitive-Behavioral Therapy
Sponsored by
Hartford Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicidal and Self-injurious Behavior

Eligibility Criteria

18 Years - 24 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Anxiety Disorders Center, Institute of Living

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

App-Enhanced Brief Cognitive-Behavioral Therapy

Arm Description

Up to 4 in-person sessions

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 25, 2022
Last Updated
August 1, 2022
Sponsor
Hartford Hospital
Collaborators
Oui Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05486091
Brief Title
A Feasibility Open Trial of App-Enhanced Brief CBT for Suicidal Inpatients
Official Title
A Feasibility Open Trial of App-Enhanced Brief CBT for Suicidal Inpatients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2022 (Anticipated)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
February 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hartford Hospital
Collaborators
Oui Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicidal and Self-injurious Behavior

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
App-Enhanced Brief Cognitive-Behavioral Therapy
Arm Type
Experimental
Arm Description
Up to 4 in-person sessions
Intervention Type
Behavioral
Intervention Name(s)
App-Enhanced Brief Cognitive-Behavioral Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Client Satisfaction at Discharge
Description
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.
Time Frame
Assessed at completion of inpatient treatment (average of 16 days from admission)
Title
App Usability at Discharge
Description
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.
Time Frame
Assessed at completion of inpatient treatment (average of 16 days from admission)
Title
Frequency of suicide attempts
Description
Frequency (percentage) of participants who made a suicide attempt over the entire follow-up period
Time Frame
3 months post-discharge from inpatient unit
Title
Suicidal Ideation Baseline
Description
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.
Time Frame
Baseline (before receiving BCBT intervention)
Title
Suicidal Ideation at Discharge
Description
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.
Time Frame
Assessed at completion of inpatient treatment (average of 16 days from admission)
Title
Suicidal Ideation 1 month
Description
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.
Time Frame
1 month after discharge
Title
Suicidal Ideation 2 months
Description
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.
Time Frame
2 months after discharge
Title
Suicidal Ideation 3 months
Description
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.
Time Frame
3 months after discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gretchen Diefenbach, PhD
Phone
860-545-7396
Email
Gretchen.Diefenbach@hhchealth.org
First Name & Middle Initial & Last Name or Official Title & Degree
David Tolin, PhD
Phone
860-545-7709
Email
David.Tolin@hhchealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gretchen Diefenbach, PhD
Organizational Affiliation
Anxiety Disorders Center, Institute of Living
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Tolin, PhD
Organizational Affiliation
Anxiety Disorders Center, Institute of Living
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anxiety Disorders Center, Institute of Living
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gretchen Diefenbach, PhD
Phone
860-545-7396
Ext
57396
Email
gretchen.diefenbach@hhchealth.org
First Name & Middle Initial & Last Name & Degree
Gretchen Diefenbach, PhD
First Name & Middle Initial & Last Name & Degree
David Tolin, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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