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

NCT ID: NCT05486091

Last Updated: 2024-08-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-03

Study Completion Date

2023-02-15

Brief Summary

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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

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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.

Conditions

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Suicidal and Self-injurious Behavior

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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App-Enhanced Brief Cognitive-Behavioral Therapy

Up to 4 in-person sessions

Group Type EXPERIMENTAL

App-Enhanced Brief Cognitive-Behavioral Therapy

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oui Therapeutics, Inc.

INDUSTRY

Sponsor Role collaborator

Hartford Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gretchen Diefenbach, PhD

Role: PRINCIPAL_INVESTIGATOR

Anxiety Disorders Center, Institute of Living

David Tolin, PhD

Role: PRINCIPAL_INVESTIGATOR

Anxiety Disorders Center, Institute of Living

Locations

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Anxiety Disorders Center, Institute of Living

Hartford, Connecticut, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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HHC-2022-0057

Identifier Type: -

Identifier Source: org_study_id

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