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Completed

NCT Number: NCT05486091

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.

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Key information

Conditions

Suicidal and Self-Injurious Behavior Behavior Behavioral Symptoms Self-Injurious Behavior

Age range

18 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Anxiety Disorders Center, Institute of Living

Hartford, Connecticut, 06106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

App-Enhanced Brief Cognitive-Behavioral Therapy

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Hartford Hospital

Other

Collaborators

  • Oui Therapeutics, Inc.

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 3, 2022
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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