NCT05486091

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 3, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

October 3, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2023

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

August 9, 2024

Completed
Last Updated

August 9, 2024

Status Verified

March 1, 2024

Enrollment Period

5 months

First QC Date

July 25, 2022

Results QC Date

June 21, 2023

Last Update Submit

March 1, 2024

Conditions

Suicidal and Self-injurious Behavior

Outcome Measures

Primary Outcomes (8)

  • Client Satisfaction at Discharge

    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.

    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. 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.

    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 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.

    Baseline (before receiving BCBT intervention)

  • Suicidal Ideation at 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.

    Assessed at completion of inpatient treatment (average of 16 days from admission)

  • Suicidal Ideation 1 Month

    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.

    1 month after discharge

  • Suicidal Ideation 2 Months

    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.

    2 months after discharge

  • Suicidal Ideation 3 Months

    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.

    3 months after discharge

Study Arms (1)

App-Enhanced Brief Cognitive-Behavioral Therapy

EXPERIMENTAL

Up to 4 in-person sessions

Behavioral: App-Enhanced Brief Cognitive-Behavioral Therapy

Interventions

App-Enhanced Brief Cognitive-Behavioral TherapyBEHAVIORAL

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.

App-Enhanced Brief Cognitive-Behavioral Therapy

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anxiety Disorders Center, Institute of Living

Hartford, Connecticut, 06106, United States

Location

MeSH Terms

Conditions

Self-Injurious Behavior

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Results Point of Contact

Title
Gretchen Diefenbach, Ph.D.
Organization
Anxiety Disorders Center
gretchen.diefenbach@hhchealth.org
860-545-7396

Study Officials

  • Gretchen Diefenbach, PhD

    Anxiety Disorders Center, Institute of Living

    PRINCIPAL INVESTIGATOR

  • David Tolin, PhD

    Anxiety Disorders Center, Institute of Living

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2022

First Posted

August 3, 2022

Study Start

October 3, 2022

Primary Completion

February 15, 2023

Study Completion

February 15, 2023

Last Updated

August 9, 2024

Results First Posted

August 9, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)