Suicidal and Self-injurious BehaviorNCT05486091

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

A study testing App-Enhanced Brief Cognitive-Behavioral Therapy in people with Suicidal and Self-injurious Behavior, run by Hartford Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 24 years
Conditions the study is for: Suicidal and Self-injurious Behavior
What is being tested?: App-Enhanced Brief Cognitive-Behavioral Therapy
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4 participants
Where: 1 siteUnited States
Study dates: 3 Oct 2022to 15 Feb 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 24 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Anxiety Disorders Center, Institute of Living
Hartford, Connecticut, 06106

Other trials in United States

About this study

Read the 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.

Conditions: Suicidal and Self-injurious Behavior
Being tested: App-Enhanced Brief Cognitive-Behavioral Therapy
Medical subject headings: Self-Injurious Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

App-Enhanced Brief Cognitive-Behavioral TherapyBehavioural
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.

Study groups in NCT05486091
Study group	Role	What they receive
App-Enhanced Brief Cognitive-Behavioral Therapy	Experimental	Up to 4 in-person sessions Receives: Behavioral: App-Enhanced Brief Cognitive-Behavioral Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months after discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Oct 202215 Feb 2023

First posted3 Aug 2022
Study start3 Oct 2022
Primary completion15 Feb 2023
Study completion15 Feb 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Suicidal and Self-injurious BehaviorStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 4 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05486091
Sponsor's protocol ID: HHC-2022-0057
Status last verified: Mar 2024
First submitted: 25 Jul 2022
Last updated: 9 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Examining the Effectiveness of a Brief Therapeutic Intervention for Reducing Self-Harm Among Adolescents
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Recruiting
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Recruiting
Neurobiological Markers of Non-suicidal Self-injury and Treatment Mechanisms of Adolescent Self-injury Intervention Skills Training
Non-suicidal Self-injury (NSSI), Adolescent
RecruitingObservational study
Evaluation of National Highly Specialized Care for Children and Adolescents With Severe Self-Harm or Eating Disorders
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Recruiting
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All Suicidal and Self-injurious Behavior trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Feasibility Open Trial of App-Enhanced Brief CBT for Suicidal Inpatients
ClinicalTrials.gov ID: NCT05486091
Acronym / sponsor ID: HHC-2022-0057
Conditions: Suicidal and Self-injurious Behavior
Study type: Interventional
Recruitment status: Completed
Enrolment: 4 participants (actual)
Lead sponsor: Hartford HospitalUniversity, hospital or other
Collaborators: Oui Therapeutics, Inc.
Study start: 3 Oct 2022 (actual)
Primary completion: 15 Feb 2023 (actual)
Study completion: 15 Feb 2023 (actual)
First posted: 3 Aug 2022 (actual)
Results: Posted 9 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
App-Enhanced Brief Cognitive-Behavioral Therapy	Experimental	Behavioral: App-Enhanced Brief Cognitive-Behavioral TherapyUp to 4 in-person sessions

Who may qualify

Ages: 18 to 24 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
App-Enhanced Brief Cognitive-Behavioral TherapyBCBT 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.	Behavioural	App-Enhanced Brief Cognitive-Behavioral Therapy

Primary outcome

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.
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.
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
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.
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.
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.
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.
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.

Results and safety

Results posted to the registry on 9 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
App-Enhanced Brief Cognitive-Behavioral Therapy	4	1

Primary outcome: Client Satisfaction at Discharge

Time frame: Assessed at completion of inpatient treatment (average of 16 days from admission). Mean (Standard Deviation). Unit: score on a scale

Measure	App-Enhanced Brief Cognitive-Behavioral Therapy n = 3
Value	29.00 (3.61)

Primary outcome: App Usability at Discharge

Time frame: Assessed at completion of inpatient treatment (average of 16 days from admission). Mean (Standard Deviation). Unit: score on a scale

Measure	App-Enhanced Brief Cognitive-Behavioral Therapy n = 3
Value	95.00 (4.33)

Primary outcome: Frequency of Suicide Attempts

Time frame: 3 months post-discharge from inpatient unit. Count of participants. Unit: Participants

Measure	App-Enhanced Brief Cognitive-Behavioral Therapy n = 3
Value	0

Primary outcome: Suicidal Ideation Baseline

Time frame: Baseline (before receiving BCBT intervention). Mean (Standard Deviation). Unit: score on a scale

Measure	App-Enhanced Brief Cognitive-Behavioral Therapy n = 4
Value	82.00 (58.09)

Adverse events

Time frame: Adverse event data was collected during the participants' inpatient admission (average length of stay 16 days) and 3 months after their discharge from the inpatient unit.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
App-Enhanced Brief Cognitive-Behavioral Therapy	0 of 4 (0%)	1 of 4 (25%)	0 of 4

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Suicidal and Self-injurious Behavior

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Examining the Effectiveness of a Brief Therapeutic Intervention for Reducing Self-Harm Among Adolescents
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Recruiting
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gretchen Diefenbach, PhD principal investigator

Anxiety Disorders Center, Institute of Living

David Tolin, PhD principal investigator

Anxiety Disorders Center, Institute of Living

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing App-Enhanced Brief Cognitive-Behavioral Therapy in people with Suicidal and Self-injurious Behavior, run by Hartford Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Client Satisfaction at Discharge (time frame: Assessed at completion of inpatient treatment (average of 16 days from admission)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05486091.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024; AzTrials last refreshed its copy on 6 Nov 2026.