Clinical trial NCT05486091: 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
Overall status: COMPLETED
Phase: NA
Conditions: Suicidal and Self-injurious Behavior
Lead sponsor: Hartford Hospital
Sponsor class: OTHER
Collaborators: name: Oui Therapeutics, Inc.
First posted: 2022-08-03
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Client Satisfaction at Discharge
timeFrame: Assessed at completion of inpatient treatment (average of 16 days from admission)
measure: App Usability at Discharge
timeFrame: Assessed at completion of inpatient treatment (average of 16 days from admission)
measure: Frequency of Suicide Attempts
timeFrame: 3 months post-discharge from inpatient unit
measure: Suicidal Ideation Baseline
timeFrame: Baseline (before receiving BCBT intervention)
measure: Suicidal Ideation at Discharge
timeFrame: Assessed at completion of inpatient treatment (average of 16 days from admission)
measure: Suicidal Ideation 1 Month
timeFrame: 1 month after discharge
measure: Suicidal Ideation 2 Months
timeFrame: 2 months after discharge
measure: Suicidal Ideation 3 Months
timeFrame: 3 months after discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Anxiety Disorders Center, Institute of Living
state: Connecticut
Study officials:
affiliation: Anxiety Disorders Center, Institute of Living
name: Gretchen Diefenbach, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Anxiety Disorders Center, Institute of Living
name: David Tolin, PhD
role: PRINCIPAL_INVESTIGATOR
References: