Trial Outcomes & Findings for A Feasibility Open Trial of App-Enhanced Brief CBT for Suicidal Inpatients (NCT NCT05486091)

Last Updated: 2024-08-09

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

4 participants

Primary outcome timeframe

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

Results posted on

2024-08-09

Participant Flow

Participant milestones

Participant milestones
Measure	App-Enhanced Brief Cognitive-Behavioral Therapy Up to 4 in-person sessions 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.
Overall Study STARTED	4
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	App-Enhanced Brief Cognitive-Behavioral Therapy Up to 4 in-person sessions 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.
Overall Study Withdrawal by Subject	1
Overall Study Lost to Follow-up	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	App-Enhanced Brief Cognitive-Behavioral Therapy n=4 Participants Up to 4 in-person sessions 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	22.00 years STANDARD_DEVIATION 2.83 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Suicidal Ideation Baseline	82.00 score on a scale STANDARD_DEVIATION 58.09 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	App-Enhanced Brief Cognitive-Behavioral Therapy n=3 Participants Up to 4 in-person sessions 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.
Client Satisfaction at Discharge	29.00 score on a scale Standard Deviation 3.61

PRIMARY outcome

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

Outcome measures

Outcome measures
Measure	App-Enhanced Brief Cognitive-Behavioral Therapy n=3 Participants Up to 4 in-person sessions 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.
App Usability at Discharge	95.00 score on a scale Standard Deviation 4.33

PRIMARY outcome

Timeframe: 3 months post-discharge from inpatient unit

Frequency (percentage) of participants who made a suicide attempt over the entire follow-up period

Outcome measures

Outcome measures
Measure	App-Enhanced Brief Cognitive-Behavioral Therapy n=3 Participants Up to 4 in-person sessions 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.
Frequency of Suicide Attempts	0 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	App-Enhanced Brief Cognitive-Behavioral Therapy n=4 Participants Up to 4 in-person sessions 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.
Suicidal Ideation Baseline	82.00 score on a scale Standard Deviation 58.09

PRIMARY outcome

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

Outcome measures

Outcome measures
Measure	App-Enhanced Brief Cognitive-Behavioral Therapy n=3 Participants Up to 4 in-person sessions 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.
Suicidal Ideation at Discharge	46.67 score on a scale Standard Deviation 19.14

PRIMARY outcome

Timeframe: 1 month after discharge

Outcome measures

Outcome measures
Measure	App-Enhanced Brief Cognitive-Behavioral Therapy n=3 Participants Up to 4 in-person sessions 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.
Suicidal Ideation 1 Month	21.00 score on a scale Standard Deviation 7.21

PRIMARY outcome

Timeframe: 2 months after discharge

Outcome measures

Outcome measures
Measure	App-Enhanced Brief Cognitive-Behavioral Therapy n=1 Participants Up to 4 in-person sessions 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.
Suicidal Ideation 2 Months	25.00 score on a scale Standard Deviation 0

PRIMARY outcome

Timeframe: 3 months after discharge

Outcome measures

Outcome measures
Measure	App-Enhanced Brief Cognitive-Behavioral Therapy n=1 Participants Up to 4 in-person sessions 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.
Suicidal Ideation 3 Months	45.00 score on a scale Standard Error 0

Adverse Events

App-Enhanced Brief Cognitive-Behavioral Therapy

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	App-Enhanced Brief Cognitive-Behavioral Therapy n=4 participants at risk Up to 4 in-person sessions 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.
Psychiatric disorders Side effects from new medication	25.0% 1/4 • Number of events 1 • 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.
Psychiatric disorders ED visit	25.0% 1/4 • Number of events 1 • 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.

Additional Information

Gretchen Diefenbach, Ph.D.

Anxiety Disorders Center

Phone: 860-545-7396

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place