Suicidal and Self-injurious Behavior
Conditions
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.
Interventions
BEHAVIORALApp-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.
Sponsors
Oui Therapeutics, Inc.
Hartford Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 24 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Client Satisfaction at Discharge | 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 | 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 | 3 months post-discharge from inpatient unit | Frequency (percentage) of participants who made a suicide attempt over the entire follow-up period |
| Suicidal Ideation 2 Months | 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 Baseline | 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 | 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 | 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 3 Months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 4 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | App-Enhanced Brief Cognitive-Behavioral Therapy |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Age, Continuous | 22.00 years STANDARD_DEVIATION 2.83 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 4 Participants |
| Suicidal Ideation Baseline | 82.00 score on a scale STANDARD_DEVIATION 58.09 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 4 |
| other Total, other adverse events | 1 / 4 |
| serious Total, serious adverse events | 0 / 4 |
Outcome results
Primary
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.
Time frame: Assessed at completion of inpatient treatment (average of 16 days from admission)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| App-Enhanced Brief Cognitive-Behavioral Therapy | App Usability at Discharge | 95.00 score on a scale | Standard Deviation 4.33 |
Primary
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.
Time frame: Assessed at completion of inpatient treatment (average of 16 days from admission)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| App-Enhanced Brief Cognitive-Behavioral Therapy | Client Satisfaction at Discharge | 29.00 score on a scale | Standard Deviation 3.61 |
Primary
Frequency of Suicide Attempts
Frequency (percentage) of participants who made a suicide attempt over the entire follow-up period
Time frame: 3 months post-discharge from inpatient unit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| App-Enhanced Brief Cognitive-Behavioral Therapy | Frequency of Suicide Attempts | 0 Participants |
Primary
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.
Time frame: 1 month after discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| App-Enhanced Brief Cognitive-Behavioral Therapy | Suicidal Ideation 1 Month | 21.00 score on a scale | Standard Deviation 7.21 |
Primary
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.
Time frame: 2 months after discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| App-Enhanced Brief Cognitive-Behavioral Therapy | Suicidal Ideation 2 Months | 25.00 score on a scale | Standard Deviation 0 |
Primary
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.
Time frame: 3 months after discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| App-Enhanced Brief Cognitive-Behavioral Therapy | Suicidal Ideation 3 Months | 45.00 score on a scale | Standard Error 0 |
Primary
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.
Time frame: Assessed at completion of inpatient treatment (average of 16 days from admission)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| App-Enhanced Brief Cognitive-Behavioral Therapy | Suicidal Ideation at Discharge | 46.67 score on a scale | Standard Deviation 19.14 |
Primary
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.
Time frame: Baseline (before receiving BCBT intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| App-Enhanced Brief Cognitive-Behavioral Therapy | Suicidal Ideation Baseline | 82.00 score on a scale | Standard Deviation 58.09 |