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| Name | Class |
|---|---|
| Oui Therapeutics, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| App-Enhanced Brief Cognitive-Behavioral Therapy | Experimental | Up to 4 in-person sessions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| App-Enhanced Brief Cognitive-Behavioral Therapy | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gretchen Diefenbach, PhD | Anxiety Disorders Center, Institute of Living | Principal Investigator |
| David Tolin, PhD | Anxiety Disorders Center, Institute of Living | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anxiety Disorders Center, Institute of Living | Hartford | Connecticut | 06106 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Assessed at completion of inpatient treatment (average of 16 days from admission) |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Side effects from new medication | Psychiatric disorders | Systematic Assessment | Increased anxiety and shaking associated with new medication (lithium) during inpatient stay |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gretchen Diefenbach, Ph.D. | Anxiety Disorders Center | 860-545-7396 | gretchen.diefenbach@hhchealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 17, 2023 | Apr 19, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 22, 2022 | Apr 19, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D016728 | Self-Injurious Behavior |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| 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 |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 will be reported utilizing all available data. | Mean | Standard Deviation | score on a scale |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Assessed at completion of inpatient treatment (average of 16 days from admission) |
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| Primary | Frequency of Suicide Attempts | Frequency (percentage) of participants who made a suicide attempt over the entire follow-up period | Posted | Count of Participants | Participants | 3 months post-discharge from inpatient unit |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline (before receiving BCBT intervention) |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Assessed at completion of inpatient treatment (average of 16 days from admission) |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | 1 month after discharge |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | 2 months after discharge |
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| 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. | Posted | Mean | Standard Error | score on a scale | 3 months after discharge |
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| 0 |
| 4 |
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| 1 |
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| ED visit | Psychiatric disorders | Systematic Assessment | ED visit for medication refill only |
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