The Center for Enhancing Treatment & Utilization for Depression and Emergent Suicidality Phase 2-Study 3-BRITEPath
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Depression
- Sponsor
- University of Pittsburgh
- Enrollment
- 101
- Locations
- 6
- Primary Endpoint
- Depression Severity
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
BRITEPath (BP) aims to support co-located mental health clinicians in the development of a high quality, effective, and personalized safety plan for referred patients who screen positive for depression and/or suicidal ideation.
BRITEPath utilizes BRITE, a safety planning and emotion regulation app that is loaded on the patient's smart phone and has previously been shown to be well accepted and to reduce suicide attempts compared to usual care in psychiatric inpatients (HR = 0.49). To support mental health clinicians in the development of effective safety plans, study investigators will develop Guide2Brite (G2B), which provides step-by-step instructions for the mental health clinician on how to populate BRITE onto the patient's smartphone and BRITEBoard, a clinician dashboard that tracks patient symptoms, app use, and rating on helpfulness of different interventions assessed through BRITE.
Detailed Description
BRITEPath has 3 components: 1) BRITE, an emotion regulation and safety planning phone app that is delivered by a co-located mental health (MH) clinician to adolescents at the time of their first therapy appointment; 2) Guide2Brite, which will guide the co-located MH clinician in working with the adolescent to population content onto BRITE; and 3) BRITEBoard, which is a clinician dashboard delivered to the MH clinician and PCP. Assignment of Interventions: This study will utilize a 1:1 randomization scheme to randomize participants to receive BRITEPath intervention or Treatment as Usual (TAU). Hypothesis: The use of BRITEPath will decrease depressive symptoms, distress, and suicidality (any self-injurious ideation, urges, or behavior) as well as improve overall functioning compared to TAU.
Investigators
Stephanie Stepp
Associate Professor of Psychiatry and Psychology
University of Pittsburgh
Eligibility Criteria
Inclusion Criteria
- •Youth aged 12-26yo
- •Own a device (e.g. smartphone, iPod, tablet) with capability to download BRITE app
- •Biological or adoptive parent is willing to provide informed consent for teen to participate
- •Youth speaks and understands English
- •Positive PHQ score or provider determines youth has depressive symptoms based on clinical interaction and refers youth to the study (in cases when PHQ is not available and study staff will complete the PHQ during the screening) OR Provider can refer if they are unclear if symptoms are depressive and PHQ scoring will be used to determine youth's eligibility. OR Screening Wizard screening questionnaire (which includes the PHQ and depressive symptom questions) indicates depression OR provider/parent have concern that youth/patient has a mood or behavioral problem
- •Family agrees to see an (embedded) MH therapist at the practice
- •PHQ scores: Score of 8 or higher on PHQ-8 -or- Score of 1 or higher on #9 of PHQ-9 suicidality item
Exclusion Criteria
- •Non English speaking
- •No parent willing to provide informed consent
- •No cell phone capability of downloading BRITE app
- •Is currently experiencing mania or psychosis
- •Evidence of an intellectual or developmental disorder (IDD)
- •Life threatening medical condition that requires immediate treatment (including emergent suicidality, homicidally, abuse/neglect, or other mental or physical condition)
- •Other cognitive or medical condition preventing youth from understanding study and/or participating.
- •Currently receiving MH treatment/currently satisfied with treatment
Outcomes
Primary Outcomes
Depression Severity
Time Frame: At 12 week follow up after Baseline
Total scores from the Patient Health Questionnaire (PHQ-9) will be used to assess depression severity, as a primary outcome. The PHQ-9 is a 9 items assessment with scoring ranging from 0-27. The higher the score, the more severe the depression symptoms are. A score of 0-4= no depression; 5-9= mild depression; 10-14= moderate depression; 15-19= moderately severe depression; 20-27= severe depression symptoms.
Suicidal Ideation and Behavior
Time Frame: At 12 week follow up after Baseline
Suicide attempt \& ideation is measured through Columbia Suicide Severity Rating Scale (C-SSRS) and Patient Health Questionnaire (PHQ-9). Assign score of 0 if no ideation/behavior present or answer is "No", assign a score of 1 if ideation/behavior present or "Yes." A "Yes" to question 9 (score=1) on PHQ-9 indicates suicidal ideation. Suicidal ideation or behavior= "yes" answer to any of suicidal behavior questions (Categories 7-10) on the CSSRS. 7- Aborted Attempt 8- Interrupted Attempt 9- Actual Attempt (non-fatal) 10- Completed Suicide. Any score greater than 0 is important/may indicate need for intervention and may indicate worse outcomes.
Quality of Life and Social/Emotional Functioning
Time Frame: At 12 week follow up after Baseline
Pediatric Quality of Life Inventory Version 4 assesses quality of life and functioning. Items on the Pediatric Quality of Life Generic Core Scales are reverse scored \& transformed to 0-100 scale. Higher scores indicate better health related quality of life. 0 ("Never") = 100; 1 ("Almost Never") = 75; 2 ("Sometimes") = 50; 3 ("Often") = 25; 4 ("Almost Always") = 0. The total score is Sum of all items over number of items answered.
Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication)
Time Frame: 12 week follow up
The Child and Adolescent Service Assessment (CASA) collects service utilization of all participants to determine the amount of services accessed. The CASA response data displayed are those who responded positively that they received the service. Those who said yes to receiving the service is scored as a 1. Multiple participants can say yes to more than 1 service.
Secondary Outcomes
- Satisfaction With Technical Components(At exit interview following week 4 study visit or week 12 study visit (depending on when youth attends mental health session that uses BRITEPath tools))
- Application Utilization-BRITE App Use by Participants(Up to 12 week follow up)
- Application Utilization-Number of Participants With Provider Who Completed Guide2BRITE Onboarding Process(Up to 12 week follow up)
- Cost Estimate for Implementation of BRITEPath Intervention(At 12 week follow up after Baseline)
- Usability and Satisfaction(At exit interview following week 4 study visit or week 12 study visit (depending on when youth attends mental health session that uses BRITEPath tools))