N/A
N=101
BRITEPath- Phase 2
Depression · Suicidal Ideation
Bottom Line
View on ClinicalTrials.gov: NCT04672798 ↗Enrolled (actual)
101
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcome: Primary: Depression Severity — 8.6; 10.8 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- BRITEPath (Behavioral); Treatment As Usual (TAU) (Behavioral)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- All
- Sponsor
- University of Pittsburgh
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Depression Severity |
8.3; 10 | — |
| PRIMARY Depression Severity |
8.3; 10 | — |
| PRIMARY Suicidal Ideation and Behavior |
0.2; 0.4; 0; 0; 0; 0 | — |
| PRIMARY Suicidal Ideation and Behavior |
0.2; 0.4; 0; 0; 0; 0 | — |
| PRIMARY Quality of Life and Social/Emotional Functioning |
87.2; 74; 63.7; 50.6; 82.6; 72.2 | — |
| PRIMARY Quality of Life and Social/Emotional Functioning |
87.2; 74; 63.7; 50.6; 82.6; 72.2 | — |
| PRIMARY Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) |
45; 23; 4; 1; 0; 0 | — |
| PRIMARY Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) |
45; 23; 4; 1; 0; 0 | — |
| SECONDARY Application Utilization-BRITE App Use by Participants |
37; 31; 29; 39; 4; 64 | — |
| SECONDARY Application Utilization-Number of Participants With Provider Who Completed Guide2BRITE Onboarding Process |
41; 27; 41; 27; 41; 27 | — |
| SECONDARY Cost Estimate for Implementation of BRITEPath Intervention |
457.43 | — |
| SECONDARY Usability and Satisfaction |
2; 11; 26; 11 | — |
| SECONDARY Usability and Satisfaction |
2; 11; 26; 11 | — |
| SECONDARY Usability and Satisfaction |
2; 11; 26; 11 | — |
| SECONDARY Satisfaction With Technical Components |
4.7; 5.2; 5; 5.3; 4.6; 1.8 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04672798). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.