Clinical trial NCT04672798: BRITEPath- Phase 2
Official title: The Center for Enhancing Treatment & Utilization for Depression and Emergent Suicidality Phase 2-Study 3-BRITEPath
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Suicidal Ideation
Keywords: depression
suicidal ideation
anxiety
treatment
app
safety planning
provider
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Kaiser Foundation Research Institute
name: National Institute of Mental Health (NIMH)
First posted: 2020-12-17
Enrollment: 101
Sex: ALL
Minimum age (years): 12
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will use a parallel study design, where participants are randomized into two groups, BRITEPath or TAU, and will receive interventions in parallel.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

1. Youth aged 12-26yo
2. Own a device (e.g. smartphone, iPod, tablet) with capability to download BRITE app
3. Biological or adoptive parent is willing to provide informed consent for teen to participate
4. Youth speaks and understands English
5. 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
6. Family agrees to see an (embedded) MH therapist at the practice
7. 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:

1. Non English speaking
2. No parent willing to provide informed consent
3. No cell phone capability of downloading BRITE app
4. Is currently experiencing mania or psychosis
5. Evidence of an intellectual or developmental disorder (IDD)
6. Life threatening medical condition that requires immediate treatment (including emergent suicidality, homicidally, abuse/neglect, or other mental or physical condition)
7. Other cognitive or medical condition preventing youth from understanding study and/or participating.
8. Currently receiving MH treatment/currently satisfied with treatment

Primary outcomes:
measure: Depression Severity
timeFrame: At 4 week follow up after Baseline
measure: Depression Severity
timeFrame: At 12 week follow up after Baseline
measure: Suicidal Ideation and Behavior
timeFrame: At 4 week follow up after Baseline
measure: Suicidal Ideation and Behavior
timeFrame: At 12 week follow up after Baseline
measure: Quality of Life and Social/Emotional Functioning
timeFrame: At 4 week follow up after Baseline
measure: Quality of Life and Social/Emotional Functioning
timeFrame: At 12 week follow up after Baseline
measure: Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication)
timeFrame: 4 week follow up
measure: Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication)
timeFrame: 12 week follow up
Secondary outcomes:
measure: Application Utilization-BRITE App Use by Participants
timeFrame: Up to 12 week follow up
measure: Application Utilization-Number of Participants With Provider Who Completed Guide2BRITE Onboarding Process
timeFrame: Up to 12 week follow up
measure: Cost Estimate for Implementation of BRITEPath Intervention
timeFrame: At 12 week follow up after Baseline
measure: Usability and Satisfaction
timeFrame: 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)
measure: Usability and Satisfaction
timeFrame: 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)
measure: Usability and Satisfaction
timeFrame: 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)
measure: Satisfaction With Technical Components
timeFrame: 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)
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Hyde Park
country: United States
facility: Northwell Hospital
state: New York
city: Moon
country: United States
facility: Children's Community Pediatrics (CCP-Moon) of Children's Hospital of Pittsburgh of UPMC
state: Pennsylvania
city: Pittsburgh
country: United States
facility: STAR- Center
state: Pennsylvania
city: Wexford
country: United States
facility: Children's Community Pediatrics (CCP- Wexford) of Children's Hospital of Pittsburgh of UPMC
state: Pennsylvania
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: University of Pittsburgh
name: Stephanie Stepp, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: David Brent, MD
role: STUDY_DIRECTOR
References: