NCT04672798

BRITEPath- Phase 2

Completed NA Results posted Last updated 5 June 2023

What this trial tests

NA trial testing BRITEPath in Depression in 101 participants. Completed in 31 July 2022.

Timeline

5 November 2020

Primary endpoint
23 March 2022

31 July 2022

Quick facts

Lead sponsor	University of Pittsburgh
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	health services research
Enrollment	101
Start date	5 November 2020
Primary completion	23 March 2022
Estimated completion	31 July 2022
Sites	6 locations across United States

Drugs / interventions tested

• BRITEPath
• Treatment As Usual (TAU) — full drug profile →

Conditions studied

• Depression — all drugs for Depression →
• Suicidal Ideation — all drugs for Suicidal Ideation →

Sponsor

University of Pittsburgh

Who can join

Adults 12 to 26, any sex, with Depression or Suicidal Ideation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Depression Severity Primary · At 4 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.

Group	Value	95% CI
BRITEPath	8.6	± 5.6
Treatment As Usual (TAU)	10.8	± 5.4

Depression Severity Primary · 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.

Group	Value	95% CI
BRITEPath	8.3	± 5.4
Treatment As Usual (TAU)	10	± 5.9

Suicidal Ideation and Behavior Primary · At 4 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

PHQ-9 question #9

Group	Value	95% CI
BRITEPath	0.3	± 0.7
Treatment As Usual (TAU)	0.5	± 0.9

C-SSRS Category 7: Aborted Attempt

Group	Value	95% CI
BRITEPath	0	± 0
Treatment As Usual (TAU)	0	± 0

C-SSRS Category 8: Interrupted Attempt

Group	Value	95% CI
BRITEPath	0	± 0
Treatment As Usual (TAU)	0	± 0

C-SSRS Category 9: Actual Attempt (non-fatal)

Group	Value	95% CI
BRITEPath	0	± 0
Treatment As Usual (TAU)	0	± 0

C-SSRS Category 10: Completed Suicide

Group	Value	95% CI
BRITEPath	0	± 0
Treatment As Usual (TAU)	0	± 0

Suicidal Ideation and Behavior Primary · 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

PHQ-9 Question 9 (ideation)

Group	Value	95% CI
BRITEPath	0.2	± 0.5
Treatment As Usual (TAU)	0.4	± 0.7

C-SSRS Category 7: Aborted Attempt

Group	Value	95% CI
BRITEPath	0	± 0.2
Treatment As Usual (TAU)	0	± 0

C-SSRS Category 8: Interrupted Attempt

Group	Value	95% CI
BRITEPath	0	± 0
Treatment As Usual (TAU)	0	± 0

C-SSRS Category 9: Actual Attempt (non-fatal)

Group	Value	95% CI
BRITEPath	0	± 0
Treatment As Usual (TAU)	0	± 0

C-SSRS Category 10: Completed Suicide

Group	Value	95% CI
BRITEPath	0	± 0
Treatment As Usual (TAU)	0	± 0

Quality of Life and Social/Emotional Functioning Primary · At 4 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.

PEDS QOL Physical Score

Group	Value	95% CI
BRITEPath	89.3	± 11.5
Treatment As Usual (TAU)	71.5	± 22.5

PEDS QOL Emotional Score

Group	Value	95% CI
BRITEPath	68.7	± 25.9
Treatment As Usual (TAU)	60.6	± 20.8

PEDS QOL Social Score

Group	Value	95% CI
BRITEPath	81.6	± 24.1
Treatment As Usual (TAU)	76.1	± 25.8

PEDS QOL Psychosocial Health Summary Score

Group	Value	95% CI
BRITEPath	73.5	± 21.6
Treatment As Usual (TAU)	64.4	± 19.9

PEDS QOL Total Score

Group	Value	95% CI
BRITEPath	79	± 16.4
Treatment As Usual (TAU)	67	± 20.4

Quality of Life and Social/Emotional Functioning Primary · 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.

PEDS QOL Physical Score

Group	Value	95% CI
BRITEPath	87.2	± 15.2
Treatment As Usual (TAU)	74	± 20.4

PEDS QOL Emotional Score

Group	Value	95% CI
BRITEPath	63.7	± 25.4
Treatment As Usual (TAU)	50.6	± 20.7

PEDS QOL Social Score

Group	Value	95% CI
BRITEPath	82.6	± 27.6
Treatment As Usual (TAU)	72.2	± 29.4

PEDS QOL Psychosocial Health Summary Score

Group	Value	95% CI
BRITEPath	72.8	± 23.2
Treatment As Usual (TAU)	61.7	± 16.4

PEDS QOL Total Score

Group	Value	95% CI
BRITEPath	77.8	± 19.3
Treatment As Usual (TAU)	65.9	± 16.4

Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) Primary · 4 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.

Use outpatient services

Group	Value	95% CI
BRITEPath	45
Treatment As Usual (TAU)	25

Use school services

Group	Value	95% CI
BRITEPath	5
Treatment As Usual (TAU)	2

Use emergency services

Group	Value	95% CI
BRITEPath	0
Treatment As Usual (TAU)	0

Use legal services

Group	Value	95% CI
BRITEPath	0
Treatment As Usual (TAU)	0

Use inpatient services

Group	Value	95% CI
BRITEPath	1
Treatment As Usual (TAU)	0

Use medications

Group	Value	95% CI
BRITEPath	33
Treatment As Usual (TAU)	18

Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) Primary · 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.

Use outpatient services

Group	Value	95% CI
BRITEPath	45
Treatment As Usual (TAU)	23

Use school services

Group	Value	95% CI
BRITEPath	4
Treatment As Usual (TAU)	1

Use emergency services

Group	Value	95% CI
BRITEPath	0
Treatment As Usual (TAU)	0

Use legal services

Group	Value	95% CI
BRITEPath	0
Treatment As Usual (TAU)	0

Use inpatient services

Group	Value	95% CI
BRITEPath	1
Treatment As Usual (TAU)	0

Use medications

Group	Value	95% CI
BRITEPath	32
Treatment As Usual (TAU)	14

Application Utilization-BRITE App Use by Participants Secondary · Up to 12 week follow up

Use of the technical components of interventions and web portals for BRITEPath with be monitored throughout Phase 2. Utilization will be measured by the number of participants who have engaged with the application over time, including rating distress levels in the app and utilizing the following app features: learn to savor, reaching out to contacts, soothe breathe, sooth guided meditation, crisis survival strategies, distract with happy thoughts, distract exercise, savor, and soothe activities to help you sleep.

First distress level

Group	Value	95% CI
BRITEPath	37
BRITEPath	31

Second distress level

Group	Value	95% CI
BRITEPath	29
BRITEPath	39

Learn to savor

Group	Value	95% CI
BRITEPath	4
BRITEPath	64

Reaching out to contacts

Group	Value	95% CI
BRITEPath	11
BRITEPath	57

Soothe Breathe

Group	Value	95% CI
BRITEPath	17
BRITEPath	51

Soothe Guided Meditation

Group	Value	95% CI
BRITEPath	9
BRITEPath	59

Crisis survival strategies

Group	Value	95% CI
BRITEPath	14
BRITEPath	54

Distract with happy thoughts

Group	Value	95% CI
BRITEPath	17
BRITEPath	51

Application Utilization-Number of Participants With Provider Who Completed Guide2BRITE Onboarding Process Secondary · Up to 12 week follow up

Use of the technical components of interventions and web portals for BRITEPath with be monitored throughout Phase 2. Use of the technical components of Guide2BRITE and the BRITEPortal for physicians will be monitored throughout Phase 1b. Utilization will be measured by the number of providers who have completed the Guide2BRITE onboarding process which includes steps 1, 1.2, 1.3, 2, 2.1, 2.2, 2.3, 2.4, 2.5, 3, 3.2, 4, 4.1, and 5. Each step includes text field components of a standard safety plan that needs to be completed. Providers who clicked "next" at each step after filling in the text boxe

Step 1

Group	Value	95% CI
BRITEPath	41
BRITEPath	27

Step 1.2

Group	Value	95% CI
BRITEPath	41
BRITEPath	27

Step 1.3

Group	Value	95% CI
BRITEPath	41
BRITEPath	27

Step 2

Group	Value	95% CI
BRITEPath	0
BRITEPath	68

Step 2.1

Group	Value	95% CI
BRITEPath	41
BRITEPath	27

Step 2.2

Group	Value	95% CI
BRITEPath	41
BRITEPath	27

Step 2.3

Group	Value	95% CI
BRITEPath	41
BRITEPath	27

Step 2.4

Group	Value	95% CI
BRITEPath	41
BRITEPath	27

Cost Estimate for Implementation of BRITEPath Intervention Secondary · At 12 week follow up after Baseline

An overall average of the cost of implementing the BRITEPath intervention (including labor, equipment, supplies, facilities) will be estimated. Outcome measure data below highlights the estimated cost of the intervention BRITEPath Intervention per participant, measures were based on estimates from staff and not on empirical data at the individual level.

Group	Value	95% CI
BRITEPath	457.43	214.10 – 597.05

Usability and Satisfaction Secondary · 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)

Satisfaction to BRITEPath will be assessed through questions developed by investigators to understand experience with the program. Questions investigators have adapted from literature reviews on satisfaction include: "If a friend were in need of mental health care for depression or suicidal thoughts or behaviors, would you recommend BRITEPath to help him/her manage symptoms?" The response options include: No, definitely not; No, I don't think so; Yes, I think so; Yes, definitely

Group	Value	95% CI
BRITEPath	8
BRITEPath	8
BRITEPath	19
BRITEPath	16

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data was collected over course of open enrollment and follow up data collection (11/05/2020 to 03/23/2022). Adverse event data was collected for each individual over 12 weeks that they were engaged in the study.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

BRITEPath

Serious: 0/68 (0%)

Deaths: 0/68

Treatment As Usual (TAU)

Serious: 0/33 (0%)

Deaths: 0/33

Other adverse events (1 terms — click to expand)

Reaction	System	BRITEPath	Treatment As Usual (TAU)
Unanticipated problem-Breach of confidentiality	Psychiatric disorders	—	—

Data from ClinicalTrials.gov NCT04672798 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Examining BRITEpath, a Digital Intervention for Reducing Adolescent Suicide Risk in Primary Care: A Randomized-Controlled Trial.
   Toukhy N, Biernesser C, Zelazny J, George-Milford B, et al · · 2026 · PMID 42261184 · DOI 10.1111/sltb.70114