The Reducing Risk Study
Reducing Risk: A Comprehensive mHealth Sleep Health Intervention for Adolescents at Risk for Depression and Anxiety Disorders
1 other identifier
interventional
59
1 country
1
Brief Summary
The present study will test an innovative mobile health adaptation of a behavioral intervention that improves sleep and mental health concerns among adolescents.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 5, 2018
CompletedFirst Posted
Study publicly available on registry
September 11, 2018
CompletedStudy Start
First participant enrolled
September 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 24, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 24, 2024
CompletedJuly 24, 2026
July 1, 2026
4.1 years
September 5, 2018
July 23, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Pittsburgh Sleep Quality Index (PSQI)
Validated questionnaire; total score range between 0 and 21, with higher numbers representing worse sleep quality
baseline to end of treatment (anticipated average exposure 2 months), months 3 and 8
Secondary Outcomes (3)
Change in the PHQ-9 (The 9 Item Patient Health Questionnaire For Depression)
baseline to end of treatment (anticipated average exposure 2 months), months 3 and 8
Change in the SCARED (Screen for Child Anxiety Related Disorders) total score
baseline, and at months 1, 2, 3 and 8
Change in cortisol reactivity and recovery in response to a stress exposure
baseline and at month 3
Study Arms (2)
mTranS-C
EXPERIMENTALAccess to a mobile and computer accessible adaptation of Transdiagnostic Sleep and Circadian Intervention
Control
ACTIVE COMPARATORAccess to a mobile and computer accessible control intervention that targets coping skills and sleep education.
Interventions
Eligibility Criteria
You may not qualify if:
- any current psychiatric illness
- currently use of medications or herbs with known effects on sleep
- hospitalization for substance use or suicide within the past 12 months
- known sleep apnea
- unstable major medical conditions
- current psychotherapy for depression, anxiety or sleep health deficits
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California, San Francisco
San Francisco, California, 94143, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lauren Asarnow, PhD
University of California, San Francisco
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Participants are asked to refrain from mentioning any information about the treatment they receive when interacting with the investigator or outcomes assessors
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2018
First Posted
September 11, 2018
Study Start
September 1, 2020
Primary Completion
October 24, 2024
Study Completion
October 24, 2024
Last Updated
July 24, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share