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OpenTrials
Completed

NCT Number: NCT03665337

The Reducing Risk Study

The present study will test an innovative mobile health adaptation of a behavioral intervention that improves sleep and mental health concerns among adolescents.

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Key information

Conditions

Insomnia Delayed Sleep Phase Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Exclusion criteria

  • 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

Treatment and study plan

mTranS-C

Behavioral

MOBILE HEALTH

Control

Behavioral

MOBILE HEALTH

Primary outcomes

  1. Change in Pittsburgh Sleep Quality Index (PSQI)

    Time frame: baseline to end of treatment (anticipated average exposure 2 months), months 3 and 8

    Validated questionnaire; total score range between 0 and 21, with higher numbers representing worse sleep quality

Secondary outcomes

  1. Change in the PHQ-9 (The 9 Item Patient Health Questionnaire For Depression)

    Time frame: baseline to end of treatment (anticipated average exposure 2 months), months 3 and 8

    A validated questionnaire measuring depressive symptom severity. The total score ranges between 0 and 19. Scores are rated as minimal (0-4), mild (5-9), moderate (10-14), and severe (15-19).

  2. Change in the SCARED (Screen for Child Anxiety Related Disorders) total score

    Time frame: baseline, and at months 1, 2, 3 and 8

    A validated 41-item questionnaire assessing self-report of anxiety in children and adolescents. Individual items are rated 'Not True or Hardly Ever True' (Score 0), 'Somewhat True or Sometimes True' (Score 1), or 'Very True or Often True' (Score 2). Individual response scores are then summed and for a total score. Total scores range from 0 to 82.

  3. Change in cortisol reactivity and recovery in response to a stress exposure

    Time frame: baseline and at month 3

    A validated biological measure of stress reactivity and recovery in response to a stress exposure. Changes in cortisol production at 15, 30 and 45 minutes following a stressor will be evaluated.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

Reducing Risk: A Comprehensive mHealth Sleep Health Intervention for Adolescents at Risk for Depression and Anxiety Disorders

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Sep 11, 2018
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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