The Reducing Risk Study

November 16, 2023 updated by: University of California, San Francisco

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • Recruiting
        • University of California, San Francisco
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mTranS-C
Access to a mobile and computer accessible adaptation of Transdiagnostic Sleep and Circadian Intervention
Behavioral: mTranS-C
MOBILE HEALTH
Active Comparator: Control
Access to a mobile and computer accessible control intervention that targets coping skills and sleep education.
Behavioral: Control
MOBILE HEALTH

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline to end of treatment (anticipated average exposure 2 months), months 3 and 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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
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.
baseline, and at months 1, 2, 3 and 8
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.
baseline and at month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Lauren Asarnow, PhD, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

September 5, 2018

First Submitted That Met QC Criteria

September 7, 2018

First Posted (Actual)

September 11, 2018

Study Record Updates

Last Update Posted (Estimated)

November 20, 2023

Last Update Submitted That Met QC Criteria

November 16, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • IRB-47676

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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