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The Reducing Risk Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03665337
Recruitment Status : Not yet recruiting
First Posted : September 11, 2018
Last Update Posted : August 19, 2019
Information provided by (Responsible Party):
Lauren Asarnow, Stanford University

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.

Condition or disease Intervention/treatment Phase
Insomnia Delayed Sleep Phase Behavioral: mTranS-C Behavioral: inJOY Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Participants are asked to refrain from mentioning any information about the treatment they receive when interacting with the investigator or outcomes assessors
Primary Purpose: Treatment
Official Title: Reducing Risk: A Comprehensive mHealth Sleep Health Intervention for Adolescents at Risk for Depression and Anxiety Disorders
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : May 30, 2023
Estimated Study Completion Date : November 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: mTranS-C
Access to a mobile and computer accessible adaptation of Transdiagnostic Sleep and Circadian Intervention
Behavioral: mTranS-C

Active Comparator: inJOY
Access to a mobile and computer accessible control intervention that targets coping skills and sleep education.
Behavioral: inJOY

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03665337

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Contact: Lauren Asarnow, PhD 650-736-4213

Sponsors and Collaborators
Stanford University

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Responsible Party: Lauren Asarnow, Instructor, Stanford University Identifier: NCT03665337     History of Changes
Other Study ID Numbers: IRB-47676
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No