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.|
|ClinicalTrials.gov Identifier: NCT03665337|
Recruitment Status : Not yet recruiting
First Posted : September 11, 2018
Last Update Posted : August 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Insomnia Delayed Sleep Phase||Behavioral: mTranS-C Behavioral: inJOY||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|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|
|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|
Access to a mobile and computer accessible adaptation of Transdiagnostic Sleep and Circadian Intervention
Active Comparator: inJOY
Access to a mobile and computer accessible control intervention that targets coping skills and sleep education.
- 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
- 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).
- 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT03665337
|Contact: Lauren Asarnow, PhDemail@example.com|