The Reducing Risk Study

Not Applicable

Recruiting

• Conditions: Insomnia; Delayed Sleep Phase
• Interventions: Behavioral: mTranS-C; Behavioral: Control

• Registration Number: NCT03665337
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-05
• Study First Submitted QC: 2018-09-07
• Study First Posted: 2018-09-11
• Study Start: 2020-09-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-16
• Last Update Posted: 2023-11-18
• Primary Completion: 2024-08-01
• Study Completion: 2024-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mTranS-C	mTranS-C	Access to a mobile and computer accessible adaptation of Transdiagnostic Sleep and Circadian Intervention
Control	Control	Access to a mobile and computer accessible control intervention that targets coping skills and sleep education.

Primary Outcome Measures

Name	Time	Method
Change in Pittsburgh Sleep Quality Index (PSQI)	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

Name	Time	Method
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	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 cortisol reactivity and recovery in response to a stress exposure	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.
Change in the SCARED (Screen for Child Anxiety Related Disorders) total score	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.

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States