The Reducing Risk Study

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03665337
• Other study ID #: IRB-47676
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: August 1, 2024

Study information

• Verified date: November 2023
• Source: University of California, San Francisco
• Contact: Lauren Asarnow, PhD
• Phone: (415) 476-7439
• Email: Lauren.Asarnow[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Delayed Sleep Phase
• Insomnia

Intervention

Behavioral:
• mTranS-C
MOBILE HEALTH
• Control
MOBILE HEALTH

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Pittsburgh Sleep Quality Index (PSQI)	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	Change in the PHQ-9 (The 9 Item Patient Health Questionnaire For Depression)	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
Secondary	Change in the SCARED (Screen for Child Anxiety Related Disorders) total score	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
Secondary	Change in cortisol reactivity and recovery in response to a stress exposure	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