Delayed Sleep Phase, Insomnia
Conditions
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.
Interventions
BEHAVIORALmTranS-C
MOBILE HEALTH
BEHAVIORALControl
MOBILE HEALTH
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, 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
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLauren Asarnow, PhD
University of California, San Francisco
Outcome results
None listed