Depression in Adolescence, Delayed Sleep Phase
Conditions
Keywords
Depression, Adolescents, Sleep, Intervention
Brief summary
The overall aim of this proposal is a confirmatory efficacy trial sufficiently powered and designed to test the hypothesis that improving the relationship between biological circadian timing and waketime, a novel modifiable target, improves depression outcomes in a subgroup of adolescents with depression and a misaligned relationship between biological circadian timing and waketime utilizing a cognitive-behavioral sleep intervention.
Interventions
BEHAVIORALTranS-C
Transdiagnostic Sleep and Circadian Intervention (TranS-C) is an evidence based cognitive-behavioral sleep therapy.
BEHAVIORALPsychoeducation
The overarching principle is to provide information about how sleep, stress, diet, health, exercise, accidents and mood are inter-related and have reciprocal effects.
Sponsors
Stanford University
National Institute of Mental Health (NIMH)
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
Exclusion criteria
* mental health/behavioral symptoms that would preclude productive engagement in study assessments or intervention (e.g., active psychosis; Bipolar Disorder; drug dependence * severe or unstable medical or psychiatric condition such that treatment has changed within the last month or is expected to change during the course of the study or that would preclude ability to adhere to study procedures (e.g. terminal end-stage cancer) * current use of medications or herbs with known effects on sleep * plan to undergo or have had medication change in the last 8 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in phase angle difference (PAD) between DLMO and waketime (PADDLMO WAKETIME ) | baseline to end of treatment (0 and 2 months) | Validated biological and behavioral assessment; range between 0 and 11 hours, with shorter numbers indicating worse alignment between circadian biology and behavior |
| Change in Children's Depression Rating Scale (CDRS-R) | baseline to end of treatment (anticipated average exposure 2 months), months 8 and 14 | Validated clinician administered depression symptom severity scale; range between 17 and 133, with higher numbers indicative of greater depression severity |
Countries
United States
Contacts
Primary ContactLauren Asarnow, PhD
Outcome results
None listed