Better Sleep Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-18
SponsorChildren's Hospital Los Angeles
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
TranS-C
BehavioralTransdiagnostic Sleep and Circadian Intervention (TranS-C) is an evidence based cognitive-behavioral sleep therapy.
Psychoeducation
BehavioralThe overarching principle is to provide information about how sleep, stress, diet, health, exercise, accidents and mood are inter-related and have reciprocal effects.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: TranS-CExperimental treatment 1 intervention
Group B: PsychoeducationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in phase angle difference (PAD) between DLMO and waketime (PADDLMO WAKETIME )
Validated biological and behavioral assessment; range between 0 and 11 hours, with shorter numbers indicating worse alignment between circadian biology and behavior
Time frame
baseline to end of treatment (0 and 2 months)2
Change in Children's Depression Rating Scale (CDRS-R)
Validated clinician administered depression symptom severity scale; range between 17 and 133, with higher numbers indicative of greater depression severity
Time frame
baseline to end of treatment (anticipated average exposure 2 months), months 8 and 14Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Children's Hospital Los Angeles
Lead sponsor
Stanford University
Collaborator
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov