Better Sleep Study

Study Overview
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Brief Summary
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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.

Official Title
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A Confirmatory Efficacy Trial of Engaging a Novel Sleep/Circadian Rhythm Target as Treatment for Depression in Adolescents

Conditions
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Depression in Adolescence, Delayed Sleep Phase

Intervention / Treatment
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* Behavioral: TranS-C
* Behavioral: Psychoeducation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TranS-C<br> | Behavioral: TranS-C<br>* Transdiagnostic Sleep and Circadian Intervention (TranS-C) is an evidence based cognitive-behavioral sleep therapy.<br>|
| Active Comparator: Psychoeducation<br> | Behavioral: Psychoeducation<br>* The overarching principle is to provide information about how sleep, stress, diet, health, exercise, accidents and mood are inter-related and have reciprocal effects.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | baseline to end of treatment (0 and 2 months) | 
| 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 | baseline to end of treatment (anticipated average exposure 2 months), months 8 and 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Adolescents, Sleep, Intervention