Recruiting

Observational Study

Sponsor:

University of Oregon

Code:

NCT05691439

Conditions

Depression in Adolescence

Eligibility Criteria

Sex: All

Age: 14 - 18

Healthy Volunteers: Not accepted

Interventions

Sleep extension and advance

Regular sleep duration and timing

Study Details

Brief summary:

This research will use biobehavioral approaches to generate understanding about the linkages between sleep duration and timing, stressful life events, and depressive symptoms in adolescents, with a long-term aim of developing effective preventative interventions.

Conditions

Depression in Adolescence

Study ID

NCT05691439

Start date

Mar 27, 2023

Status verified date

Nov, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. 14-18 years of age
2. Currently in high school
3. short and late sleep (weekday sleep duration ≤ 7 h and bedtime ≥ 22:30 (10:30 pm); n=100) or long and early sleep (weekday sleep duration > 7 hours and bedtime ≤ 22:30 (10:30 pm); n=50), indexed by the Munich Chronotype Questionnaire
4. Lifetime stressful event frequency ≥ 2 on the Stress and Adversity Inventory (STRAIN) Screener
5. Depressive symptom severity t-score greater than or equal to 45 on the Patient Reported Outcomes (PROMIS) Depression scale
6. English language fluency

Exclusion Criteria:

1. Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for current moderate to severe alcohol/substance use disorder (≥4 symptoms);
2. Current clinician-provided diagnosis of narcolepsy or idiopathic hypersomnia;
3. Lifetime diagnosis of bipolar or schizophrenia spectrum disorder;
4. Certain medical conditions (e.g., serious neurological disorder, heart failure or serious heart trouble, history of head injury with unconsciousness > 5 minutes);
5. Conditions that are contraindicated for magnetic resonance imaging (MRI; e.g., ferrous metal in the body);
6. Positive screen for participant-reported eye disease, epilepsy, or photosensitizing medications that are contraindicated during the manipulation condition when bright light is administered (e.g., psychiatric neuroleptic drugs \[e.g., phenothiazine\], psoralen drugs, antiarrhythmic drugs \[e.g., amiodarone\], antimalarial and antirheumatic drugs, porphyrin drugs used in photodynamic treatment of skin diseases);
7. Use of melatonin if participant is not willing to discontinue use for the duration of the study.

We will schedule around (i.e., delay appointments as needed) to avoid the timeframe of the following events:

1. urgent suicide risk, defined by moderate/severe risk per Columbia Suicide Severity Rating Scale (CSSRS) and clinician determination that current risk requires immediate action;
2. travel across two or more time zones within the month prior to the overnight study visits;
3. beginning or ending a prescribed medication within 2 months of the observational study;
4. prescribed medication dose changes within the timeframe calculated as 5x the drug's half-life \[the time to reach pharmacokinetic steady-state\] before the initiation of the observational or experimental studies;
5. anticipated change in prescribed medications or medication dosing during the observational or experimental studies;
6. current symptoms of airborne infectious illness prior to laboratory visits.

Participants with positive breathalyzer screen (blood alcohol level > .02) will be rescheduled for an alternative overnight visit date.

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Sleep extension and advance "Lark Routine"

Participants go to bed 90 minutes earlier than their typical average bedtime to extend sleep duration and advance sleep timing

active comparator: Regular sleep duration and timing "Owl Routine"

Participants go to bed at their typical average bedtime

Interventions

Sleep extension and advance

Participants in the sleep extension and advance condition will maintain a stable sleep schedule that extends sleep duration and advances bedtime by 90 min relative to weekday bedtime. This chronotherapeutic manipulation will include blocking phase-delaying light in the evening using goggles with orange lenses ("blue blockers") beginning 2 h prior to bedtime, and 30 min of 506 lux blue-green light exposure in the morning beginning at rise time using bright light goggles (ReTimer Pty Ltd., Australia). Schedule and chronotherapy adherence will be reinforced using motivational techniques (e.g., securing motivation, preplanning, problem-solving), requiring participants to text the study coordinator and complete morning assessments at rise time, and monetary incentives.

Regular sleep duration and timing

Participants in the regular sleep duration and timing condition will keep a stable sleep schedule that matches their typical weekday sleep opportunity and timing. Schedule adherence will be reinforced using motivational techniques (e.g., securing motivation, preplanning, problem-solving), requiring participants to text the study coordinator and complete morning assessments at rise time, and monetary incentives.

Primary outcome measure

  • Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Depression Scale - Short Form (8-item) [ Time Frame: 2 months ]
  • Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Positive Affect Scale - Short Form (8-item) [ Time Frame: 2 months ]
  • Dimensional Anhedonia Rating Scale (DARS) [ Time Frame: 2 months ]
  • Reward-related brain function [ Time Frame: 2 weeks ]
  • Stress-related brain function [ Time Frame: 2 weeks ]

Central Contacts and Locations

Central contacts

Locations

University of Oregon

Recruiting

Eugene, Oregon, United States, 97403

Contacts

More Information

Sponsor

University of Oregon

Last update posted

Nov 17, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Oregon on 2025-11-17.