RECRUITING

Mechanisms of Depression and Anhedonia in Adolescents: Linking Sleep to Reward- and Stress-Related Brain Function

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Mechanisms of Depression and Anhedonia in Adolescents: Linking Sleep Duration and Timing to Reward- and Stress-Related Brain Function

Quick Facts

Study Start:2023-03-27

Study Completion:2026-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05691439

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:14 Years to 18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion 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	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. 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.

Inclusion Criteria

Exclusion 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

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.
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.

Contacts and Locations

Study Contact

Amanda Johnson

CONTACT

541-346-4107

anj@uoregon.edu

Principal Investigator

Melynda D Casement, PhD

PRINCIPAL_INVESTIGATOR

University of Oregon

Study Locations (Sites)

University of Oregon

Eugene, Oregon, 97403

United States

Collaborators and Investigators

Sponsor: University of Oregon

Melynda D Casement, PhD, PRINCIPAL_INVESTIGATOR, University of Oregon

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-27

Study Completion Date2026-12-31

Study Record Updates

Study Start Date2023-03-27

Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

Depression in Adolescence