Improved Sleep Habits for Adolescent Depression

(MoDA Trial)

Overseen By Amanda Johnson

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Oregon

Must not be taking: Neuroleptics, Psoralen, Antiarrhythmics, others

Disqualifiers: Alcohol/substance use disorder, Narcolepsy, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 8 weeks

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how sleep habits, such as going to bed earlier or at a regular time, affect depression symptoms in high school students. Researchers aim to understand the connection between sleep patterns, stressful events, and depression to develop better prevention strategies. The study involves two groups: one adjusts their bedtime to sleep longer (sleep extension and advance), while the other maintains their usual sleep schedule (regular sleep duration and timing). Teens who sleep less than 7 hours a night, go to bed late, and have experienced stressful events may be well-suited for this trial. As an unphased trial, it offers participants the chance to contribute to valuable research that could lead to improved mental health strategies for teens.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it mentions that you should not begin or end a prescribed medication within 2 months of the study, and there should be no changes in medication dosing during the study. If you use melatonin, you must stop using it for the duration of the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that more sleep and better sleep habits benefit teenagers. One study found that gradually increasing sleep time and providing advice on good sleep practices improved sleep quality and reduced depression symptoms. No negative effects were reported, suggesting this approach is safe.

While detailed safety information specifically for teens improving their sleep habits is limited, experts generally agree that better sleep is beneficial and poses no significant risks. The trial is labeled "Not Applicable" in phase because it focuses on understanding effects rather than testing a new drug or treatment. Therefore, joining this type of trial is considered safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how adjusting sleep patterns can help alleviate adolescent depression, which is a fresh approach compared to the usual treatments like medication and therapy. The "Lark Routine" involves going to bed 90 minutes earlier, aiming to extend and adjust sleep timing, which could offer a non-invasive way to improve mental health. Unlike standard treatments that often involve medication, this approach focuses on natural sleep modifications, potentially reducing side effects and making it easier for young people to adopt. By studying these sleep habits, researchers hope to uncover a simple yet effective method to boost mood and mental well-being in teens.

What evidence suggests that this trial's treatments could be effective for adolescent depression?

Research has shown that getting more sleep and going to bed earlier can help reduce depression in teenagers. In this trial, participants will join one of two treatment arms. The "Sleep extension and advance 'Lark Routine'" arm requires going to bed 90 minutes earlier than their usual bedtime to extend sleep duration and advance sleep timing. The "Regular sleep duration and timing 'Owl Routine'" arm involves maintaining their usual bedtime. Studies have found that following good sleep habits can improve sleep quality and lessen feelings of depression. One study showed that gradually getting more sleep improved both sleep and thinking skills in teens. Another study found that better sleep habits reduced sleep problems and feelings of depression. These findings suggest that changing sleep patterns can be important for managing depression in young people. ^{1 6 7 8 9}

Who Is on the Research Team?

Melynda D Casement, PhD

Principal Investigator

University of Oregon

Are You a Good Fit for This Trial?

Adolescents aged 14-19, currently in high school with fluent English skills. They must have experienced significant stress (score >4 on STRAIN) and exhibit certain sleep patterns: either short/late or long/early as per the Munich Chronotype Questionnaire. Participants should also show depressive symptoms but not have severe psychiatric disorders, substance abuse issues, or conditions that conflict with study procedures.

Inclusion Criteria

Lifetime stressful event frequency ≥ 2 on the Stress and Adversity Inventory (STRAIN) Screener

English language fluency

I either sleep less than 7 hours and go to bed after 10:30 PM, or I sleep 7 hours or more and go to bed by 10:30 PM.

Exclusion Criteria

Current sleep disorders other than insomnia, delayed sleep phase, or hypersomnia, determined by the Structured Clinical Interview for DSM-5 Sleep Disorders

Urgent suicide risk, defined by moderate/severe risk as per Columbia Suicide Severity Rating (CSSR) Community Card, and clinician determination that current risk requires immediate action, precluding engagement in study

Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for current moderate to severe alcohol/substance use disorder (≥4 symptoms)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo sleep manipulation with either the 'Lark Routine' or 'Owl Routine' to evaluate changes in reward- and stress-related brain function

8 weeks

Weekly visits for monitoring and assessments

Follow-up

Participants are monitored for changes in depressive symptoms and anhedonia after the treatment phase

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Regular sleep duration and timing
• Sleep extension and advance

Trial Overview The trial is exploring how changing sleep patterns can affect depression and lack of pleasure (anhedonia) in teenagers. It involves adjusting their sleep to be longer and earlier or maintaining regular sleep duration/timing while examining brain function related to stress and reward.

How Is the Trial Designed?

Group I: Sleep extension and advance "Lark Routine" Experimental Treatment 1 Intervention

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

Group II: Regular sleep duration and timing "Owl Routine" Active Control 1 Intervention

Participants go to bed at their typical average bedtime

Who Is Running the Clinical Trial?

University of Oregon

Lead Sponsor

Trials

91

Recruited

46,700+

Oregon Research Institute

Collaborator

Trials

87

Recruited

62,600+

University of Pittsburgh

Collaborator

Trials

1,820

Recruited

16,360,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

In a study involving 23 adolescents with major depressive disorder and 23 normal controls, those with depression exhibited significantly shorter REM sleep latencies, indicating a potential disruption in their sleep patterns (P = 0.005).

Additionally, the depressed adolescents had longer sleep latencies compared to the controls (P = 0.04), suggesting that they took longer to fall asleep, which may be an important factor in understanding sleep disturbances associated with adolescent depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

REM latency in endogenously depressed adolescents. Kutcher, S., Williamson, P., Marton, P., et al.[2019]

In a study involving 10 adolescents with major depression and 10 controls, no significant differences in sleep patterns were found between the two groups, suggesting that sleep disturbances seen in adults with depression may not be present in adolescents.

The findings indicate that abnormalities in REM sleep characteristics, such as latency and density, which are common in adult depression, do not appear to affect adolescents, highlighting potential developmental differences in how depression manifests in younger individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Polysomnographic findings in adolescents with major depression. Khan, AU., Todd, S.[2019]

The authors propose that addressing insomnia through cognitive behavioral therapy could enhance the effectiveness of traditional depression treatments in youth, as sleep issues are linked to higher depression risk and can hinder treatment success.

This approach is based on existing research and aims to improve the modest response and remission rates seen in current youth depression treatments, highlighting the importance of sleep in mental health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The complex role of sleep in adolescent depression. Clarke, G., Harvey, AG.[2021]

About 46% of Swedish adolescents sleep less than the recommended eight hours on weekdays, with this number rising to 68% among those with clinically relevant depression, indicating a strong link between insufficient sleep and depression.

Shorter weekday sleep duration, poor sleep quality, and a late chronotype are significant predictors of depression in adolescents, suggesting that interventions like later school start times could help improve mental health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Associations between sleep habits, quality, chronotype and depression in a large cross-sectional sample of Swedish adolescents. Lemke, T., Hökby, S., Wasserman, D., et al.[2023]

In a study involving 41 youth aged 12-20, combining cognitive behavioral therapy for insomnia (CBT-I) with standard depression treatment (CBT-D) led to significant improvements in sleep and depression outcomes, including a 99-minute increase in total sleep time by week 12.

The experimental group receiving CBT-I showed faster recovery rates and a higher percentage of participants recovering from depression compared to those receiving only sleep hygiene control, indicating that addressing sleep issues can enhance depression treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral treatment of insomnia and depression in adolescents: A pilot randomized trial. Clarke, G., McGlinchey, EL., Hein, K., et al.[2018]

Emerging evidence indicates that sleep difficulties in adolescents may precede the onset of depression, suggesting a complex relationship where sleep issues can contribute to the development of depressive symptoms.

The review highlights various contributors to sleep problems in adolescents, such as delayed circadian rhythms and restricted sleep duration, and recommends evidence-based interventions like bright light therapy and cognitive-behavioral techniques to improve sleep and alleviate depression symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep's role in the development and resolution of adolescent depression. Gradisar, M., Kahn, M., Micic, G., et al.[2022]

Adolescent cognitive-behavioral sleep interventions significantly improved subjective total sleep time by about 29.5 minutes and reduced sleep onset latency by approximately 21.4 minutes, indicating their efficacy in enhancing sleep quality among adolescents.

The interventions also led to improvements in global sleep quality, daytime sleepiness, and symptoms of depression and anxiety, suggesting a broader positive impact on mental health, although more high-quality randomized controlled trials are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Review and Meta-analysis of Adolescent Cognitive-Behavioral Sleep Interventions. Blake, MJ., Sheeber, LB., Youssef, GJ., et al.[2020]

A study involving 55 adolescents with chronic sleep reduction showed that gradual sleep extension, combined with sleep hygiene advice, significantly improved sleep duration and quality, leading to earlier bedtimes and reduced insomnia symptoms.

Participants in the sleep extension group also experienced a notable decrease in depressive symptoms, suggesting that improving sleep can positively impact mood in adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of sleep extension and sleep hygiene advice on sleep and depressive symptoms in adolescents: a randomized controlled trial. Dewald-Kaufmann, JF., Oort, FJ., Meijer, AM.[2015]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/24252173/

The effects of sleep extension and sleep hygiene advice on ... Gradual sleep extension combined with sleep hygiene advice seems to have beneficial effects on sleep, self-reported sleep problems and depressive symptoms.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9208261/

Sleep's role in the development and resolution ... A combination of exogenous melatonin and bright light therapy might therefore be particularly effective at treating comorbid depression and sleep difficulties.

3. mentalhealth.bmj.com mentalhealth.bmj.com/content/17/4/122

Sleep therapy is effective in reducing symptoms of ... Sleep therapy is effective in reducing symptoms of depression among adolescents ... Normative data on the sleep habits of Australian children and adolescents.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1389945713000622

The effects of sleep extension on sleep and cognitive ... Gradual sleep extension has beneficial effects on adolescents' sleep and is related to changes in some aspects of cognitive performance.

5. researchgate.net researchgate.net/publication/258765541_The_effects_of_sleep_extension_and_sleep_hygiene_advice_on_sleep_and_depressive_symptoms_in_adolescents_A_randomized_controlled_trial

The effects of sleep extension and sleep hygiene advice on ... Sleep extension and unstructured sleep hygiene advice can improve sleep quality, insomnia, and depressive symptoms even in adolescents not ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10899925/

Efficacy of sleep extension therapy using a remote support ... The effects of sleep extension and sleep hygiene advice on sleep and depressive symptoms in adolescents: a randomized controlled trial. J ...

7. withpower.com withpower.com/trial/improved-sleep-habits-for-adolescent-depression-609f4

Improved Sleep Habits for Adolescent Depression The research does not provide specific safety data for improving sleep habits in adolescents, but it generally suggests that addressing sleep issues can be ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S295000442500029X

Effect of depression treatment on subjective sleep ... Depression treatment improves some, not all, subjective sleep disturbance components, with benefits diminishing after termination.

9. jaacap.org jaacap.org/article/S0890-8567(24)02021-5/fulltext

Umbrella Review and Meta-Analysis: The Efficacy ... Objectively measured sleep continuity in children and adolescents with ADHD: a systematic review and meta-analysis