Sleep Intervention for Teen Depression

Overseen By Lauren Asarnow, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Must not be taking: Sleep medications

Disqualifiers: Active psychosis, Bipolar, Drug dependence, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 2 months

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how improving sleep patterns can reduce depression in teenagers. It aims to align the body's natural clock with waking times through a cognitive-behavioral sleep program. Participants will receive either psychoeducation (educational therapy) or a new treatment called TranS-C (Transdiagnostic Sleep and Circadian Rhythm Intervention), which researchers are testing for effectiveness. Teens who may be suitable have depression and struggle with sleep timing, without recent medication changes or severe medical conditions. As an unphased trial, this study provides a unique opportunity for teens to explore innovative treatments that could enhance their mental health and sleep.

Will I have to stop taking my current medications?

The trial requires that participants do not use medications or herbs that affect sleep and have not changed medications in the last 8 weeks. If you are taking such medications, you may need to stop or adjust them before joining the trial.

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

Research shows that psychoeducation is generally safe and well-tolerated for teenagers with depression. Studies have found that it can help teens adhere to their treatment plans and improve their social interactions. When teens receive psychoeducational support, they are more likely to follow their treatment and engage better in social activities.

Specific safety data for TranS-C is not available in the sources. However, since this trial is not in its early stages, the treatment is likely considered safe enough for testing with more participants. Researchers believe TranS-C could be safe for participants, but discussing any concerns with the trial team is always important.

In summary, current evidence supports the safety of psychoeducation. While specific data for TranS-C is lacking, its inclusion in this trial suggests it might be safe for teenagers. Always consult the trial staff to understand the risks and benefits before deciding to join. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Sleep Intervention for Teen Depression trial because it explores innovative approaches to managing depression in adolescents. Unlike traditional treatments like antidepressants and talk therapy, this trial investigates psychoeducation and TranS-C (Transdiagnostic Sleep and Circadian Intervention). TranS-C is particularly exciting because it focuses on improving sleep and regulating the body's internal clock, which are often disrupted in depression. By addressing sleep and circadian rhythms, TranS-C may offer a new pathway to alleviate depressive symptoms without the side effects associated with medication. This approach could provide a valuable alternative or complement to existing treatments, especially for teens who struggle with sleep issues alongside depression.

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

In this trial, participants will join one of two treatment arms. Research has shown that psychoeducation, one of the treatments under study, can help treat depression in teenagers. It increases the likelihood that teens will adhere to their treatment plans and can enhance their social and personal functioning.

The other treatment arm will examine TranS-C, a program addressing sleep and body clock issues. TranS-C has shown promising results in reducing depression in teens by aligning body clocks, improving sleep quality, and reducing sleep difficulties. Studies have demonstrated that TranS-C leads to better sleep and overall well-being. Both treatments focus on different approaches to managing depression and offer potential benefits for teens facing this condition. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adolescents with depression and misaligned sleep patterns, who are stable in their medical/psychiatric condition and not on medications or herbs affecting sleep. Those with active psychosis, bipolar disorder, drug dependence, or severe conditions like terminal cancer cannot join.

Inclusion Criteria

Not applicable.

Exclusion Criteria

I do not have any severe health or mental conditions that would stop me from following the study's procedures.

I have changed my medication recently or plan to.

I am currently taking medication or herbs that affect my sleep.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a cognitive-behavioral sleep intervention to improve circadian rhythm alignment

2 months

Follow-up

Participants are monitored for changes in depression severity and circadian alignment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Psychoeducation
• TranS-C

Trial Overview The study tests if aligning biological circadian timing with wake time using a cognitive-behavioral sleep intervention can improve depression in adolescents. It's a confirmatory efficacy trial focused on this novel treatment target.

How Is the Trial Designed?

Group I: TranS-C Experimental Treatment 1 Intervention

Group II: Psychoeducation Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

In a study involving 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]

The TranS-C cognitive behavioral sleep intervention significantly reduced the severity of Major Depressive Disorder (MDD) in adolescents with evening circadian preference, showing lasting effects up to 12 months after treatment.

Improved alignment between circadian biology and sleep-wake behavior was identified as a key mechanism for the reduction in depression symptoms, suggesting that addressing sleep patterns can be crucial in treating depression in adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Report from a randomized control trial: improved alignment between circadian biology and sleep-wake behavior as a mechanism of depression symptom improvement in evening-type adolescents with depressive symptoms. Asarnow, LD., Soehner, A., Dolsen, E., et al.[2023]

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]

In a study involving 62 juvenile inpatients with moderate to severe depression, both wake therapy followed by bright light therapy and bright light therapy alone led to decreased depressive symptoms and improved sleep quality.

Bright light therapy alone showed continued improvement in depressive symptoms two weeks after treatment, while the one-night wake therapy did not provide lasting benefits, highlighting the potential of bright light therapy as a more effective long-term intervention for juvenile depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronotherapeutic treatments for depression in youth. Gest, S., Holtmann, M., Bogen, S., et al.[2018]

The Transdiagnostic Sleep and Circadian Intervention (TranS-C) improved eveningness circadian preference and some sleep quality measures in adolescents over a 6-month follow-up, compared to Psychoeducation about sleep and health (PE).

However, TranS-C did not significantly reduce risks in five health domains, while PE showed benefits in reducing parent-reported behavioral health risks during the same period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A transdiagnostic sleep and circadian intervention for adolescents: six-month follow-up of a randomized controlled trial. Dong, L., Dolsen, MR., Martinez, AJ., et al.[2021]

The study will implement the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) in community mental health centers across California, involving 576 clients and 96 providers, to evaluate its effectiveness in treating serious mental illness (SMI) by addressing sleep and circadian issues.

The research aims to determine if adapting TranS-C to fit the community mental health context improves provider perceptions and patient outcomes, potentially enhancing the delivery of evidence-based psychological treatments in routine practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) for serious mental illness in community mental health part 1: study protocol for a hybrid type 2 effectiveness-implementation cluster-randomized trial. Sarfan, LD., Agnew, ER., Diaz, M., et al.[2023]

The TranS-C intervention significantly improved sleep and circadian functioning in adolescents with an eveningness chronotype over a 12-month period compared to psychoeducation, with a notable reduction in eveningness.

Text messaging reminders enhanced the effectiveness of the TranS-C intervention, helping to maintain treatment benefits throughout the follow-up period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transdiagnostic Sleep and Circadian Intervention for Adolescents Plus Text Messaging: Randomized Controlled Trial 12-month Follow-up. Dolsen, EA., Dong, L., Harvey, AG.[2023]

The German version of the SCRAM questionnaire, validated in a sample of 860 adolescents, effectively measures sleep, circadian preference, and depressive symptoms, highlighting the interconnectedness of these factors in mental health assessment.

The exploratory factor analysis identified a 4-factor model, suggesting a solid structural foundation for the SCRAM questionnaire, although further research is necessary to confirm its reliability and validity across diverse adolescent populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translation and validation of the SCRAM questionnaire in a German adolescent inpatient sample. Kirschbaum-Lesch, I., Byrne, JEM., Holtmann, M., et al.[2022]

In a study of 108 adults with serious mental illness, higher dosages of certain modules from the TranS-C intervention were linked to significant improvements in functional impairment, psychiatric symptoms, and sleep health, suggesting that more intensive module delivery can enhance treatment outcomes.

However, some modules showed that higher dosages could worsen certain outcomes, indicating that not all modules benefit from increased delivery and highlighting the need for careful training and fidelity in module implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of module dosage on treatment response in a modular transdiagnostic intervention for sleep and circadian dysfunction (TranS-C). Callaway, CA., Sarfan, LD., Gumport, NB., et al.[2023]

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]

Citations

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Psychoeducational interventions in adolescent depression Findings from a recent systematic review concluded that PIs are effective in improving the clinical course, treatment adherence, and psychosocial functioning of ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2150592/

Effects of Psychotherapy for Depression in Children and ... Overall, the mean effect size generated by treatments for youth depression was 0.34, averaging across all of the studies. This value lies about midway between ...

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Evidence-Base Update of Psychosocial and Combination ... Results showed no significant difference between the treatment conditions, although both treatments showed positive within-group effects in ...

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Psychoeducation as an adjunctive treatment for depression Psychoeducation (PE) demonstrates potential as an adjunctive psychosocial treatment for Major Depressive Disorder(MDD) in patients during depressive episodes.

5. jmir.org jmir.org/2021/9/e28765

Finding Relevant Psychoeducation Content for ... Prior Work. According to previous studies, psychoeducation seems to be effective in treating depression, although as an integral component of ...

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Diagnosis and management of depression in adolescents We review the diagnosis and management of depression in adolescents, drawing on available evidence and recommendations from international guidelines.

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Depression in Children and Adolescents: Evaluation and ... Evidence from a good-quality randomized trial suggests that adolescents are most likely to achieve remission with 12 weeks of combined therapy ...

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Treatment Outcomes of an Adolescent Intensive Outpatient ... Studies of youth attending a nationwide remote-only DBT- and CBT-informed IOP have demonstrated high attendance rates and significant reductions in depression, ...