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

Trial Summary

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.

What data supports the effectiveness of the treatment TranS-C for teen depression?

Research shows that the TranS-C treatment, which focuses on improving sleep and circadian rhythms, can help reduce depression symptoms in teens. Studies found that aligning sleep patterns with natural body rhythms can improve mood and decrease depressive symptoms over time. ^{1 2 3 4 5}

Is the Transdiagnostic Sleep and Circadian Intervention (TranS-C) safe for humans?

The studies on the Transdiagnostic Sleep and Circadian Intervention (TranS-C) do not report any specific safety concerns, suggesting it is generally safe for use in humans. ^{1 2 3 6 7}

How is the Sleep Intervention for Teen Depression treatment different from other treatments for depression?

This treatment is unique because it focuses on aligning sleep patterns and circadian rhythms (the body's internal clock) to improve depression symptoms, rather than just addressing mood directly. It combines psychoeducation and a specific sleep intervention (TranS-C) to target the underlying sleep issues that often precede and contribute to depression in teens. ^{1 2 8 9 10}

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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]

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]

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 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]

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 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 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]

References

1. England 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. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Transdiagnostic Sleep and Circadian Intervention for Adolescents Plus Text Messaging: Randomized Controlled Trial 12-month Follow-up. [2023]

3. England pubmed.ncbi.nlm.nih.gov

A transdiagnostic sleep and circadian intervention for adolescents: six-month follow-up of a randomized controlled trial. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

The complex role of sleep in adolescent depression. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

Chronotherapeutic treatments for depression in youth. [2018]

6. England 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). [2023]

7. England 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. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Sleep's role in the development and resolution of adolescent depression. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral treatment of insomnia and depression in adolescents: A pilot randomized trial. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Translation and validation of the SCRAM questionnaire in a German adolescent inpatient sample. [2022]