Sleep and Circadian Intervention for Depression

Recruiting at 1 trial location

Overseen By Delaney M Wilkinson, BS

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Obstructive sleep apnea, Restless legs, Psychosis, Bipolar, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

90 Participants Needed

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Sleep Feedback, TranS-C for depression?

Research shows that the TranS-C treatment can improve depression symptoms and sleep issues in both older and younger adults. Additionally, similar treatments involving sleep adjustments, like sleep deprivation followed by sleep phase advance, have been effective in improving mood in depressed patients. ^{1 2 3 4 5}

Is the Sleep and Circadian Intervention for Depression safe for humans?

The Sleep and Circadian Intervention, also known as TranS-C, has been studied in various trials and is generally considered safe for humans. These studies have focused on improving sleep and circadian rhythms in people with mental health conditions, and no significant safety concerns have been reported. ^{1 2 6 7 8}

How is the TranS-C treatment different from other treatments for depression?

TranS-C is unique because it focuses on improving sleep and circadian rhythms (the body's internal clock) to help with depression, rather than directly targeting mood symptoms like most traditional treatments. This approach can be particularly beneficial for those whose depression is linked to sleep issues. ^{1 2 3 4 9}

What is the purpose of this trial?

Suicide is the second leading cause of death in youth, and recent statistics indicate disproportionate risk for suicidal behavior among Black youth. Despite this, few interventions effectively prevent youth suicidal thoughts and behaviors (STB). Sleep difficulties may be a particularly promising target for youth STB prevention efforts. To date, no intervention targeting sleep difficulties have been examined among youth at-risk for STBs nor tailored to Black youth; this research is critical for maximizing intervention acceptability and impact. The Transdiagnostic Sleep and Circadian Intervention (TranS-C) is an evidence-based, modularized intervention that targets a range of sleep and circadian difficulties, making it especially well-suited for treating adolescent sleep. Delivery of this intervention will be through telehealth with a Sleep Therapist. Youth will wear an actigraphy watch that monitors sleep and will complete daily sleep diaries via smartphone or email; sleep feedback reports of sleep diary and actigraphy data are available on demand after completing a diary entry. The adolescents will also wear bright light glasses in the morning and blue light blocking glasses in the evening. Adolescents will also attend weekly or biweekly sessions with a Sleep Therapist. The Sleep Therapist will review sleep feedback generated from actigraph and sleep diary data with adolescents during sessions. In the Sleep Feedback alone intervention, adolescents will wear an actigraphy watch and complete daily diaries; they are able to view their sleep feedback on demand through user-friendly graphs of naturalistic objective and subjective sleep data.

Research Team

Tina Goldstein, Ph.D

Principal Investigator

University of Pittsburgh

Eligibility Criteria

This trial is for adolescents with depression or sleep issues, including parasomnia and insomnia. It's especially focused on Black youth at risk of suicidal thoughts and behaviors. Participants must be comfortable using telehealth services, wear an actigraphy watch, and use bright light glasses.

Inclusion Criteria

I am currently experiencing moderate to severe depression.

I have trouble sleeping.

I can speak and read English well enough to follow study instructions.

Exclusion Criteria

Evidence of a developmental disability precluding comprehension of study procedures per electronic health record and eligibility screening

I have been diagnosed with obstructive sleep apnea.

I often feel uncomfortable sensations in my legs that make me move them.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Transdiagnostic Sleep and Circadian Intervention (TranS-C) and Sleep Feedback or Sleep Feedback alone, including wearing an actigraphy watch, completing daily sleep diaries, and attending sessions with a Sleep Therapist.

16 weeks

Weekly or biweekly sessions (telehealth)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of sleep disturbance, depression, and risk for suicidal thoughts and behaviors.

4 weeks

Treatment Details

Interventions

• Sleep Feedback
• TranS-C

Trial Overview The study tests the Transdiagnostic Sleep and Circadian Intervention (TranS-C), which includes therapy sessions via telehealth, sleep monitoring with an actigraphy watch, daily diaries, and the use of special glasses. A second group only receives sleep feedback based on their diaries without additional therapy.

Participant Groups

Group I: TranS-C and Sleep Feedback Experimental Treatment 1 Intervention

Participants receive an actigraphy watch to track their sleep and activity levels and complete a daily sleep diary; sleep feedback graphs show participants their actigraphy watch and sleep diary data on demand.

Group II: TranS-C Only Experimental Treatment 2 Interventions

Participants will attend 6-8 TranS-C sessions with a Sleep therapist. Participants will also wear bright light glasses in the morning and blue light blocking glasses in the evening throughout the intervention.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

University of Oregon

Collaborator

Trials

91

Recruited

46,700+

Children's Hospital of Philadelphia

Collaborator

Trials

749

Recruited

11,400,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Findings from Research

The TranS-C intervention, when combined with usual care, significantly reduced functional impairment, psychiatric symptoms, and sleep disturbances in adults with serious mental illness, as shown in a study of 121 participants over 8 weeks.

These improvements were not only significant immediately after treatment but were also largely maintained at a 6-month follow-up, indicating the potential long-term benefits of the TranS-C approach for enhancing sleep and overall functioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) to improve serious mental illness outcomes in a community setting. Harvey, AG., Dong, L., Hein, K., et al.[2022]

The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) significantly improved depression response rates (35.0% vs. 8.8% for treatment as usual) in adults with serious mental illness, indicating its efficacy as a nonpharmacologic treatment.

Improvements in insomnia symptoms were strongly correlated with reductions in depression symptoms, particularly in younger adults, suggesting that enhancing sleep quality may be a key mechanism for TranS-C's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction for Depression Symptoms and Sleep-Wake Disruption in Older and Younger Adults: Secondary Age-Stratified Analysis of a Randomized Controlled Trial. Smagula, SF., Gasperetti, CE., Buysse, DJ., et al.[2023]

In a study of 194 bipolar depressed patients, over 60% responded positively to a treatment combining total sleep deprivation and light therapy (TSD + LT), indicating its potential efficacy for depression.

The study found that chronotype, or whether a person is a 'morning' or 'evening' type, significantly influenced treatment response, with evening-type patients showing higher rates of improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronotype influences response to antidepressant chronotherapeutics in bipolar patients. Dallaspezia, S., Suzuki, M., Clara, L., et al.[2019]

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]

References

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

A randomized controlled trial of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) to improve serious mental illness outcomes in a community setting. [2022]

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

Efficacy of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction for Depression Symptoms and Sleep-Wake Disruption in Older and Younger Adults: Secondary Age-Stratified Analysis of a Randomized Controlled Trial. [2023]

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

Treatment-resistant depression: Neurobiological correlates and the effect of sleep deprivation with sleep phase advance for the augmentation of pharmacotherapy. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Chronotype influences response to antidepressant chronotherapeutics in bipolar patients. [2019]

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

How to preserve the antidepressive effect of sleep deprivation: A comparison of sleep phase advance and sleep phase delay. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Antidepressants and Circadian Rhythm: Exploring Their Bidirectional Interaction for the Treatment of Depression. [2023]

7. 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]

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

Circadian abnormalities, molecular clock genes and chronobiological treatments in depression. [2012]

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

Neural and genetic correlates of antidepressant response to sleep deprivation: a functional magnetic resonance imaging study of moral valence decision in bipolar depression. [2013]