Sleep and Circadian Intervention for Depression

Recruiting at 1 trial location

Overseen By Beth Hafer

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial seeks new ways to assist adolescents with moderate to severe depression and sleep issues. It explores a special sleep intervention called TranS-C, which includes bright light therapy, blue light-blocking glasses, and sessions with a sleep therapist. Researchers will compare participants to those receiving regular sleep feedback from a watch and diary. Teens aged 12-18 with significant sleep troubles and depression may be suitable candidates. The goal is to determine if improving sleep can reduce suicidal thoughts and behaviors in at-risk youth. As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative research that could lead to new treatment approaches.

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 prior data suggests that this sleep intervention is safe for adolescents?

Research has shown that better sleep can improve mental health. A large study found that certain sleep treatments, such as cognitive behavioral therapy for insomnia (CBT-I), reduced suicidal thoughts in veterans. This suggests that focusing on sleep can safely and effectively boost mental health.

The TranS-C treatment uses bright light and blue-blocking glasses, which generally pose low risk. These tools adjust sleep patterns by altering light exposure and typically do not cause serious side effects.

In summary, both the TranS-C and sleep feedback treatments are well-tolerated. They aim to improve sleep, which has been shown to positively affect mental health, including reducing depression and suicidal thoughts. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they offer a fresh approach to managing depression by focusing on sleep and circadian rhythms, rather than directly targeting neurotransmitters like many traditional antidepressants such as SSRIs or SNRIs. The Sleep Feedback intervention provides participants with real-time insights into their sleep patterns through an actigraphy watch and daily sleep diary, empowering them to make informed changes to their sleep habits. The TranS-C + Sleep Feedback arm adds an innovative twist by combining therapeutic sessions with the use of bright light glasses in the morning and blue light blocking glasses in the evening, aiming to reset the body's natural sleep-wake cycle. This dual approach targets the root of sleep disturbances, which are often intertwined with depression, potentially offering a more holistic and side-effect-free alternative to existing treatments.

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

Research has shown that better sleep can greatly improve mental health, including reducing depression and anxiety. One study found that improved sleep led to a noticeable improvement in overall mental health and depression symptoms. This trial will evaluate specific sleep treatments, including the Sleep Feedback method, which might help improve mental health.

Another treatment arm in this trial involves the TranS-C method, where participants previously saw positive results in dealing with various sleep problems. This method uses bright light and glasses that block blue light to help regulate sleep patterns, which are closely linked to mood and mental health. The TranS-C method's comprehensive approach makes it a promising option for addressing sleep issues and improving depression symptoms. ^{2 3 6 7 8}

Who Is on the Research Team?

Tina Goldstein, Ph.D

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: TranS-C + Sleep Feedback 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.

Group II: 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.

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+

Published Research Related to This Trial

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, 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11616206/

Role of Sleep in Depressive Disorders and the Potential ... The efficiency of sleep deprivation therapy is estimated at approximately 40% to 60%, even in treatment-refractory patients [26,27,31].

2. 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.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8651630/

Improving sleep quality leads to better mental health Improving sleep led to a significant medium-sized effect on composite mental health (g+ = −0.53), depression (g+ = −0.63), anxiety (g+ = −0.51), and rumination.

4. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2024.1432538/full

The impact of sleep disturbances on treatment efficacy and ... We found that baseline status of sleep disturbances had no impact to pharmacological treatment outcomes of both depression and anxiety disorders ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0165032724011947

The relationship between wearable-derived sleep features ... High intraindividual variability in sleep parameters is associated with worse depression outcomes over time.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12272457/

The effect and safety of sleep interventions on suicidal ... A large-scale evaluation found that CBT-I was associated with reduced suicidal ideation among veterans, even after accounting for changes in depression severity ...

7. mental.jmir.org mental.jmir.org/2023/1/e47433/

The Safety of Digital Mental Health Interventions: Systematic ... In this study, we conducted a systematic review of the published safety outcome data to establish the current state of practice, highlight gaps ...

8. tandfonline.com tandfonline.com/doi/full/10.1080/14789949.2022.2111320

Behavioural, medical & environmental interventions to ... The current work aimed to identify the effect of interventions for improving sleep quality for these inpatients and identify moderating factors.