160 Participants Needed

Habit-Based Sleep Intervention with Texting for Circadian Dysregulation

EO
ST
Overseen BySondra Tiab, BA
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: University of California, Berkeley
Must be taking: Sleep medications
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

The study will test a sleep-health intervention that leverages the science on habit formation. It will evaluate if adding a text messaging intervention improves habit formation. The participants will be 18-30 years old.

Will I have to stop taking my current medications?

If you are taking medication for sleep, you can continue as long as the dose and frequency have been stable for at least 4 weeks. The trial does not specify about other medications.

What data supports the effectiveness of the Habit-Based Sleep Intervention with Texting for Circadian Dysregulation treatment?

Research shows that digital and app-based interventions can effectively improve sleep, reaching a wide audience and being suitable for daily use. Mobile health apps have demonstrated promise for improving sleep at scale, with user engagement being key to their effectiveness.12345

Is the Habit-Based Sleep Intervention with Texting safe for humans?

The available research on similar mobile health interventions for sleep suggests they are generally safe, with studies focusing on feasibility, acceptability, and engagement rather than reporting any significant safety concerns.23467

How is the Habit-Based Sleep Intervention with Texting different from other treatments for circadian dysregulation?

This treatment is unique because it uses text messages to promote sleep hygiene, which is a novel approach compared to traditional methods that may not involve digital communication. It focuses on habit-based interventions, making it more accessible and engaging, especially for younger populations who frequently use mobile devices.2891011

Research Team

AH

Allison G Harvey, PhD

Principal Investigator

University of California, Berkeley

Eligibility Criteria

This trial is for young adults aged 18-30 who speak English and are willing to participate. They should have stable sleep medication use if applicable, irregular sleep patterns or late sleep times on weekends, and be 'at risk' in emotional, cognitive, behavioral, physical or social health domains. Excluded are those with substance abuse/dependence, severe mental or physical illness, pregnancy/breastfeeding individuals, certain sleep disorders unless treated.

Inclusion Criteria

You have challenges in one of the five areas of health: emotions, thinking, behavior, physical health, or social interactions. This is measured by scoring 4 or higher on a specific scale.
My sleep medication dose has been the same for at least 4 weeks.
I am between 18 and 30 years old.
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Exclusion Criteria

I might have sleep issues like sleep apnea or restless legs but haven't been diagnosed or treated yet.
You work at night at least twice a week between midnight and 6am.
If you have a mental or physical condition that would make it difficult for you to take part in the study or if there is a high risk of harm if the treatment for your other condition is delayed because of the study.
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Habit-based Sleep Health Intervention with or without text messages, consisting of 3x50-minute weekly sessions followed by 6x30-minute weekly sessions

9 weeks
9 visits (in-person)

Post-treatment Follow-up

Participants are monitored for sleep health behavior and circadian outcomes at 1-week post-treatment

1 week

Long-term Follow-up

Participants are monitored for sleep health behavior and circadian outcomes at 6 and 12 months post-treatment

12 months

Treatment Details

Interventions

  • Habit-based Sleep Health Intervention
  • Text messaging intervention
Trial OverviewThe study tests a habit-based sleep-health intervention aimed at improving participants' quality of rest through the science of habit formation. It also examines whether adding text message reminders enhances this process.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Habit-based Sleep Health Intervention plus text messages (HABITs+texts)Experimental Treatment2 Interventions
Participants in this condition participate in the HABITs intervention which includes 3x50-minute weekly sessions followed by 6x30-minute weekly sessions. Additionally, participants in this group will receive the text messaging intervention.
Group II: Habit-based Sleep Health Intervention (HABITs)Experimental Treatment1 Intervention
Participants in this condition participate in the HABITs intervention which includes 3x50-minute weekly sessions followed by 6x30-minute weekly sessions. Participants in this group will not receive the texts discussed below.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, Berkeley

Lead Sponsor

Trials
193
Recruited
716,000+

Findings from Research

The app-based intervention 'Refresh' significantly improved sleep quality in participants with insomnia symptoms, showing a medium effect size (d=0.45) in those with poor sleep, and these improvements were maintained at a 6-month follow-up.
Despite its effectiveness, about one-third of participants did not access the intervention, highlighting the need for better strategies to enhance uptake and adherence to app-based sleep interventions.
Effectiveness of an App-Based Short Intervention to Improve Sleep: Randomized Controlled Trial.Vollert, B., Müller, L., Jacobi, C., et al.[2023]
A study involving 27 young participants (ages 14-18) from diverse backgrounds revealed that while they were interested in using smartphone apps to improve sleep, they faced barriers such as reluctance to change sleep routines on weekends and concerns about using electronics at bedtime.
Feedback on two commercially available sleep apps was generally positive, indicating good adherence and perceived health benefits, suggesting that app-based interventions could be effective if tailored to the specific needs and preferences of young people.
A Qualitative Assessment of the Acceptability of Smartphone Applications for Improving Sleep Behaviors in Low-Income and Minority Adolescents.Quante, M., Khandpur, N., Kontos, EZ., et al.[2023]
A study involving 31 Japanese office workers showed that receiving objective push-type sleep feedback improved sleep timing and reduced physical symptoms like fatigue and neck stiffness, indicating potential benefits for overall well-being.
While the feedback group experienced better mood and physical symptom scores upon waking, there were no significant differences in daily work performance, suggesting that while sleep feedback can enhance certain aspects of health, it may not directly impact work productivity.
The Effects of Objective Push-Type Sleep Feedback on Habitual Sleep Behavior and Momentary Symptoms in Daily Life: mHealth Intervention Trial Using a Health Care Internet of Things System.Takeuchi, H., Suwa, K., Kishi, A., et al.[2022]

References

Effectiveness of an App-Based Short Intervention to Improve Sleep: Randomized Controlled Trial. [2023]
A Qualitative Assessment of the Acceptability of Smartphone Applications for Improving Sleep Behaviors in Low-Income and Minority Adolescents. [2023]
The Effects of Objective Push-Type Sleep Feedback on Habitual Sleep Behavior and Momentary Symptoms in Daily Life: mHealth Intervention Trial Using a Health Care Internet of Things System. [2022]
Exploring User Needs and Preferences for Mobile Apps for Sleep Disturbance: Mixed Methods Study. [2020]
Individualized sleep promotion in acute care hospitals: managing specific factors that affect patient sleep. [2022]
A clinical trial to evaluate the dayzz smartphone app on employee sleep, health, and productivity at a large US employer. [2023]
Impact of an Online Sleep and Circadian Education Program on University Students' Sleep Knowledge, Attitudes, and Behaviours. [2021]
Effects of a sleep hygiene text message intervention on sleep in college students. [2020]
Sleep apps and behavioral constructs: A content analysis. [2020]
10.United Statespubmed.ncbi.nlm.nih.gov
Mobile app for personalized sleep-wake management for shift workers: A user testing trial. [2023]
A feasibility study of a mobile app to treat insomnia. [2021]