Habit-Based Sleep Intervention with Texting for Circadian Dysregulation
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of California, Berkeley
No Placebo Group
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.
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.
24789What 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.
246910How 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.
123511Will 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.
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
I am between 18 and 30 years old.
Participant Groups
The 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.
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
Research locations nearbySelect from list below to view details:
University of CaliforniaBerkeley, CA
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Who is running the clinical trial?
University of California, BerkeleyLead Sponsor
References
Sleep apps and behavioral constructs: A content analysis. [2020]Although sleep apps are among the most popular commercially available health apps, little is known about how well these apps are grounded in behavioral theory. Three-hundred and sixty-nine apps were initially identified using the term "sleep" from the Google play store and Apple iTunes in September 2015. The final sample consisted of 35 apps that met the following inclusion criteria: 1) Stand-alone functionality; 2) Sleep tracker or monitor apps ranked by 100 + users; 3) Sleep Alarm apps ranked by 1000 + users; and 4) English language. A coding instrument was developed to assess the presence of 19 theoretical constructs. All 35 apps were downloaded and coded. The inter-rater reliability between coders was 0.996. A "1" was assigned if a construct was present in the app and "0" if it was not. Mean scores were calculated across all apps, and comparisons were made between total scores and app ratings using R. The mean behavior construct scores (BCS) across all apps was 34% (5% - 84%). Behavioral constructs for realistic goal setting (86%), time management (77%), and self-monitoring (66%) were most common. Although a positive association was observed between BCS and user ratings, this was not found to be statistically significant (p > 0.05). The mean persuasive technology score was 42% (20% to 80%), with higher scores for paid compared to free apps (p < 0.05). While the overall behavior construct scores were low, an opportunity exists to develop or modify existing apps to support sustainable sleep hygiene practices.
A Qualitative Assessment of the Acceptability of Smartphone Applications for Improving Sleep Behaviors in Low-Income and Minority Adolescents. [2023]Background: Daily behaviors such as sleep can be targeted by smartphone app-based interventions, with potential utility among young people of minority ethnic backgrounds who commonly access smartphone devices and are short sleepers. There is a need to understand the acceptability and youth's readiness to use apps to improve sleep, and to identify desired app components that would motivate engagement. Participants and Methods: We conducted three focus group discussions (N = 27 total, age 14-18 years) within low- and middle-income ethnically diverse Boston neighborhoods. We also interviewed 10 participants who provided specific feedback on two commercially available sleep-promoting apps, one of which they had used on their smartphone preceding the interviews. All focus group discussions and interviews were audio-recorded, transcribed, and thematically analyzed. Results: We identified several barriers to adoption of sleep hygiene interventions, namely reluctance to follow scheduled sleep routines on weekends and concern about "parting" with electronics at bedtime. Participants were intrigued by the idea of adopting an app-based sleep intervention, but were skeptical that they could successfully adopt sleep hygiene practices, and were more interested in making changes on school days than on weekends. Nonetheless, the overall feedback on two commercial sleep apps, neither targeted at youth, was positive, with a good adherence and engagement rate, and perceived health benefits. Conclusions: Our findings highlight the need to adapt sleep hygiene recommendations to targeted populations, considering preferences and social and cultural contextual factors. Our research also underscores the importance of the platform, setting, and messenger when delivering health information to adolescents.
Effects of a sleep hygiene text message intervention on sleep in college students. [2020]To test the effectiveness of a text-message intervention to promote sleep hygiene to improve sleep in young adult college students.
Exploring User Needs and Preferences for Mobile Apps for Sleep Disturbance: Mixed Methods Study. [2020]Mobile health (mHealth) apps demonstrate promise for improving sleep at scale. End-user engagement is a prerequisite for sustained use and effectiveness.
A feasibility study of a mobile app to treat insomnia. [2021]Insomnia is a major public health concern. Sleep restriction therapy (SRT) is an effective behavioral treatment but its delivery is impeded by a shortage of trained clinicians. We developed a mobile app delivering SRT to individuals with insomnia. This feasibility study employed a mixed-methods design to examine the engagement, acceptability, and potential efficacy of the mobile app. Fifteen participants diagnosed with insomnia disorder used the mobile app synchronized with a wearable device for 3 weeks. Those who persisted with the study (n = 12) found the mobile app to be highly acceptable and engaging, logging on average 19 nightly sleep diary entries across the 21 day period. Significant improvements were observed for sleep measures (insomnia severity and sleep efficiency) and daytime symptoms (fatigue and sleepiness). The results suggest that a mobile app delivering SRT to individuals with insomnia is engaging, acceptable, and potentially efficacious. Further, a full-scale effectiveness study is warranted.
Individualized sleep promotion in acute care hospitals: managing specific factors that affect patient sleep. [2022]Improving sleep for hospitalized patients is an essential clinical need. Compared to the traditional "one-size-fits-all" interventions designed by clinicians for all patients, an individualized strategy engaging patients to identify salient sleep disruptors and seek their input how to address these disruptors are more likely to succeed. Followed by our work of developing the Factors Affecting Inpatient Sleep (FAIS) scale, in this report we developed a set of icons illustrating 14 common sleep disruptors on the FAIS scale, and proposed behavioral sleep promotion tips addressing each sleep disruptor. The set of icons and sleep promotion tips were built into the mobile health (mHealth) tool SLEEPKit, which was the start of our endeavor using mHealth technology to support individualized sleep promotion.
Impact of an Online Sleep and Circadian Education Program on University Students' Sleep Knowledge, Attitudes, and Behaviours. [2021]University students consistently report poor sleep. We conducted a before-and-after study to evaluate the impact of an online 10-week course on undergraduate students' sleep knowledge, attitudes, and behaviours at 6-month follow-up. Data were collected via baseline course surveys (August-September 2020) and follow-up surveys distributed via email (February-March 2021). n = 212 students completed baseline surveys and n = 75 (35%) completed follow-up. Students retained to follow-up possessed higher baseline sleep knowledge and received higher course grades. At the 6-month follow-up, sleep knowledge had increased (mean score out of 5: 3.0 vs. 4.2, p < 0.001). At baseline, 85% of students aimed to increase their sleep knowledge and 83% aimed to improve their sleep. At follow-up, 91% reported being more knowledgeable and 37% reported improved sleep. A novel Stages of Change item revealed that 53% of students' attitudes towards their sleep behaviours had changed from baseline. There was a reduction in sleep latency at follow-up (mean 33.3 vs. 25.6 min, p = 0.015), but no change in the total Pittsburgh Sleep Quality Index score. In summary, completion of an online course led to increased sleep and circadian knowledge and changed sleep attitudes, with no meaningful change in sleep behaviours. Future interventions should consider components of behavioural change that go beyond the knowledge-attitudes-behaviour continuum.
A clinical trial to evaluate the dayzz smartphone app on employee sleep, health, and productivity at a large US employer. [2023]Sleep deficiency is a hidden cost of our 24-7 society, with 70% of adults in the US admitting that they routinely obtain insufficient sleep. Further, it is estimated that 50-70 million adults in the US have a sleep disorder. Undiagnosed and untreated sleep disorders are associated with diminished health for the individual and increased costs for the employer. Research has shown that adverse impacts on employees and employers can be mitigated through sleep health education and sleep disorder screening and treatment programs. Smartphone applications (app) are increasingly commonplace and represent promising, scalable modalities for such programs. The dayzz app is a personalized sleep training program that incorporates assessment of sleep disorders and offers a personalized comprehensive sleep improvement solution. Using a sample of day workers affiliated with a large institution of higher education, we will conduct a single-site, parallel-group, randomized, waitlist control trial. Participants will be randomly assigned to either use the dayzz app throughout the study or receive the dayzz app at the end of the study. We will collect data on feasibility and acceptability of the dayzz app; employee sleep, including sleep behavioral changes, sleep duration, regularity, and quality; employee presenteeism, absenteeism, and performance; employee mood; adverse and safety outcomes; and healthcare utilization on a monthly basis throughout the study, as well as collect more granular daily data from the employee during pre-specified intervals. Our results will illuminate whether a personalized smartphone app is a viable approach for improving employee sleep, health, and productivity. Trial registration: ClinicalTrials.gov Identifier: NCT04224285.
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]Sleep is beneficial for physical and mental health. Several mobile and wearable sleep-tracking devices have been developed, and personalized sleep feedback is the most common functionality among these devices. To date, no study has implemented an objective push-type feedback message and investigated the characteristics of habitual sleep behavior and diurnal symptoms when receiving sleep feedback.
Effectiveness of an App-Based Short Intervention to Improve Sleep: Randomized Controlled Trial. [2023]A growing body of evidence for digital interventions to improve sleep shows promising effects. The interventions investigated so far have been primarily web-based; however, app-based interventions may reach a wider audience and be more suitable for daily use.
Mobile app for personalized sleep-wake management for shift workers: A user testing trial. [2023]Label="Objective" NlmCategory="UNASSIGNED">Development of personalized sleep-wake management tools is critical to improving sleep and functional outcomes for shift workers. The objective of the current study was to test the performance, engagement and usability of a mobile app (SleepSync) for personalized sleep-wake management in shift workers that aid behavioural change and provide practical advice by providing personalized sleep scheduling recommendations and education.