Active — Not RecruitingNot Applicable

Maintaining Behavior Change: An Evaluation of a Habit-based Sleep Health Intervention

United States160 participantsStarted 2022-05-04

Plain-language summary

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.

Who can participate

Age range

18 Years – 30 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Scoring less than or equal to 26 on the Composite Scale of Morningness OR Mid-point of sleep later than 4:30 AM for 18-24 yo and 3:50 AM for 25-30 yo on work-free/weekend days over the past month OR Night-to-night variation in sleep and wake times across one month of 2 hours or more.
. 'At risk' in one of the five health domains: the emotional domain, the cognitive domain, the behavioral domain, the physical domain and the social domain. "Risk" is defined as scoring 4 or higher on one item from an adapted version of the Work and Social Adjustment Scale.
. Age between 18 and 30.
. English language fluency.
. Able and willing to give informed assent.
. If taking medication for sleep, the dose and frequency of use must have been stable for at least 4 weeks.

Exclusion criteria

. Presence of substance abuse/dependence, mental illness, physical illness, suicidality or developmental disorder only if it makes participation in the study unfeasible or if there is a significant risk of harm and/or decompensation if treatment of that comorbid condition is delayed due to participating in this study.
. Evidence of sleep apnea, restless legs or periodic limb movements during sleep. Youth presenting with provisional diagnoses of any of these disorders will be referred for a non-study polysomnography evaluation and will be enrolled only if the diagnosis is disconfirmed or if the disorder is treated.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Self-Report Automaticity Habits Index integrated with the Utilization Scale

Timeframe: Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up

Utilization Scale

Timeframe: Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up

Composite Sleep Health Score

Timeframe: Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up

Composite Scale of Morningness

Timeframe: Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up

Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment (PROMIS-SRI)

Timeframe: Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up

Patient-Reported Outcomes Measurement Information System - Sleep Disturbance (PROMIS-SD)

Timeframe: Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up

Trial details

NCT IDNCT05167695

SponsorUniversity of California, Berkeley

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-20

View on ClinicalTrials.gov More Circadian Dysregulation trials

Who can participate

Age range

18 Years – 30 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Scoring less than or equal to 26 on the Composite Scale of Morningness OR Mid-point of sleep later than 4:30 AM for 18-24 yo and 3:50 AM for 25-30 yo on work-free/weekend days over the past month OR Night-to-night variation in sleep and wake times across one month of 2 hours or more.
. 'At risk' in one of the five health domains: the emotional domain, the cognitive domain, the behavioral domain, the physical domain and the social domain. "Risk" is defined as scoring 4 or higher on one item from an adapted version of the Work and Social Adjustment Scale.
. Age between 18 and 30.
. English language fluency.
. Able and willing to give informed assent.
. If taking medication for sleep, the dose and frequency of use must have been stable for at least 4 weeks.

Exclusion criteria

. Presence of substance abuse/dependence, mental illness, physical illness, suicidality or developmental disorder only if it makes participation in the study unfeasible or if there is a significant risk of harm and/or decompensation if treatment of that comorbid condition is delayed due to participating in this study.
. Evidence of sleep apnea, restless legs or periodic limb movements during sleep. Youth presenting with provisional diagnoses of any of these disorders will be referred for a non-study polysomnography evaluation and will be enrolled only if the diagnosis is disconfirmed or if the disorder is treated.

What they're measuring

Self-Report Automaticity Habits Index integrated with the Utilization Scale

Timeframe: Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up

Utilization Scale

Timeframe: Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up

Composite Sleep Health Score

Timeframe: Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up

Composite Scale of Morningness

Timeframe: Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up

Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment (PROMIS-SRI)

Timeframe: Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up

Patient-Reported Outcomes Measurement Information System - Sleep Disturbance (PROMIS-SD)

Timeframe: Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up