Evaluating a sleep health intervention using habit formation and text messaging

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

This study is testing a new sleep program for young adults that uses habit-building techniques and text messages to see if it helps them sleep better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 18 Years to 30 Years
• Sex: All
• Sponsor: University of California, Berkeley (Academic / other)
• Locations: 1 site (Berkeley, California)
• Trial ID: NCT05167695 on ClinicalTrials.gov

What this trial studies

This study tests a sleep-health intervention that focuses on habit formation to improve sleep and circadian outcomes among young adults aged 18-30. It evaluates whether incorporating a text messaging component enhances the effectiveness of the intervention. Participants will be assessed on their sleep health behaviors and overall functioning in various health domains both immediately after the intervention and at follow-up points of 6 and 12 months. The goal is to determine if the combined approach leads to stronger habit formation and better sleep health.

Who should consider this trial

Good fit: Ideal candidates are young adults aged 18-30 who experience circadian dysregulation and are at risk in one of the five health domains.

Not a fit: Patients with severe mental illness, substance abuse issues, or other conditions that make participation unfeasible may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly improve sleep quality and health outcomes for young adults struggling with circadian dysregulation.

How similar studies have performed: Other studies have shown promise in using habit formation techniques for health interventions, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

1. 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.
2. '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.
3. Age between 18 and 30.
4. English language fluency.
5. Able and willing to give informed assent.
6. If taking medication for sleep, the dose and frequency of use must have been stable for at least 4 weeks.

Exclusion Criteria:

1. 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.
2. 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.
3. Night shifter worker where the shift is scheduled between the hours of midnight to 6am \> 2 nights per week.
4. Pregnancy or breast-feeding.

Where this trial is running

Berkeley, California

• University of California — Berkeley, California, United States (Recruiting)

Study contacts

• Principal investigator: Allison Harvey, PhD — University of California, Berkeley
• Study coordinator: Estephania Ovalle Patino, BA

Conditions Circadian Dysregulation; Habits; Circadian; Sleep; transdiagnostic; Intervention