Maintaining Behavior Change: An Evaluation of a Habit-based Sleep Health Intervention (NCT05167695) | Clinical Trial Compass
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 range18 Years – 30 Years
SexALL
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.
✕. Night shifter worker where the shift is scheduled between the hours of midnight to 6am \> 2 nights per week.
What they're measuring
1
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
2
Utilization Scale
Timeframe: Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up
3
Composite Sleep Health Score
Timeframe: Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up
4
Composite Scale of Morningness
Timeframe: Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up
5
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
6
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
7
Adapted version of the Work and Social Adjustment Scale
Timeframe: Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up