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

Study Overview
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Brief Summary
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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.

Detailed Description
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The study will test a sleep-health intervention that leverages the science on habit formation. Additionally, the investigators will evaluate whether adding a text messaging intervention improves habit formation. The participants will be 18-30 years old. This is a distinct developmental period in which priorities shift toward self-sufficiency and personal responsibility, which are supported by developing adaptive habits. Main Aim. To evaluate if adding a text messaging intervention, derived from learning theory, to HABITs improves the utilization of sleep health behavior and improves sleep and circadian outcomes and functioning in the five health-relevant domain outcomes in the short (post-treatment) and longer term (6 and 12-months later), relative to HABITs without text messaging. Main Hypothesis. Relative to HABITs, youth in HABITs+Texts will (a) establish stronger sleep health behavior habits, (b) report utilizing more sleep health behaviors and (c) exhibit improved sleep and circadian functioning and lower health-relevant risk. These effects will be observed at post-treatment as well as 6 and 12-months later. Exploratory Aim: To evaluate if the Habit-based Sleep Health Intervention ('HABITs') is associated with an improvement in the utilization of sleep health behavior, an improvement in sleep and circadian outcomes and an improvement in functioning in the five health-relevant domain outcomes in the short (post-treatment) and longer term (6 and 12-months later), relative to baseline. Exploratory Hypothesis. Combining across the HABITs and HABITs+Texts treatment arms, receiving either intervention will be associated with (a) improved sleep health behavior habits, (b) more utilization of sleep health behaviors, (c) improved sleep and circadian functioning and (d) lower health-relevant risk at post-treatment, 6- and 12-month follow-up, relative to baseline. Additional exploratory analyses: To examine (a) if sleep health behavior that has become habitual mediates the effects of treatment on improvement in sleep, circadian and health outcomes and (b) if intervention effects are moderated by selected variables (e.g., age, sex, minority group, socioeconomic status (SES), season).

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

Conditions
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Circadian Dysregulation

Intervention / Treatment
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* Behavioral: Habit-based Sleep Health Intervention
* Behavioral: Text messaging intervention


Participation Criteria
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Eligibility Criteria
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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. Pregnancy or breast-feeding.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Habit-based Sleep Health Intervention (HABITs)<br>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. | Behavioral: Habit-based Sleep Health Intervention<br>* A novel low-cost approach derived by leveraging the science of habit formation<br>|
| Experimental: Habit-based Sleep Health Intervention plus text messages (HABITs+texts)<br>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. | Behavioral: Habit-based Sleep Health Intervention<br>* A novel low-cost approach derived by leveraging the science of habit formation<br>Behavioral: Text messaging intervention<br>* In addition to the Habit-based Sleep Health Intervention, the participants will also receive the text messaging intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-Report Automaticity Habits Index integrated with the Utilization Scale | 16-item; 0-4 scale. Scores can range from 0 to 64 (Higher score means more automaticity in utilization). | Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up | 
| Utilization Scale | 16-item; 0-4 scale. Scores can range from 0 to 64 (Higher score means more utilization). | Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up | 
| Composite Sleep Health Score | Composite Sleep Health Score which is defined as the sum of scores on 6 sleep health dimensions: Regularity (Midpoint fluctuation), Satisfaction (Sleep quality question on PROMIS-SD), Alertness (Daytime sleepiness question on PROMIS-SRI), Timing (Mean midpoint), Efficiency (Sleep efficiency) and Duration (Total Sleep Time). The Sleep Health Composite was constructed such that higher score indicates better sleep health. | Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up | 
| Composite Scale of Morningness | Sum of 13-item; Mix of 4-point and 5-point response scale. Scores can range from 13 (extreme evening) to 55 (extreme morning). | 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) | Sum of 8-items rated on a 5-point response scale. Scores can range from 8 to 40 (Higher score means more Sleep Related impairment) | 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) | Sum of 8-items rated on a 5-point response scale. Scores can range from 8 to 40 (Higher score means more Sleep Disturbance) | Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up | 
| Adapted version of the Work and Social Adjustment Scale | A measure of emotional, cognitive, physical, social and behavioral risk. The 5 items are each rated on a 0-8 scale. The 5 individual item scores will be summed into a total score (range: 0 to 40; Higher score means worse outcome). | Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pittsburgh Sleep Quality Index | 19-item. First four items are integer responses. The rest of the items are on a 0-3 scale. Creates 7 composite scores, with the sum of the composite scores ranging from 0 to 21. (Higher score means increased severity of difficulty in all sleep area components). | Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up | 
| Sleep Diary | (Not a scale); Night-to-night variability in the mid-point of sleep | Baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up | 
| Actigraphy | (Not a scale); Night-to-night variability in the mid-point of sleep | Baseline to 1-week post treatment | 
| Depression, Anxiety, and Stress Scale (DASS) | Three subscales-depression, anxiety, stress-of 7 items each, ranging from 0-3 per item. Subscale scores range from 0-21. Final scores are multiplied by two. Higher scores mean worse outcomes. Total score will also be calculated. | Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up | 
| Brief Sensation Seeking Scale | 8-item; 5-point response scale; Scores can range from 8 to 40 (Higher score means higher sensation seeking). | Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up | 
| Physical Health Questionnaire | Sum of 15-item, 0-2 response scale. Scores can range from 0 to 30 (Higher score means worse physical symptoms) | Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up | 
| PROMIS-Cognitive Function | 6-item; 1-5 response scale. Scores can range from 6-30 (Higher score means better cognitive functioning) | Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up | 
| PROMIS-Ability to participate | 4-item; 1-5 response scale. Scores can range from 4-20 (Higher score means better social functioning) | Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up | 
| Ecological Momentary Assessment Composite Risk Score of Functioning - Emotion | (Not a scale) Measured via Ecological Momentary Assessment. a 16-item version of the Positive and Negative Affect Schedule will be administered. The Positivity Ratio will also be calculated. | Change from baseline to 1-week post treatment | 
| Ecological Momentary Assessment Composite Risk Score of Functioning - Cognitive Domain | (Not a scale) Measured via Ecological Momentary Assessment. Concentration, distractedness and focus are rated on a 5 point scale. | Change from baseline to 1-week post treatment | 
| Ecological Momentary Assessment (EMA) Composite Risk Score of Functioning - Behavioral Domain | (Not a scale) Measured via Ecological Momentary Assessment. The investigators assess eating, caffeine, alcohol, nicotine, marijuana, opioids and prescription and over the counter (OTC) stimulants and sleep aids. Participants will also be asked to list the use of additional psychoactive drugs (e.g. cocaine). The investigators tabulate the average weekly frequency and intake of each substance. | Change from baseline to 1-week post treatment | 
| Ecological Momentary Assessment Composite Risk Score of Functioning - Social Domain | (Not a scale) Measured via Ecological Momentary Assessment. will assess if the participant is with anyone at the time of the call. Positivity Ratio (see EMA for Emotional Health) will be calculated when the participant is alone, with a family member or with a friend. | Change from baseline to 1-week post treatment | 
| Ecological Momentary Assessment Composite Risk Score of Functioning - Physical Domain | (Not a scale) Measured via Ecological Momentary Assessment. Physical activity and sedentary behaviors will be assessed. | Change from baseline to 1-week post treatment | 
| Self Report Habit Index: Primary habit bundle to build | 6 items rated on 1-5 scale. Scores can range from 1 to 30 | At the end of the 2nd through last treatment session, which starts 2 to 3 weeks after the beginning of treatment. Also at 1-week post treatment, 6-month follow-up and 12-month follow-up | 
| Self Report Habit Index: Primary habit bundle to dismantle | 6 items rated on 1-5 scale. Scores can range from 0 to 30 | At the end of the 2nd through last treatment session, which starts 2 to 3 weeks after the beginning of treatment. Also at 1-week post treatment, 6-month follow-up and 12-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Habits, Circadian, Sleep, transdiagnostic, Intervention