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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
160
A novel low-cost approach derived by leveraging the science of habit formation
In addition to the Habit-based Sleep Health Intervention, the participants will also receive the text messaging intervention.
University of California
Berkeley, California, United States
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).
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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)
Time frame: 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)
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Time frame: 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).
Time frame: Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up
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).
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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).
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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