Clinical trial NCT05167695: Maintaining Behavior Change: An Evaluation of a Habit-based Sleep Health Intervention
Official title: Maintaining Behavior Change: An Evaluation of a Habit-based Sleep Health Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Circadian Dysregulation
Keywords: Habits
Circadian
Sleep
transdiagnostic
Intervention
Lead sponsor: University of California, Berkeley
Sponsor class: OTHER
First posted: 2021-12-22
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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).

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.

Primary outcomes:
measure: 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
measure: Utilization Scale
timeFrame: Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up
measure: Composite Sleep Health Score
timeFrame: Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up
measure: Composite Scale of Morningness
timeFrame: Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up
measure: 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
measure: 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
measure: 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
Secondary outcomes:
measure: Pittsburgh Sleep Quality Index
timeFrame: Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up
measure: Sleep Diary
timeFrame: Baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up
measure: Actigraphy
timeFrame: Baseline to 1-week post treatment
measure: Depression, Anxiety, and Stress Scale (DASS)
timeFrame: Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up
measure: Brief Sensation Seeking Scale
timeFrame: Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up
measure: Physical Health Questionnaire
timeFrame: Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up
measure: PROMIS-Cognitive Function
timeFrame: Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up
measure: PROMIS-Ability to participate
timeFrame: Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up
measure: Ecological Momentary Assessment Composite Risk Score of Functioning - Emotion
timeFrame: Change from baseline to 1-week post treatment
measure: Ecological Momentary Assessment Composite Risk Score of Functioning - Cognitive Domain
timeFrame: Change from baseline to 1-week post treatment
measure: Ecological Momentary Assessment (EMA) Composite Risk Score of Functioning - Behavioral Domain
timeFrame: Change from baseline to 1-week post treatment
measure: Ecological Momentary Assessment Composite Risk Score of Functioning - Social Domain
timeFrame: Change from baseline to 1-week post treatment
measure: Ecological Momentary Assessment Composite Risk Score of Functioning - Physical Domain
timeFrame: Change from baseline to 1-week post treatment
measure: Self Report Habit Index: Primary habit bundle to build
timeFrame: 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
measure: Self Report Habit Index: Primary habit bundle to dismantle
timeFrame: 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
Other outcomes:
measure: Adapted version of the Work and Social Adjustment Scale (individual items)
timeFrame: Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up
measure: Self Report Habit Index: Secondary habit bundle to build
timeFrame: 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
measure: Self Report Habit Index: Secondary habit bundle to dismantle
timeFrame: 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
measure: Height
timeFrame: Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up
measure: Weight
timeFrame: Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up
measure: Hip circumference
timeFrame: Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up
measure: Waist circumference
timeFrame: Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up
measure: Sleep Diary
timeFrame: Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up
measure: Actigraphy
timeFrame: Change from baseline to 1-week post treatment
measure: Sussex-Oxford Compassion Scale (SOCS)
timeFrame: Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up
measure: Suicidal Behavior Questionnaire - Revised
timeFrame: Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up
measure: Alexian Brothers Urge to Self Injure Scale
timeFrame: Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up
measure: State authenticity
timeFrame: Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up
measure: Past month estimates of sleep mid-point workfree days and night-to-night sleep variability
timeFrame: Once at baseline
measure: Sleep Medication Log
timeFrame: Once at baseline
measure: Credibility Expectancy Questionnaire
timeFrame: After the 2nd treatment session, which is 2 to 3 weeks after the beginning of treatment. Again at the post-treatment assessment which is 1-week post treatment
measure: Adverse Events Checklist
timeFrame: At the 1-week post treatment assessment only
measure: Proportion of text messages read
timeFrame: At the 1-week post treatment assessment only
measure: Script Elicitation Worksheet
timeFrame: After starting treatment, at the end of the 1st through 3rd treatment session (week 1 through week 3 of treatment)
Locations:
city: Berkeley
country: United States
facility: University of California
state: California
Study officials:
affiliation: University of California, Berkeley
name: Allison Harvey, PhD
role: PRINCIPAL_INVESTIGATOR
References: