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

Circadian Dysregulation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05167695
• Other study ID #: 2021-06-14409
• Status: Recruiting
• Phase: N/A
• Start date: May 4, 2022
• Est. completion date: July 1, 2026

Study information

• Verified date: October 2023
• Source: University of California, Berkeley
• Contact: Estephania Ovalle Patino, BA
• Phone: 6613127786
• Email: estephaniao[@]berkeley.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: July 1, 2026
• Est. primary completion date: December 20, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronobiology Disorders
• Circadian Dysregulation

Intervention

Behavioral:
• Habit-based Sleep Health Intervention
A novel low-cost approach derived by leveraging the science of habit formation
• Text messaging intervention
In addition to the Habit-based Sleep Health Intervention, the participants will also receive the text messaging intervention.

Locations

Country	Name	City	State
United States	University of California	Berkeley	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Berkeley

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adapted version of the Work and Social Adjustment Scale (individual items)	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 reported separately (range: 0 to 8; Higher score means worse outcome).	Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up
Other	Self Report Habit Index: Secondary habit bundle to build	1 item rated on 1-5 scale. Scores can range from 1 to 5	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	Self Report Habit Index: Secondary habit bundle to dismantle	1 items rated on 1-5 scale. Scores can range from 1 to 5	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	Height	(cm)	Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up
Other	Weight	Pounds (lbs)	Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up
Other	Hip circumference	(cm)	Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up
Other	Waist circumference	(cm)	Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up
Other	Sleep Diary	(Not a scale); Consensus sleep diary variables, including total sleep time, bedtime, and wake-time, calculated separately for weekdays and weekends.	Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up
Other	Actigraphy	(Not a scale); Sleep parameters, including sleep onset time, sleep offset time, and total sleep time, calculated separately for weekdays and weekends.	Change from baseline to 1-week post treatment
Other	Sussex-Oxford Compassion Scale (SOCS)	Sum of 20-item, 5-point response scale. Scores can range from 20 to 100 (Higher score means higher compassion for self).; Sub-scale items included.	Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up
Other	Suicidal Behavior Questionnaire - Revised	4-item. Total scores can range from 3-18 (Higher Score means higher Suicidal ideation); Sub-scale items included.	Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up
Other	Alexian Brothers Urge to Self Injure Scale	5-item. 0-6 point scale. Total scores can range from 0-30 (Higher Score means higher Suicidal ideation)	Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up
Other	State authenticity	A measure of state authenticity. The 4 items are each rated on a 1-7 scale. The sum is averaged (range 1-7; higher scores mean more authenticity)	Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up
Other	Past month estimates of sleep mid-point workfree days and night-to-night sleep variability	Questions to assess mid-point and night-to-night variability eligibility criteria	Once at baseline
Other	Sleep Medication Log	Questions to assess use of medications	Once at baseline
Other	Credibility Expectancy Questionnaire	first 3 items are on a 1-9 scale. The final item is on a 0-100 scale. (Higher score means the treatment was evaluated as more credible).	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
Other	Adverse Events Checklist	16 items to assess adverse events experienced during treatment	At the 1-week post treatment assessment only
Other	Proportion of text messages read	1 item rated from 0% to 100%	At the 1-week post treatment assessment only
Other	Script Elicitation Worksheet	(Not a scale); Individualized for each patient, the worksheet includes primary and secondary habit bundles to build and dismantle (e.g., sleep-onset habits, WASO habits, rise-up habits, daytime habits, sleep efficiency habits), and strategy to dismantle primary and secondary habit bundles (e.g., substitution, removing or curtailing, reorganizing)	After starting treatment, at the end of the 1st through 3rd treatment session (week 1 through week 3 of treatment)
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	Actigraphy	(Not a scale); Night-to-night variability in the mid-point of sleep	Baseline to 1-week post treatment
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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