Habit-based Sleep Health Intervention for Circadian Dysregulation

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of California, Berkeley, CACircadian DysregulationHabit-based Sleep Health Intervention - Behavioral
Eligibility
18 - 30
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test whether a sleep-health intervention that uses habit-formation science can improve outcomes by adding a text-messaging component. Participants will be 18-30 years old.

Eligible Conditions
  • Circadian Dysregulation

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

13 Primary · 12 Secondary · Reporting Duration: 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

Week 3
Credibility Expectancy Questionnaire
At the 1-week post treatment assessment only
Adverse Events Checklist
Week 3
Self Report Habit Index
Change from baseline to 1-week post treatment
Actigraphy
Ecological Momentary Assessment (EMA) Composite Risk Score of Functioning - Behavioral Domain
Ecological Momentary Assessment Composite Risk Score of Functioning - Cognitive Domain
Ecological Momentary Assessment Composite Risk Score of Functioning - Emotion
Ecological Momentary Assessment Composite Risk Score of Functioning - Physical Domain
Ecological Momentary Assessment Composite Risk Score of Functioning - Social Domain
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
Adapted version of the Work and Social Adjustment Scale (individual items)
Alexian Brothers Urge to Self Injure Scale
Brief Sensation Seeking Scale
Change in Brief Sensation Seeking Scale
Change in Depression, Anxiety, and Stress Scale (DASS)
Change in Modifiable Activity Questionnaire
Change in Patient-Reported Outcomes Measurement Information System - Ability to Participate in Social Roles & Activities
Change in Patient-Reported Outcomes Measurement Information System - Companionship
Change in Patient-Reported Outcomes Measurement Information System - Emotional Support
Change in Patient-Reported Outcomes Measurement Information System - Social Isolation
Change in Patient-Reported Outcomes Measurement Information System -Alcohol Use
Change in Patient-Reported Outcomes Measurement Information System -Cognitive Function
Change in Patient-Reported Outcomes Measurement Information System -Severity of Substance Use
Change in Patient-Reported Outcomes Measurement Information System-Cognitive Function - Abilities
Change in Physical Health Questionnaire
Composite Scale of Morningness
Composite Sleep Health Score
Depression, Anxiety, and Stress Scale (DASS)
Ecological Momentary Assessment(EMA) Composite Risk Score of Functioning - Behavioral Domain
Height
Hip circumference
PROMIS-Ability to participate
PROMIS-Cognitive Function
Patient-Reported Outcomes Measurement Information System - Global health scale
Patient-Reported Outcomes Measurement Information System - Sleep Disturbance (PROMIS-SD)
Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment (PROMIS-SRI)
Physical Health Questionnaire
Pittsburgh Sleep Quality Index
Self-Report Automaticity Habits Index integrated with the Utilization Scale
Self-Report Behavioral Automaticity Index integrated with the Utilization Scale
Self-Report Composite Score for Emotional domain
Self-Report Score for Behavioral Domain
Self-Report Score for Cognitive Domain
Self-Report Score for Physical Domain
Self-Report Score for Social Domain
Sleep Diary
State authenticity
Suicidal Behavior Questionnaire - Revised
Sussex-Oxford Compassion Scale (SOCS)
Utilization Scale
Waist circumference
Weight
Once at baseline
Past month estimates of sleep mid-point workfree days and night-to-night sleep variability
Sleep Medication Log

Trial Safety

Safety Progress

1 of 3

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1
Smartphone + Text Messaging with Health Coach
2
Personalized Trial ABCCBA
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Trial Design

2 Treatment Groups

Habit-based Sleep Health Intervention (HABITs)
1 of 2
Habit-based Sleep Health Intervention plus text messages (HABITs+texts)
1 of 2

Experimental Treatment

160 Total Participants · 2 Treatment Groups

Primary Treatment: Habit-based Sleep Health Intervention · No Placebo Group · N/A

Habit-based Sleep Health Intervention (HABITs)
Behavioral
Experimental Group · 1 Intervention: Habit-based Sleep Health Intervention · Intervention Types: Behavioral
Habit-based Sleep Health Intervention plus text messages (HABITs+texts)Experimental Group · 2 Interventions: Habit-based Sleep Health Intervention, Text messaging intervention · Intervention Types: Behavioral, Behavioral

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 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

Who is running the clinical trial?

University of California, BerkeleyLead Sponsor
156 Previous Clinical Trials
590,807 Total Patients Enrolled
4 Trials studying Circadian Dysregulation
1,174 Patients Enrolled for Circadian Dysregulation
Allison Harvey, PhDPrincipal InvestigatorUniversity of California, Berkeley
6 Previous Clinical Trials
1,613 Total Patients Enrolled
3 Trials studying Circadian Dysregulation
1,066 Patients Enrolled for Circadian Dysregulation

Eligibility Criteria

Age 18 - 30 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have trouble waking up early in the morning or have a habit of sleeping past a certain time. You also experience a lot of variation in your sleep schedule from night-to-night.
You have significant problems in one of these areas: emotions, thinking ability, behavior, physical health, or social interactions. This is determined by scoring 4 or higher on one question from a specific survey.
References

Frequently Asked Questions

Does the enrollment criteria for this trial include individuals under 45 years of age?

"This clinical study is open to those aged between 18 and 30 years old; however, there are other trials available for minors or individuals over the age of 65. Specifically, 3 studies dedicated to younger patients and 16 specially designed for seniors." - Anonymous Online Contributor

Unverified Answer

Is this experiment still recruiting participants?

"Affirmative. According to clinicaltrials.gov, the trial was initially published on May 4th 2022 and has since been revised. Currently, 160 participants are sought from 1 site for this ongoing recruitment effort." - Anonymous Online Contributor

Unverified Answer

What is the current patient participation rate for this research study?

"Indeed, the clinicaltrials.gov page for this experiment reveals that it is still accepting participants. It was initially posted on May 4th 2022 and has been updated recently on 16 of the same month. A total of 160 people are needed from 1 particular site." - Anonymous Online Contributor

Unverified Answer

What is the purpose of this clinical experiment?

"The main objective of this clinical trial is to observe the evolution in Self-Report Score for Physical Domain, with assessments being conducted at baseline, one week post treatment, 6 months and 12 months. Secondary outcomes include an Ecological Momentary Assessment Composite Risk Score for Functioning - Behavioral Domain (not a scale), which will track weekly frequencies and intakes of substances such as caffeine or opioids; Social Domain which evaluates if the participant is alone or not when assessed; and Cognitive Domain where concentration, distractedness and focus are rated on a 5 point scale." - Anonymous Online Contributor

Unverified Answer

For whom would this research study be most beneficial?

"The requirements for eligibility in this trial include having a circadian rhythm disorder and being of the age 18 to 30. To complete the study, 160 volunteers must be secured." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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