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Habit-Based Sleep Intervention with Texting for Circadian Dysregulation
N/A
Recruiting
Led By Allison Harvey, PhD
Research Sponsored by University of California, Berkeley
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age between 18 and 30
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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
Awards & highlights
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.
Who is the study for?
This trial is for young adults aged 18-30 who speak English and are willing to participate. They should have stable sleep medication use if applicable, irregular sleep patterns or late sleep times on weekends, and be 'at risk' in emotional, cognitive, behavioral, physical or social health domains. Excluded are those with substance abuse/dependence, severe mental or physical illness, pregnancy/breastfeeding individuals, certain sleep disorders unless treated.Check my eligibility
What is being tested?
The study tests a habit-based sleep-health intervention aimed at improving participants' quality of rest through the science of habit formation. It also examines whether adding text message reminders enhances this process.See study design
What are the potential side effects?
Since the interventions involve behavior modification and communication via text messaging rather than medications or invasive procedures, significant side effects are not anticipated.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 30 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 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
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adapted version of the Work and Social Adjustment Scale
Composite Scale of Morningness
Composite Sleep Health Score
+4 moreSecondary outcome measures
Brief Sensation Seeking Scale
Depression, Anxiety, and Stress Scale (DASS)
Ecological Momentary Assessment (EMA) Composite Risk Score of Functioning - Behavioral Domain
+10 moreOther outcome measures
Actigraphy
Adapted version of the Work and Social Adjustment Scale (individual items)
Adverse Events Checklist
+16 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Habit-based Sleep Health Intervention plus text messages (HABITs+texts)Experimental Treatment2 Interventions
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.
Group II: Habit-based Sleep Health Intervention (HABITs)Experimental Treatment1 Intervention
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.
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Who is running the clinical trial?
University of California, BerkeleyLead Sponsor
181 Previous Clinical Trials
720,850 Total Patients Enrolled
6 Trials studying Circadian Dysregulation
1,366 Patients Enrolled for Circadian Dysregulation
Allison Harvey, PhDPrincipal InvestigatorUniversity of California, Berkeley
9 Previous Clinical Trials
1,935 Total Patients Enrolled
5 Trials studying Circadian Dysregulation
1,258 Patients Enrolled for Circadian Dysregulation
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have challenges in one of the five areas of health: emotions, thinking, behavior, physical health, or social interactions. This is measured by scoring 4 or higher on a specific scale.My sleep medication dose has been the same for at least 4 weeks.I am between 18 and 30 years old.I often sleep late or my sleep schedule varies by 2+ hours.I might have sleep issues like sleep apnea or restless legs but haven't been diagnosed or treated yet.You work at night at least twice a week between midnight and 6am.If you have a mental or physical condition that would make it difficult for you to take part in the study or if there is a high risk of harm if the treatment for your other condition is delayed because of the study.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Habit-based Sleep Health Intervention plus text messages (HABITs+texts)
- Group 2: Habit-based Sleep Health Intervention (HABITs)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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