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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 below
Select...
I am between 18 and 30 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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

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 more
Secondary outcome measures
Brief Sensation Seeking Scale
Depression, Anxiety, and Stress Scale (DASS)
Ecological Momentary Assessment (EMA) Composite Risk Score of Functioning - Behavioral Domain
+10 more
Other outcome measures
Actigraphy
Adapted version of the Work and Social Adjustment Scale (individual items)
Adverse Events Checklist
+16 more

Trial 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.

Find a Location

Who is running the clinical trial?

University of California, BerkeleyLead Sponsor
181 Previous Clinical Trials
720,996 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
1,959 Total Patients Enrolled
5 Trials studying Circadian Dysregulation
1,258 Patients Enrolled for Circadian Dysregulation

Media Library

Habit-based Sleep Health Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05167695 — N/A
Habit-based Sleep Health Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05167695 — N/A
Circadian Dysregulation Research Study Groups: Habit-based Sleep Health Intervention plus text messages (HABITs+texts), Habit-based Sleep Health Intervention (HABITs)
Circadian Dysregulation Clinical Trial 2023: Habit-based Sleep Health Intervention Highlights & Side Effects. Trial Name: NCT05167695 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Maintaining Behavior Change: An Evaluation of a Habit-based Sleep Health Intervention
Allison Harvey 2022. "Maintaining Behavior Change: An Evaluation of a Habit-based Sleep Health Intervention". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05167695.
~71 spots leftby Dec 2025
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