Implementation Intentions for Circadian Dysregulation

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Circadian Dysregulation+2 MoreImplementation Intentions - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing different ways to help people break bad habits.

Eligible Conditions
  • Good Sleep Hygiene
  • Circadian Dysregulation
  • Sleep Disorders

Treatment Effectiveness

Effectiveness Progress

1 of 3

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2
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1
Habit-based Sleep Health Intervention

Study Objectives

4 Primary · 4 Secondary · Reporting Duration: Change from screening to 6-week follow-up, 3-month follow-up

1 week after baseline
Credibility Expectancy Scale
Baseline
Composite Sleep Health Score
Change from baseline to 6-week follow-up and 3-month follow-up
Patient-Reported Outcomes Measurement Information System - Sleep Disturbance
Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment
Change from baseline to 6-week follow-up, and 3-month follow-up
Interference and Motivation Items
Month 3
New Habit Questionnaire
Old Habit Questionnaire
Change from screening to 6-week follow-up, 3-month follow-up
Insomnia Severity Index - Interference Item

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Monitor sleep, mood, and substance use
3
Tasimelteon
1
Habit-based Sleep Health Intervention

Trial Design

2 Treatment Groups

Brief education
1 of 2
Treatment condition
1 of 2

Experimental Treatment

462 Total Participants · 2 Treatment Groups

Primary Treatment: Implementation Intentions · No Placebo Group · N/A

Brief education
Behavioral
Experimental Group · 1 Intervention: Brief Education · Intervention Types: Behavioral
Treatment conditionExperimental Group · 6 Interventions: Implementation Intentions, RISE-UP Routine, Awareness Training, Vigilant Monitoring, Brief Education, Values-based Approach · Intervention Types: Behavioral, Behavioral, Behavioral, Behavioral, Behavioral, Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Implementation Intentions
2012
Completed Phase 2
~140
Brief Education
2013
N/A
~120

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: change from screening to 6-week follow-up, 3-month follow-up

Who is running the clinical trial?

University of California, BerkeleyLead Sponsor
154 Previous Clinical Trials
1,128,954 Total Patients Enrolled
4 Trials studying Circadian Dysregulation
872 Patients Enrolled for Circadian Dysregulation
Allison Harvey, PhDPrincipal InvestigatorUniversity of California, Berkeley
6 Previous Clinical Trials
1,311 Total Patients Enrolled
3 Trials studying Circadian Dysregulation
764 Patients Enrolled for Circadian Dysregulation
Laurel Sarfan, PhDPrincipal InvestigatorUniversity of California, Berkeley

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are over 18 years of age.
You live in the United States.
You have a 95% acceptance rate on MTurk.
You have irregular wake-up times of 60 minutes or more across the week.
You have slept in bed for more than 30 minutes on a typical morning in the past week.
Screened participants will complete a demographic form to enable us to compare the demographics of those included with those who are excluded.
References

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