- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07410585
Testing the Effectiveness of an Intervention That Aligns Circadian Rhythm With Daily Activities on Student Flourishing (Not Required)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The aim of this clinical study is to test the effectiveness of an intervention (through an app called Owaves: MyBodyClock that will be provided free of cost) designed to help students align daily activities in accordance with their circadian rhythm. The questions include:
- Does the intervention improve both trait and state measures of student flourishing, including general well-being (i.e., happiness), focus, and energy levels?
- Does the intervention alter the types of activities participants engage in?
- Does the intervention impact the likelihood of seeking resources for physical and mental health?
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Karen Dobkins, PhD
- Phone Number: 16198468152
- Email: KDOBKINS@UCSD.EDU
Study Locations
-
-
California
-
La Jolla, California, United States, 92037
- Recruiting
- UC San Diego
-
Contact:
- Karen Dobkins, PhD
- Phone Number: 6198468152
- Email: KDOBKINS@UCSD.EDU
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Currently an undergraduate students from University of California, San Diego (UCSD)
- Age 18 or older
- has access to a device to answer Qualtrics questions
- has access to a device that can download the MyBodyClock App (Apple iPhone or Apple iPad)
Exclusion Criteria:
- Participants who are under the age of 18, are not undergraduate students at UCSD, or do not have access to the Qualtrics question platform and/or the MyBodyClock App
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group who uses OWAVES App for 7 weeks
|
Students use the Owaves app for 7 weeks and psychological measures are obatined pre and post to determine the effectiveness of the App
|
|
No Intervention: Control group who does not use the OWAVES app
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Trait Happiness (Subjective Happiness Scale)
Time Frame: Baseline (Weeks 1/2) and Weeks 8/9.
|
Subjective Happiness Scale (SHS) Trait questionnaire.
The SHS is a 4-item scale of global subjective happiness.
It is scored on a 7-point Likert scale where 1 = less happy to 7 = more happy.
Total scores range from 4 to 28 where higher scores indicate greater subjective happiness.
|
Baseline (Weeks 1/2) and Weeks 8/9.
|
|
Focus Trait (Barkley Adult ADHD Rating Scale (Inattention Subscale) and Academic Time Management and Procrastination Measure)
Time Frame: Baseline (Weeks 1/2) and Weeks 8/9.
|
The Barkley Adult ADHD Rating Scale is a self-report questionnaire with 18-items which rates the frequency of ADHD symptoms and behaviors.
Each item is scored on a 4-point scale ranging from 1 = never or rarely, to 4 = very often.
A lower score indicates less severe ADHD symptoms and behaviors.
|
Baseline (Weeks 1/2) and Weeks 8/9.
|
|
Energy Trait (Subjective Vitality Scale)
Time Frame: Baseline (Weeks 1/2) and Weeks 8/9.
|
Subjective Vitality Scale (SVS) is a 6 - item self-report questionnaire to measure the subjective vitality of a participant.
It is scored on a 7-point Likert scale where 1 = completely disagree to 7 = completely agree.
Higher scores indicates higher level of subjective vitality.
|
Baseline (Weeks 1/2) and Weeks 8/9.
|
|
Mindfulness Trait (Five Facet Mindfulness Questionnaire (FFMQ))
Time Frame: Baseline (Weeks 1/2) and Weeks 8/9.
|
The Five Facet Mindfulness Questionnaire (FFMQ) short form is a 24-item questionnaire that measures mindfulness in participants.
Items are scored on a 5-point Likert-type scale ranging from 1 = never/very rarely true to 5 = very often/always true.
Higher scores indicate greater levels of mindfulness.
|
Baseline (Weeks 1/2) and Weeks 8/9.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
States
Time Frame: 7 weeks
|
State measures will be obtained within three days of the trait assessments (also in weeks 1/2 and 8/9) using the Daily Reconstruction Method (DRM), in which participants are asked to reconstruct their previous day into episodes and retrospectively report on state variables during each episode (see Raynes & Dobkins, 2025). The state measures will match the trait measures and ask about:
|
7 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IRB: #813010
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronotypes and Health
-
BIO-CAT Microbials, LLCBiofortis Clinical Research, Inc.CompletedImmune Health | Cardiovascular Health | Gastrointestinal Health | Digestive HealthUnited States
-
Cambridge Health AllianceNot yet recruitingMental Health | Adolescent Health | Minority Health | Community Health Services
-
King's College LondonNational Cancer Institute (NCI); Cancer Research UK; French National Cancer Institute... and other collaboratorsNot yet recruitingCancer | Mental Health | Resilience | Other | Allergies | Cardiovascular Health | Cognitive Health | Respiratory Health | Metabolic Health | Eye Health | Ageing Well | Psychological Health | Musculoskeletal Health | Neurological Health | Environmental Health Effects
-
Universiti Teknologi MaraUniversiti Putra Malaysia; Ministry of Health, Malaysia; Institute for Health... and other collaboratorsRecruitingHealth Attitude | Health Behavior | Knowledge, Attitudes, Practice | Health Knowledge, Attitudes, Practice | Health-Related Behavior | Behavior, Health | Attitude to Health | Preparedness | OutbreaksMalaysia
-
Ankara Yildirim Beyazıt UniversityNot yet recruitingHealth Attitude | Health Behavior | Health KnowledgeTurkey
-
Nag Food Supplement Trading LLCCitruslabsCompletedSkin Health | Hair Health | Joint HealthUnited States
-
BIO-CAT Microbials, LLCOhio State University; Biofortis Clinical Research, Inc.CompletedImmune Health | Gastrointestinal Health | Digestive HealthUnited States
-
VA Office of Research and DevelopmentCompletedMental Health | Veterans Health | Rural HealthUnited States
-
UMC UtrechtCompletedCardiovascular Health | Metabolic Health | Pulmonary HealthNetherlands
-
Holbaek SygehusCompletedHealth Behavior | Health Knowledge, Attitudes, Practice | Health-Related Behavior | Health LiteracyDenmark
Clinical Trials on Use of Owaves App
-
University of ValenciaCompletedObsessive-Compulsive DisorderSpain
-
VA Office of Research and DevelopmentCompleted
-
Casa di Cura Dott. PederzoliRecruitingPain Management | Pancreatectomy | Caregiver | Post Surgery Patients | Nutritional Evaluation | Ductal Adenocarcinoma of PancreasItaly
-
Mayo ClinicCompleted
-
Stanford UniversityChildren's Hospital of Philadelphia; University of Pittsburgh Medical CenterCompleted
-
Chelsea and Westminster NHS Foundation TrustSuspendedSmoking | Smoking Cessation | Smoking Reduction | Smoking HabitUnited Kingdom
-
University of Michigan Rogel Cancer CenterRogel Cancer Center Cancer Control and Population Sciences O-SURE initiativeCompletedOvarian CancerUnited States
-
Stanford UniversityNational Institutes of Health (NIH); Medable Inc.CompletedCancerUnited States
-
University Hospital MuensterCompletedQuality of Life | EndometriosisGermany
-
University of Sao Paulo General HospitalUnknownthe Focus of This Study is to Develop an Application for Postoperative Follow-up of Patients With Prostate Cancer