Teen depression study tracks heartbeats and family bonds
NCT ID NCT07430774
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at how heart rate variability (a measure of stress response) relates to emotional control and parent-teen relationships in 74 adolescents with depression. Teens will wear a Fitbit while sleeping for a week and fill out questionnaires. The goal is to better understand these connections, not to test a treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 74 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The study will enroll 74 adolescents (ages 12-18 years) diagnosed with MDD and their primary caregivers. Participants must live with a caregiver for ≥50% of the time. Recruitment will occur through Children's Medical Center Dallas and will reflect the racial and ethnic diversity of the Dallas-Fort Worth area.
- Ages
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12 to 18 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Aged 12-18 years at the time of screening. 2. Current Major Depressive Disorder (MDD) documented in the electronic medical record by a licensed clinician; diagnosis verified using the Mental Health History - Parent Form. 3. Lives with a parent/legal guardian at least 50% of the time, confirmed on the Demographics Form. 4. Able and willing to provide assent, with a parent/legal guardian able and willing to provide informed consent. 5. Willingness to comply with all study procedures, including wearing a Fitbit Charge 5 for 7 nights, syncing the device through a compatible smartphone, and completing all required assessments (DERS-36, PHQ-9, anthropometrics, Youth Activity Profile, caffeine logs, PACHIQ-R). 6. Primary caregiver willing to participate, including completion of the PACHIQ-R (Caregiver). 7. If taking antidepressant medication, must be on a stable dose for at least 4 weeks before screening, verified on the Self-Administered Comorbidity Questionnaire. 8. English-speaking adolescent and caregiver, as all measures used in the study are validated in English. 9. Available for two in-person study visits within the study period. Exclusion Criteria 1. Medical conditions affecting autonomic function or HRV (arrhythmia, congenital heart disease, cardiomyopathy, Type 1 or Type 2 diabetes, thyroid disorders, or moderate-to-severe sleep apnea), as reported on the Self-Administered Comorbidity Questionnaire. 2. Use of medications known to affect heart rate or HRV, including beta-blockers, calcium channel blockers, antiarrhythmics, tricyclic antidepressants, stimulants, or antipsychotics, as documented on the NIMH Concomitant Medication Log. 3. Active substance use, including nicotine/tobacco, alcohol, marijuana, recreational drugs, or energy drinks, as assessed by the Drug Use Screening Inventory. 4. Habitual high caffeine intake (\>200 mg/day, equivalent to \>4 cups of coffee or \>2 cans of caffeinated soda per day), as assessed by a caffeine screening question during eligibility screening. 5. Psychotic disorders or active psychotic symptoms, as reported on the Mental Health History Questionnaire (Parent) and the Self-Administered Comorbidity Questionnaire. 6. Acute suicidal ideation requiring immediate intervention, defined as endorsement of agree and strongly agree on items 14-16 of the Concise Health Risk Tracking Self-Report (CHRT-SR), indicating active suicide risk. 7. Severe cognitive or intellectual impairment interfering with study participation, determined during eligibility screening based on parent report on the Mental Health History Questionnaire and observed inability to complete screening or consent procedures. 8. Current eating disorder diagnosis (anorexia nervosa, bulimia nervosa, or binge eating disorder), as reported on the Mental Health History Questionnaire. 9. Concurrent participation in another study involving wearable devices or daily monitoring, as reported on the Eligibility Screening Form. 10. Skin conditions or sensitivities prevent continuous wear of a wrist-worn device reported on the Eligibility Screening Form.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Child and adolescent psychiatrist at the Children's Health Psychiatry Clinic.
Dallas, Texas, 75247, United States
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