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Stress Dynamics and Familial Risk for Depression in Female Adolescents

Tracking the Dynamic Trajectory of Behavioral, Physiological, and Neurobiological Stress Responses in Female Adolescents at High and Low Familial Risk for Depression

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06816329
Enrollment
148
Registered
2025-02-10
Start date
2025-10-15
Completion date
2030-03-31
Last updated
2025-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

Keywords

stress, depression, adolescents, neuroimaging, familial risk

Brief summary

Stress and a parental history of major depressive disorder (MDD) are among the strongest risk factors for future development of MDD. Studies have shown that having a parental history of MDD may be associated with behavioral, psychophysiological, and hormonal responses to stress that are associated with poorer stress coping. . Adolescence is a vulnerable developmental window linked to increased MDD risk, especially for females, as rates of MDD surge relative to males. Despite the central role of stress in MDD onset, little is known about the brain mechanisms underlying stress responses in susceptible female adolescents at high familial risk for MDD. Also, it is unclear how stress-related brain network alterations may relate to real-world maladaptive stress responses and whether these stress-related brain network changes are predictive of future depression onset. We will fulfill these research gaps by combining neuroimaging with intensive longitudinal tracking of depressive symptomology as well as behavioral and physiological responses to real world stress using smartphone and smartwatch technology. Elucidating these neural mechanisms may aid in the discovery of MDD biomarkers that could identify youth at greatest risk for future MDD development and lead to earlier intervention efforts.

Detailed description

Participants in this research study will include female adolescent between the age of 13 to 15, who may or may not have a parental history of depression. About 148 adolescents will take part in this study along with a biological parent/parent(s) over the next five years. The study will include five sessions over the span of 18-months, including: * A clinical diagnostic interview as well as filling out a series of questionnaires and assessments. This can be done virtually over Zoom or in-person. * The second session will include a functional magnetic resonance imaging (fMRI) brain scan to be conducted at the McLean Hospital Imaging Center. Participants will be asked to respond to surveys on their cell phone in the two-weeks following the fMRI brain scan. Participants will also be given and asked to wear a smartwatch that tracks their heart rate, activity level, and sleep patterns for two-weeks. * The third session will include a diagnostic interview, assessments, and questionnaires to be completed six-months after the fMRI brain scan. Participants will be asked to complete surveys on their cell phone during the two-weeks following this six month follow-up session. Participants will also be given and asked to wear a smartwatch that tracks their heart rate, activity level, and sleep patterns for two-weeks. * The fourth session will include a diagnostic interview, assessments, and questionnaires to be completed 12-months after the fMRI brain scan. Participants will be asked to complete surveys on their cell phone during the two-weeks following this 12-month follow-up session. Participants will also be given and asked to wear a smartwatch that tracks their heart rate, activity level, and sleep patterns for two-weeks. * The fifth session will include a diagnostic interview, assessments, and questionnaires to be completed 18-months after the fMRI brain scan. Participants will be asked to complete surveys on their cell phone during the two-weeks following this 18-month follow-up session. Participants will also be given and asked to wear a smartwatch that tracks their heart rate, activity level, and sleep patterns for two-weeks.

Interventions

Participants will complete computer tasks.

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
Mclean Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

Case-Control Design

Eligibility

Sex/Gender
FEMALE
Age
13 Years to 15 Years
Healthy volunteers
Yes

Inclusion criteria

General Inclusion Criteria for all Adolescent Cohorts: * Female sex assigned at birth * Ages 13-15 * English as first language or English Fluency * Right-handed * Have a personal cell phone to complete the ecological momentary assessments * Ability to give signed, informed consent/assent either written or electronic (via RedCap eConsent) * Normal or corrected to normal vision and hearing Additional Inclusion Criteria for Female Adolescents with a Parental History of MDD, high-risk group: • A biological parent meeting DSM-5 criteria for at least one past/current major depressive episode

Exclusion criteria

General

Design outcomes

Primary

MeasureTime frameDescription
Time Spent in Default Mode-Frontoparietal Network Coactivation Pattern (CAP)Throughout a 1.75 hour MRI scan collected during the middle of a 3.5 hour 2nd study sessionTime Spent in Default Mode-Frontoparietal Network Coactivation Pattern (CAP). An fMRI variable. (the number of volumes spent in this CAP).
Persistence in default mode network-frontoparietal network co-activation patternThroughout a 1.75 hour MRI scan collected during the middle of a 3.5 hour 2nd study sessionPersistence in default mode network-frontoparietal network CAP. An fMRI measure. (the average number of consecutive volumes spent in this CAP)
Depressive SymptomsCollected at baseline, the beginning of a 1.75 hour MRI, and at 6-, 12-, and 18-month follow-upsThe total score on the Mood and Feelings Questionnaire \[Min Score: 0, Max Score: 66, higher scores mean more severe depressive symptoms)

Secondary

MeasureTime frameDescription
heart rate variabilityCollected during a two-week period immediately after the 2nd study session (i.e., the MRI session), and then in the two-weeks immediately after the 6-, 12-, and 18-month follow-up sessions, respectivelyheart rate variability expressed as the root mean square of successive differences (RMSSD)
CortisolCollected throughout a 3.5 hour second study session that involves a 1.75 hour MRI conducted at the middle of the sessionSaliva rating to be collected throughout the fMRI brain scan
Sleep durationCollected during a two-week period immediately after the 2nd study session (i.e., the MRI session), and then in the two-weeks immediately after the 6-, 12-, and 18-month follow-up sessions, respectivelysleep duration computed as the difference in minutes between sleep onset and sleep offset
Stress RatingsCollected during a two-week period immediately after the 2nd study session (i.e., the MRI session), and then in the two-weeks immediately after the 6-, 12-, and 18-month follow-up sessions, respectivelyStress ratings (0-100 sliding bar scale) collected via smartphone.
Average heart rate (beats per minute)Collected during a two-week period immediately after the 2nd study session (i.e., the MRI session), and then in the two-weeks immediately after the 6-, 12-, and 18-month follow-up sessions, respectivelycompute average heart rate through smartwatch technology

Countries

United States

Contacts

Primary ContactEmily Belleau
ebelleau@mclean.harvard.edu617-855-4245

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026