Trials / Recruiting
RecruitingNCT06816329
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
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 148 (estimated)
- Sponsor
- Mclean Hospital · Academic / Other
- Sex
- Female
- Age
- 13 Years – 15 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Computer Task Manipulation | Participants will complete computer tasks. |
Timeline
- Start date
- 2025-10-15
- Primary completion
- 2030-03-31
- Completion
- 2030-03-31
- First posted
- 2025-02-10
- Last updated
- 2025-10-23
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT06816329. Inclusion in this directory is not an endorsement.