- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06426459
Social Media Usage in Adolescent Girls
Positive and Negative Effects of Social Media Usage in Adolescent Girls
Study Overview
Status
Conditions
Detailed Description
For each participant, there is a screening session, a month-long EMA assessment and two experimental fMRI sessions are planned.
After making sure the participants fill the inclusion and exclusion criteria, the investigators will invite them to the laboratory for a screening session (T0). In this session, the participants will provide written informed consent and assent in case of those under 18 years old and written, informed consent for those who are 18 year old. Furthermore, the participants will participate in a standardized clinical interview to screen for mental disorders (Kinder-DIPS). Subsequently, they will be informed about the study details. Finally, they will fill out questionnaires about personality, depressive symptoms, anxiety symptoms, gender identity and norms, mood, loneliness, social media disorder, internet use, social support, and fear of missing out.
Naturally cycling adolescent girls will join the two fMRI measurements (T1 & T2) during the follicular and luteal phase of the menstrual cycle. Adolescent girls using combined oral contraceptives will join the first fMRI measurement during the pill intake period, and the second measurement during the break period. The fMRI sessions will comprise of filling out questionnaires, fMRI measurements, and blood collection for hormonal assessment.
Questionnaires on depressive symptoms, state anxiety, mood, gender identity, self-esteem, loneliness, fear of missing out (FOMO), social media disorder, internet use, social support and social media use will be administered through RedCap platform. This will ensure the assessment of subjective, self-report data and its changes throughout the measurement time of one month.
The sequence of fMRI measurements incudes four main parts, namely anatomical scan, resting-state scan, Effort Allocation Task (EAT), and diffusion tensor imaging (DTI). This protocol ensures the acquisition of the structural and functional data of the brain in the participants. The detailed protocol components are as follows:
- Anatomical scan: This first sequence of the protocol ensures assessment and insight into the anatomy of the brain, thus providing structural data of the participants' brain. This will last approximately 8 minutes.
- Resting-state scan: The next sequence involves participants watching a movie that was designed to improve imaging at rest for approximately 10 minutes. This sequence ensures insight into brain activity when no task is being performed and when the participant is at rest.
- Effort Allocation Task (EAT): This next sequence aims to assess reward processing and reward behavior in the participants. During this task, participants have to exert physical effort on a grip force device when faced with monetary points at stake. There are two types of reward a participant can face; low and high reward. Additionally, there are two difficulty levels during the task, one being easier and the other more difficult. The payoff for the invested effort will be proportional to its duration. The task will last approximately 17 minutes.
- Diffusion Tensor Imaging (DTI): During the final sequence, participants will undergo DTI assessment to ensure insight into white matter microstructure and connectivity. This will last approximately 7-8 minutes.
To thoroughly investigate the participants' experiences in their natural environments, Ecological Momentary Assessment (EMA) will be conducted. This will be done through an app called m-Path where participants will fill out daily questionnaires about social media use, self-esteem, premenstrual symptoms, and mood throughout one month. A daily questionnaire lasts approximately 10 minutes. This assessment will ensure data about subjective experiences with high ecological validity.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Edita Karavidaj, MSc
- Phone Number: +491746443856
- Email: edita.karavidaj@med.uni-tuebingen.de
Study Contact Backup
- Name: Isabel Brandhorst, Dr. Dipl.-Psych.
- Email: isabel.brandhorst@med.uni-tuebingen.de
Study Locations
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Baden-Wuerttemberg
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Tuebingen, Baden-Wuerttemberg, Germany, 72076
- University Clinic Tuebingen, Department of Psychiatry & Psychotherapy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Between 15 and 18 years old adolescent girls
- Body mass index(18-25kg/m2)
- Natural menstrual cycle (between 25 to 31 days) OR use of combined oral contraceptives for at least 4 months
- Social media use (e.g., Instagram, TikTok, Snapchat, Facebook, X, BeReal)
- Non-smoking
- German language fluency
- Attending age-appropriate school
Exclusion Criteria:
- Any neurological or psychiatric disease based on the standardized diagnostic interview (Kinder-DIPS)
- Medical problems such as hormonal, metabolic, developmental or chronic diseases (e.g., congenital disorders, diabetes, dysfunctions of the thyroid, or congestive heart failure)
- Pregnancy
- Females who gave birth or were breastfeeding within the last year
- Use of any other kind of steroid hormonal treatment (except combined oral contraceptives) or psychotropic treatment in the last three months
- Females with premenstrual dysphoric disorder(PMDD)
- Not willing to be informed about incidental fMRI findings
Additional exclusion criteria for fMRI:
- Individuals with non-removable metal objects on or in the body such as cardiac pacemaker, artificial heart valve, metal prostheses, metal implants, metal splinters, etc.
- Tattoos (if fMRI-incompatible according to expert guidelines)
- Claustrophobia
- Surgery less than three months ago
- Pathological hearing or increased sensitivity to loud noises
- Neurological disease or injury
- Moderate or severe head injury
- Restricted (corrected) vision
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Natural menstrual cycle
Adolescent girls who have a natural menstrual cycle and have not used any kind of hormonal contraception for at least 6 months.
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Oral contraceptive
Adolescent girls who use combined oral contraceptives for at least 4 months.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Brain disparities: Contrasting naturally cycling adolescent girls with those using combined oral contraceptives
Time Frame: Measured twice appr. 2-3 weeks apart; approximately 45 minutes each time
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Possible differences between naturally cycling adolescent girls and those taking combined oral contraceptives in brain structure
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Measured twice appr. 2-3 weeks apart; approximately 45 minutes each time
|
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Brain disparities: Contrasting naturally cycling adolescent girls with those using combined oral contraceptives
Time Frame: Measured twice appr. 2-3 weeks apart; approximately 45 minutes each time]
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Possible differences between naturally cycling adolescent girls and those taking combined oral contraceptives in brain function (functional activation based on BOLD effect)
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Measured twice appr. 2-3 weeks apart; approximately 45 minutes each time]
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Reward-processing disparities: Contrasting naturally cycling adolescent girls with those using combined oral contraceptives
Time Frame: Measured twice appr. 2-3 weeks apart; approx. 17 minutes each time
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Possible differences between naturally cycling adolescent girls and those taking combined oral contraceptives on reward processing
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Measured twice appr. 2-3 weeks apart; approx. 17 minutes each time
|
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Social media use disparities: Contrasting naturally cycling adolescent girls and those using combined oral contraceptives
Time Frame: Measured through ecological momentary assessment every day throughout one month
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Possible differences in social media use between the two groups
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Measured through ecological momentary assessment every day throughout one month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Social media use disparities: Contrasting follicular and luteal phase in naturally cycling adolescent girls
Time Frame: Measured through ecological momentary assessment every day throughout one month
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Possible differences between the two phases of the menstrual cycle in social media use
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Measured through ecological momentary assessment every day throughout one month
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Brain Disparities: Contrasting follicular and luteal phase in naturally cycling adolescent girls
Time Frame: Measured twice appr. 2-3 weeks apart; circa 45 minutes each time
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Possible differences in brain function and structure in naturally cycling girls in follicular vs. luteal phase
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Measured twice appr. 2-3 weeks apart; circa 45 minutes each time
|
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Reward-processing disparities: Contrasting follicular and luteal phase in naturally cycling adolescent girls
Time Frame: Measured twice appr. 2-3 weeks apart; circa 45 minutes each time
|
Possible differences in reward processing and reward behavior between the two menstrual cycle phases
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Measured twice appr. 2-3 weeks apart; circa 45 minutes each time
|
|
Associations between personality and brain function & structure
Time Frame: Measured twice appr. 2-3 weeks apart; circa 45 minutes each time
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Possible effects of personality type on brain structure and brain function for both groups.
Personality measured by the NEO-Five-Factor-Inventory.
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Measured twice appr. 2-3 weeks apart; circa 45 minutes each time
|
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Associations between personality and reward processing & behavior
Time Frame: Measured twice appr. 2-3 weeks apart; circa 17 minutes each time
|
Possible effects of personality type on reward processing for both groups.
Personality measured by the NEO-Five-Factor-Inventory.
|
Measured twice appr. 2-3 weeks apart; circa 17 minutes each time
|
|
Self-esteem differences: Contrasting follicular and luteal phase in naturally cycling adolescent girls
Time Frame: Measured through ecological momentary assessment every day throughout one month
|
Possible differences in self-esteem between the two phases of the menstrual cycle
|
Measured through ecological momentary assessment every day throughout one month
|
Collaborators and Investigators
Investigators
- Principal Investigator: Tobias Renner, Prof. Dr. med., Child Psychiatry, University Clinic Tübingen
- Principal Investigator: Tomas Furmark, Dr., Department of Psychology, Uppsala University, Sweden
Study record dates
Study Major Dates
Study Start (Estimated)
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
Keywords
Other Study ID Numbers
- IRTG_P09
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.
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