An observational study in Menstrual Cycle and Oral Contraceptive, sponsored by International Research Training Group 2804. Not yet recruiting at 1 site in Germany. Open to female participants aged 15 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-23.
Sponsored by International Research Training Group 2804 · Observational
The study aims to explore the effects of hormonal fluctuations throughout the menstrual cycle on social media use, brain architecture, neural reward processing and reward behavior, and affective status in adolescent girls. Additionally, it strives to compare the effects of exogenous and endogenous hormones on the above-mentioned aspects. For this purpose, the investigators will compare two main groups in the study: 1. Naturally cycling adolescent girls, 2. Adolescent girls using combined oral contraceptives. This study will combine self-report data via questionnaires, ecological data via Ecological Momentary Assessment (EMA), endocrine data via blood collection, and neural data via fMRI assessment to enhance the understanding of the neurobiological mechanisms underlying social media use in adolescent girls. Furthermore, it seeks to elucidate whether there are vulnerable periods throughout the menstrual cycle when adolescent girls are especially prone to dysfunctional social media use and help to design more specific interventions as well as therapy.
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:
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.
International Research Training Group 2804 is the lead sponsor of 8 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study participants will be primarily recruited from residents of Tübingen and surrounding areas.
Exclusion Criteria:
Additional exclusion criteria for fMRI:
Adolescent girls who have a natural menstrual cycle and have not used any kind of hormonal contraception for at least 6 months.
Adolescent girls who use combined oral contraceptives for at least 4 months.
Brain disparities: Contrasting naturally cycling adolescent girls with those using combined oral contraceptives
Possible differences between naturally cycling adolescent girls and those taking combined oral contraceptives in brain structure
Time frame: Measured twice appr. 2-3 weeks apart; approximately 45 minutes each time
Brain disparities: Contrasting naturally cycling adolescent girls with those using combined oral contraceptives
Possible differences between naturally cycling adolescent girls and those taking combined oral contraceptives in brain function (functional activation based on BOLD effect)
Time frame: Measured twice appr. 2-3 weeks apart; approximately 45 minutes each time]
Reward-processing disparities: Contrasting naturally cycling adolescent girls with those using combined oral contraceptives
Possible differences between naturally cycling adolescent girls and those taking combined oral contraceptives on reward processing
Time frame: Measured twice appr. 2-3 weeks apart; approx. 17 minutes each time
Social media use disparities: Contrasting naturally cycling adolescent girls and those using combined oral contraceptives
Possible differences in social media use between the two groups
Time frame: Measured through ecological momentary assessment every day throughout one month
Social media use disparities: Contrasting follicular and luteal phase in naturally cycling adolescent girls
Possible differences between the two phases of the menstrual cycle in social media use
Time frame: Measured through ecological momentary assessment every day throughout one month
Brain Disparities: Contrasting follicular and luteal phase in naturally cycling adolescent girls
Possible differences in brain function and structure in naturally cycling girls in follicular vs. luteal phase
Time frame: Measured twice appr. 2-3 weeks apart; circa 45 minutes each time
Reward-processing disparities: Contrasting follicular and luteal phase in naturally cycling adolescent girls
Possible differences in reward processing and reward behavior between the two menstrual cycle phases
Time frame: Measured twice appr. 2-3 weeks apart; circa 45 minutes each time
Associations between personality and brain function & structure
Possible effects of personality type on brain structure and brain function for both groups. Personality measured by the NEO-Five-Factor-Inventory.
Time frame: Measured twice appr. 2-3 weeks apart; circa 45 minutes each time
Associations between personality and reward processing & behavior
Possible effects of personality type on reward processing for both groups. Personality measured by the NEO-Five-Factor-Inventory.
Time frame: 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
Possible differences in self-esteem between the two phases of the menstrual cycle
Time frame: Measured through ecological momentary assessment every day throughout one month
This study is not yet recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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International Research Training Group 2804