Menstrual CycleNCT06426459
Social Media Usage in Adolescent Girls
An observational study of Menstrual Cycle and Oral Contraceptive, run by International Research Training Group 2804 at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menstrual Cycle, Oral Contraceptive
- Type of treatment
- Pill or oral medicine
- How many people
- 70 participants
- Where
- 1 siteGermany
- Study dates
- 29 May 2024to 1 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: The study participants will be primarily recruited from residents of Tübingen and surrounding areas.
Who may be able to join
- 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
Who cannot join
- 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)
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Isabel Brandhorst, Dr. Dipl.-Psych. contact
Germany1 site
University Clinic Tuebingen, Department of Psychiatry & Psychotherapy
Tübingen, Baden-Wurttemberg, 72076
About this study
Official title: Positive and Negative Effects of Social Media Usage in Adolescent Girls
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.
Read the 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.
- Conditions
- Menstrual Cycle, Oral Contraceptive
- Keywords
- Social media use, Adolescent girls, Menstrual cycle, Oral contraceptive, Neuroimaging, Women's mental health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| Oral contraceptive | Adolescent girls who use combined oral contraceptives for at least 4 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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
Measured: 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
Measured: Measured through ecological momentary assessment every day throughout one month
Secondary outcomes (6)
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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: Measured through ecological momentary assessment every day throughout one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2024
- Study start29 May 2024 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menstrual CycleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Research Training Group 2804
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation, University Hospital Tuebingen, Uppsala University
- Responsible party
- Sponsor
- Investigators
- Tobias Renner, Prof. Dr. med., Principal investigator, Child Psychiatry, University Clinic TübingenTomas Furmark, Dr., Principal investigator, Department of Psychology, Uppsala University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06426459
- Sponsor's protocol ID
- IRTG_P09
- Status last verified
- May 2024
- First submitted
- 14 Apr 2024
- Last updated
- 23 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positive and Negative Effects of Social Media Usage in Adolescent Girls
- ClinicalTrials.gov ID
- NCT06426459
- Acronym / sponsor ID
- IRTG_P09
- Conditions
- Menstrual Cycle, Oral Contraceptive
- Keywords
- Social media use, Adolescent girls, Menstrual cycle, Oral contraceptive, Neuroimaging, Women's mental health
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- International Research Training Group 2804University, hospital or other
- Collaborators
- German Research Foundation, University Hospital Tuebingen, Uppsala University
- Study start
- 29 May 2024 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 23 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
| Oral contraceptive | – | –Adolescent girls who use combined oral contraceptives for at least 4 months. |
Who may qualify
- Ages
- 15 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The study participants will be primarily recruited from residents of Tübingen and surrounding areas.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Possible differences between naturally cycling adolescent girls and those taking combined oral contraceptives in brain structure
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]
Possible differences between naturally cycling adolescent girls and those taking combined oral contraceptives in brain function (functional activation based on BOLD effect)
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
Possible differences between naturally cycling adolescent girls and those taking combined oral contraceptives on reward processing
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
Possible differences in social media use between the two groups
6 secondary outcomes
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
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
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
Associations between personality and brain function & structure
Time frame: Measured twice appr. 2-3 weeks apart; circa 45 minutes each time
Associations between personality and reward processing & behavior
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
Time frame: Measured through ecological momentary assessment every day throughout one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabel Brandhorst, Dr. Dipl.-Psych. contact
Tobias Renner, Prof. Dr. med. principal investigator
Child Psychiatry, University Clinic Tübingen
Tomas Furmark, Dr. principal investigator
Department of Psychology, Uppsala University, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menstrual Cycle and Oral Contraceptive, run by International Research Training Group 2804 at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Edita Karavidaj, MSc (+491746443856, edita.karavidaj@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2024.