NCT06426459

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 23, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

May 29, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

May 23, 2024

Status Verified

May 1, 2024

Enrollment Period

1.5 years

First QC Date

April 14, 2024

Last Update Submit

May 17, 2024

Conditions

Keywords

Social media useAdolescent girlsMenstrual cycleOral contraceptiveNeuroimagingWomen's mental health

Outcome Measures

Primary Outcomes (4)

  • 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 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 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 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 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

    Measured through ecological momentary assessment every day throughout one month

  • Brain Disparities: Contrasting follicular and luteal phase in naturally cycling adolescent girls

    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

    Measured twice appr. 2-3 weeks apart; circa 45 minutes each time

  • Associations between personality and brain function & structure

    Measured twice appr. 2-3 weeks apart; circa 45 minutes each time

  • Associations between personality and reward processing & behavior

    Measured twice appr. 2-3 weeks apart; circa 17 minutes each time

  • +1 more secondary outcomes

Study Arms (2)

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.

Eligibility Criteria

Age15 Years - 18 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study participants will be primarily recruited from residents of Tübingen and surrounding areas.

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Clinic Tuebingen, Department of Psychiatry & Psychotherapy

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood collection for hormonal assessment

Study Officials

  • Tobias Renner, Prof. Dr. med.

    Child Psychiatry, University Clinic Tübingen

    PRINCIPAL INVESTIGATOR
  • Tomas Furmark, Dr.

    Department of Psychology, Uppsala University, Sweden

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabel Brandhorst, Dr. Dipl.-Psych.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2024

First Posted

May 23, 2024

Study Start

May 29, 2024

Primary Completion

December 1, 2025

Study Completion

March 1, 2026

Last Updated

May 23, 2024

Record last verified: 2024-05

Locations