The Effect of Oral Contraceptive Onset on Emotion Regulation in Adolescence

The Effect of Oral Contraceptive Onset on Emotion Regulation in Adolescence - A Bitter Pill

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON50830

Enrollment

126

Registered

2021-09-16

Start date

2021-09-01

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

sub-klinische depressie en angst scores en emotieregulatie metingen anxiety and depression symptoms mood problems

Interventions

None listed

Eligibility

Age

12 Years to 64 Years

Inclusion criteria

Inclusion criteria: • Healthy (no somatic or psychiatric diagnoses) • 14-18 years • Body Mass Index (BMI) between 14-30 • Regular menstrual cycle (25-32 days) • Pillgroup: girls who will start the use of the oral contraceptive pill for the first time or after a break of minimum 6 months (assuming the use of the standard prescription of ethinylestradiol/levonorgestrel 0,03/0,15 mg; a pill with androgenic function, however other androgenic pills will also be included) • Control group: girls who have never taken hormonal contraceptives or not taken hormonal contraceptives for at least the past 6 months

Exclusion criteria

Exclusion criteria: • Starting an oral contraceptive pill with anti-androgenic function after the first lab visit • Use of hormones 6 months before study onset • Use of psychotropic medication/drugs three months before study onset • Pregnant or breastfeeding • Hormone disorders • Endometriosis • Polycystic ovarian syndrome (PCOS) • Current or previous diagnosed psychiatric or neurological disorders (self-report) • Participants will be asked to prevent intake of marijuana (>48h), alcohol (>24h) and caffeine (>2h) before onset of the experiment.

Design outcomes

Primary

Measure	Time frame
The primary study parameters are the measurements regarding emotion regulation that are associated with fear and pill use in adults: the extent of fear acquisition and extinction by subjective measures and skin conductance (during the emotion regulation experiments).	—

Secondary

Measure	Time frame
The other study parameters include the Late Positive Potential (LPP) as a neural marker and electromyographie (EMG) as a physical marker for emotional reactivity that is modulated by emotion regulation (during the emotion regulation experiments) , and cortisol, self-evaluation and task performance changes after induced psychosocial stress (during the stress experiments), and mood questionnaires. These different study parameters are included to form a comprehensive view on the effects of the pill on neural, physiological and psychological processes underlying depression and anxiety in adolescents.	—

Measure

Time frame

The other study parameters include the Late Positive Potential (LPP) as a neural marker and electromyographie (EMG) as a physical marker for emotional reactivity that is modulated by emotion regulation (during the emotion regulation experiments) , and cortisol, self-evaluation and task performance changes after induced psychosocial stress (during the stress experiments), and mood questionnaires. These different study parameters are included to form a comprehensive view on the effects of the pill on neural, physiological and psychological processes underlying depression and anxiety in adolescents.

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Countries

Netherlands

Outcome results