Depressive Symptoms and Subjective Stress in the Course of the Menstrual Cycle - an Ambulatory Assessment Study.

NCT ID: NCT04086316

Last Updated: 2023-02-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 77 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-15
• Study Completion Date: 2022-12-30

Brief Summary

Background:

Major changes in female sex hormone concentrations influence the development of depressive symptoms in women. This hypothesis has been thoroughly investigated with regard to the menopause, the postpartal phase and also premenstrual dysphoric disorder. However, much less is known regarding the impact of female sex hormone fluctuations on depression during the regular menstrual cycle. There are indications that during the luteal phase, women might be more vulnerable to the development of depressive symptoms, while during the follicular phase and at ovulation, hormone concentrations might present a protective factor against depressive symptomatology. Subjective stress could mediate the relationship between depressive symptom development and the menstrual cycle phases. The complex interaction between sex hormones and psychological symptoms in the course of menstrual cycle phases is still understudied.

Method:

74 women (37 with and 37 without current depressive episode), will take part in a smartphone-based ambulatory assessment. Women will provide daily ratings of depressive symptoms and perceived stress for a period of one menstrual cycle (approx. 26-30 days). Three menstrual cycle phases will be assessed - the follicular phase, ovulation and the luteal phase. An ambulatory assessment will be used for these daily assessments. To assess the menstrual cycle phase participants will use ovulation tests on five days in the late follicular phase.

The following research questions will be investigated:

Research question 1: Do depressive symptoms (number and severity) change in the course of the menstrual cycle within the two groups? Research question 2: Which depressive symptoms are particularly sensitive to changes in the course of the menstrual cycle phases? Research question 3: Does the subjective stress change in the course of the menstrual cycle within the two groups? Research question 4: Are there differences between depressive and healthy women in terms of changes in depressive symptoms and subjective stress experience?

Implications:

The aim of the study is to investigate women-specific psychobiological factors influencing depression. Therefore, fluctuations in depressive symptoms and subjective stress experience will be investigated as a function of the respective menstrual cycle phases. The identification of cycle phases associated with increased or reduced vulnerability to depressive symptoms will support the development of women-specific prevention and treatment programs.

Conditions

Major Depressive Episode

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Depression Group

Naturally cycling women with a major depressive episode, assessed by Structured Clinical Interview for DSM-5 (SCID Clinical Version)

No interventions assigned to this group

Healthy Group

Naturally cycling women without a major depressive episode, assessed by Structured Clinical Interview for DSM-5 (SCID Clinical Version)

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• female sex
• current diagnosis of a major depression episode
• minimum age of 18 years
• regular menstrual cycle.

• female sex;
• minimum age of 18 years;
• regular menstrual cycle.

Exclusion Criteria

• Pregnancy less than one year ago;
• women who are breastfeeding;
• bipolar disorder;
• acute suicidal tendencies;
• schizophrenic disorders (F20-29);
• substance use disorders
• psychotropic drugs in the last six months;
• chronic somatic diseases.

For participants without major depressive episode:

• current or lifetime mental disorder;
• pregnancy less than one year ago;
• women who are breastfeeding;
• psychotropic drugs in the last six months;
• chronic somatic diseases.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Freie Universität Berlin

OTHER

Sponsor Role: lead

Responsible Party

Dr. Sarah Schumacher

Postdoctoral researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sarah Schumacher, PhD

Role: PRINCIPAL_INVESTIGATOR

Freie Universität Berlin

Locations

Freie Universität Berlin

Berlin, , Germany

Countries

Germany

References

Klusmann H, Brose A, Schulze L, Engel S, Laufer S, Bucklein E, Knaevelsrud C, Schumacher S. Menstrual cycle related depressive symptoms and their diurnal fluctuations - an ambulatory assessment study. BMC Womens Health. 2024 Nov 18;24(1):611. doi: 10.1186/s12905-024-03438-9.

Reference Type: DERIVED

PMID: 39551735 (View on PubMed)

Other Identifiers

CycleDepression

Identifier Type: -

Identifier Source: org_study_id