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

Vulnerable and Resilient Phases During the Menstrual Cycle and Their Influence on Depressive Symptoms and Stress. An Ambulatory Assessment Study on Healthy Women and Women With Depression.

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.

Study Overview

• Status: Completed
• Conditions: Major Depressive Episode

• Study Type: Observational
• Enrollment (Actual): 77

Contacts and Locations

• Study Contact: Name: Sarah Schumacher, PhD; Phone Number: +493083850434; Email: sarah.schumacher@fu-berlin.de
• Study Contact Backup: Name: Hannah F Klusmann, M.Sc; Phone Number: +493083854183; Email: h.klusmann@fu-berlin.de

Study Locations

• Germany
  • Berlin, Germany, 14195
    • Freie Universität Berlin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Sample will be recruited all over Germany.

Description

For participants with major depressive episode:

Inclusion criteria:

• female sex
• current diagnosis of a major depression episode
• 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:

Inclusion criteria:

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

Exclusion criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Depression Group; Naturally cycling women with a major depressive episode, assessed by Structured Clinical Interview for DSM-5 (SCID Clinical Version)
Healthy Group; Naturally cycling women without a major depressive episode, assessed by Structured Clinical Interview for DSM-5 (SCID Clinical Version)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Depressive Symptoms between the menstrual cycle phases	Depressive Symptoms will be measured with the Patient Health Questionnaire (PHQ-9), which will be adapted for the ambulatory assessment use (e.g. changing "in the last two weeks" to "right now").	Depressive Symptoms will be assessed daily with an ambulatory assessment for the duration of one menstrual cycle (approx. 28 days).
Changes in subjective stress (self report) between the menstrual cycle phases	Stress Symptoms will be measured with the short Version of the Perceived Stress Scale (PSS-4), which will be adapted for the ambulatory assessment use (e.g. changing "in the last two weeks" to "right now").	Subjective stress will be assessed daily with an ambulatory assessment for the duration of one menstrual cycle (approx. 28 days).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences between women with and without a Major depressive Episode	Differences between women with and without a Major depressive Episode (measured with the SCID-CV)	Depressive Symptoms will be assessed daily with an ambulatory assessment for the duration of one menstrual cycle (approx. 28 days).
Differences between women with and without a Major depressive Episode	Differences between women with and without a Major depressive Episode (measured with the SCID-CV)	Subjective stress will be assessed daily with an ambulatory assessment for the duration of one menstrual cycle (approx. 28 days).

Collaborators and Investigators

• Sponsor: Freie Universität Berlin

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2020
• Primary Completion (Actual): April 15, 2021
• Study Completion (Actual): December 30, 2022

Study Registration Dates

• First Submitted: August 27, 2019
• First Submitted That Met QC Criteria: September 10, 2019
• First Posted (Actual): September 11, 2019

Study Record Updates

• Last Update Posted (Actual): February 17, 2023
• Last Update Submitted That Met QC Criteria: February 16, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Depression; Stress; Menstrual Cycle; Female; Major Depressive Disorder; Sex hormones; Ambulatory Assessment
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: CycleDepression

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No