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

NCT04086316 | Completed

• 1 other identifier: CycleDepression
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

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

Keywords

Menstrual Cycle; Major Depressive Disorder; Stress; Sex hormones; Depression; Female; Ambulatory Assessment

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Differences between women with and without a Major depressive Episode

  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

  Subjective stress will be assessed daily with an ambulatory assessment for the duration of one menstrual cycle (approx. 28 days).

Study Arms (2)

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)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Sample will be recruited all over Germany.

You may qualify if:

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

You may not qualify if:

• 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:
• female sex;
• minimum age of 18 years;
• regular menstrual cycle.
• current or lifetime mental disorder;
• pregnancy less than one year ago;
• women who are breastfeeding;

Sponsors & Collaborators

• Freie Universität Berlin: lead

Study Sites (1)

Freie Universität Berlin

Berlin, 14195, Germany

Location

Related Publications (1)

• 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.

  PMID: 39551735 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Sarah Schumacher, PhD

  Freie Universität Berlin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral researcher

Study Record Dates

• First Submitted: August 27, 2019
• First Posted: September 11, 2019
• Study Start: January 15, 2020
• Primary Completion: April 15, 2021
• Study Completion: December 30, 2022
• Last Updated: February 17, 2023

Record last verified: 2023-02

Locations

DE (1)