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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.
Sponsor study identifier
observational
77
1 country
1
Study Start
January 15, 2020
Actual (reported)Primary Completion
April 15, 2021
Actual (reported)Study Completion
December 30, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 30, 2022
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 27, 2019
Actual (reported)September 11, 2019
Actual (reported)January 15, 2020
Actual (reported)April 15, 2021
Actual (reported)December 30, 2022
Actual (reported)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).
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).
Naturally cycling women with a major depressive episode, assessed by Structured Clinical Interview for DSM-5 (SCID Clinical Version)
Naturally cycling women without a major depressive episode, assessed by Structured Clinical Interview for DSM-5 (SCID Clinical Version)
Sample will be recruited all over Germany.
Freie Universität Berlin
Berlin, 14195, Germany
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.
Sarah Schumacher, PhD
Freie Universität Berlin
77 participants (actual enrollment reported by the registry).
First Submitted
August 27, 2019
First Posted
September 11, 2019
Study Start
January 15, 2020
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
April 15, 2021
Actual (reported)Study Completion
December 30, 2022
Actual (reported)Last Updated
February 17, 2023
Record last verified: 2023-02
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Source: ClinicalTrials.gov.
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