Exploring the effects of transcutaneous vagus nerve stimulation on postpartum mental health

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of transcutaneous vagus nerve stimulation (tVNS) in preventing mood swings and depressive symptoms in women during the postpartum phase. It employs a crossover design where participants receive either high-intensity tVNS, low-intensity tVNS, or no stimulation over a period of six weeks, followed by a switch in protocols. The study also assesses various factors such as physiological functions, chronic stress, hormones, and personality traits, alongside daily mood assessments and psychometric tests. Participants' partners may also contribute by providing insights into their mental health and support roles.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* No malformation of fetal organs (no abnormalities detected during "organ screening").
* Ability to provide written consent for themselves.
* Sufficient German language skills to communicate and understand study procedures.

Exclusion Criteria:

* Exclusion criteria for tVNS use (i.e., pregnancy, active implants such as cochlear implants or cardiac pacemakers, cerebral shunts, skin problems, cardiovascular health issues).
* Cardiac arrhythmias or coronary heart disease.
* Neurological disorders.
* Current diagnosis or episode of a mood disorder.
* Diagnosed schizophrenia spectrum and other psychotic disorders.
* Severe substance use disorders.
* Individual exclusion may also occur based on other health issues if the study clinician determines that participation in the study may pose a disadvantage for the participant or the child.

Where it's running

• University Hospital Tuebingen; Department of Psychiatry and Psychotherapy
  Tübingen, Baden-Wurttemberg, Germany Recruiting

Study contacts

• Principal investigator: Birgit Derntl, Prof., PhD — University Hospital Tuebingen
• Study coordinator: Julia Siodmiak, M.sc.
• Email: julia.siodmiak@med.uni-tuebingen.de
• Phone: +49 (0)7071 29-85736

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.