E-health Intervention in Women With Pregnancy Distress

Tilburg University

Status

Completed

Conditions

Pregnancy Distress

Treatments

Behavioral: eHealth mindfulness intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT03917745

50-54300-98-244

Details and patient eligibility

About

The study aims to reduce the levels of distress (depression and anxiety) during pregnancy. The study investigates the effectiveness of an eHealth pregnancy distress-reducing mindfulness training in women with pregnancy distress.

Full description

During pregnancy, women are at risk for mental health problems: up to 20% present with distress symptoms (depression and/or anxiety). Apart from the adverse effects on the woman herself, pregnancy distress negatively affects pregnancy outcome, infant health, postpartum mother-child interaction and child development.

Mindfulness-based interventions are a type of intervention that is increasingly being used to treat symptoms of stress, anxiety and depression. They are cheap and accessible to the whole population.

Current study aims to examine the effectiveness of a mindfulness training to reduce distress during pregnancy. Women who score above cut off on the Edinburgh Depression Scale (EDS) and Tilburg Pregnancy Distress Scale (TPDS) at 12 weeks of gestation, will be randomly allocated to the intervention or control group. Women in the intervention group will be contacted and invited to participate in the mindfulness-based intervention, which consists of 8 weeks of internet mindfulness training. The control group will receive care as usual.

The primary outcome of the study is: Does the mindfulness internet training "Ontspannen zwanger", offered during pregnancy, reduce pregnancy distress, compared to care as usual? The secondary outcome is: Does the mindfulness internet training result in better mindfulness skills?

Enrollment

219 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Pregnant women (18+y) who have their first antenatal visit < 12 weeks;
Score above cut off on the Edinburgh Depression Scale (EDS) and Tilburg Pregnancy Distress Scale (TPDS) at 12 weeks of gestation;
Dutch-speaking or understanding Dutch.

Exclusion criteria

Gemelli pregnancy (or higher order pregnancy);
Known endocrine disorder before pregnancy (diabetes-I, Rheumatoid arthritis);
Severe psychiatric disease (schizophrenia, borderline or bipolar disorder);
HIV;
Drug or alcohol addiction problems;
Any other disease resulting in treatment with drugs that are potentially adverse for the fetus and need careful follow-up during pregnancy;
No access to the internet.