Clinical trial NCT03917745: E-health Intervention in Women With Pregnancy Distress
Official title: E-health Intervention in Women With Pregnancy Distress: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Distress
Keywords: anxiety
depression
eHealth
mindfulness
pregnancy distress
Lead sponsor: Tilburg University
Sponsor class: OTHER
First posted: 2019-04-17
Enrollment: 219
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is part of a large longitudinal cohort study among pregnant women. The study targets a specific subgroup of pregnant women with symptoms of psychological distress (depression and anxiety). 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.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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?

Eligibility criteria: 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.

Primary outcomes:
measure: Depressive symptoms
timeFrame: Difference between the intervention group en the control group, measured at 28 weeks (after the intervention).
Secondary outcomes:
measure: Negative Affect
timeFrame: Difference between the intervention group en the control group, measured at 28 weeks (after the intervention).
Other outcomes:
measure: Mindfulness skills
timeFrame: Measured in the intervention group, the difference between 16 weeks (before the intervention) and 28 weeks (after the intervention).
measure: Rumination
timeFrame: Measured in the intervention group, the difference between 16 weeks (before the intervention) and 28 weeks (after the intervention).
measure: Self compassion
timeFrame: Measured in the intervention group, the difference between 16 weeks (before the intervention) and 28 weeks (after the intervention).
Locations:
city: Tilburg
country: Netherlands
facility: Tilburg University
Study officials:
References:
citation: Hulsbosch LP, Nyklicek I, Potharst ES, Meems M, Boekhorst MGBM, Pop VJM. Online mindfulness-based intervention for women with pregnancy distress: design of a randomized controlled trial. BMC Pregnancy Childbirth. 2020 Mar 13;20(1):159. doi: 10.1186/s12884-020-2843-0.