E-health Intervention in Women With Pregnancy Distress

Study Overview
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Brief Summary
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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
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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?

Official Title
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E-health Intervention in Women With Pregnancy Distress: a Randomized Controlled Trial

Conditions
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Pregnancy Distress

Intervention / Treatment
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* Behavioral: eHealth mindfulness intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: eHealth mindfulness intervention group<br>8 weeks of internet mindfulness training | Behavioral: eHealth mindfulness intervention<br>* The web-based intervention consists of eight sessions including psycho-education about the mechanisms of stress, coping and relaxation, especially related to pregnancy, practicing mindfulness skills (i.e. mindful breathing, mindful moving, observing and letting-go of thoughts and emotions with a non-judgmental attitude), sharing experiences, and doing home assignments. The sessions have been developed specifically for pregnant women and acknowledge pregnancy-related distress. An online coach will review questions and home assignments of the participants. Women will start the training at 16 weeks gestation.<br>* Other names: Ontspannen zwanger;|
| No Intervention: Control group<br>Care as usual | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depressive symptoms | Measured by the 10-item Edinburgh Depression Scale (EDS). The EDS is the most widely used self-rating scale to assess depressive symptoms in the perinatal period. It consists of ten items and three sub-scales: anhedonia, anxiety and depression. The questionnaire has been validated in Dutch pregnant women. The EDS total score ranges from 0 to 30, with higher scores indicating more depressive symptoms. | Difference between the intervention group en the control group, measured at 28 weeks (after the intervention). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Negative Affect | Measured by a subscale of the Tilburg Pregnancy Distress Scale (TPDS): Negative Affect, which consists of 10 items. The TPDS has been validated among Dutch pregnant women and it is a reliable measure to assess pregnancy-related emotional distress. The total score ranges from 0 to 30, with higher scores indicating more emotional distress symptoms. | Difference between the intervention group en the control group, measured at 28 weeks (after the intervention). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anxiety, depression, eHealth, mindfulness, pregnancy distress