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Completed

NCT Number: NCT03917745

E-health Intervention in Women With Pregnancy Distress

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tilburg University

Tilburg, Netherlands

About this study

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?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

eHealth mindfulness intervention

Behavioral

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.

Other names: Ontspannen zwanger

Primary outcomes

  1. Depressive symptoms

    Time frame: Difference between the intervention group en the control group, measured at 28 weeks (after the intervention).

    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.

Secondary outcomes

  1. Negative Affect

    Time frame: Difference between the intervention group en the control group, measured at 28 weeks (after the intervention).

    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.

Other outcomes

  1. Mindfulness skills

    Time frame: Measured in the intervention group, the difference between 16 weeks (before the intervention) and 28 weeks (after the intervention).

    Measured by three facets of the Five Facet Mindfulness Questionnaire Short Form (FFMQ-3-SF): acting with awareness, non-judging and non-reacting, which consists of 15 items. The validity of the measure is established and indices of internal reliability were found to be adequate. The total score ranges from 0 to 60, with higher scores indicating better mindfulness skills.

  2. Rumination

    Time frame: Measured in the intervention group, the difference between 16 weeks (before the intervention) and 28 weeks (after the intervention).

    Measured by the Rumination-Reflection Questionnaire (RRQ), which consists of 12 items and is a validated and reliable instrument. The score ranges from 0 to 48, with higher scores indicating more rumination.

  3. Self compassion

    Time frame: Measured in the intervention group, the difference between 16 weeks (before the intervention) and 28 weeks (after the intervention).

    Measured by the Self Compassion Scale Short Form (SCS-SF), which consists of 12 items, and is a validated and reliable measure. The total score ranges from 0 to 72, with higher scores indicating higher self compassion.

Sponsors and collaborators

Lead sponsor

Tilburg University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Apr 17, 2019
Registry last updated
Jul 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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