E-health Intervention in Women With Pregnancy Distress

NCT ID: NCT03917745

Last Updated: 2022-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 219 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-12
• Study Completion Date: 2022-06-16

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?

Conditions

Pregnancy Distress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

eHealth mindfulness intervention group

8 weeks of internet mindfulness training

Group Type: EXPERIMENTAL

eHealth mindfulness intervention

Intervention Type: 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.

Control group

Care as usual

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

eHealth mindfulness intervention

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Ontspannen zwanger

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Tilburg University

OTHER

Sponsor Role: lead

Responsible Party

prof.dr. Victor J Pop

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tilburg University

Tilburg, , Netherlands

Countries

Netherlands

References

Hulsbosch LP, Potharst ES, Schwabe I, Boekhorst MGBM, Pop VJM, Nyklicek I. Online mindfulness-based intervention for women with pregnancy distress: A randomized controlled trial. J Affect Disord. 2023 Jul 1;332:262-272. doi: 10.1016/j.jad.2023.04.009. Epub 2023 Apr 12.

Reference Type: DERIVED

PMID: 37054897 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32169030 (View on PubMed)

Other Identifiers

50-54300-98-244

Identifier Type: -

Identifier Source: org_study_id