Pregnancy DistressNCT03917745
E-health Intervention in Women With Pregnancy Distress
A study testing eHealth mindfulness intervention in people with Pregnancy Distress, run by Tilburg University at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy Distress
- What is being tested?
- eHealth mindfulness intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 219 participants
- Where
- 1 siteNetherlands
- Study dates
- 12 Aug 2019to 16 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: E-health Intervention in Women With Pregnancy Distress: a Randomized Controlled Trial
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.
Read the 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
- Being tested
- eHealth mindfulness intervention
- Keywords
- anxiety, depression, eHealth, mindfulness, pregnancy distress
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eHealth mindfulness interventionBehavioural
Also called Ontspannen zwanger
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.
| Study group | Role | What they receive |
|---|---|---|
| eHealth mindfulness intervention group | Experimental | 8 weeks of internet mindfulness training Receives: Behavioral: eHealth mindfulness intervention |
| Control group | No intervention | Care as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Difference between the intervention group en the control group, measured at 28 weeks (after the intervention).
Secondary outcomes (1)
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.
Measured: Difference between the intervention group en the control group, measured at 28 weeks (after the intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2019
- Study start12 Aug 2019
- Primary completion16 Jun 2022
- Study completion16 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pregnancy DistressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tilburg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, prof.dr. Victor J Pop, Tilburg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03917745
- Sponsor's protocol ID
- 50-54300-98-244
- Status last verified
- Jul 2022
- First submitted
- 3 Apr 2019
- Last updated
- 14 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37054897Hulsbosch 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.
PubMed 32169030
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- E-health Intervention in Women With Pregnancy Distress: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03917745
- Acronym / sponsor ID
- 50-54300-98-244
- Conditions
- Pregnancy Distress
- Keywords
- anxiety, depression, eHealth, mindfulness, pregnancy distress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- Tilburg UniversityUniversity, hospital or other
- Study start
- 12 Aug 2019 (actual)
- Primary completion
- 16 Jun 2022 (actual)
- Study completion
- 16 Jun 2022 (actual)
- First posted
- 17 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| eHealth mindfulness intervention group | Experimental | Behavioral: eHealth mindfulness intervention8 weeks of internet mindfulness training |
| Control group | No intervention | –Care as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eHealth mindfulness interventionAlso: Ontspannen zwangerThe 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. | Behavioural | eHealth mindfulness intervention group |
Primary outcome
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.
1 secondary outcome
Negative Affect
Time frame: Difference between the intervention group en the control group, measured at 28 weeks (after the intervention).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2022.
- Derived from this study: PubMed 37054897Hulsbosch 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.
- Derived from this study: PubMed 32169030Hulsbosch 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eHealth mindfulness intervention in people with Pregnancy Distress, run by Tilburg University at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive symptoms (time frame: Difference between the intervention group en the control group, measured at 28 weeks (after the intervention).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03917745, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2022.