Perinatal Mental HealthNCT05300646
Mindfulness-Based Stress Reduction for Psycho-socially Vulnerable Pregnant Women.
A study testing Prenatal mindfulness-based stress reduction in people with Perinatal Mental Health and Pregnancy Related, run by University of Aarhus at 2 sites in Denmark.
Trial summary
The aim of the study is to address the need for a wider array of evidence-based and non-pharmacological options to improve mental health in a psycho-socially highly vulnerable group of pregnant women. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Perinatal Mental Health, Pregnancy Related
- What is being tested?
- Prenatal mindfulness-based stress reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Mar 2022to 31 Dec 2024
- 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
- Estimated due date no sooner than three months from start of the intervention. This criterion is included in order for the women to be able to complete the intervention before their due date.
- Eighteen + years of age.
- Speak and write Danish.
- Available for group intervention scheduled sessions. Being unavailable for two or more sessions is reason for exclusion from study participation.
- Written informed consent to study criteria.
Who cannot join
- Active substance dependence.
- Psychotic disorders (e.g. schizophrenia or bipolar disorder).
- Suicidality.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites, 2 recruiting
- Recruiting
The Danish Center for Mindfulness, Department of Clinical Medicine, Aarhus University
Aarhus C, 8000
Sine Skovbjerg, PhD, 26357227, sine.skovbjerg@clin.au.dk
Lone Fjorback, PhD, lone.overby.fjorback@clin.au.dk
- Recruiting
Copenhagen University Hospital, Hvidovre
Copenhagen, Capital Region, 2650
Sine Skovbjerg, PhD, 26357227, sine.skovbjerg@clin.au.dk
Claire Corstorphine, 23419869, claire.louise.corstorphine@regionh.dk
About this study
Official title: The Effect of an Adapted Mindfulness-Based Stress Reduction Program on Mental Health, Maternal Bonding and Birth Outcomes in Psycho-socially Vulnerable Pregnant Women: a Randomized Controlled Trial.
The aim of the study is to address the need for a wider array of evidence-based and non-pharmacological options to improve mental health in a psycho-socially highly vulnerable group of pregnant women. In more detail, the primary outcome is to estimate the effect of prenatal Mindfulness-Based Stress Reduction (MBSR) as an add-on to usual care on mental well-being when compared to usual care alone. Second, to estimate the effect of prenatal MBSR on perceived stress and symptoms of depression and anxiety, and third to explore the effect on maternal bonding and childbirth, e.g. gestational age and experience of childbirth. Finally, to examine the mediating effect of mindfulness and self-compassion on the primary outcome.
Read the detailed description
Background A history of psychopathology or psychosocial adversities are risk factors for mental disorders in the perinatal period. Mental disorders in pregnancy can adversely affect the developing fetus, which call for early prevention. Mindfulness-Based-Stress-Reduction (MBSR) is an acceptable intervention for pregnant women and has a growing evidence-base with meta-analyses consistently pointing to reductions in symptoms of stress, anxiety and depression. The aim of this study is to address the need for a wider array of evidence-based and non-pharmacological options to improve mental health in a psychosocially highly vulnerable group of pregnant women.
Methods/design Pregnant women (n = 238) referred to an outpatient clinic at Copenhagen University Hospital, Amager and Hvidovre, Denmark will be recruited for the study. The design is a single-center, parallel group, randomized controlled trial, with an adapted MBSR program as add on to usual care. The primary outcome is mental wellbeing. Secondary and exploratory outcomes include stress, anxiety, depression, mindfulness, compassion, antenatal attachment and childbirth experience. Participants will be randomized in a 1:1 ratio to prenatal MBSR or usual care.
Implications for perinatal mental health Teaching the skills of mindfulness meditation to a psychosocially vulnerable group of pregnant women could prove a viable and non-pharmacological approach to improve mental health during pregnancy, reduce stress and support the transition to parenthood. The MBSR program does not target a particular group, and results from the study is thus of potential relevance for pregnant women in general as a means of reducing stress and improving perinatal mental health.
- Conditions
- Perinatal Mental Health, Pregnancy Related
- Being tested
- Prenatal mindfulness-based stress reduction
- Keywords
- Mindfulness, Mindfulness-based stress reduktion, MBSR, Perinatal mental health, Self-compassion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prenatal mindfulness-based stress reductionBehavioural
An adapted mindfulness-based stress reduction (MBSR) program with a particular focus on pregnancy and early motherhood.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The prenatal MBSR program is an adaptation of MBSR. Details on the adaptation process is described in Skovbjerg S et al. Pilot and feasibility studies, 2021 Jun 3; 7 (1):118. Prenatal MBSR include nine weekly two-hour classes and is delivered in a combination between physical attendance and live-online teaching. The recommended time for daily mindfulness training between sessions is 15 minutes a day with options for longer practice. Audio recordings with guided meditations and a video with yoga programs for pregnancy is provided for home practice. Receives: Behavioral: Prenatal mindfulness-based stress reduction |
| Treatment as usual | No intervention | Standard clinical practice, usual care (TAU), consists of an average of six routine pregnancy visits to the outpatient antenatal clinic at Copenhagen University Hospital, Hvidovre and to a General Practitioner. Routine pregnancy visits involves primarily preventive counselling by midwifes, and in some cases consultations with a physician or social worker throughout pregnancy and the early post-partum period. In some cases, usual care may include consultations with a psychologist, although usually limited to a few sessions, and in more severe cases referral to psychiatric treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The World Health Organization - Five Well-Being Index (WHO-5)
The WHO-5 is a global rating scale measuring subjective well-being and consists of five statements and the respondent is asked to rate how well each of the statements applies to her when considering the last 14 days. Each item is scored from 5 "all of the time" to 0 "none of the time". Final scores range from 0 - 100 with higher scores representing greater well-being.
Measured: From baseline to 6 months after completion of the intervention.
Secondary outcomes (4)
The Depression Anxiety Stress Scales (DASS-21)
DASS-21 has three sub-scales designed to discriminate between depression, anxiety and stress in the last week. Each sub-scale include seven items. Response to each item is rated on a four-point Likert scale ranging from 'never' to 'very much/most of the time'. Scores are calculated for each sub-scale and higher scores point to more symptoms of stress, anxiety or depression.
Measured: From baseline to 6 months after completion of the intervention.
The Edinburgh Depression Scale (EDS)
The EDS is a screening questionnaire for depression in the perinatal period that contains 10 questions on how the respondent has felt in the past seven days with each item scored 0 - 3 yielding a maximum score of 30. A higher score points to more depressive symptoms.
Measured: From baseline to 6 months after completion of the intervention.
The Five-Facet Mindfulness Questionnaire (FFMQ)
The FFMQ assesses five general facets of being mindful in daily life: observing, describing, acting with awareness, non-reactivity to inner experience, and non-judging of inner experience. Items are rated on a five-point Likert scale ranging from 1 "never or very rarely true" to 5 "very often or always true". Higher scores suggest higher levels of mindfulness.
Measured: From baseline to 6 months after completion of the intervention.
The Self-Compassion Scale (SCS)
The SCS measures the ability to have a healthy stand towards oneself that does not involve evaluations of self-worth. The scale consists of 12 items and responses are given on a 5-point scale from ranging from 1 "almost never" to 5 "almost always". Higher scores indicate more self-compassionate behavior.
Measured: From baseline to 6 months after completion of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start1 Mar 2022
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Perinatal Mental HealthStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A single-center, parallel group, randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 238 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Hvidovre
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05300646
- Sponsor's protocol ID
- 2554
- Status last verified
- Mar 2022
- First submitted
- 10 Mar 2022
- Last updated
- 29 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Skovbjerg S, Sumbundu A, Kolls M, Kjaerbye-Thygesen A, Fjorback LO. The effect of an adapted Mindfulness-Based Stress Reduction program on mental health, maternal bonding and birth outcomes in psychosocially vulnerable pregnant women: a study protocol for a randomized controlled trial in a Danish hospital-based outpatient setting. BMC Complement Med Ther. 2023 Oct 14;23(1):364. doi: 10.1186/s12906-023-04194-3.
PubMed 37838672
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of an Adapted Mindfulness-Based Stress Reduction Program on Mental Health, Maternal Bonding and Birth Outcomes in Psycho-socially Vulnerable Pregnant Women: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05300646
- Acronym / sponsor ID
- 2554
- Conditions
- Perinatal Mental Health, Pregnancy Related
- Keywords
- Mindfulness, Mindfulness-based stress reduktion, MBSR, Perinatal mental health, Self-compassion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 238 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Hvidovre
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 29 Mar 2022 (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 aim of the study is to address the need for a wider array of evidence-based and non-pharmacological options to improve mental health in a psycho-socially highly vulnerable group of pregnant women. In more detail, the primary outcome is to estimate the effect of prenatal Mindfulness-Based Stress Reduction (MBSR) as an add-on to usual care on mental well-being when compared to usual care alone. Second, to estimate the effect of prenatal MBSR on perceived stress and symptoms of depression and anxiety, and third to explore the effect on maternal bonding and childbirth, e.g. gestational age and experience of childbirth. Finally, to examine the mediating effect of mindfulness and self-compassion on the primary outcome.
Detailed description
Background A history of psychopathology or psychosocial adversities are risk factors for mental disorders in the perinatal period. Mental disorders in pregnancy can adversely affect the developing fetus, which call for early prevention. Mindfulness-Based-Stress-Reduction (MBSR) is an acceptable intervention for pregnant women and has a growing evidence-base with meta-analyses consistently pointing to reductions in symptoms of stress, anxiety and depression. The aim of this study is to address the need for a wider array of evidence-based and non-pharmacological options to improve mental health in a psychosocially highly vulnerable group of pregnant women.
Methods/design Pregnant women (n = 238) referred to an outpatient clinic at Copenhagen University Hospital, Amager and Hvidovre, Denmark will be recruited for the study. The design is a single-center, parallel group, randomized controlled trial, with an adapted MBSR program as add on to usual care. The primary outcome is mental wellbeing. Secondary and exploratory outcomes include stress, anxiety, depression, mindfulness, compassion, antenatal attachment and childbirth experience. Participants will be randomized in a 1:1 ratio to prenatal MBSR or usual care.
Implications for perinatal mental health Teaching the skills of mindfulness meditation to a psychosocially vulnerable group of pregnant women could prove a viable and non-pharmacological approach to improve mental health during pregnancy, reduce stress and support the transition to parenthood. The MBSR program does not target a particular group, and results from the study is thus of potential relevance for pregnant women in general as a means of reducing stress and improving perinatal mental health.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A single-center, parallel group, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Prenatal mindfulness-based stress reductionThe prenatal MBSR program is an adaptation of MBSR. Details on the adaptation process is described in Skovbjerg S et al. Pilot and feasibility studies, 2021 Jun 3; 7 (1):118. Prenatal MBSR include nine weekly two-hour classes and is delivered in a combination between physical attendance and live-online teaching. The recommended time for daily mindfulness training between sessions is 15 minutes a day with options for longer practice. Audio recordings with guided meditations and a video with yoga programs for pregnancy is provided for home practice. |
| Treatment as usual | No intervention | –Standard clinical practice, usual care (TAU), consists of an average of six routine pregnancy visits to the outpatient antenatal clinic at Copenhagen University Hospital, Hvidovre and to a General Practitioner. Routine pregnancy visits involves primarily preventive counselling by midwifes, and in some cases consultations with a physician or social worker throughout pregnancy and the early post-partum period. In some cases, usual care may include consultations with a psychologist, although usually limited to a few sessions, and in more severe cases referral to psychiatric treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Estimated due date no sooner than three months from start of the intervention. This criterion is included in order for the women to be able to complete the intervention before their due date.
- Eighteen + years of age.
- Speak and write Danish.
- Available for group intervention scheduled sessions. Being unavailable for two or more sessions is reason for exclusion from study participation.
- Written informed consent to study criteria.
Key exclusion criteria (3 listed)
- Active substance dependence.
- Psychotic disorders (e.g. schizophrenia or bipolar disorder).
- Suicidality.
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 |
|---|---|---|
| Prenatal mindfulness-based stress reductionAn adapted mindfulness-based stress reduction (MBSR) program with a particular focus on pregnancy and early motherhood. | Behavioural | Intervention |
Primary outcome
The World Health Organization - Five Well-Being Index (WHO-5)
Time frame: From baseline to 6 months after completion of the intervention.
The WHO-5 is a global rating scale measuring subjective well-being and consists of five statements and the respondent is asked to rate how well each of the statements applies to her when considering the last 14 days. Each item is scored from 5 "all of the time" to 0 "none of the time". Final scores range from 0 - 100 with higher scores representing greater well-being.
4 secondary outcomes
The Depression Anxiety Stress Scales (DASS-21)
Time frame: From baseline to 6 months after completion of the intervention.
The Edinburgh Depression Scale (EDS)
Time frame: From baseline to 6 months after completion of the intervention.
The Five-Facet Mindfulness Questionnaire (FFMQ)
Time frame: From baseline to 6 months after completion of the intervention.
The Self-Compassion Scale (SCS)
Time frame: From baseline to 6 months after completion of the intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Derived from this study: PubMed 37838672Skovbjerg S, Sumbundu A, Kolls M, Kjaerbye-Thygesen A, Fjorback LO. The effect of an adapted Mindfulness-Based Stress Reduction program on mental health, maternal bonding and birth outcomes in psychosocially vulnerable pregnant women: a study protocol for a randomized controlled trial in a Danish hospital-based outpatient setting. BMC Complement Med Ther. 2023 Oct 14;23(1):364. doi: 10.1186/s12906-023-04194-3.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prenatal mindfulness-based stress reduction in people with Perinatal Mental Health and Pregnancy Related, run by University of Aarhus at 2 sites in Denmark.
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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sine Skovbjerg, PhD (+ 45 26357227, sine.skovbjerg@clin.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The World Health Organization - Five Well-Being Index (WHO-5) (time frame: From baseline to 6 months after completion of 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 NCT05300646, which also lists 1 linked publication.
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 29 Mar 2022.