Pregnancy, Childbirth and PostpartumNCT03247491
Effectiveness of a Mindfulness and Compassion Intervention for Pregnant Women and Their Partners for the Prevention of Stress and Depression During Pregnancy and Breastfeeding
A study testing Mindfulness in people with Pregnancy, Childbirth and Postpartum, run by Javier Garcia Campayo at 1 site in Spain.
Trial summary
The aim of this study is to assess a mindfulness and compassion group intervention for pregnant women and their partners (8 weeks) for the prevention, reduction and treatment of stress, negative affect and depression in pregnancy and breastfeeding. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Childbirth and Postpartum
- What is being tested?
- Mindfulness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2017to 1 Dec 2019
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be at least 18 years old
- Willingness to participate in the study and signing informed consent
- Ability to understand and write Spanish.
- Women will be in their 6 to 25 weeks of pregnancy.
- All women eligible will be accepted with our without their partner.
Who cannot join
- Any diagnose of disease that may affect central nervous system (brain pathology, traumatic brain injury, dementia, etc.),
- Other psychiatric diagnoses or acute psychiatric illness (substance dependence or abuse, history of schizophrenia or other psychotic disorders, eating disorders, etc.),
- Any medical, infectious or degenerative disease that may affect mood, presence of delusional ideas or hallucinations consistent or not with mood, and suicide risk
- Currently taking psychopharmacological medication or under psychopharmacological treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Mindfulness and Compassion Group Intervention Applied to Pregnant Women and Their Partners to Decrease Stress, Negative Affect and Depression During Pregnancy and Breastfeeding. Controlled and Randomized Study
The aim of this study is to assess a mindfulness and compassion group intervention for pregnant women and their partners (8 weeks) for the prevention, reduction and treatment of stress, negative affect and depression in pregnancy and breastfeeding. This group intervention will also be compared with a Treatment as usual (TAU) group consisting in a childbirth education class taught by the Health Center midwife. The principal hypothesis is that the mindfulness and compassion intervention will be more effective than TAU.
Read the detailed description
The aim of this study is to assess a mindfulness and compassion group intervention for pregnant women and their partners (8 weeks) for the prevention, reduction and treatment of stress, negative affect and depression in pregnancy and breastfeeding.
There will be two groups:
- A face to face mindfulness and compassion intervention for pregnant women in their second trimester of pregnancy and their partners in group format (8 weeks) based in the Mindfulness Based Childbirth and Parenting program from Nancy Bardacke. This group will also receive in their third trimester of pregnancy the childbirth education classes taught by midwives (6-8 weeks) that every pregnant woman normally attends to in the National Health Care System in Spain (TAU).
- A control group that will receive only the childbirth education class by midwives (TAU) group consisting in a childbirth education class taught by the Health Center midwife at the third trimester of pregnancy.
Each group will be composed of 60 participants with a total sample of 120. The principal hypothesis is that the mindfulness and compassion intervention will be more effective than TAU in the decrease of stress, negative affect and depression and in the increase of positive affect during pregnancy and breastfeeding.
The differences between the intervention and control group will be analyzed. Finally, a qualitative study will be conducted.
- Conditions
- Pregnancy, Childbirth and Postpartum
- Being tested
- Mindfulness
- Keywords
- Mindfulness, Compassion, Depression during Pregnancy and Postpartum, Prevention, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindfulnessBehavioural
TAU + mindfulness applied face to face 8 sessions of 120 minutes/session Mindfulness and Compassion based intervention applied in groups of 12-15 people in traditional format. Written material and sound recordings will be offered as support elements. The estimated duration of the face to face program is two months.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | TAU + mindfulness applied face to face 8 sessions of 120 minutes/session Mindfulness and Compassion based intervention applied in groups of 12-15 people in traditional format. Written material and sound recordings will be offered as support elements. The estimated duration of the face to face program is two months. Receives: Behavioral: Mindfulness |
| No intervention | No intervention | Usual medical treatment (TAU) In this group the midwife will apply the usual treatment (childbirth education class in the third trimester of pregnancy). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Edinburgh postnatal depression scale (EPDS)
In the mindfulness and compassion based intervention group
Measured: Baseline
Edinburgh postnatal depression scale (EPDS)
In the TAU control group
Measured: Baseline
Edinburgh postnatal depression scale (EPDS)
Measured: Post-treatment 8 weeks from baseline in intervention group
Edinburgh postnatal depression scale (EPDS)
Measured: Post-treatment 8 weeks from baseline in TAU control group
Edinburgh postnatal depression scale (EPDS)
Measured: Post-partum 3 months follow up in 8 weeks intervention group
Edinburgh postnatal depression scale (EPDS)
Measured: Post-partum 3 months follow up in TAU control group
Edinburgh postnatal depression scale (EPDS)
Measured: Post-partum 6 months follow up in 8 weeks intervention group
Edinburgh postnatal depression scale (EPDS)
Measured: Post-partum 6 months follow up in TAU control group
Secondary outcomes (42)
Sociodemographic data Gender, age, marital status, education, occupation, economical level
In the mindfulness-based intervention applied face-to-face and TAU control group
Measured: Baseline
M.I.N.I. International Neuropsychiatric Interview
only if needed
Measured: baseline applied in TAU and in intervention group
Client service receipt inventory (CSRI)
In the mindfulness-based intervention applied face-to-face and TAU control group
Measured: Baseline
Client service receipt inventory (CSRI)
Measured: Post-partum 6 months follow up in 8 weeks intervention group
Client service receipt inventory (CSRI)
Measured: Post-partum 6 months follow up in TAU control group
Medical data regarding delivery and breastfeeding
In the mindfulness-based intervention applied face-to-face and TAU control group
Measured: 2 months after delivery
Perceived Stress Scale (PSS)
In the mindfulness and compassion based intervention group
Measured: Baseline
Perceived Stress Scale (PSS)
In the TAU control group
Measured: Baseline
Perceived Stress Scale (PSS)
Measured: Post-treatment 8 weeks from baseline in 8 weeks intervention group
Perceived Stress Scale (PSS)
Measured: Post-treatment 8 weeks from baseline in TAU control group
Perceived Stress Scale (PSS)
Measured: Post-partum 3 months follow up in 8 weeks intervention group
Perceived Stress Scale (PSS)
Measured: Post-partum 3 months follow up in TAU control group
Perceived Stress Scale (PSS)
Measured: Post-partum 6 months follow up in 8 weeks intervention group
Perceived Stress Scale (PSS)
Measured: Post-partum 6 weeks follow up in TAU control group
Positive and negative affect (PANAS)
In the mindfulness and compassion based intervention group
Measured: Baseline
Positive and negative affect (PANAS)
In the TAU control group
Measured: Baseline
Positive and negative affect (PANAS)
Measured: Post-treatment 8 weeks from baseline in 8 weeks intervention group
Positive and negative affect (PANAS)
Measured: Post-treatment 8 weeks from baseline in TAU control group
Positive and negative affect (PANAS)
Measured: Post-partum 3 months follow up in 8 weeks intervention group
Positive and negative affect (PANAS)
Measured: Post-partum 3 months follow up in TAU control group
Positive and negative affect (PANAS)
Measured: Post-partum 6 months follow up in 8 weeks intervention group
Positive and negative affect (PANAS)
Measured: Post-partum 6 months follow up in TAU control group
Five Facets and factors of mindfulness (FFMQ)
In the mindfulness and compassion based intervention group
Measured: Baseline
Five Facets and factors of mindfulness (FFMQ)
In the TAU control group
Measured: Baseline
Five Facets and factors of mindfulness (FFMQ)
Measured: Post-treatment 8 weeks from baseline in 8 weeks intervention group
Five Facets and factors of mindfulness (FFMQ)
Measured: Post-treatment 8 weeks from baseline in TAU control group
Five Facets and factors of mindfulness (FFMQ)
Measured: Post-partum 3 months follow up in 8 weeks intervention group
Five Facets and factors of mindfulness (FFMQ)
Measured: Post-partum 3 months follow up in TAU control group
Five Facets and factors of mindfulness (FFMQ)
Measured: Post-partum 6 months follow up in 8 weeks intervention group
Five Facets and factors of mindfulness (FFMQ)
Measured: Post-partum 6 months follow up in TAU control group
Self Compassion Scale (SCS)
In the mindfulness and compassion based intervention group
Measured: Baseline
Self Compassion Scale (SCS)
In the TAU control group
Measured: Baseline
Self Compassion Scale (SCS)
In the mindfulness and compassion based intervention group
Measured: Post-treatment 8 weeks from baseline in 8 weeks intervention group
Self Compassion Scale (SCS)
Measured: Post-treatment 8 weeks from baseline in TAU control group
Self Compassion Scale (SCS)
Measured: Post-partum 3 months follow up in 8 weeks intervention group
Self Compassion Scale (SCS)
Measured: Post-partum 3 months follow up in TAU control group
Self Compassion Scale (SCS)
Measured: Post-partum 6 months follow up in 8 weeks intervention group
Self Compassion Scale(SCS)
Measured: Post-partum 6 months follow up in TAU control group
Parental Evaluation Scale (EEP)
Measured: Post-partum 3 months follow up in 8 weeks intervention group
Parental Evaluation Scale (EEP)
Measured: Post-partum 3 months follow up in TAU control group
Parental Evaluation Scale (EEP)
Measured: Post-partum 6 months follow up in 8 weeks intervention group
Parental Evaluation Scale (EEP)
Measured: Post-partum 6 months follow up in TAU control group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2017
- Study start1 Oct 2017
- Primary completion2 Oct 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pregnancy, Childbirth and PostpartumStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Javier Garcia Campayo
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Nacional de Educación a Distancia
- Responsible party
- Sponsor-investigator, Javier Garcia Campayo, Hospital Miguel Servet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03247491
- Sponsor's protocol ID
- 50/2014/04
- Status last verified
- Dec 2019
- First submitted
- 9 Aug 2017
- Last updated
- 3 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Duncan LG, Bardacke N. Mindfulness-Based Childbirth and Parenting Education: Promoting Family Mindfulness During the Perinatal Period. J Child Fam Stud. 2010 Apr;19(2):190-202. doi: 10.1007/s10826-009-9313-7. Epub 2009 Oct 10.
PubMed 20339571Duncan, L.G., Cohn, M.A., Chao, M.T., Cook, J.G., Riccobono, J., & Bardacke, N. (2014a) Mind in labor: Effects of mind/body training on childbirth appraisals and pain medication use during labor. The Journal of Alternative and Complementary Medicine, 20, A17-A17.
Duncan, L.G., Cohn, M.A., Cook, J.G., Hecht, F.M., & Bardacke, N. (2014b) The mind in labor: Employing mindfulness to alleviate fear and pain in childbirth. Poster presented at the 2nd biennial International Symposium for Contemplative Studies. Boston, MA.
Duncan LG, Shaddix C. Mindfulness-Based Childbirth and Parenting (MBCP): Innovation in Birth Preparation to Support Healthy, Happy Families. Int J Birth Parent Educ. 2015 Jan;2(2):30-33. No abstract available.
PubMed 29051821Duncan LG, Cohn MA, Chao MT, Cook JG, Riccobono J, Bardacke N. Benefits of preparing for childbirth with mindfulness training: a randomized controlled trial with active comparison. BMC Pregnancy Childbirth. 2017 May 12;17(1):140. doi: 10.1186/s12884-017-1319-3.
PubMed 28499376Sacristan-Martin O, Santed MA, Garcia-Campayo J, Duncan LG, Bardacke N, Fernandez-Alonso C, Garcia-Sacristan G, Garcia-Sacristan D, Barcelo-Soler A, Montero-Marin J. A mindfulness and compassion-based program applied to pregnant women and their partners to decrease depression symptoms during pregnancy and postpartum: study protocol for a randomized controlled trial. Trials. 2019 Nov 28;20(1):654. doi: 10.1186/s13063-019-3739-z.
PubMed 31779683
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Mindfulness and Compassion Group Intervention Applied to Pregnant Women and Their Partners to Decrease Stress, Negative Affect and Depression During Pregnancy and Breastfeeding. Controlled and Randomized Study
- ClinicalTrials.gov ID
- NCT03247491
- Acronym / sponsor ID
- 50/2014/04
- Conditions
- Pregnancy, Childbirth and Postpartum
- Keywords
- Mindfulness, Compassion, Depression during Pregnancy and Postpartum, Prevention, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Javier Garcia CampayoUniversity, hospital or other
- Collaborators
- Universidad Nacional de Educación a Distancia
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 2 Oct 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 11 Aug 2017 (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 this study is to assess a mindfulness and compassion group intervention for pregnant women and their partners (8 weeks) for the prevention, reduction and treatment of stress, negative affect and depression in pregnancy and breastfeeding. This group intervention will also be compared with a Treatment as usual (TAU) group consisting in a childbirth education class taught by the Health Center midwife. The principal hypothesis is that the mindfulness and compassion intervention will be more effective than TAU.
Detailed description
The aim of this study is to assess a mindfulness and compassion group intervention for pregnant women and their partners (8 weeks) for the prevention, reduction and treatment of stress, negative affect and depression in pregnancy and breastfeeding.
There will be two groups:
- A face to face mindfulness and compassion intervention for pregnant women in their second trimester of pregnancy and their partners in group format (8 weeks) based in the Mindfulness Based Childbirth and Parenting program from Nancy Bardacke. This group will also receive in their third trimester of pregnancy the childbirth education classes taught by midwives (6-8 weeks) that every pregnant woman normally attends to in the National Health Care System in Spain (TAU).
- A control group that will receive only the childbirth education class by midwives (TAU) group consisting in a childbirth education class taught by the Health Center midwife at the third trimester of pregnancy.
Each group will be composed of 60 participants with a total sample of 120. The principal hypothesis is that the mindfulness and compassion intervention will be more effective than TAU in the decrease of stress, negative affect and depression and in the increase of positive affect during pregnancy and breastfeeding.
The differences between the intervention and control group will be analyzed. Finally, a qualitative study will be conducted.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: MindfulnessTAU + mindfulness applied face to face 8 sessions of 120 minutes/session Mindfulness and Compassion based intervention applied in groups of 12-15 people in traditional format. Written material and sound recordings will be offered as support elements. The estimated duration of the face to face program is two months. |
| No intervention | No intervention | –Usual medical treatment (TAU) In this group the midwife will apply the usual treatment (childbirth education class in the third trimester of pregnancy). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Be at least 18 years old
- Willingness to participate in the study and signing informed consent
- Ability to understand and write Spanish.
- Women will be in their 6 to 25 weeks of pregnancy.
- All women eligible will be accepted with our without their partner.
Key exclusion criteria (4 listed)
- Any diagnose of disease that may affect central nervous system (brain pathology, traumatic brain injury, dementia, etc.),
- Other psychiatric diagnoses or acute psychiatric illness (substance dependence or abuse, history of schizophrenia or other psychotic disorders, eating disorders, etc.),
- Any medical, infectious or degenerative disease that may affect mood, presence of delusional ideas or hallucinations consistent or not with mood, and suicide risk
- Currently taking psychopharmacological medication or under psychopharmacological treatment.
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 |
|---|---|---|
| MindfulnessTAU + mindfulness applied face to face 8 sessions of 120 minutes/session Mindfulness and Compassion based intervention applied in groups of 12-15 people in traditional format. Written material and sound recordings will be offered as support elements. The estimated duration of the face to face program is two months. | Behavioural | Experimental |
Primary outcome
Edinburgh postnatal depression scale (EPDS)
Time frame: Baseline
In the mindfulness and compassion based intervention group
Edinburgh postnatal depression scale (EPDS)
Time frame: Baseline
In the TAU control group
Edinburgh postnatal depression scale (EPDS)
Time frame: Post-treatment 8 weeks from baseline in intervention group
Edinburgh postnatal depression scale (EPDS)
Time frame: Post-treatment 8 weeks from baseline in TAU control group
Edinburgh postnatal depression scale (EPDS)
Time frame: Post-partum 3 months follow up in 8 weeks intervention group
Edinburgh postnatal depression scale (EPDS)
Time frame: Post-partum 3 months follow up in TAU control group
Edinburgh postnatal depression scale (EPDS)
Time frame: Post-partum 6 months follow up in 8 weeks intervention group
Edinburgh postnatal depression scale (EPDS)
Time frame: Post-partum 6 months follow up in TAU control group
42 secondary outcomes
Sociodemographic data Gender, age, marital status, education, occupation, economical level
Time frame: Baseline
M.I.N.I. International Neuropsychiatric Interview
Time frame: baseline applied in TAU and in intervention group
Client service receipt inventory (CSRI)
Time frame: Baseline
Client service receipt inventory (CSRI)
Time frame: Post-partum 6 months follow up in 8 weeks intervention group
Client service receipt inventory (CSRI)
Time frame: Post-partum 6 months follow up in TAU control group
Medical data regarding delivery and breastfeeding
Time frame: 2 months after delivery
Perceived Stress Scale (PSS)
Time frame: Baseline
Perceived Stress Scale (PSS)
Time frame: Baseline
Perceived Stress Scale (PSS)
Time frame: Post-treatment 8 weeks from baseline in 8 weeks intervention group
Perceived Stress Scale (PSS)
Time frame: Post-treatment 8 weeks from baseline in TAU control group
Perceived Stress Scale (PSS)
Time frame: Post-partum 3 months follow up in 8 weeks intervention group
Perceived Stress Scale (PSS)
Time frame: Post-partum 3 months follow up in TAU control group
Perceived Stress Scale (PSS)
Time frame: Post-partum 6 months follow up in 8 weeks intervention group
Perceived Stress Scale (PSS)
Time frame: Post-partum 6 weeks follow up in TAU control group
Positive and negative affect (PANAS)
Time frame: Baseline
Positive and negative affect (PANAS)
Time frame: Baseline
Positive and negative affect (PANAS)
Time frame: Post-treatment 8 weeks from baseline in 8 weeks intervention group
Positive and negative affect (PANAS)
Time frame: Post-treatment 8 weeks from baseline in TAU control group
Positive and negative affect (PANAS)
Time frame: Post-partum 3 months follow up in 8 weeks intervention group
Positive and negative affect (PANAS)
Time frame: Post-partum 3 months follow up in TAU control group
Positive and negative affect (PANAS)
Time frame: Post-partum 6 months follow up in 8 weeks intervention group
Positive and negative affect (PANAS)
Time frame: Post-partum 6 months follow up in TAU control group
Five Facets and factors of mindfulness (FFMQ)
Time frame: Baseline
Five Facets and factors of mindfulness (FFMQ)
Time frame: Baseline
Five Facets and factors of mindfulness (FFMQ)
Time frame: Post-treatment 8 weeks from baseline in 8 weeks intervention group
Five Facets and factors of mindfulness (FFMQ)
Time frame: Post-treatment 8 weeks from baseline in TAU control group
Five Facets and factors of mindfulness (FFMQ)
Time frame: Post-partum 3 months follow up in 8 weeks intervention group
Five Facets and factors of mindfulness (FFMQ)
Time frame: Post-partum 3 months follow up in TAU control group
Five Facets and factors of mindfulness (FFMQ)
Time frame: Post-partum 6 months follow up in 8 weeks intervention group
Five Facets and factors of mindfulness (FFMQ)
Time frame: Post-partum 6 months follow up in TAU control group
Self Compassion Scale (SCS)
Time frame: Baseline
Self Compassion Scale (SCS)
Time frame: Baseline
Self Compassion Scale (SCS)
Time frame: Post-treatment 8 weeks from baseline in 8 weeks intervention group
Self Compassion Scale (SCS)
Time frame: Post-treatment 8 weeks from baseline in TAU control group
Self Compassion Scale (SCS)
Time frame: Post-partum 3 months follow up in 8 weeks intervention group
Self Compassion Scale (SCS)
Time frame: Post-partum 3 months follow up in TAU control group
Self Compassion Scale (SCS)
Time frame: Post-partum 6 months follow up in 8 weeks intervention group
Self Compassion Scale(SCS)
Time frame: Post-partum 6 months follow up in TAU control group
Parental Evaluation Scale (EEP)
Time frame: Post-partum 3 months follow up in 8 weeks intervention group
Parental Evaluation Scale (EEP)
Time frame: Post-partum 3 months follow up in TAU control group
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 3 Dec 2019.
- Background: PubMed 20339571Duncan LG, Bardacke N. Mindfulness-Based Childbirth and Parenting Education: Promoting Family Mindfulness During the Perinatal Period. J Child Fam Stud. 2010 Apr;19(2):190-202. doi: 10.1007/s10826-009-9313-7. Epub 2009 Oct 10.
- BackgroundDuncan, L.G., Cohn, M.A., Chao, M.T., Cook, J.G., Riccobono, J., & Bardacke, N. (2014a) Mind in labor: Effects of mind/body training on childbirth appraisals and pain medication use during labor. The Journal of Alternative and Complementary Medicine, 20, A17-A17.
- BackgroundDuncan, L.G., Cohn, M.A., Cook, J.G., Hecht, F.M., & Bardacke, N. (2014b) The mind in labor: Employing mindfulness to alleviate fear and pain in childbirth. Poster presented at the 2nd biennial International Symposium for Contemplative Studies. Boston, MA.
- Background: PubMed 29051821Duncan LG, Shaddix C. Mindfulness-Based Childbirth and Parenting (MBCP): Innovation in Birth Preparation to Support Healthy, Happy Families. Int J Birth Parent Educ. 2015 Jan;2(2):30-33. No abstract available.
- Background: PubMed 28499376Duncan LG, Cohn MA, Chao MT, Cook JG, Riccobono J, Bardacke N. Benefits of preparing for childbirth with mindfulness training: a randomized controlled trial with active comparison. BMC Pregnancy Childbirth. 2017 May 12;17(1):140. doi: 10.1186/s12884-017-1319-3.
- Derived from this study: PubMed 31779683Sacristan-Martin O, Santed MA, Garcia-Campayo J, Duncan LG, Bardacke N, Fernandez-Alonso C, Garcia-Sacristan G, Garcia-Sacristan D, Barcelo-Soler A, Montero-Marin J. A mindfulness and compassion-based program applied to pregnant women and their partners to decrease depression symptoms during pregnancy and postpartum: study protocol for a randomized controlled trial. Trials. 2019 Nov 28;20(1):654. doi: 10.1186/s13063-019-3739-z.
- 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.
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 Mindfulness in people with Pregnancy, Childbirth and Postpartum, run by Javier Garcia Campayo at 1 site in Spain.
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 4 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 3 Dec 2019. 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 Spain. 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?
Edinburgh postnatal depression scale (EPDS) (time frame: Baseline). The study lists 8 primary outcomes in all. 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 NCT03247491, which also lists 6 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 3 Dec 2019.