NCT03247491

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 11, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 2, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

December 3, 2019

Status Verified

December 1, 2019

Enrollment Period

2 years

First QC Date

August 9, 2017

Last Update Submit

December 1, 2019

Conditions

Pregnancy, Childbirth and Postpartum

Keywords

MindfulnessCompassionDepression during Pregnancy and PostpartumPreventionStress

Outcome Measures

Primary Outcomes (8)

  • Edinburgh postnatal depression scale (EPDS)

    In the mindfulness and compassion based intervention group

    Baseline

  • Edinburgh postnatal depression scale (EPDS)

    In the TAU control group

    Baseline

  • Edinburgh postnatal depression scale (EPDS)

    Post-treatment 8 weeks from baseline in intervention group

  • Edinburgh postnatal depression scale (EPDS)

    Post-treatment 8 weeks from baseline in TAU control group

  • Edinburgh postnatal depression scale (EPDS)

    Post-partum 3 months follow up in 8 weeks intervention group

  • Edinburgh postnatal depression scale (EPDS)

    Post-partum 3 months follow up in TAU control group

  • Edinburgh postnatal depression scale (EPDS)

    Post-partum 6 months follow up in 8 weeks intervention group

  • Edinburgh postnatal depression scale (EPDS)

    Post-partum 6 months follow up in TAU control group

Secondary Outcomes (42)

  • Sociodemographic data Gender, age, marital status, education, occupation, economical level

    Baseline

  • M.I.N.I. International Neuropsychiatric Interview

    baseline applied in TAU and in intervention group

  • Client service receipt inventory (CSRI)

    Baseline

  • Client service receipt inventory (CSRI)

    Post-partum 6 months follow up in 8 weeks intervention group

  • Client service receipt inventory (CSRI)

    Post-partum 6 months follow up in TAU control group

  • +37 more secondary outcomes

Study Arms (2)

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.

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).

Interventions

MindfulnessBEHAVIORAL

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.

Experimental

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Nacional de Educacion a Distancia

Valladolid, 47013, Spain

Location

Related Publications (6)

  • 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.

    PMID: 20339571BACKGROUND

  • Duncan, 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 29051821BACKGROUND

  • Duncan 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.

    PMID: 28499376BACKGROUND

  • Sacristan-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.

    PMID: 31779683DERIVED

MeSH Terms

Interventions

Mindfulness

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Co-director of Olga Sacristán´s (principal investigator) ph dissertation

Study Record Dates

First Submitted

August 9, 2017

First Posted

August 11, 2017

Study Start

October 1, 2017

Primary Completion

October 2, 2019

Study Completion

December 1, 2019

Last Updated

December 3, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)