Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Universidad Nacional de Educación a Distancia | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Sociodemographic data Gender, age, marital status, education, occupation, economical level | In the mindfulness-based intervention applied face-to-face and TAU control group | Baseline |
| M.I.N.I. International Neuropsychiatric Interview |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad Nacional de Educacion a Distancia | Valladolid | 47013 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20339571 | Background | 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. | |
| Background | 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. | ||
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
only if needed
| 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 | 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 |
| Medical data regarding delivery and breastfeeding | In the mindfulness-based intervention applied face-to-face and TAU control group | 2 months after delivery |
| Perceived Stress Scale (PSS) | In the mindfulness and compassion based intervention group | Baseline |
| Perceived Stress Scale (PSS) | In the TAU control group | Baseline |
| Perceived Stress Scale (PSS) | Post-treatment 8 weeks from baseline in 8 weeks intervention group |
| Perceived Stress Scale (PSS) | Post-treatment 8 weeks from baseline in TAU control group |
| Perceived Stress Scale (PSS) | Post-partum 3 months follow up in 8 weeks intervention group |
| Perceived Stress Scale (PSS) | Post-partum 3 months follow up in TAU control group |
| Perceived Stress Scale (PSS) | Post-partum 6 months follow up in 8 weeks intervention group |
| Perceived Stress Scale (PSS) | Post-partum 6 weeks follow up in TAU control group |
| Positive and negative affect (PANAS) | In the mindfulness and compassion based intervention group | Baseline |
| Positive and negative affect (PANAS) | In the TAU control group | Baseline |
| Positive and negative affect (PANAS) | Post-treatment 8 weeks from baseline in 8 weeks intervention group |
| Positive and negative affect (PANAS) | Post-treatment 8 weeks from baseline in TAU control group |
| Positive and negative affect (PANAS) | Post-partum 3 months follow up in 8 weeks intervention group |
| Positive and negative affect (PANAS) | Post-partum 3 months follow up in TAU control group |
| Positive and negative affect (PANAS) | Post-partum 6 months follow up in 8 weeks intervention group |
| Positive and negative affect (PANAS) | 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 | Baseline |
| Five Facets and factors of mindfulness (FFMQ) | In the TAU control group | Baseline |
| Five Facets and factors of mindfulness (FFMQ) | Post-treatment 8 weeks from baseline in 8 weeks intervention group |
| Five Facets and factors of mindfulness (FFMQ) | Post-treatment 8 weeks from baseline in TAU control group |
| Five Facets and factors of mindfulness (FFMQ) | Post-partum 3 months follow up in 8 weeks intervention group |
| Five Facets and factors of mindfulness (FFMQ) | Post-partum 3 months follow up in TAU control group |
| Five Facets and factors of mindfulness (FFMQ) | Post-partum 6 months follow up in 8 weeks intervention group |
| Five Facets and factors of mindfulness (FFMQ) | Post-partum 6 months follow up in TAU control group |
| Self Compassion Scale (SCS) | In the mindfulness and compassion based intervention group | Baseline |
| Self Compassion Scale (SCS) | In the TAU control group | Baseline |
| Self Compassion Scale (SCS) | In the mindfulness and compassion based intervention group | Post-treatment 8 weeks from baseline in 8 weeks intervention group |
| Self Compassion Scale (SCS) | Post-treatment 8 weeks from baseline in TAU control group |
| Self Compassion Scale (SCS) | Post-partum 3 months follow up in 8 weeks intervention group |
| Self Compassion Scale (SCS) | Post-partum 3 months follow up in TAU control group |
| Self Compassion Scale (SCS) | Post-partum 6 months follow up in 8 weeks intervention group |
| Self Compassion Scale(SCS) | Post-partum 6 months follow up in TAU control group |
| Parental Evaluation Scale (EEP) | Post-partum 3 months follow up in 8 weeks intervention group |
| Parental Evaluation Scale (EEP) | Post-partum 3 months follow up in TAU control group |
| Parental Evaluation Scale (EEP) | Post-partum 6 months follow up in 8 weeks intervention group |
| Parental Evaluation Scale (EEP) | Post-partum 6 months follow up in TAU control group |
| 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. |
| 28499376 | Background | 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. |
| 31779683 | Derived | 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. |
| ID | Term |
|---|---|
| D064866 | Mindfulness |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided