Effectiveness of a Mindfulness and Compassion Intervention for Pregnant Women and Their Partners for the Prevention of Stress and Depression During Pregnancy and Breastfeeding

Study Overview
=================
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.

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.

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

Conditions
-----------------
Pregnancy, Childbirth and Postpartum

Intervention / Treatment
-----------------
* Behavioral: Mindfulness


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>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<br>* 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.<br>|
| No Intervention: No intervention<br>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 the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mindfulness, Compassion, Depression during Pregnancy and Postpartum, Prevention, Stress