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Maternal Well-being in the Postnatal Stage (BIEMAT)

Primary Purpose

Postpartum Depression, Postpartum Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Positive Psychology Intervention
Cognitive Behavior Therapy
Sponsored by
Universidad Complutense de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postpartum Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Women who have been mothers in the last year Exclusion Criteria: Women who have been mothers in the last month, Women who meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for substance abuse and/or dependence within 30 days prior to study participation, Women who have a serious mental disorder that makes it difficult to follow the protocol (e.g. serious neurocognitive problems or brain damage; schizophrenia and other psychotic disorders).

Sites / Locations

  • Covadonga Chaves VélezRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Positive Psychology Intervention

Cognitive Behavior Therapy

Arm Description

Ten weekly sessions. Session duration: 90 minutes.

Ten weekly sessions. Session duration: 90 minutes.

Outcomes

Primary Outcome Measures

Postpartum depression change
Edinburgh Postpartum depression scale (EPDS). Scores range from 0 to 30, where higher scores mean a worse outcome.

Secondary Outcome Measures

Positive and Negative Affect change
Positive and Negative Affect Scale (PANAS). Positive emotions scores range from 10 to 50, where higher scores mean a better outcome. Negative emotions scores range from 10 to 50, where higher scores mean a worse outcome.
Satisfaction with life change (SWLS). Scores range from 5 to 35, where higher scores mean a better outcome.
Satisfaction With Life Scale
Beliefs about pregnancy change
The Pregnancy Related Beliefs Questionnaire (PRBQ-8). Scores range from 8 to 56. Higher scores indicate greater levels of dysfunctional attitudes towards motherhood.
Psychological well-being change
Psychological well-being scale by Ryff (PWBS). PWBS-29 is composed for 29 items with a minumum score of 29 and a maximum score of 174. Self-acceptance scores range from 4 to 24; Positive Relationships with others scores range from 5 to 30; Autonomy scores range from 6 to 36; Environmental mastery scores range from 5 to 30; Purpose in life scores range from 5 to 30 and Personal Growth scores range from 4 to 24. Higher score in each subscale means a better outcome.
Maternal filial bond in the postpartum change
The Postpartum Bonding Questionnaire (PBQ). Scores Range from 0 to 120. General factor scores range from 0 to 60 (Cut-off score 11= normal, 12 = high). Rejection of the infant scores range from 0 to 35. (cut-off 16 = normal, 17 = high). Infant-focused anxiety scores range from 0 to 10 (cut- off 9 = normal, 10 = high). Incipient abuse scores range from 0 to 10 ( cut-off 2 = normal, 3 = high). A high score in each factor indicates pathology.
Maternal self-efficacy change
Maternal Self-efficacy Questionnaire (MSQ). Scores range from 10 to 40, where equal or greater scores than 31 means a high perception of maternal self-efficacy.

Full Information

First Posted
November 10, 2022
Last Updated
June 5, 2023
Sponsor
Universidad Complutense de Madrid
Collaborators
Universidad Pontificia de Salamanca
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1. Study Identification

Unique Protocol Identification Number
NCT05676918
Brief Title
Maternal Well-being in the Postnatal Stage
Acronym
BIEMAT
Official Title
Maternal Well-being in the Postnatal Stage: Evaluation of Cognitive Biases and Validation of a Psychological Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 16, 2023 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad Complutense de Madrid
Collaborators
Universidad Pontificia de Salamanca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The objective of this study is to design and validate an online intervention aimed at promoting well-being in women with postpartum depression. For this, the design of a multicomponent protocol consisting of empirically validated positive interventions and comparing these with a group Cognitive Behavioral Therapy (CBT) is proposed, following the National Institute for Health and Care Excellence (NICE) recommendations for the treatment of depression. Participants will be screened for inclusion in the program if they meet clinical criteria. After that, they will be randomly assigned to a CBT group or a positive psychology intervention (PPI) group.
Detailed Description
Participants will be randomly assigned to the CBT group or the PPI group. Both groups will be treated identically except for the type of intervention. Group assignment will be blind to both patients and investigators. Both interventions have 10 weekly sessions. Sessions will be in groups and online. CBT includes 3 modules: behavioral activation, cognitive restructuring, and interpersonal skills. Main contents (10 sessions): (1) Symptoms of Depression. Myths about motherhood. CBT approach; (2) Stress and Anxiety. Relaxation; (3 and 4) Increase pleasurable activities. Balance in life. To manage time; (5) Management of negative thoughts. Health concerns; (5 and 6) Increase positive thoughts; (7) social skills; (8) Communication skills and parner support; (9) Plan for the future. New routines and strategies; (10) Relapse prevention. CBT has been shown to be effective in reducing depressive symptoms and modifying attentional biases (Pearson et al., 2013). On the other hand, a new protocol of positive interventions adapted for women after maternity (PPI) will be designed and applied. This multicomponent protocol includes interventions that have already been empirically validated in treating depression. PPI includes 2 modules: hedonic well-being and eudaimonic well-being. Main contents (10 sessions): (1) Symptoms of Depression. Myths about motherhood. PPI approach; (2) Mindfulness and positive emotions; (3) Gratitude and savoring; (4) Emotion regulation (5) Positive relationships and social support; (6) Compassion; (7) Personal strengths; (8) Goals and values; (9) Resilience; (10) Relapse prevention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Depression, Postpartum Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
98 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Positive Psychology Intervention
Arm Type
Experimental
Arm Description
Ten weekly sessions. Session duration: 90 minutes.
Arm Title
Cognitive Behavior Therapy
Arm Type
Active Comparator
Arm Description
Ten weekly sessions. Session duration: 90 minutes.
Intervention Type
Behavioral
Intervention Name(s)
Positive Psychology Intervention
Intervention Description
PPI includes 2 modules: hedonic well-being and eudaimonic well-being.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavior Therapy
Intervention Description
CBT includes 3 modules: behavioral activation, cognitive restructuring, and interpersonal skills.
Primary Outcome Measure Information:
Title
Postpartum depression change
Description
Edinburgh Postpartum depression scale (EPDS). Scores range from 0 to 30, where higher scores mean a worse outcome.
Time Frame
Immediately before and after the intervention
Secondary Outcome Measure Information:
Title
Positive and Negative Affect change
Description
Positive and Negative Affect Scale (PANAS). Positive emotions scores range from 10 to 50, where higher scores mean a better outcome. Negative emotions scores range from 10 to 50, where higher scores mean a worse outcome.
Time Frame
Immediately before and after the intervention
Title
Satisfaction with life change (SWLS). Scores range from 5 to 35, where higher scores mean a better outcome.
Description
Satisfaction With Life Scale
Time Frame
Immediately before and after the intervention
Title
Beliefs about pregnancy change
Description
The Pregnancy Related Beliefs Questionnaire (PRBQ-8). Scores range from 8 to 56. Higher scores indicate greater levels of dysfunctional attitudes towards motherhood.
Time Frame
Immediately before and after the intervention
Title
Psychological well-being change
Description
Psychological well-being scale by Ryff (PWBS). PWBS-29 is composed for 29 items with a minumum score of 29 and a maximum score of 174. Self-acceptance scores range from 4 to 24; Positive Relationships with others scores range from 5 to 30; Autonomy scores range from 6 to 36; Environmental mastery scores range from 5 to 30; Purpose in life scores range from 5 to 30 and Personal Growth scores range from 4 to 24. Higher score in each subscale means a better outcome.
Time Frame
Immediately before and after the intervention
Title
Maternal filial bond in the postpartum change
Description
The Postpartum Bonding Questionnaire (PBQ). Scores Range from 0 to 120. General factor scores range from 0 to 60 (Cut-off score 11= normal, 12 = high). Rejection of the infant scores range from 0 to 35. (cut-off 16 = normal, 17 = high). Infant-focused anxiety scores range from 0 to 10 (cut- off 9 = normal, 10 = high). Incipient abuse scores range from 0 to 10 ( cut-off 2 = normal, 3 = high). A high score in each factor indicates pathology.
Time Frame
Immediately before and after the intervention
Title
Maternal self-efficacy change
Description
Maternal Self-efficacy Questionnaire (MSQ). Scores range from 10 to 40, where equal or greater scores than 31 means a high perception of maternal self-efficacy.
Time Frame
Immediately before and after the intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women who have been mothers in the last year Exclusion Criteria: Women who have been mothers in the last month, Women who meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for substance abuse and/or dependence within 30 days prior to study participation, Women who have a serious mental disorder that makes it difficult to follow the protocol (e.g. serious neurocognitive problems or brain damage; schizophrenia and other psychotic disorders).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Covadonga Chaves
Phone
+34635321643
Email
cchavesv@psi.ucm.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Covadonga Chaves, PhD
Organizational Affiliation
Universidad Complutense de Madrid
Official's Role
Principal Investigator
Facility Information:
Facility Name
Covadonga Chaves Vélez
City
Madrid
State/Province
Pozuelo De Alarcón
ZIP/Postal Code
28223
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Covadonga Chaves Vélez
Phone
+36 635321643
Email
cchavesv@psi.ucm.es
First Name & Middle Initial & Last Name & Degree
Almudena Duque
Email
aduquesa@upsa.es
First Name & Middle Initial & Last Name & Degree
Almudena Duque Sánchez

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Information on the evaluation and intervention protocol can be requested from the researchers. Likewise, the individual participant data can be provided on demand to guarantee the transparency of the study.
IPD Sharing Time Frame
Since the end of the study (June 2024) and for 10 years
IPD Sharing Access Criteria
The individual participant data can be provided on demand to guarantee the transparency of the study.

Learn more about this trial

Maternal Well-being in the Postnatal Stage

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