Maternal Well-being in the Postnatal Stage

Postpartum Depression Clinical Trial

— BIEMAT  

Official title:

Maternal Well-being in the Postnatal Stage: Evaluation of Cognitive Biases and Validation of a Psychological Intervention

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05676918
• Other study ID #: UCM-UPS-WELLBEING
• Status: Recruiting
• Phase: N/A
• Start date: January 16, 2023
• Est. completion date: June 2024

Study information

• Verified date: November 2022
• Source: Universidad Complutense de Madrid
• Contact: Covadonga Chaves
• Phone: +34635321643
• Email: cchavesv[@]psi.ucm.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 98
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Depression, Postpartum
• Postpartum Depression
• Postpartum Disorder
• Puerperal Disorders

Intervention

Behavioral:
• Positive Psychology Intervention
PPI includes 2 modules: hedonic well-being and eudaimonic well-being.
• Cognitive Behavior Therapy
CBT includes 3 modules: behavioral activation, cognitive restructuring, and interpersonal skills.

Locations

Country	Name	City	State
Spain	Covadonga Chaves Vélez	Madrid	Pozuelo De Alarcón

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid	Universidad Pontificia de Salamanca

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postpartum depression change	Edinburgh Postpartum depression scale (EPDS). Scores range from 0 to 30, where higher scores mean a worse outcome.	Immediately before and after the intervention
Secondary	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.	Immediately before and after the intervention
Secondary	Satisfaction with life change (SWLS). Scores range from 5 to 35, where higher scores mean a better outcome.	Satisfaction With Life Scale	Immediately before and after the intervention
Secondary	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.	Immediately before and after the intervention
Secondary	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.	Immediately before and after the intervention
Secondary	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.	Immediately before and after the intervention
Secondary	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.	Immediately before and after the intervention