Maternal Well-being in the Postnatal Stage
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversidad Complutense de Madrid
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women who have been mothers in the last year
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Positive Psychology Intervention
BehavioralPPI includes 2 modules: hedonic well-being and eudaimonic well-being.
Cognitive Behavior Therapy
BehavioralCBT includes 3 modules: behavioral activation, cognitive restructuring, and interpersonal skills.
Treatment groups
98 Participants
are divided into 2 treatment groupsGroup A: Positive Psychology InterventionExperimental treatment 1 intervention
Group B: Cognitive Behavior TherapyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Postpartum depression change
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 interventionSecondary outcomes
1
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.
Time frame
Immediately before and after the intervention2
Satisfaction with life change (SWLS). Scores range from 5 to 35, where higher scores mean a better outcome.
Satisfaction With Life Scale
Time frame
Immediately before and after the intervention3
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.
Time frame
Immediately before and after the intervention4
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.
Time frame
Immediately before and after the interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Universidad Complutense de Madrid
Lead sponsor
Universidad Pontificia de Salamanca
Collaborator
Source ClinicalTrials.gov