Effectiveness of an Online Biopsychosocial Intervention to Improve Well-being and Mental Health During Pregnancy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity Rovira i Virgili
About this trial
This study aims to develop and implement a preventive intervention through a mobile application to help pregnant women feel better emotionally and cope with the changes of pregnancy in a more positive way. The idea is to offer practical and accessible tools that allow them to better manage stress, emotions and preparation for motherhood. The intervention proposed in this study is based on psychological strategies that have proven to be effective, such as relaxation exercises, techniques to manage stress and strategies to improve mood, strengthen the relationship with the partner and foster the bond with the baby before its birth.
The application is designed to accompany pregnant women from the beginning of pregnancy to the postpartum period. It has different programs that include weekly activities on various important topics, such as physical health care, emotional management, connection with the baby during pregnancy, preparation for childbirth and the first months of the newborn's life.
To evaluate the effectiveness of this tool, a study will be carried out with pregnant women treated by the Catalan Health Service. Participants will be randomly assigned to one of two study groups: the experimental group (in which participants, in addition to the usual medical care offered during pregnancy, will have access to the programs and activities of the app organized in a weekly plan of 5 activities and will have to answer the study questionnaires at weeks 16 and 36 of pregnancy and postpartum) or the control group (in which participants will receive the usual medical care offered during pregnancy, but will not have access to the programs and activities of the app and will have to answer the study questionnaires at weeks 16 and 36 of pregnancy and postpartum).
Women who use the app are expected to experience greater emotional well-being and a lower risk of developing mental health problems during pregnancy. In addition, they may feel more prepared for motherhood, take better care of their health, have a more positive birth experience and a lower risk of postpartum depression. These women are also expected to develop a stronger bond with their baby and adapt better to the new stage of motherhood.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Pregnant women
Pregnancy of less than 15 weeks of gestation
More than 18 years old age
Able to read, write, and understand Spanish
Disqualifiers
Having a high-risk pregnancy that entails transfer to another specialized health centre
Having diagnosis of disease that may affect the central nervous system, such as brain pathology or traumatic brain injury
Having other psychiatric diagnosis or acute psychiatric illness, such as substance dependence or abuse, a presence of schizophrenia or other psychotic disorders or risk for suicide
To be under psychopharmacological medication or under psychopharmacological treatment.
Trial design
Design model
Parallel
Treatments tested in this trial
Biopsychosocial Cognitive Behavioral Intervention
Other interventionThe study intervention is based on a biopsychosocial approach (considers the interaction between: biological factors such as physical health, fetal development and physiological changes; psychological factors such as stress management, emotions and thoughts; and social factors such as couple relationships, social support and the maternal role) with cognitive-behavioral strategies designed to promote comprehensive well-being during pregnancy and the postpartum. Techniques such as psychoeducation, reflection and self-observation, cognitive restructuring, problem solving, stress inoculation, progressive muscle relaxation, guided visualizations and mindfulness are applied. The program consists of 10 modules focused on different areas: introduction to the study, mindfulness and breathing techniques, physical and mental health at different stages of pregnancy, fetal development and prenatal attachment, couple relationship, preparation for childbirth and postpartum, and care of the newborn.
Treatment groups
228 Participants
are divided into 2 treatment groupsGroup A: Control GroupNo intervention 0 interventions
Group B: Experimental groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Subjective well-being
Assessment of overall satisfaction with life during pregnancy and postpartum. Instrument: Satisfaction With Life Scale (SWLS). Measurement units: Total score. The range of questionnaire scores is from 5 to 25. Higher scores indicate greater satisfacion with life.
Time frame
Basal (15 weeks of gestation ). Post-Intervention (36 weeks of gestation). Follow-up (45 days postpartum)..2
Daily emotional state
Assessment of the emotional state of the pregnant woman in real time. Instrument: Visual mood tracker in the study's mobile application.
Time frame
According to the frequency with which the pregnant woman accesses the application.3
Well-being
Assessment of the current mental well-being of the pregnant woman. World Health Organisation-5 Well-Being Index (WHO-5). Measurement units: Total score. The range of questionnaire scores is from 5 to 25. Higher scores indicate greater well-being.
Time frame
Basal (15 weeks of gestation ). Post-Intervention (36 weeks of gestation). Follow-up (45 days postpartum).4
General psychological well-being
Psychological well-being in different areas: subjective, material, occupational and couple. Instrument: Psychological Wellbeing Scale (PWS). Measurement units: Total score. The range of questionnaire scores is from 65 to 325. Higher scores indicate greater psychological well-being.
Time frame
Basal (15 weeks of gestation ). Post-Intervention (36 weeks of gestation). Follow-up (45 days postpartum).Secondary outcomes
1
Healthy lifestyle habits
Assessment of a general lifestyle habits. Instrument: The Mediterranian Lifestyle Index (MEDLIFE). Measurement units: Total score. The range of questionnaire scores is from 0 to 28. Higher scores indicate greater life style habits.
Time frame
Basal (15 weeks of gestation ). Post-Intervention (36 weeks of gestation).2
Lenght of pregnancy
Instrument: Medical history. Measurement units: Weeks of gestation.
Time frame
Follow-up (10 days postpartum).3
Type of birth
Type of birth. Instrument: Clinical record. Categories: No instrumental delivery; Instrumental delivery - forceps; Instrumental delivery - caesarean section.
Time frame
Follow-up (10 days postpartum).4
Infant Birth Weight
Instrument: Medical history. Measurement units: grams.
Time frame
Follow-up (10 days postpartum).Sponsors and contacts
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Source ClinicalTrials.gov