Effectiveness of an Online Biopsychosocial Intervention to Improve Well-being and Mental Health During Pregnancy

Condition(s) studied

Investigational drug(s) / intervention(s)

Biopsychosocial Cognitive Behavioral Intervention: The 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.

Study summary

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

Primary outcome measure(s)

• Subjective well-being — Basal (15 weeks of gestation ). Post-Intervention (36 weeks of gestation). Follow-up (45 days postpartum)..
  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.
• Daily emotional state — According to the frequency with which the pregnant woman accesses the application.
  Assessment of the emotional state of the pregnant woman in real time. Instrument: Visual mood tracker in the study's mobile application.
• Well-being — Basal (15 weeks of gestation ). Post-Intervention (36 weeks of gestation). Follow-up (45 days postpartum).
  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.
• General psychological well-being — Basal (15 weeks of gestation ). Post-Intervention (36 weeks of gestation). Follow-up (45 days postpartum).
  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.
• Depressive symptoms — Basal (15 weeks of gestation ). Post-Intervention (36 weeks of gestation). Follow-up (45 days postpartum).
  Depressive symptoms. Instrument: Edinburgh Postpartum Depression Scale (EPDS). Measurement units: Total score. Presence or absence of symptoms in a clinical range. The range of questionnaire scores is from 0 to 30. Higher scores indicate greater depressive symptoms.
• Anxiety symptoms — Basal (15 weeks of gestation ). Post-Intervention (36 weeks of gestation). Follow-up (45 days postpartum).
  Assessment of the main symptoms of anxiety. Instrument: Wholey Anxiety Questionnaire (Wholey). Measurement units: Presence or absence of anxiety symptoms.
• State Trait Anxiety Symptoms — Basal (15 weeks of gestation ). Post-Intervention (36 weeks of gestation). Follow-up (45 days postpartum).
  Assessment of state anxiety (situational and transient anxiety) and trait anxiety (stable predisposition to anxiety). The range of questionnaire scores is from 0 to 60. Higher scores indicate greater state or trait anxiety levels. Instrument: State-Trait Anxiety Inventory (STAI). Measurement units: Total score.
• Fears and concerns related to pregnancy — Basal (15 weeks of gestation ). Post-Intervention (36 weeks of gestation).
  Assessment of fear of childbirth, concerns about the integrity of the baby, and concerns about personal appearance. Instrument: Pregnancy Related Anxiety Questionnaire (PRAQ-R2). Measurement units: Total score. The range of questionnaire scores is from 20 to 100. Higher scores indicate greater pregnancy-related anxiety.
• Prenatal bonding and psychosocial adaptation to pregnancy — Basal (15 weeks of gestation ). Post-Intervention (36 weeks of gestation).
  Evaluation of prenatal emotional bonding and emotional and psychosocial adaptation to pregnancy. Instrument: Scale for the Evaluation of Affective Bonding and Prenatal Adaptation (EVAP). Measurement units: Total score. The range of questionnaire scores is from 21 to 105. Higher scores indicate greater parental adaptation to pregnancy.
• Parental self-efficacy — Follow-up (45 days postpartum).
  Assessment of perceived confidence and competence in the parental role. Instrument: Parenting Sense of Competence Scale (PSOC). Measurement units: Total score. The range of questionnaire scores is from 21 to 105. Higher scores indicate greater parental self-efficacy.
• Parental stress — Follow-up (45 days postpartum).
  Assessment of stress associated with parenting. Instrument: Parent Stress Index-Short Form (PSI-SF). The range of questionnaire scores is from 36 to 180. Higher scores indicate higher stress related to parenting. Measurement units: Total score.

Trial sites (1)

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