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

NCT06871397 | Recruiting

• 2 other identifiers: BienGestar StudyPID2021-126291OA-I00
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prenatal Anxiety; Prenatal Depression; Wellbeing; Obstetrical Complications; Postnatal Depression

Keywords

wellbeing; anxiety; depression; eHealth; maternal mental health; health promotion; cognitive behavioral intervention; randomized controlled trial; pregnancy

Outcome Measures

Primary Outcomes (11)

• 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.

  Basal (15 weeks of gestation ). Post-Intervention (36 weeks of gestation). Follow-up (45 days postpartum)..

• 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.

  According to the frequency with which the pregnant woman accesses the application.

• 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.

  Basal (15 weeks of gestation ). Post-Intervention (36 weeks of gestation). Follow-up (45 days postpartum).

• 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.

  Basal (15 weeks of gestation ). Post-Intervention (36 weeks of gestation). Follow-up (45 days postpartum).

• Depressive symptoms

  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.

  Basal (15 weeks of gestation ). Post-Intervention (36 weeks of gestation). Follow-up (45 days postpartum).

• Anxiety symptoms

  Assessment of the main symptoms of anxiety. Instrument: Wholey Anxiety Questionnaire (Wholey). Measurement units: Presence or absence of anxiety symptoms.

  Basal (15 weeks of gestation ). Post-Intervention (36 weeks of gestation). Follow-up (45 days postpartum).

• State Trait Anxiety Symptoms

  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.

  Basal (15 weeks of gestation ). Post-Intervention (36 weeks of gestation). Follow-up (45 days postpartum).

• Fears and concerns related to pregnancy

  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.

  Basal (15 weeks of gestation ). Post-Intervention (36 weeks of gestation).

• Prenatal bonding and psychosocial adaptation to pregnancy

  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.

  Basal (15 weeks of gestation ). Post-Intervention (36 weeks of gestation).

• Parental self-efficacy

  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.

  Follow-up (45 days postpartum).

• Parental stress

  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.

  Follow-up (45 days postpartum).

Secondary Outcomes (4)

• Healthy lifestyle habits

  Basal (15 weeks of gestation ). Post-Intervention (36 weeks of gestation).

• Lenght of pregnancy

  Follow-up (10 days postpartum).

• Type of birth

  Follow-up (10 days postpartum).

• Infant Birth Weight

  Follow-up (10 days postpartum).

Study Arms (2)

Control Group

NO INTERVENTION

Participants in the control group will receive routine prenatal care as provided in the Spanish healthcare system. Standard care includes regular obstetric and midwifery follow-ups, screening for emotional distress during pregnancy, and referral to a mental health professional when clinically relevant symptoms of emotional disorders are detected. Emotional screening is integrated into prenatal visits to identify potential depressive, anxious, or other psychological symptoms, ensuring appropriate psychological or psychiatric support when necessary. This group will not receive the digital intervention and will serve as a comparator to evaluate the added benefits of the experimental intervention.

Experimental group

EXPERIMENTAL

Participants in the experimental group will receive the same standard prenatal care as the control group, including routine emotional screening and referrals if necessary. Additionally, they will have access to a biopsychosocial, cognitive-behavioral digital intervention designed to promote gestational well-being and prevent emotional disorders during pregnancy. This intervention, delivered via a smartphone application, incorporates psychoeducation, cognitive restructuring, stress management techniques, progressive muscle relaxation, mindfulness, and guided visualization. It is structured into 10 interactive modules covering mental health promotion, prenatal attachment, childbirth preparation, and postpartum adaptation, aiming to enhance self-efficacy, emotional regulation, and maternal psychological resilience.

Other: Biopsychosocial Cognitive Behavioral Intervention

Interventions

Biopsychosocial Cognitive Behavioral Intervention OTHER

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.

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: This study is open to cisgender women who are pregnant. Eligibility is restricted to individuals who self-identify as women and were assigned female at birth. Participants must be pregnant at the time of enrollment. The study does not include transgender, non-binary, or other gender identities outside of cisgender women.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women
• Pregnancy of less than 15 weeks of gestation
• More than 18 years old age
• Able to read, write, and understand Spanish
• In possession of a smartphone
• Able to manage smartphone apps
• Have signed a written informed consent document

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Rovira i Virgili: lead

Study Sites (1)

Centre d'Atenció Primària Sant Pere

Reus, Tarragona, 43202, Spain

RECRUITING

Related Publications (1)

• Hernandez-Martinez C, Canals-Sans J, Patricio D, Sombrero I, Ruiz F, Rey-Renones C. Effectiveness of an online biopsychosocial cognitive-behavioural preventive intervention to improve wellbeing and mental health during pregnancy. Randomized controlled trial (BienGestar). BMC Pregnancy Childbirth. 2025 Dec 13. doi: 10.1186/s12884-025-08557-1. Online ahead of print.

  PMID: 41390643 DERIVED

MeSH Terms

Conditions

Depression, Postpartum; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Carmen Hernández Martínez, Doctor

  University Rovira i Virgili

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carmen Hernández Martínez, Doctor

CONTACT

+34675245881; carmen.hernandez@urv.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: March 11, 2025
• Study Start: April 3, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)