Online group therapy for mothers of babies with congenital heart disease
Online Group Therapy to Improve Depression, Anxiety and Psychological Well-being in Mothers of Babies With Congenital Heart Disease
This study is testing whether online group therapy can help mothers of babies with congenital heart disease feel less anxious and depressed.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Instituto de Cardiologia do Rio Grande do Sul Academic / other |
| Locations | 1 site (Porto Alegre, Rio Grande Do Sul) |
| Trial ID | NCT05956249 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of online group therapy in improving depressive symptoms, anxiety, and psychological well-being among mothers of babies diagnosed with congenital heart disease. It is a randomized, parallel clinical trial involving 72 participants who will be assigned to either an intervention group receiving therapy or a control group. The study utilizes validated instruments such as the BECK-II, BAI, and Ryff's Psychological Well-Being Scale to assess outcomes before and after the intervention. Randomization will be conducted using a web-based tool to ensure unbiased group allocation.
Who should consider this trial
Good fit: Ideal candidates for this study are mothers aged 18 and older of babies with congenital heart disease who are receiving care at a cardiac hospital.
Not a fit: Patients who may not benefit from this study include mothers unable to complete the questionnaires or those whose children are over two years old.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance the mental health and overall well-being of mothers facing the challenges of caring for infants with congenital heart disease.
How similar studies have performed: Other studies have shown success with online group therapy approaches for mental health support, indicating potential for positive outcomes in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Mothers of babies with congenital heart disease, over 18 years of age, assisted at the outpatient clinic or during their child's hospitalization in the pediatric hospitalization or Pediatric ICU of a cardiac hospital who agree to participate and sign the Informed Consent Form. Exclusion Criteria: * Mothers unable to answer the questionnaires at the time of application. * Mothers who do not wish to continue answering the survey. * Mothers of children over two years old.
Where this trial is running
Porto Alegre, Rio Grande Do Sul
- Marcia Moura Schmidt — Porto Alegre, Rio Grande Do Sul, Brazil (Recruiting)
Study contacts
- Principal investigator: Marcia M Schmidt — Institute of Cardiology of Rio Grande do Sul
- Study coordinator: Marcia M Schmidt
- Email: mouramarcia050@gmail.com
- Phone: 555132303600
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.