Online Cognitive Behavioral Groupherapy for Mothers of Babies With Congenital Heart Disease

NCT05956249 | Completed DMC

• 1 other identifier: UP 6014/22
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Mothers of babies with congenital heart disease tend to have higher levels of depression, stress and anxiety. Currently, psychological support group technology has been a resource increasingly used by health professionals, with a therapeutic objective as an instrument to promote care. Objective: The aim of this study is to evaluate the effectiveness of a group intervention in improving depression, anxiety and the psychological well-being of mothers of babies with congenital heart disease. Methods: Randomized, parallel clinical trial, in which the factor under study will be online group therapy and the outcome the level of depressive symptoms, anxiety and psychological well-being, assessed using the instruments: BECK-II, BAI and Wellness Scale Ryff's psychological well-being at the beginning and after the intervention. The fellow who will reapply the instruments will be blinded to the groups. Patients will be randomized 1:1, with odd numbers assigned to treatment (online group therapy) and even numbers assigned to controls (no online group therapy). The intervention group will have 8 weekly group consultations, psychoeducational and focused on depression, anxiety and psychological well-being. The sample size was calculated at 36 individuals for each group. Data will be analyzed using the statistical program Statistical Package for Social Sciences (SPSS) version 27.0. For comparison between groups, Student's t test or Kruskall-Wallis or Chi-square test will be used. A two-tailed value of p≤ 0.05 will be considered significant. The normality of instrument scores will be evaluated using the Kolmogorov-Smirnov test. Covariance analysis will be performed to assess the influence of initial scores of anxiety, depression and well-being and their changes after intervention. The effect size will also be calculated. Expected results: It is expected to know and describe the population studied with regard to the level of depressive symptoms, anxiety and psychological well-being. In addition to seeking knowledge about the effectiveness of Group Therapy for these variables.

Conditions

Depressive Symptoms; Anxiety State; Psychological Well-Being

Keywords

Online group therapy; Depression; Anxiety; Well-being; Congenital heart disease

Outcome Measures

Primary Outcomes (2)

• Changes in Beck Depression Inventory scores

  Changes in the depression scores evaluation

  From baseline to 3 months

• Changes in Beck Anxiety Inventory scores

  Changes in the anxiety scores evaluation

  From baseline to 3 months

Secondary Outcomes (1)

• Changes in Ryff psychological well-being scale scores

  From baseline to 3 months

Study Arms (2)

Intervention Group: Online group therapy

EXPERIMENTAL

Online Cognitive Behavioral grouptherapy for the treatment of depression, anxiety and improvement of emotional well-being.The intervention will be carried out in 6 groups of 6 participants. All meetings will be weekly, in groups and will last an average of 1 hour. After the end of the intervention, a scientific initiation fellow will contact the study participants, from both groups, to reapply the scales.

Other: Online group therapy

Control Group: Without online group therapy

ACTIVE COMPARATOR

The control group will only receive the intervention after the reassessment of the scales by the scholarship holder, who is blind to the groups.

Other: Control Group

Interventions

Online group therapy OTHER

Online group therapy for the treatment of depression, anxiety and improvement of emotional well-being.The intervention will be carried out in 6 groups of 6 participants.

Intervention Group: Online group therapy

Control Group OTHER

Without intervention at the first moment, but the control group will receive the intervention after the reassessment of the scales by the scholarship holder was done.

Control Group: Without online group therapy

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto de Cardiologia do Rio Grande do Sul: lead

Study Sites (1)

Marcia Moura Schmidt

Porto Alegre, Rio Grande do Sul, 90620-000, Brazil

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Psychological Well-Being; Heart Defects, Congenital

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Personal Satisfaction; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• MARCIA M SCHMIDT

  Institute of Cardiology of Rio Grande do Sul

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinding will occur for the scientific initiation scholarship holder responsible for reassessing the scales.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2023
• First Posted: July 21, 2023
• Study Start: June 10, 2023
• Primary Completion: February 17, 2025
• Study Completion: February 18, 2025
• Last Updated: August 19, 2025

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)