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

Online Cognitive Behavioral Grouptherapy to Improve Depression, Anxiety and Psychological Well-being in Mothers of Babies With Congenital Heart Disease

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.

Study Overview

• Status: Completed
• Conditions: Depressive Symptoms; Anxiety State; Psychological Well-Being
• Intervention / Treatment: Other: Online group therapy; Other: Control Group

Detailed Description

Design: Randomized, parallel clinical trial, with blinding for the application and evaluation of the instruments.

Participants: 72 mothers (≥ or equal to 18 years old) of babies with congenital heart disease will be included.

Procedures: Patients will be invited to participate in the study on the day of the outpatient consultation or during their children's hospitalization. All participants who agree to participate in the research will respond to the following instruments: BAI, BDI-II and Ryff Psychological Well-Being Scale.

Randomization envelopes will be opened during the interview. Patients in the control group will be informed that they will receive care after the second evaluation.

Patients will be randomized 1:1 according to the order of interviews. Odd numbers assigned to treatment (intervention group therapy) and even numbers assigned to controls. The randomization sequence was generated by the website www.random.org and can be found here: https://www.random.org/sequences/?min=1&max=50&col=1&format=html&rnd=new. Sealed and sequentially numbered envelopes will be made in the order of randomization.

From the randomization, the participants will be allocated to the intervention group (GI) or control group (CG). The intervention will be carried out in 6 groups of 6 participants.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90620-000
      • Marcia Moura Schmidt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group: Without online group therapy; 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; 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.
Experimental: Intervention Group: Online group therapy; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Ryff psychological well-being scale scores	Changes in the well-being scales	From baseline to 3 months

Collaborators and Investigators

• Sponsor: Instituto de Cardiologia do Rio Grande do Sul
• Investigators: Principal Investigator: MARCIA M SCHMIDT, Institute of Cardiology of Rio Grande do Sul

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2023
• Primary Completion (Actual): February 17, 2025
• Study Completion (Actual): February 18, 2025

Study Registration Dates

• First Submitted: June 28, 2023
• First Submitted That Met QC Criteria: July 13, 2023
• First Posted (Actual): July 21, 2023

Study Record Updates

• Last Update Posted (Actual): August 19, 2025
• Last Update Submitted That Met QC Criteria: August 14, 2025
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Depression; Anxiety; Well-being; Congenital heart disease; Online group therapy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Behavioral Symptoms; Congenital Abnormalities; Cardiovascular Abnormalities; Depression; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: UP 6014/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No