Online Group Therapy for Mothers of Babies With Congenital Heart Disease

Depressive Symptoms Clinical Trial

Official title:

Online Group Therapy to Improve Depression, Anxiety and Psychological Well-being in Mothers of Babies With Congenital Heart Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05956249
• Other study ID #: UP 6014/22
• Status: Recruiting
• Phase: N/A
• Start date: May 10, 2023
• Est. completion date: May 10, 2024

Study information

• Verified date: June 2023
• Source: Instituto de Cardiologia do Rio Grande do Sul
• Contact: MARCIA M SCHMIDT
• Phone: 555132303600
• Email: mouramarcia050[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: May 10, 2024
• Est. primary completion date: November 10, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety State
• Depression
• Depressive Symptoms
• Heart Defects, Congenital
• Heart Diseases
• Psychological Well-Being

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Marcia Moura Schmidt	Porto Alegre	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Cardiologia do Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Beck Depression Inventory scores	Changes in the depression scores evaluation	From baseline to 3 months
Primary	Changes in Beck Anxiety Inventory scores	Changes in the anxiety scores evaluation	From baseline to 3 months
Secondary	Changes in Ryff psychological well-being scale scores	Changes in the well-being scales	From baseline to 3 months