Online Group Therapy for Mothers of Babies With Congenital Heart Disease

Sponsor

Instituto de Cardiologia do Rio Grande do Sul (Other)

Overall Status

Recruiting

CT.gov ID

NCT05956249

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Depressive Symptoms Anxiety State Psychological Well-Being	Other: Online group therapy Other: Control Group	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

Blinding will occur for the scientific initiation scholarship holder responsible for reassessing the scales.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 10, 2023

Anticipated Primary Completion Date :

Nov 10, 2023

Anticipated Study Completion Date :

May 10, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Group: 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. 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.
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.

Arm

Intervention/Treatment

Experimental: Intervention Group: 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. 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.

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.

Outcome Measures

Primary Outcome Measures

Changes in Beck Depression Inventory scores [From baseline to 3 months]
Changes in the depression scores evaluation
Changes in Beck Anxiety Inventory scores [From baseline to 3 months]
Changes in the anxiety scores evaluation

Secondary Outcome Measures

Changes in Ryff psychological well-being scale scores [From baseline to 3 months]
Changes in the well-being scales

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.