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Online Group Therapy for Mothers of Babies With Congenital Heart Disease

Primary Purpose

Depressive Symptoms, Anxiety State, Psychological Well-Being

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Online group therapy
Control Group
Sponsored by
Instituto de Cardiologia do Rio Grande do Sul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Symptoms focused on measuring Online group therapy, Depression, Anxiety, Well-being, Congenital heart disease

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept 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. 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.

Sites / Locations

  • Marcia Moura SchmidtRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention Group: Online group therapy

Control Group: Without online group therapy

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Changes in Beck Depression Inventory scores
Changes in the depression scores evaluation
Changes in Beck Anxiety Inventory scores
Changes in the anxiety scores evaluation

Secondary Outcome Measures

Changes in Ryff psychological well-being scale scores
Changes in the well-being scales

Full Information

First Posted
June 28, 2023
Last Updated
July 13, 2023
Sponsor
Instituto de Cardiologia do Rio Grande do Sul
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1. Study Identification

Unique Protocol Identification Number
NCT05956249
Brief Title
Online Group Therapy for Mothers of Babies With Congenital Heart Disease
Official Title
Online Group Therapy to Improve Depression, Anxiety and Psychological Well-being in Mothers of Babies With Congenital Heart Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 10, 2023 (Actual)
Primary Completion Date
November 10, 2023 (Anticipated)
Study Completion Date
May 10, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Cardiologia do Rio Grande do Sul

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Symptoms, Anxiety State, Psychological Well-Being
Keywords
Online group therapy, Depression, Anxiety, Well-being, Congenital heart disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Blinding will occur for the scientific initiation scholarship holder responsible for reassessing the scales.
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group: Online group therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group: Without online group therapy
Arm Type
Active Comparator
Arm Description
The control group will only receive the intervention after the reassessment of the scales by the scholarship holder, who is blind to the groups.
Intervention Type
Other
Intervention Name(s)
Online group therapy
Intervention Description
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 Type
Other
Intervention Name(s)
Control Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in Beck Depression Inventory scores
Description
Changes in the depression scores evaluation
Time Frame
From baseline to 3 months
Title
Changes in Beck Anxiety Inventory scores
Description
Changes in the anxiety scores evaluation
Time Frame
From baseline to 3 months
Secondary Outcome Measure Information:
Title
Changes in Ryff psychological well-being scale scores
Description
Changes in the well-being scales
Time Frame
From baseline to 3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
MARCIA M SCHMIDT
Phone
555132303600
Ext
4127
Email
mouramarcia050@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Unidade de Pesquisa
Phone
555132303600
Ext
4161
Email
editoracao-up@cardiologia.org.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MARCIA M SCHMIDT
Organizational Affiliation
Institute of Cardiology of Rio Grande do Sul
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marcia Moura Schmidt
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90620-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcia M Schmidt, PhD
Phone
555192289840
Email
mouramarcia050@gmail.com
First Name & Middle Initial & Last Name & Degree
Fernanda Poester
Phone
555132303600
Ext
4133
Email
editoracao-pc@cardiologia.org.br

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Online Group Therapy for Mothers of Babies With Congenital Heart Disease

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