Depressive SymptomsNCT05956249
Online Cognitive Behavioral Groupherapy for Mothers of Babies With Congenital Heart Disease
A study testing Online group therapy in people with Depressive Symptoms and Anxiety State, run by Instituto de Cardiologia do Rio Grande do Sul at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Depressive Symptoms, Anxiety State, Psychological Well-Being
- What is being tested?
- Online group therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Jun 2023to 18 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Depressive Symptoms, Anxiety State, Psychological Well-Being
- Being tested
- Online group therapy, Control Group
- Keywords
- Online group therapy, Depression, Anxiety, Well-being, Congenital heart disease
- Medical subject headings
- Depression, Anxiety Disorders, Psychological Well-Being, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online group therapyOther
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 GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Beck Depression Inventory scores
Changes in the depression scores evaluation
Measured: From baseline to 3 months
Changes in Beck Anxiety Inventory scores
Changes in the anxiety scores evaluation
Measured: From baseline to 3 months
Secondary outcomes (1)
Changes in Ryff psychological well-being scale scores
Changes in the well-being scales
Measured: From baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start10 Jun 2023
- Primary completion17 Feb 2025
- Study completion18 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MARCIA M SCHMIDT, Principal investigator, Institute of Cardiology of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05956249
- Sponsor's protocol ID
- UP 6014/22
- Status last verified
- Jun 2023
- First submitted
- 28 Jun 2023
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Cognitive Behavioral Grouptherapy to Improve Depression, Anxiety and Psychological Well-being in Mothers of Babies With Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT05956249
- Acronym / sponsor ID
- UP 6014/22
- Conditions
- Depressive Symptoms, Anxiety State, Psychological Well-Being
- Keywords
- Online group therapy, Depression, Anxiety, Well-being, Congenital heart disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do SulUniversity, hospital or other
- Study start
- 10 Jun 2023 (actual)
- Primary completion
- 17 Feb 2025 (actual)
- Study completion
- 18 Feb 2025 (actual)
- First posted
- 21 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group: Online group therapy | Experimental | Other: Online group therapyOnline 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. |
| Control Group: Without online group therapy | Active comparator | Other: Control GroupThe control group will only receive the intervention after the reassessment of the scales by the scholarship holder, who is blind to the groups. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online group therapyOnline 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. | Other | Intervention Group: Online group therapy |
| Control GroupWithout 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. | Other | Control Group: Without online group therapy |
Primary outcome
Changes in Beck Depression Inventory scores
Time frame: From baseline to 3 months
Changes in the depression scores evaluation
Changes in Beck Anxiety Inventory scores
Time frame: From baseline to 3 months
Changes in the anxiety scores evaluation
1 secondary outcome
Changes in Ryff psychological well-being scale scores
Time frame: From baseline to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MARCIA M SCHMIDT principal investigator
Institute of Cardiology of Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online group therapy in people with Depressive Symptoms and Anxiety State, run by Instituto de Cardiologia do Rio Grande do Sul at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Beck Depression Inventory scores (time frame: From baseline to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.