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
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.
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02909387 -
Adapting Project UPLIFT for Blacks in Georgia
|
N/A | |
Completed |
NCT05702086 -
Making SPARX Fly in Nunavut: Pilot Testing an E-intervention for Boosting Resilience Against Youth Depression
|
N/A | |
Terminated |
NCT04921332 -
Bright Light Therapy for Depression Symptoms in Adults With Cystic Fibrosis (CF) and COPD
|
N/A | |
Completed |
NCT03535805 -
Transdiagnostic, Cognitive and Behavioral Intervention for in School-aged Children With Emotional and Behavioral Disturbances
|
N/A | |
Recruiting |
NCT06100146 -
Effectiveness of Fortification With Folic Acid and Vitamin B12 Among Teenage Girls
|
N/A | |
Recruiting |
NCT03272230 -
Assessment of Apathy in a Real-life Situation, With a Video and Sensors-based System
|
N/A | |
Completed |
NCT03514355 -
MBSR in Rheumatoid Arthritis Patients With Controlled Disease But Persistent Depressive Symptoms
|
N/A | |
Completed |
NCT05376397 -
Testing THRIVE 365 for Black Sexual Minority Men (On The Daily)
|
N/A | |
Terminated |
NCT04367636 -
The Effects of Attention Training on Emotion Regulation and Stress Related Complaints During COVID-19
|
N/A | |
Completed |
NCT04403126 -
To Increase Psychological Well-being by the Implementation of Forgiveness Education
|
N/A | |
Recruiting |
NCT05078424 -
Cognitive Behavioural Therapy for Youths With Depressive and Anxiety Symptoms in Hong Kong
|
N/A | |
Recruiting |
NCT06053775 -
Non-Invasive Brain Stimulation and Cognitive Training for Depressive Symptomatology Related to Breast Cancer (ONCODEP)
|
N/A | |
Active, not recruiting |
NCT04084795 -
Augmentation of EMDR With tDCS in the Treatment of Fibromyalgia
|
N/A | |
Recruiting |
NCT04082052 -
Evaluating and Predicting Response to a Single Session Intervention for Self-Dislike
|
N/A | |
Completed |
NCT04011540 -
Digital Data in Mental Health Therapy
|
N/A | |
Not yet recruiting |
NCT06413849 -
Telephone-coached "Graphic Narrative" Bibliotherapy for Dementia Caregivers
|
N/A | |
Not yet recruiting |
NCT03659591 -
Triple Aim Psychotherapy: Aimed at Improving Patient Experience, Population Health, and Cost
|
N/A | |
Not yet recruiting |
NCT02133170 -
"Mindfulness vs Psychoeducation in Bipolar Disorder"
|
N/A | |
Completed |
NCT02314390 -
Group- Versus Individual-Mindfulness-Based Cognitive Therapy: a Randomized Trial
|
N/A | |
Completed |
NCT01628016 -
The Effect of Attention Bias Modification Training on Reducing Depressive Symptoms
|
N/A |