NCT06467474Recruiting
Psychoeducational Group for Depression
Psychoeducation for Major Depressive Disorder: Development and Evaluation of Effectiveness
Source: ClinicalTrials.gov · Last updated 21 Jun 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The study aims to investigate the efficacy of a psychoeducational program as an adjunctive treatment for depression. The study will involve 338 patients diagnosed with Major Depressive Disorder (MDD) of moderate severity. Participants will be randomly assigned to receive either Treatment as usual (TAU) alone or TAU plus the psychoeducational program. The program consists of six weekly group sessions covering information and techniques for coping with depression. Primary outcomes include a reduction in depressive symptoms measured by the Beck Depression Inventory-II (BDI-II) and increased knowledge of depression. Secondary outcomes include improvements in functionality and quality of life. The study aims to provide insights into the effectiveness of psychoeducation in improving outcomes for individuals with depression
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 338 (estimated)
- First submitted
- 14 Jun 2024
- Start date
- 1 Mar 2024
- Primary completion date
- 1 Jun 2025
- Lead sponsor
- Ricardo Alberto Moreno, M.D., Ph.D.
- Diseases
- Depression
- NCT number
- NCT06467474
What you commit to
- Study type: Interventional
- Planned participants: 338
- From 1 Mar 2024 to the primary completion date, 1 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- Inclusion:
- Both sexes;
- Ages between 18 and 65 years old;
- Diagnosis of Major Depressive Disorder (MDD) made by a clinician according to Diagnostic Statistical Manual criteria-5-Text Revised (DSM-5-TR)
- Patients with Hamilton Depressive Rating Scale-17 items (HDRS-17) scores 14-23;
- Informed and signed consent form.
- Exclusion:
- Unstable serious clinical or neurological diseases;
- Postpartum depression or other types of depressive disorders (disruptive mood dysregulation disorder, pre-menstrual, substance/medication-induced depressive disorder, depressive disorder due to another medical condition, another disorder specified depressive disorder and unspecified depressive disorder);
- Other psychiatric disorders;
- Patients with active psychotic symptoms;
- Suicidality risks
- Patients already undergoing any other psychological treatment for MDD;
- Discontinuation:
- More than two absences during treatment;
- Those who miss more than two sessions/consultations, whether medical treatment or the psychoeducational program;
- Non-response to the use of Sertraline over the initial eight weeks; Presence of hypomanic symptoms at any time during treatment (Young \<7)
Age in the registry: 18 years to 59 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institute of Psychiatry - Faculty of Medicine from University of Sao Paulo Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.