Psychoeducational program for treating depression
Psychoeducation for Major Depressive Disorder: Development and Evaluation of Effectiveness
This study tests if adding a six-week group program that teaches coping strategies can help people with Major Depressive Disorder feel better and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 338 (estimated) |
| Ages | 18 Years to 59 Years |
| Sex | All |
| Sponsor | University of Sao Paulo Academic / other |
| Locations | 1 site (São Paulo) |
| Trial ID | NCT06467474 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of a psychoeducational program as an additional treatment for individuals with Major Depressive Disorder (MDD). It involves 338 participants who will be randomly assigned to receive either standard treatment or standard treatment plus the psychoeducational program, which consists of six weekly group sessions focused on coping strategies for depression. The primary outcomes measured will include reductions in depressive symptoms and increased knowledge about depression, while secondary outcomes will assess improvements in functionality and quality of life. The goal is to determine if psychoeducation can enhance treatment outcomes for those suffering from depression.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 65 diagnosed with moderate Major Depressive Disorder.
Not a fit: Patients with other psychiatric disorders, severe clinical conditions, or those currently receiving other psychological treatments for depression may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide patients with valuable coping strategies and improve their overall mental health outcomes.
How similar studies have performed: Previous studies have shown that psychoeducational interventions can be effective in managing depression, suggesting a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
São Paulo
- Institute of Psychiatry - Faculty of Medicine from University of Sao Paulo — São Paulo, Brazil (Recruiting)
Study contacts
- Study coordinator: Ricardo A Moreno
- Email: ricardo.moreno@hc.fm.usp.br
- Phone: 55-2661-6648
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.