Psychoeducational program for treating depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.