Recruiting

Psychoeducational Group for Depression

ClinicalTrials.gov IDNCT06467474

PhaseNA

Enrollment338

SponsorRicardo Alberto Moreno, M.D., Ph.D.

Age18 Years

SexALL

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Conditions studied

Major Depressive Disorder (MDD

About this study

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

Interventions

Behavioral: PEG-D program — PEG-D will be carried out in person, open format, for six consecutive weeks lasting 90 minutes each. An approximate group of 6 to 10 participants will be led by a team of experienced psychologists and psychiatrists. Each group will have a main therapist and a co-therapist to ensure effective support and guidance for participants. Before the start of the group, participants received a booklet containing the content of the sessions.
Drug: TAU — The treatment will start with Sertraline (SSRI) - doses of 50 mg and adjusting as necessary according to the patient\'s profile. After 8 weeks, if the patient experiences remission, they will continue on monotherapy with Sertraline. In case of relapse Bupropion, Quetiapine, Lithium or Aripiprazole might be add-on. In this case, add-on medications will be determined according to the patient profile, by the clinician. If there is a response above 25% of the symptoms, but without remission, the patient will proceed to augmentation with the aforementioned medications and if there is no improvement of at least 25%, the patient will be considered drop-out. Associations with Lorazepam if necessary will be allowed in any phase of the study.

Primary outcomes

Knowledge level (Time: baseline, post 6 weeks and 12 months.)
Depressive levels (Baseline, post 6 weeks, 3, 6 and 12 months.)

Eligibility information

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)

Study locations

Institute of Psychiatry - Faculty of Medicine from University of Sao Paulo, São Paulo, 05403903 Brazil

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.