Psychoeducation for Major Depressive Disorder: Development and Evaluation of Effectiveness

Status: Recruiting
Location: See location...
Intervention Type: Drug, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 59
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Brazil
Institute of Psychiatry - Faculty of Medicine from University of Sao Paulo
RECRUITING
São Paulo
Contact Information
Primary
Ricardo A Moreno
ricardo.moreno@hc.fm.usp.br
55-2661-6648
Time Frame
Start Date: 2024-03-01
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 338
Treatments
Experimental: Clinical Group
Participants will receive treatment as usual (TAU) associated with the psychoeducational program.
Active_comparator: Control Group
The usual treatment will consist of outpatient follow-up for a period of twelve months.
Related Therapeutic Areas
Sponsors
Leads: Ricardo Alberto Moreno, M.D., Ph.D.

This content was sourced from clinicaltrials.gov

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