Actively Recruiting

Phase Not Applicable
Age: 18Years - 59Years
All Genders
NCT06467474

Psychoeducational Group for Depression

Led by Ricardo Alberto Moreno, M.D., Ph.D. · Updated on 2024-06-21

338

Participants Needed

1

Research Sites

143 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Psychoeducational Group for Depression

Who Can Participate

Age: 18Years - 59Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Both sexes
  • Ages between 18 and 65 years old
  • Diagnosis of Major Depressive Disorder made by a clinician according to DSM-5-TR criteria
  • Hamilton Depressive Rating Scale-17 items scores between 14 and 23
  • Signed informed consent form
Not Eligible

You will not qualify if you...

  • Unstable serious clinical or neurological diseases
  • Postpartum depression or other specified types of depressive disorders
  • Other psychiatric disorders
  • Active psychotic symptoms
  • Risk of suicidality
  • Currently undergoing any other psychological treatment for Major Depressive Disorder
  • More than two absences during treatment sessions
  • Missing more than two sessions or consultations
  • Non-response to Sertraline after eight weeks
  • Presence of hypomanic symptoms during treatment (Young score less than 7)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Institute of Psychiatry - Faculty of Medicine from University of Sao Paulo

São Paulo, Brazil, 05403903

Actively Recruiting

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Research Team

R

Ricardo A Moreno

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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Psychoeducational Group for Depression | DecenTrialz