Psychoeducational Group for Depression
NCT Number: NCT06467474
Acronym: PEG-D
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Major Depressive Disorder (MDD
Interventions: BEHAVIORAL: PEG-D program|DRUG: TAU
Sponsor: Ricardo Alberto Moreno, M.D., Ph.D.
Sex: ALL
Age: ADULT
Enrollment: 338
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-03-01
Completion Date: 2026-12-01
Locations: Institute of Psychiatry - Faculty of Medicine from University of Sao Paulo, Sao Paulo, 05403903, Brazil

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

Primary Outcome Measures: Knowledge level, Learning quiz: Comprising of open and closed questions questions, it was designed to evaluate participants' level of knowledge regarding depression, Time: baseline, post 6 weeks and 12 months.|Depressive levels, Beck Depression Inventory-BDI-II. It consists of 21 items and measures the intensity of depression in the last 14 days. The instrument has 21 items, and the higher the score, the greater the intensity of depression., Baseline, post 6 weeks, 3, 6 and 12 months.
Secondary Outcome Measures: Depressive Thoughts, Depressive Thoughts Scale (EPD): The instrument has 26 items, divided into two factors, the first being low self-esteem/hopelessness, with 16 items referring to the subject's negative perception of themselves and their future perspectives and the second on functionality in relationships, with 10 items on the positive evaluation that the subject presents about their relationship with others and how they evaluate the support they receive., Baseline, post 6 weeks, 3, 6 and 12 months|Avoidance behaviors, Cognitive Behavioral Avoidance Scale (CBAS): The instrument assesses typical avoidance styles of depressed people and has 31 items, divided into four factors, namely: Behavioral/Social (8 items), Non-Social Behavioral (6 items), Social Cognitive (7 items) and Non-Social Cognitive ( 10 items)., Baseline, post 6 weeks, 3, 6 and 12 months.|Functionality, Global Functioning Ranting Scale (GAF): The GAF is a functioning assessment scale that ranges from 0 to 100, with higher scores indicative of higher levels of functioning. The Clinical Global Impression Scale (CGI) will also be used, a general summary measure determined by the physician that takes into account all available information, including knowledge of the patient's history and the impact of symptoms on the patient's functional capacity, with measures ranging from 1 (much better) to 7 (much worse)., Baseline, post 6 weeks, 3, 6 and 12 months.