Psychoeducation Group for Depression (PEG-D): Study protocol for a prospective, randomized, single-blind, crossover trial.
Adriana Munhoz Carneiro, Sara Lisboa Teodoro Silva, Fernando Dos Santos Fernandes...
https://pubmed.ncbi.nlm.nih.gov/40779501/Actively Recruiting
Led by Ricardo Alberto Moreno, M.D., Ph.D. · Updated on 2024-06-21
338
Participants Needed
1
Research Sites
78 weeks
Total Duration
Researchers are evaluating a psychoeducational program as an additional treatment for adults with moderate Major Depressive Disorder MDD. The study involves 338 patients diagnosed with MDD, comparing standard care alone to standard care plus a six-week group psychoeducation program. The goal is to assess whether this program can reduce depressive symptoms and improve knowledge about depression, functionality, and quality of life. Participants are randomly assigned to either receive treatment as usual TAU alone or TAU combined with the psychoeducational program. The psychoeducation consists of six weekly group sessions, each lasting 90 minutes and led by experienced psychologists and psychiatrists. Before starting, participants receive a booklet outlining the session content. TAU includes medication with Sertraline starting at 50 mg, adjusted as needed, with possible add-on medications if symptoms persist or relapse. The usual treatment follows outpatient care for 12 months. During the study, participants will be assessed at multiple time points including baseline, post-treatment at 6 weeks, and follow-ups at 3, 6, and 12 months. Measurements include depressive symptom levels using the Beck Depression Inventory-II, knowledge about depression, depressive thoughts, avoidance behaviors, and functionality. Attendance will be monitored, and participants missing more than two sessions may be discontinued. The study aims to provide a comprehensive understanding of how psychoeducation may support depression treatment over one year.
CONDITIONS
Psychoeducational Group for Depression
R
Ricardo A Moreno
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Ricardo Alberto Moreno, M.D., Ph.D.
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants receive the PEG-D psychoeducational group program in addition to treatment as usual, which includes medication management and outpatient follow-up.
Weekly group sessions lasting 90 minutes each
Duration - Up to 12 months
Participants continue outpatient follow-up with usual treatment and are monitored for depressive symptoms and other outcomes.
Assessments at 3, 6, and 12 months post-treatment
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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Adriana Munhoz Carneiro, Sara Lisboa Teodoro Silva, Fernando Dos Santos Fernandes...
https://pubmed.ncbi.nlm.nih.gov/40779501/Ricardo Alberto Moreno, M.D., Ph.D.
Lead Sponsor