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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinical Group | Experimental | Participants will receive treatment as usual (TAU) associated with the psychoeducational program. |
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| Control Group | Active Comparator | The usual treatment will consist of outpatient follow-up for a period of twelve months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEG-D program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion:
Exclusion:
Discontinuation:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ricardo A Moreno | Contact | 55-2661-6648 | ricardo.moreno@hc.fm.usp.br |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Psychiatry - Faculty of Medicine from University of Sao Paulo | Recruiting | São Paulo | 05403903 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40779501 | Derived | Carneiro AM, Silva SLT, Fernandes FDS, Barretto JR, de Brito TR, Moreno LH, Pimentel FC, Jorge BA, Dos Santos LA, Fernandes Ramos MR, Moreno RA. Psychoeducation Group for Depression (PEG-D): Study protocol for a prospective, randomized, single-blind, crossover trial. PLoS One. 2025 Aug 8;20(8):e0329006. doi: 10.1371/journal.pone.0329006. eCollection 2025. |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| TAU | Drug | 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. |
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| 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. |