NCT Number: NCT06467474
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
Interested in participating?
Request Info18 year–59 year
All sexes
Interventional
Not applicable
São Paulo, 05403903, Brazil
Location status: Recruiting
Adriana Carneiro AM Adriana Carneiro, DsC.
CONTACT
Adriana M. Carneiro, DsC
PRINCIPAL_INVESTIGATOR
Institute of Psychiatry IPqFMUSP Moreno, RA, PhD
CONTACT
Sara L. T. Silva
SUB_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion:
Exclusion:
Discontinuation:
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.
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.
Time frame: Time: baseline, post 6 weeks and 12 months.
Learning quiz: Comprising of open and closed questions questions, it was designed to evaluate participants' level of knowledge regarding depression
Time frame: Baseline, post 6 weeks, 3, 6 and 12 months.
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.
Time frame: Baseline, post 6 weeks, 3, 6 and 12 months
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.
Time frame: Baseline, post 6 weeks, 3, 6 and 12 months.
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).
Time frame: Baseline, post 6 weeks, 3, 6 and 12 months.
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).
Contact information is provided by the study sponsor or research team.
Ricardo Alberto Moreno, M.D., Ph.D.
Other
Psychoeducation for Major Depressive Disorder: Development and Evaluation of Effectiveness
Acronym: PEG-D
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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