IPT-based Group Intervention by Non-specialist for Improvement of Depressive Symptoms in Community Young Adults in Brazil
NCT Number: NCT06480019
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Depression|Interpersonal Relations
Interventions: BEHAVIORAL: Interpersonal psychotherapy
Sponsor: Hospital de Clinicas de Porto Alegre
Sex: ALL
Age: ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-03-01
Completion Date: 2028-12-31
Locations: Clinical Hospital for Porto Alegre, Porto Alegre, RS, 90035-903, Brazil

Summary:
Major depressive disorder is a highly prevalent, recurrent, and debilitating disease, the third cause of years of lost life in the world, and it may be the most common disease in 2030, according to the World Health Organization (WHO). Furthermore, it's also related to decreased quality of life and high mortality. Interpersonal psychotherapy (IPT) is a first-line treatment and can also be used for the prevention of depression.

This randomized controlled clinical trial is planned to have 50 participants randomized between an interventional and a control group (waiting list). Our study covers young adults (18 to 24 years old) with depression. Participants will be invited by social media to undergo treatment in an IPT group. The intervention group will be separated into groups with up to 10 participants, with a weekly meeting for eight weeks. The intervention will focus on interpersonal relationships within the model of IPT and will be held by a university student and a doctor trained in IPT.

Primary Outcome Measures: Patient Health Questionnaire-9, It measures depressive symptoms in the last 2 weeks, Pre-treatment, Week 1 to 8|Quality of Life (WHOQOL-BREF), It measures quality of life through physical, psychological, social relationships and the environment., Pre-treatment, Week 1 to 8|Hospital Anxiety and Depression Scale (HADS), It recognizes symptoms related to anxiety and depression., Pre-treatment, Week 1 to 8|Self-Reporting Questionnaire (SRQ-20), It measures the level of suspicion of mental disorders., Pre-treatment, Week 1 to 8|Social support scale (MOS-SSS), It measures an individual's perception of social support., Pre-treatment, Week 1 to 8|Attachment (RSQ), It assesses attachment through 30 declarative statements that express feelings and thoughts related to close relationships with people., Week 1 and 8
Secondary Outcome Measures: General Health Questionnaire (GHQ-12), It aims to assess the individual's general health., Pre-treatment, Week 1 to 8|Resilience (CD-RISC-10), It measures the capacity or ability of individuals to deal with and adapt, physically, mentally and spiritually, to the circumstances imposed by life (resilience)., Pre-treatment, Week 1 to 8|Clinical Global Impression (CGI), It scores the overall severity of the disease, the change in the clinical picture over time and the effectiveness of the intervention used., Pre-treatment, Week 1 to 8|Psychotherapy side effects (UE-ATR checklist), It allows finding, classifying and discriminating between undesirable effects, adverse reactions to treatment and side effects of psychotherapy, based on the assessment of possible domains of unwanted effects in severity and relationship with the treatment., Week 1 to 8|Childhood Trauma Questionnaire (CTQ), It evaluates situations of trauma/abuse in childhood using 28 items., Week 1|Life Stressful Events Questionnaire, It assesses through closed questions, with dichotomous answers (yes vs. no), covering stressful life events., Week 1 to 8