IPT-based Group Intervention by Non-specialist for Improvement of Depressive Symptoms in Community Young Adults in Brazil

NCT06480019 | Recruiting DMC

• 1 other identifier: 2023-0283
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression; Interpersonal Relations

Outcome Measures

Primary Outcomes (1)

• Hospital Anxiety and Depression Scale (HADS)

  The Hospital Anxiety and Depression Scale consists of 14 items, of which 7 assess anxiety and 7 assess depression. Each item is scored from 0 to 3, and each subscale has a maximum score of 21 points with higher scores indicating greater symptom severity.

  Pre-treatment, Week 1 to 8

Secondary Outcomes (5)

• Patient Health Questionnaire-9

  Pre-treatment, Week 1 to 8

• Social support scale (MOS-SSS)

  Pre-treatment, Week 1 to 8

• Quality of Life (WHOQOL-BREF)

  Pre-treatment, Week 1 to 8

• Clinical Global Impression (CGI)

  Pre-treatment, Week 1 to 8

• Beck Depression Inventory (BDI)

  Pre-treatment; Week 1-8

Other Outcomes (6)

• Resilience (CD-RISC-10)

  Pre-treatment, Week 1 to 8

• Psychotherapy side effects (UE-ATR checklist)

  Week 1 to 8

• Childhood Trauma Questionnaire (CTQ)

  Week 1

Study Arms (2)

Intervention

OTHER

Participants that receive psychotherapy

Behavioral: Interpersonal psychotherapy

Waiting list

NO INTERVENTION

Participants that are waiting for intervention

Interventions

Interpersonal psychotherapy BEHAVIORAL

Interpersonal psychotherapy is a first-line treatment and can also be used for the prevention of depression.

Intervention

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Young adults (between 18 and 24 years old)
• Young adults who work, live or study in Porto Alegre
• PHQ ≥ 5 - without suicide ideation

You may not qualify if:

• Maniac or hypomanic episode
• Psychotic Syndrome
• Substance Abuse
• Suicide Risk or Ideation

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Clinical Hospital for Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

RECRUITING

MeSH Terms

Conditions

Depression

Interventions

Interpersonal Psychotherapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Neusa Sica da Rocha, PhD

CONTACT

55(51) 3359-8000; nrocha@hcpa.edu.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: June 28, 2024
• Study Start: March 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 13, 2026

Record last verified: 2025-10

Locations

BR (1)