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

IPT-based Group Intervention by Non-specialist for Improvement of Depressive Symptoms in Community Young Adults in Brazil: a Randomized Clinical Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Depression; Interpersonal Relations
• Intervention / Treatment: Behavioral: Interpersonal psychotherapy

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Neusa Sica da Rocha, PhD; Phone Number: 55(51) 3359-8000; Email: nrocha@hcpa.edu.br

Study Locations

• Brazil
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
      • Recruiting
      • Clinical Hospital for Porto Alegre
      • Contact: Neusa Sica da Rocha, PhD; Phone Number: (5551) 3359-8000; Email: nrocha@hcpa.edu.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Intervention; Participants that receive psychotherapy	Behavioral: Interpersonal psychotherapy; Interpersonal psychotherapy is a first-line treatment and can also be used for the prevention of depression.
No Intervention: Waiting list; Participants that are waiting for intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire-9	The PHQ-9 is a self-administered instrument that quantitatively assesses the severity of depressive symptoms over the past two weeks. It consists of nine items corresponding to the diagnostic criteria for major depressive disorder in the DSM-IV. Each item is scored on a 4-point Likert scale (0 = not at all to 3 = nearly every day), resulting in a score ranging from 0 to 27.	Pre-treatment, Week 1 to 8
Social support scale (MOS-SSS)	The Medical Outcomes Study Social Support Survey (MOS-SSS) measures each individual's perceptions of personal support. The scale comprises five support factors (emotional, informational, material, affective, and positive social interaction). Higher scores indicate greater perceived support.	Pre-treatment, Week 1 to 8
Quality of Life (WHOQOL-BREF)	The WHOQOL-BREF is a scale with 26 items that measure quality of life. It includes two general items and 24 items representing four domains (physical, psychological, social relationships, and environmental).	Pre-treatment, Week 1 to 8
Clinical Global Impression (CGI)	The Clinical Global Impressions (CGI) scale is an instrument that enables clinicians to assess the overall severity of the illness, the change in clinical status over time, and the effectiveness of the intervention used. Its score can range from 1 (not ill) to 7 (extremely ill).	Pre-treatment, Week 1 to 8
Beck Depression Inventory (BDI)	It's a self-report instrument and assesses the presence and severity of depressive symptoms. It consists of 21 items describing cognitive, affective, and somatic manifestations of depression. Each item is scored in a Likert scale ranging from 0 to 3, varying from 0 to 63 points	Pre-treatment; Week 1-8

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Life Stressful Events Questionnaire	It assesses through closed questions, with dichotomous answers (yes vs. no), covering stressful life events.	Week 1 to 8
Resilience (CD-RISC-10)	The 10-item Connor-Davidson Resilience Scale (CD-RISC-10) is an abbreviated version of the original 25-item scale. It measures the capacity to adapt physically, mentally, and spiritually to the circumstances imposed by life. The 10 items are scored from 0 to 4, yielding a total score from 0 to 40. Higher scores indicate higher levels of resilience.	Pre-treatment, Week 1 to 8
Childhood Trauma Questionnaire (CTQ)	The Childhood Trauma Questionnaire is a retrospective self-report instrument designed to assess experiences of childhood abuse and neglect. It consists of 28 items scored on a 5-point Likert scale, measuring five domains of maltreatment: emotional abuse, physical abuse, sexual abuse, emotional neglect, and physical neglect.	Week 1
Attachment (RSQ)	The Relationship Scales Questionnaire (RSQ) assesses attachment styles in interpersonal relationships. It consists of 30 items describing thoughts and feelings in close relationships. Respondents rate their agreement with each item on a 5-point Likert scale. It assesses attachment through 30 declarative statements that express feelings and thoughts related to close relationships with people.	Week 1 and 8
Eysenck Personality Questionnaire-Revised (EPQR-A)	It is a self-administered questionnaire composed of 24 items divided into four domains: the three dimensions of personality (neuroticism, extraversion, and psychoticism) and a validity scale (social desirability).	Pre-treatment; Week 1-8

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: June 24, 2024
• First Submitted That Met QC Criteria: June 24, 2024
• First Posted (Actual): June 28, 2024

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Behavior; Depression; Psychotherapy; Behavioral Disciplines and Activities; Interpersonal Psychotherapy
• Other Study ID Numbers: 2023-0283

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No