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NCT Number: NCT06480019

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

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.

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Key information

Age range

18 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Hospital for Porto Alegre

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

Location status: Recruiting

Location contact

Neusa Sica da Rocha, PhD

CONTACT

[email protected]

(5551) 3359-8000

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

interpersonal psychotherapy

Behavioral

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

Primary outcomes

  1. Hospital Anxiety and Depression Scale (HADS)

    Time frame: Pre-treatment, Week 1 to 8

    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.

Secondary outcomes

  1. Patient Health Questionnaire-9

    Time frame: Pre-treatment, Week 1 to 8

    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.

  2. Social support scale (MOS-SSS)

    Time frame: Pre-treatment, Week 1 to 8

    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.

  3. Quality of Life (WHOQOL-BREF)

    Time frame: Pre-treatment, Week 1 to 8

    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).

  4. Clinical Global Impression (CGI)

    Time frame: Pre-treatment, Week 1 to 8

    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).

  5. Beck Depression Inventory (BDI)

    Time frame: Pre-treatment; Week 1-8

    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

Other outcomes

  1. Resilience (CD-RISC-10)

    Time frame: Pre-treatment, Week 1 to 8

    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.

  2. Psychotherapy side effects (UE-ATR checklist)

    Time frame: Week 1 to 8

    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.

  3. Childhood Trauma Questionnaire (CTQ)

    Time frame: Week 1

    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.

  4. Life Stressful Events Questionnaire

    Time frame: Week 1 to 8

    It assesses through closed questions, with dichotomous answers (yes vs. no), covering stressful life events.

  5. Attachment (RSQ)

    Time frame: Week 1 and 8

    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.

  6. Eysenck Personality Questionnaire-Revised (EPQR-A)

    Time frame: Pre-treatment; Week 1-8

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Neusa Sica da Rocha, PhD

CONTACT

[email protected]

55(51) 3359-8000

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Jun 28, 2024
Registry last updated
Apr 13, 2026

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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