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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-24
SponsorHospital de Clinicas de Porto Alegre

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Young adults (between 18 and 24 years old)

Young adults who work, live or study in Porto Alegre

PHQ ≥ 5 - without suicide ideation

Disqualifiers

Maniac or hypomanic episode

Psychotic Syndrome

Substance Abuse

Suicide Risk or Ideation

Trial design

Design model

Parallel

Treatments tested in this trial

  • Interpersonal psychotherapy

    Behavioral

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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: InterventionOther 1 intervention
Group B: Waiting listNo intervention 0 interventions

Trial outcomes

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.

Time frame
Pre-treatment, Week 1 to 8

Secondary outcomes

1

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.

Time frame
Pre-treatment, Week 1 to 8
2

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.

Time frame
Pre-treatment, Week 1 to 8
3

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).

Time frame
Pre-treatment, Week 1 to 8
4

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).

Time frame
Pre-treatment, Week 1 to 8

Other outcomes

1

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.

Time frame
Pre-treatment, Week 1 to 8
2

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.

Time frame
Week 1 to 8
3

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.

Time frame
Week 1
4

Life Stressful Events Questionnaire

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

Time frame
Week 1 to 8

Sponsors and contacts

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