Clinical Hospital for Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Location status: Recruiting
NCT Number: NCT06480019
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.
Interested in participating?
Request Info18 year–24 year
All sexes
Interventional
Not applicable
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Interpersonal psychotherapy is a first-line treatment and can also be used for the prevention of depression.
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.
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.
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.
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).
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).
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
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.
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.
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.
Time frame: Week 1 to 8
It assesses through closed questions, with dichotomous answers (yes vs. no), covering stressful life events.
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.
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).
Contact information is provided by the study sponsor or research team.
Hospital de Clinicas de Porto Alegre
Other
IPT-based Group Intervention by Non-specialist for Improvement of Depressive Symptoms in Community Young Adults in Brazil: a Randomized Clinical Trial
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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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