Effectiveness of IPT-G in Major Depression

NCT04015206 | Terminated

• 1 other identifier: 2018-0547
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Although antidepressants are the primary treatment for major depression, response and remission rates are unsatisfactory. The primary objective of this study is to identify if adding interpersonal group therapy (IPT-G) to the usual psychopharmacological and clinical management treatment will improve depressive symptoms in major depression outpatients.

Conditions

Depressive Disorder, Major

Keywords

Major Depressive Disorder; Group Interpersonal Psychotherapy (IPT-G)

Outcome Measures

Primary Outcomes (1)

• Rate of Depression symptoms

  The Beck Depression Inventory (BDI- II) brazilian version is an self-evaluation instrument, that the scale total scores aims to identify and quantify mild, moderate and severe depression. The patient is invited to answer how he has felt in the last week. The scale consists in 21 items including symptoms and attitudes, whose intensity varies from 0 to 3. The items refer to sadness, pessimism, past failure, lack of satisfaction, loss of pleasure, feelings of guilt, sense of punishment, self-steam, self-criticism, thoughts or desires of suicide, crying, agitation, loss of interest, indecision, devaluation, lack of energy, change in sleep patterns, irritability, changes in appetite, concentration difficulty, fatigue, loss of interest in sex. For patients diagnosed with Major Depression, the cut points are: 0-13 minimum, 14-19 mild depression, 20-28 moderate depression, 29-63 severe depression.

  14 weeks

Secondary Outcomes (5)

• Rate of Anxiety symptoms

  14 weeks

• Rate of Quality of life domains

  14 weeks

• Rate of Social support

  14 weeks

• Rate of Resilience

  14 weeks

• Style of Attachment

  14 weeks

Study Arms (2)

IPT-G+UCT

EXPERIMENTAL

10 sessions of Group Interpersonal therapy added to pharmacotherapy + clinical management plus one individual session pre-group and one session pos-group

Other: Group Interpersonal Psychotherapy

Usual treatment (UCT)

ACTIVE COMPARATOR

Pharmacotherapy + Clinical management once a month

Other: Group Interpersonal Psychotherapy

Interventions

Group Interpersonal Psychotherapy OTHER

Group Interpersonal Psychotherapy added to usual treatment (Pharmacotherapy + clinical management)

Also known as: IPT-G

IPT-G+UCT; Usual treatment (UCT)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Major Depressive Episode evaluated by the MINI-plus instrument.
• Patients attending the depression outpatient clinic (HCPorto Alegre) for 6 months or more
• History of two previous appropriate antidepressant treatments (dose: equivalent of 75 mg / day of amitriptyline and time: the minimum of four weeks)
• Beck Depression Inventory scores above 18.

You may not qualify if:

• Patients with bipolar disorder
• Patients with substance abuse disorder,
• Patients with risk of suicide
• Patients with antisocial personality disorder
• Patients with psychotic syndrome,
• Patients with intellectual disability
• Patients receiving some kind of psychotherapy at the present time and in the last four weeks.
• Patients who are unable to communicate.
• Patients with Dismissive Attachment Style

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clinicas de Porto Alegre

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

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Marcelo Fleck, PhD, Md.

  Hospital de Clinicas de Porto Alegre

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor will aply the scales being blind for the arm the participant was assigned
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Study Type: Interventional Enrollment: 104 participants Allocation: Randomized Intervention Model: Parallel

Study Record Dates

• First Submitted: April 13, 2019
• First Posted: July 10, 2019
• Study Start: August 25, 2019
• Primary Completion: April 20, 2020
• Study Completion: March 20, 2021
• Last Updated: March 25, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)