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Effectiveness of IPT-G in Major Depression (IPT-GinMD)

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ClinicalTrials.gov Identifier: NCT04015206
Recruitment Status : Recruiting
First Posted : July 10, 2019
Last Update Posted : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

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.

Condition or disease Intervention/treatment Phase
Depressive Disorder, Major Other: Group Interpersonal Psychotherapy Not Applicable

Detailed Description:

Patients presenting a current unipolar depression episode (BDI-II > 18) without response to 2 adequate antidepressants trials (optimized by dose and time) will be randomly allocated to two arms: a) Treatment-as-usual (TAU) arm: antidepressant + Clinical management; b) Add-on strategy arm: 14 sessions of IPT-Group added to TAU.

IPT-Group will be delivered following manualized guidelines (WHO, 2016 and Stuart et al. 2012). The choice of antidepressants for TAU will be based on the Canadian Network for Mood and Anxiety Treatments (CANMAT) recommendations. Clinical management will follow the National Institute for Mental Health (NIMH) recommendations for clinical management.

Depression episode will be diagnosed using the Mini International Neuropsychiatric Interview (MINI-PLUS).

The following variables will be evaluated at baseline and the end of the add-on intervention in both arms of the study:

a) depression symptoms- Beck Depression Inventory (BDI-II; b) anxiety symptoms - Beck Anxiety Inventory (BAI); c) quality of life- World Health Organization Quality of life Instrument short version (WHOQOL-bref); d) social support- Medical Outcomes Study Social. Support Survey (MOS-SSS); e) resilience- The Brief Resilience Scale (BRS); f) attachment- The Adult Attachment Scale (AAS-R) Depression symptoms are the primary outcome. Anxiety symptoms and quality of life the secondary outcomes. Social support, resilience, and attachment will be considered as both secondary outcome and mediator or moderators in a multivariate model.

The database will be built using REDCap (Research Electronic Data Capture). Sample size estimation to detect a 5-point difference between the groups with a standard deviation of 6, considering α = 0,05 and power of 90%, suggests a 64 subjects sample. With the estimation of a loss of 25% of the sample during the study, 80 patients will be included (40 in each arm). A trained psychotherapist will conduct five IPT-G groups with eight patients in each group.

Study design and analysis will use Intention-to-treat analysis. For quantitative variables testing, student-T test t (normal distribution) or Mann Whitney (absence of normal distribution) will be used with a 5% level of significance. Categorical variables will be tested using the Chi-square with exact Fischer test with a 5% level of significance. Hierarchical linear regression will be used to determine the variables that could predict a reduction in the depression scores of the BDI-II. All analysis will be performed using the Statistical Package for the Social Sciences (SPSS) version 20.0.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Study Type: Interventional Enrollment: 104 participants Allocation: Randomized Intervention Model: Parallel
Masking: Single (Outcomes Assessor)
Masking Description: The outcomes assessor will aply the scales being blind for the arm the participant was assigned
Primary Purpose: Treatment
Official Title: Effectiveness of Interpersonal Psychotherapy Group (IPT-G) as an add-on Strategy in the Treatment of Major Depression
Actual Study Start Date : August 25, 2019
Estimated Primary Completion Date : December 20, 2021
Estimated Study Completion Date : December 20, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IPT-G+UCT
12 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
Group Interpersonal Psychotherapy added to usual treatment (Pharmacotherapy + clinical management)
Other Name: IPT-G

Active Comparator: Usual treatment (UCT)
Pharmacotherapy + Clinical management once a month
Other: Group Interpersonal Psychotherapy
Group Interpersonal Psychotherapy added to usual treatment (Pharmacotherapy + clinical management)
Other Name: IPT-G




Primary Outcome Measures :
  1. Rate of Depression symptoms [ Time Frame: 14 weeks ]

    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.



Secondary Outcome Measures :
  1. Rate of Anxiety symptoms [ Time Frame: 14 weeks ]
    The Beck Anxiety Inventory (BAI) brazilian version is a self-evaluation scale, total scores consists in 21 questions about how the individual has felt in the last week, expressed in common anxiety symptoms, such as sweating and feelings of anguish. The possible answers are: no, slightly, moderately and severely. The scores are: 0-10 minimum degree of anxiety, 11-19 mild anxiety, 20-30 moderate anxiety, 31-63 severe anxiety.

  2. Rate of Quality of life domains [ Time Frame: 14 weeks ]

    Differences in the World Health Organization Quality of life abbreviated questionaire instrument (WHOQOL-Bref) brazilian version scale scores in four domains (Physical, Psychological, Social Relationships and Environmental).

    Consists in 26 questions (each with a scale of Likert type composed of five degrees of intensity), two of them related to overall quality of life and health status and 24 facets of quality of life in general. The results can be: needs to improve (1 to 2,9), regular (3 to 3,9), good (4 to 4,9) and very good (5).


  3. Rate of Social support [ Time Frame: 14 weeks ]
    Difference in the Social Support Scale (MOS) validated for Brazil scores. Composed of self-applied items, multiple choice with a score of 1 to 5 (Likert scale) evaluates the perception of individuals on social support in health contexts. It consists in 19 items distributed in 4 dimensions: positive social interaction, possible social support, affective social support, emotional social support and informational social support. The patient should answer to each option: never, rarely, sometimes, often or always. In the end, the results are transformed in a punctuation of 0 to 100.

  4. Rate of Resilience [ Time Frame: 14 weeks ]
    Difference in the Brief Resilience Scale (BRS) total scores. The self-evaluation scale is a short version validated for Portuguese in Brazil and it is composed of 14 items, in the Likert format, with the score 1 to 7 for each question. It evaluates the perception of individuals about psychological characteristics linked to resilience. Higher overall scores indicate greater resilience. It is organized in 6 factors: self perception, future planning, social competences, family cohesion, social resources and structured style.

  5. Style of Attachment [ Time Frame: 14 weeks ]
    Difference in the Adult Attachment Scale (AAS-R) scores. The Portuguese version will be used, which has previously been used in the Brazilian population. It is a self-evaluation scale that consists in 18 items, marked on a Likert scale of 5 points. It measures the attachment style of the adults defined according to 3 dimensions: anxiety, comfort with proximity and confidence in others.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patients with bipolar disorder
  2. Patients with substance abuse disorder,
  3. Patients with risk of suicide
  4. Patients with antisocial personality disorder
  5. Patients with psychotic syndrome,
  6. Patients with intellectual disability
  7. Patients receiving some kind of psychotherapy at the present time and in the last four weeks.
  8. Patients who are unable to communicate.
  9. Patients with Dismissive Attachment Style

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04015206


Contacts
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Contact: Maria Isabel Perez Mattos, PhD student 5551981519947 ext 555199618300 misabelmattos2@gmail.com
Contact: Marcelo Fleck, PhD. Md. 555199618300 ext 555199618300 mpafleck@gmail.com

Locations
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Brazil
Hospital de Clinicas de Porto Alegre Recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
Contact: Maria Isabel R Mattos         
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
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Study Director: Marcelo Fleck, PhD, Md. Hospital de Clinicas de Porto Alegre

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Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT04015206     History of Changes
Other Study ID Numbers: 2018-0547
First Posted: July 10, 2019    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospital de Clinicas de Porto Alegre:
Major Depressive Disorder
Group Interpersonal Psychotherapy (IPT-G)
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders