Effectiveness of IPT-G in Major Depression

NCT ID: NCT04015206

Last Updated: 2021-03-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-25
• Study Completion Date: 2021-03-20

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.

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.

Conditions

Depressive Disorder, Major

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

IPT-G+UCT

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

Group Type: EXPERIMENTAL

Group Interpersonal Psychotherapy

Intervention Type: OTHER

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

Usual treatment (UCT)

Pharmacotherapy + Clinical management once a month

Group Type: ACTIVE_COMPARATOR

Group Interpersonal Psychotherapy

Intervention Type: OTHER

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

Interventions

Group Interpersonal Psychotherapy

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

Intervention Type: OTHER

Other Intervention Names

IPT-G

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marcelo Fleck, PhD, Md.

Role: STUDY_DIRECTOR

Hospital de Clinicas de Porto Alegre

Locations

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

Other Identifiers

2018-0547

Identifier Type: -

Identifier Source: org_study_id