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

Hospital de Clinicas de Porto Alegre

Status: Terminated

Conditions: Depressive Disorder, Major

Treatments: Other: Group Interpersonal Psychotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04015206

2018-0547

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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18 participants in 2 patient groups

IPT-G+UCT

Experimental group

Description:

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

Treatment:

Other: Group Interpersonal Psychotherapy

Usual treatment (UCT)

Active Comparator group

Description:

Pharmacotherapy + Clinical management once a month

Treatment:

Other: Group Interpersonal Psychotherapy