Clinical trial NCT04015206: Effectiveness of IPT-G in Major Depression
Official title: Effectiveness of Interpersonal Psychotherapy Group (IPT-G) as an add-on Strategy in the Treatment of Major Depression
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Depressive Disorder, Major
Keywords: Major Depressive Disorder
Group Interpersonal Psychotherapy (IPT-G)
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2019-07-10
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study Type: Interventional Enrollment: 104 participants Allocation: Randomized Intervention Model: Parallel
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Rate of Depression symptoms
timeFrame: 14 weeks
Secondary outcomes:
measure: Rate of Anxiety symptoms
timeFrame: 14 weeks
measure: Rate of Quality of life domains
timeFrame: 14 weeks
measure: Rate of Social support
timeFrame: 14 weeks
measure: Rate of Resilience
timeFrame: 14 weeks
measure: Style of Attachment
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: Rio Grande Do Sul
Study officials:
affiliation: Hospital de Clinicas de Porto Alegre
name: Marcelo Fleck, PhD, Md.
role: STUDY_DIRECTOR
References: