Effectiveness of Interpersonal Psychotherapy Group (IPT-G) as an add-on Strategy in the Treatment of Major Depression
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Rate of Depression symptoms
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
The outcomes assessor will aply the scales being blind for the arm the participant was assigned
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Arms & Interventions
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
Intervention: Group Interpersonal Psychotherapy (Other)
Usual treatment (UCT)
Pharmacotherapy + Clinical management once a month
Intervention: Group Interpersonal Psychotherapy (Other)
Outcomes
Primary Outcomes
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 Outcomes
- Rate of Quality of life domains(14 weeks)
- Rate of Social support(14 weeks)
- Rate of Resilience(14 weeks)
- Rate of Anxiety symptoms(14 weeks)
- Style of Attachment(14 weeks)