The primary aim of this randomized controlled trial is to determine the acute antidepressant efficacy of interpersonal psychotherapy (IPT) in depressed patients with Parkinson's Disease.
The primary aim of this study is to determine whether IPT is more efficacious than an intervention that controls for non-specific factors (i.e., supportive psychotherapy) in reducing depressive symptoms. A secondary aim is to determine whether IPT is better than supportive therapy in improving quality of life, interpersonal functioning, attachment patters, and motor symptoms, and whether treatment gains are durable at 6-months follow-up. An exploratory aim of the study is identify moderators and mediators of treatment outcome. Patients who meet study criteria will be randomly assigned to either 12 sessions of IPT or 12 sessions of supportive therapy. The primary efficacy measure (Hamilton Depression Rating Scale) will be administered at baseline, weeks 6 and 12, and at 6 months follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
63
A 12-week intervention that focuses on resolving interpersonal stressors that are linked to the onset, maintenance or exacerbation of depressive symptoms
A 12-week intervention that focuses on non-specific factors that contribute to therapy outcome
The Ottawa Hospital and University of Ottawa
Ottawa, Ontario, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
Hamilton Depression Rating Scale (HAM-A)
17-item clinician rated scale that assesses severity of depressive symptoms
Time frame: Change from baseline to week 12 and 6-months follow-up
Beck Depression Inventory (BDI)
The BDI is a self report measure of depressive symptoms
Time frame: Change from baseline to week 12 and 6-months follow-up
Beck Anxiety Inventory (BAI)
The BAI is a self-report measure of anxiety symptoms
Time frame: Change from baseline to week 12 and 6-months follow-up
Parkinson's Disease Questionnaire (PDQ-39)
Self-report questionnaire that assesses quality of life in patients with Parkinson's Disease
Time frame: Change from baseline to week 12 and 6-months follow-up
Interpersonal Relationships Inventory (IPRI)
Self-report inventory that measures aspects of interpersonal relationships
Time frame: Change from baseline to week 12 and 6-months follow-up
Experiences in Close Relationship Scale-Revised (ECR-R)
Self-report scale that assesses attachment style in adult relationships
Time frame: Change from baseline to week 12 and 6-months follow-up
Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Clinician rated scale that provides comprehensive coverage of motor symptoms in Parkinson's Disease
Time frame: Change from baseline to week 12 and 6-months follow-up
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