Efficacy of Psychotherapy for Depressed Parkinson's Disease Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of Two Psychotherapies for Depressed Patients With Parkinson's Disease

Conditions
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Depression, Parkinson's Disease

Intervention / Treatment
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* Behavioral: Interpersonal Psychotherapy
* Behavioral: Supportive Psychotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Outpatients with idiopathic Parkinson's disease and between stages 1 and 3 in the modified Hohn & Yahr Clinical Staging Scale Diagnosis of a depressive disorder Score ≥ 12 on the 17-item Hamilton Depression Rating Scale Living independently Exclusion Criteria: History of bipolar disorder or psychotic symptoms (other than drug induced) Substance-related disorders in the last 12 months Acutely suicidal or history of suicide attempts in the past 5 years Presence of cognitive deficits (i.e., score ≤ 24 on the Mini Mental Status Exam) or history of significant cognitive disorders Presence of other significant neurological problems Presence of unstable comorbid medical conditions Currently receiving psychotherapy Unable to attend weekly therapy sessions

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interpersonal Psychotherapy (IPT)<br>Patients assigned to IPT will receive 12 sessions of individual therapy of approximately 50 minutes duration. Therapy will be manualized and slightly adapted to meet the needs of patients with Parkinson's Disease. Therapy focuses on one of four interpersonal events that are linked with onset or maintenance of depression (role transition, role disputes, unresolved grief, and interpersonal deficits). | Behavioral: Interpersonal Psychotherapy<br>* A 12-week intervention that focuses on resolving interpersonal stressors that are linked to the onset, maintenance or exacerbation of depressive symptoms<br>|
| Active Comparator: Supportive Psychotherapy (SP)<br>Patients assigned to SP will receive 12 sessions of individual therapy of approximately 50 minutes duration. SP strives to create a supportive therapeutic relationship by emphasizing non-specific therapeutic interactions and techniques. Therapy will be manualized, | Behavioral: Supportive Psychotherapy<br>* A 12-week intervention that focuses on non-specific factors that contribute to therapy outcome<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Depression Rating Scale (HAM-A) | 17-item clinician rated scale that assesses severity of depressive symptoms | Change from baseline to week 12 and 6-months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck Depression Inventory (BDI) | The BDI is a self report measure of depressive symptoms | 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 | 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 | Change from baseline to week 12 and 6-months follow-up | 
| Interpersonal Relationships Inventory (IPRI) | Self-report inventory that measures aspects of interpersonal relationships | 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 | 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 | Change from baseline to week 12 and 6-months follow-up |