Evaluation of Two Psychotherapies for Depressed Patients With Parkinson's Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Depression
- Sponsor
- Hopital Montfort
- Enrollment
- 63
- Locations
- 2
- Primary Endpoint
- Hamilton Depression Rating Scale (HAM-A)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Hamilton Depression Rating Scale (HAM-A)
Time Frame: Change from baseline to week 12 and 6-months follow-up
17-item clinician rated scale that assesses severity of depressive symptoms
Secondary Outcomes
- Experiences in Close Relationship Scale-Revised (ECR-R)(Change from baseline to week 12 and 6-months follow-up)
- Parkinson's Disease Questionnaire (PDQ-39)(Change from baseline to week 12 and 6-months follow-up)
- Interpersonal Relationships Inventory (IPRI)(Change from baseline to week 12 and 6-months follow-up)
- Beck Depression Inventory (BDI)(Change from baseline to week 12 and 6-months follow-up)
- Beck Anxiety Inventory (BAI)(Change from baseline to week 12 and 6-months follow-up)
- Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)(Change from baseline to week 12 and 6-months follow-up)