Depression, Parkinson's Disease
Conditions
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.
Interventions
BEHAVIORALInterpersonal Psychotherapy
A 12-week intervention that focuses on resolving interpersonal stressors that are linked to the onset, maintenance or exacerbation of depressive symptoms
BEHAVIORALSupportive Psychotherapy
A 12-week intervention that focuses on non-specific factors that contribute to therapy outcome
Sponsors
The Ottawa Hospital
Hopital Montfort
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Depression Rating Scale (HAM-A) | Change from baseline to week 12 and 6-months follow-up | 17-item clinician rated scale that assesses severity of depressive symptoms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Beck Anxiety Inventory (BAI) | Change from baseline to week 12 and 6-months follow-up | The BAI is a self-report measure of anxiety symptoms |
| Parkinson's Disease Questionnaire (PDQ-39) | Change from baseline to week 12 and 6-months follow-up | Self-report questionnaire that assesses quality of life in patients with Parkinson's Disease |
| Beck Depression Inventory (BDI) | Change from baseline to week 12 and 6-months follow-up | The BDI is a self report measure of depressive symptoms |
| Experiences in Close Relationship Scale-Revised (ECR-R) | Change from baseline to week 12 and 6-months follow-up | Self-report scale that assesses attachment style in adult relationships |
| Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) | Change from baseline to week 12 and 6-months follow-up | Clinician rated scale that provides comprehensive coverage of motor symptoms in Parkinson's Disease |
| Interpersonal Relationships Inventory (IPRI) | Change from baseline to week 12 and 6-months follow-up | Self-report inventory that measures aspects of interpersonal relationships |
Countries
Canada
Outcome results
None listed