Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The Ottawa Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interpersonal Psychotherapy (IPT) | Experimental | 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). |
|
| Supportive Psychotherapy (SP) | Active Comparator | 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, |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interpersonal Psychotherapy | Behavioral | A 12-week intervention that focuses on resolving interpersonal stressors that are linked to the onset, maintenance or exacerbation of depressive symptoms |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Diana Koszycki, PhD | Montfort Hospital and the University of Ottawa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ottawa Hospital and University of Ottawa | Ottawa | Ontario | K1K 0T1 | Canada | ||
| The Ottawa Hospital |
No plan to share data
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003863 | Depression |
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000079062 | Interpersonal Psychotherapy |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Supportive Psychotherapy | Behavioral | A 12-week intervention that focuses on non-specific factors that contribute to therapy outcome |
|
| 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 |
| Ottawa |
| Ontario |
| K1Y 4E9 |
| Canada |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |