Clinical trial NCT02552836: Efficacy of Psychotherapy for Depressed Parkinson's Disease Patients
Official title: Evaluation of Two Psychotherapies for Depressed Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Parkinson's Disease
Lead sponsor: Hopital Montfort
Sponsor class: OTHER
Collaborators: name: The Ottawa Hospital
First posted: 2015-09-17
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Hamilton Depression Rating Scale (HAM-A)
timeFrame: Change from baseline to week 12 and 6-months follow-up
Secondary outcomes:
measure: Beck Depression Inventory (BDI)
timeFrame: Change from baseline to week 12 and 6-months follow-up
measure: Beck Anxiety Inventory (BAI)
timeFrame: Change from baseline to week 12 and 6-months follow-up
measure: Parkinson's Disease Questionnaire (PDQ-39)
timeFrame: Change from baseline to week 12 and 6-months follow-up
measure: Interpersonal Relationships Inventory (IPRI)
timeFrame: Change from baseline to week 12 and 6-months follow-up
measure: Experiences in Close Relationship Scale-Revised (ECR-R)
timeFrame: Change from baseline to week 12 and 6-months follow-up
measure: Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
timeFrame: Change from baseline to week 12 and 6-months follow-up
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital and University of Ottawa
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
Study officials:
affiliation: Montfort Hospital and the University of Ottawa
name: Diana Koszycki, PhD
role: PRINCIPAL_INVESTIGATOR
References: