Efficacy of Psychotherapy for Depressed Parkinson's Disease Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Depression; Parkinson's Disease
• Intervention / Treatment: Behavioral: Interpersonal Psychotherapy; Behavioral: Supportive Psychotherapy

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.

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1Y 4E9
      • The Ottawa Hospital
    • Ottawa, Ontario, Canada, K1K 0T1
      • The Ottawa Hospital and University of Ottawa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interpersonal Psychotherapy (IPT); 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; A 12-week intervention that focuses on resolving interpersonal stressors that are linked to the onset, maintenance or exacerbation of depressive symptoms
Active Comparator: Supportive Psychotherapy (SP); 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; A 12-week intervention that focuses on non-specific factors that contribute to therapy outcome

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hopital Montfort
• Collaborators: The Ottawa Hospital
• Investigators: Principal Investigator: Diana Koszycki, PhD, Montfort Hospital and the University of Ottawa

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): March 1, 2023
• Study Completion (Actual): March 1, 2023

Study Registration Dates

• First Submitted: September 15, 2015
• First Submitted That Met QC Criteria: September 15, 2015
• First Posted (Estimated): September 17, 2015

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: Montfort Hospital

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share data