Efficacy of Psychotherapy for Depressed Parkinson's Disease Patients

Not Applicable

Completed

• Conditions: Parkinson's Disease; Depression
• Interventions: Behavioral: Interpersonal Psychotherapy; Behavioral: Supportive Psychotherapy

• Registration Number: NCT02552836
• Lead Sponsor: Hopital Montfort

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.

Study Timeline

• Study First Submitted: 2015-09-15
• Study First Submitted QC: 2015-09-15
• Study First Posted: 2015-09-17
• Study Start: 2016-03
• Primary Completion: 2023-03
• Study Completion: 2023-03
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-18
• Last Update Posted: 2024-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interpersonal Psychotherapy (IPT)	Interpersonal Psychotherapy	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)	Supportive Psychotherapy	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,

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
Interpersonal Relationships Inventory (IPRI)	Change from baseline to week 12 and 6-months follow-up	Self-report inventory that measures aspects of interpersonal relationships
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
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
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

Trial Locations

Locations (2)

The Ottawa Hospital and University of Ottawa; 🇨🇦 Ottawa, Ontario, Canada

The Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada