Efficacy of Psychotherapy for Depressed Parkinson's Disease Patients

Sponsor

Hopital Montfort (Other)

Overall Status

Recruiting

CT.gov ID

NCT02552836

Collaborator

The Ottawa Hospital (Other)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Depression Parkinson's Disease	Behavioral: Interpersonal Psychotherapy Behavioral: Supportive Psychotherapy	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 1, 2016

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Ottawa Hospital and University of Ottawa	Ottawa	Ontario	Canada	K1K 0T1
2	The Ottawa Hospital	Ottawa	Ontario	Canada	K1Y 4E9

Sponsors and Collaborators

Hopital Montfort
The Ottawa Hospital

Investigators

Principal Investigator: Diana Koszycki, PhD, Montfort Hospital and the University of Ottawa

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hopital Montfort

ClinicalTrials.gov Identifier:

NCT02552836

Other Study ID Numbers:

Montfort Hospital

First Posted:

Sep 17, 2015

Last Update Posted:

Sep 16, 2021

Last Verified:

Aug 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Parkinson Disease

Study Results

No Results Posted as of Sep 16, 2021