search
Back to results

Efficacy of Psychotherapy for Depressed Parkinson's Disease Patients

Primary Purpose

Depression, Parkinson's Disease

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Interpersonal Psychotherapy
Supportive Psychotherapy
Sponsored by
Hopital Montfort
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • The Ottawa Hospital and University of Ottawa
  • The Ottawa Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Interpersonal Psychotherapy (IPT)

Supportive Psychotherapy (SP)

Arm Description

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).

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,

Outcomes

Primary Outcome Measures

Hamilton Depression Rating Scale (HAM-A)
17-item clinician rated scale that assesses severity of depressive symptoms

Secondary Outcome Measures

Beck Depression Inventory (BDI)
The BDI is a self report measure of depressive symptoms
Beck Anxiety Inventory (BAI)
The BAI is a self-report measure of anxiety symptoms
Parkinson's Disease Questionnaire (PDQ-39)
Self-report questionnaire that assesses quality of life in patients with Parkinson's Disease
Interpersonal Relationships Inventory (IPRI)
Self-report inventory that measures aspects of interpersonal relationships
Experiences in Close Relationship Scale-Revised (ECR-R)
Self-report scale that assesses attachment style in adult relationships
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

Full Information

First Posted
September 15, 2015
Last Updated
March 6, 2023
Sponsor
Hopital Montfort
Collaborators
The Ottawa Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02552836
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 2016 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Montfort
Collaborators
The Ottawa Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Parkinson's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interpersonal Psychotherapy (IPT)
Arm Type
Experimental
Arm Description
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).
Arm Title
Supportive Psychotherapy (SP)
Arm Type
Active Comparator
Arm Description
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,
Intervention Type
Behavioral
Intervention Name(s)
Interpersonal Psychotherapy
Intervention Description
A 12-week intervention that focuses on resolving interpersonal stressors that are linked to the onset, maintenance or exacerbation of depressive symptoms
Intervention Type
Behavioral
Intervention Name(s)
Supportive Psychotherapy
Intervention Description
A 12-week intervention that focuses on non-specific factors that contribute to therapy outcome
Primary Outcome Measure Information:
Title
Hamilton Depression Rating Scale (HAM-A)
Description
17-item clinician rated scale that assesses severity of depressive symptoms
Time Frame
Change from baseline to week 12 and 6-months follow-up
Secondary Outcome Measure Information:
Title
Beck Depression Inventory (BDI)
Description
The BDI is a self report measure of depressive symptoms
Time Frame
Change from baseline to week 12 and 6-months follow-up
Title
Beck Anxiety Inventory (BAI)
Description
The BAI is a self-report measure of anxiety symptoms
Time Frame
Change from baseline to week 12 and 6-months follow-up
Title
Parkinson's Disease Questionnaire (PDQ-39)
Description
Self-report questionnaire that assesses quality of life in patients with Parkinson's Disease
Time Frame
Change from baseline to week 12 and 6-months follow-up
Title
Interpersonal Relationships Inventory (IPRI)
Description
Self-report inventory that measures aspects of interpersonal relationships
Time Frame
Change from baseline to week 12 and 6-months follow-up
Title
Experiences in Close Relationship Scale-Revised (ECR-R)
Description
Self-report scale that assesses attachment style in adult relationships
Time Frame
Change from baseline to week 12 and 6-months follow-up
Title
Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Description
Clinician rated scale that provides comprehensive coverage of motor symptoms in Parkinson's Disease
Time Frame
Change from baseline to week 12 and 6-months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diana Koszycki, PhD
Organizational Affiliation
Montfort Hospital and the University of Ottawa
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ottawa Hospital and University of Ottawa
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1K 0T1
Country
Canada
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4E9
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share data

Learn more about this trial

Efficacy of Psychotherapy for Depressed Parkinson's Disease Patients

We'll reach out to this number within 24 hrs