Efficacy of Psychotherapy for Depressed Parkinson's Disease Patients

NCT ID: NCT02552836

Last Updated: 2024-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2023-03-31

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.

Conditions

Depression; Parkinson's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

Interpersonal Psychotherapy

Intervention Type: BEHAVIORAL

A 12-week intervention that focuses on resolving interpersonal stressors that are linked to the onset, maintenance or exacerbation of depressive symptoms

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,

Group Type: ACTIVE_COMPARATOR

Supportive Psychotherapy

Intervention Type: BEHAVIORAL

A 12-week intervention that focuses on non-specific factors that contribute to therapy outcome

Interventions

Interpersonal Psychotherapy

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

Supportive Psychotherapy

A 12-week intervention that focuses on non-specific factors that contribute to therapy outcome

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Ottawa Hospital

OTHER

Sponsor Role: collaborator

Hopital Montfort

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Diana Koszycki, PhD

Role: PRINCIPAL_INVESTIGATOR

Montfort Hospital and the University of Ottawa

Locations

The Ottawa Hospital and University of Ottawa

Ottawa, Ontario, Canada

The Ottawa Hospital

Ottawa, Ontario, Canada

Countries

Canada

Other Identifiers

Montfort Hospital

Identifier Type: -

Identifier Source: org_study_id