Efficacy of Psychotherapy for Depressed Parkinson's Disease Patients

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02552836
• Other study ID #: Montfort Hospital
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: March 2023

Study information

• Verified date: March 2024
• Source: Hopital Montfort
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: March 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Parkinson Disease
• Parkinson's Disease

Intervention

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

Locations

Country	Name	City	State
Canada	The Ottawa Hospital	Ottawa	Ontario
Canada	The Ottawa Hospital and University of Ottawa	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Hopital Montfort	The Ottawa Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Interpersonal Relationships Inventory (IPRI)	Self-report inventory that measures aspects of interpersonal relationships	Change from baseline to week 12 and 6-months follow-up
Secondary	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
Secondary	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