Efficacy of Psychotherapy for Depressed Parkinson's Disease Patients

NCT02552836 | Completed

• 1 other identifier: Montfort Hospital
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 2

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.

Conditions

Depression; Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Beck Depression Inventory (BDI)

  Change from baseline to week 12 and 6-months follow-up

• Beck Anxiety Inventory (BAI)

  Change from baseline to week 12 and 6-months follow-up

• Parkinson's Disease Questionnaire (PDQ-39)

  Change from baseline to week 12 and 6-months follow-up

• Interpersonal Relationships Inventory (IPRI)

  Change from baseline to week 12 and 6-months follow-up

• Experiences in Close Relationship Scale-Revised (ECR-R)

  Change from baseline to week 12 and 6-months follow-up

Study Arms (2)

Interpersonal Psychotherapy (IPT)

EXPERIMENTAL

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

Supportive Psychotherapy (SP)

ACTIVE COMPARATOR

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

Interventions

Interpersonal Psychotherapy BEHAVIORAL

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

Interpersonal Psychotherapy (IPT)

Supportive Psychotherapy BEHAVIORAL

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

Supportive Psychotherapy (SP)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hopital Montfort: lead
• The Ottawa Hospital: collaborator

Study Sites (2)

The Ottawa Hospital and University of Ottawa

Ottawa, Ontario, K1K 0T1, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, K1Y 4E9, Canada

Location

MeSH Terms

Conditions

Depression; Parkinson Disease

Interventions

Interpersonal Psychotherapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Diana Koszycki, PhD

  Montfort Hospital and the University of Ottawa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2015
• First Posted: September 17, 2015
• Study Start: March 1, 2016
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: March 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)