Efficacy of Psychotherapy for Depressed Parkinson's Disease Patients

Hopital Montfort

Status: Completed

Conditions: Parkinson's Disease; Depression

Treatments: Behavioral: Supportive Psychotherapy; Behavioral: Interpersonal Psychotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02552836

Montfort Hospital

Details and patient eligibility

About

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.

Full 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.

Enrollment: 63 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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63 participants in 2 patient groups

Interpersonal Psychotherapy (IPT)

Experimental group

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).

Treatment:

Behavioral: Interpersonal Psychotherapy

Supportive Psychotherapy (SP)

Active Comparator group

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,

Treatment:

Behavioral: Supportive Psychotherapy