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Completed

NCT Number: NCT02552836

Efficacy of Psychotherapy for Depressed Parkinson's Disease Patients

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ottawa Hospital, Ottawa, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

supportive psychotherapy

Behavioral

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

Primary outcomes

  1. Hamilton Depression Rating Scale (HAM-A)

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

    17-item clinician rated scale that assesses severity of depressive symptoms

Secondary outcomes

  1. Beck Depression Inventory (BDI)

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

    The BDI is a self report measure of depressive symptoms

  2. Beck Anxiety Inventory (BAI)

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

    The BAI is a self-report measure of anxiety symptoms

  3. Parkinson's Disease Questionnaire (PDQ-39)

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

    Self-report questionnaire that assesses quality of life in patients with Parkinson's Disease

  4. Interpersonal Relationships Inventory (IPRI)

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

    Self-report inventory that measures aspects of interpersonal relationships

  5. Experiences in Close Relationship Scale-Revised (ECR-R)

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

    Self-report scale that assesses attachment style in adult relationships

  6. Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

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

    Clinician rated scale that provides comprehensive coverage of motor symptoms in Parkinson's Disease

Sponsors and collaborators

Lead sponsor

Hopital Montfort

Other

Collaborators

  • The Ottawa Hospital

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Sep 17, 2015
Registry last updated
Mar 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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