Psychosocial Treatment of Depression in Parkinson's Disease

November 15, 2012 updated by: Amy Farabaugh, PhD
The purpose of the study is to examine the effects of a form of talk therapy called cognitive behavior therapy (CBT) in the treatment of major depression in individuals with Parkinson's disease (PD).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

CBT is a specific type of treatment that has been shown to be as helpful in treating depression as medications for depression. CBT focuses on thoughts, feelings, and behaviors. It focuses on the here and now, rather than the past. CBT offers concrete strategies and skills for coping with depression, PD, and other life problems. Previous research leads us to believe that this type of therapy may help people with PD cope with their depression.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

In addition to the DSM-IV diagnostic criteria for major depressive disorder, the following conditions must be met for patient eligibility:

  • Written informed consent.
  • Subjects with a primary diagnosis of PD who also currently meet DSM-IV criteria for MDD
  • Subjects must be stable on their anti-Parkinson treatment, as defined by no medication changes over the past 6 weeks
  • Subjects may be taking an antidepressant as long as they have had a stable dose for up to 6 weeks and do not alter the dosage during the course of the study
  • Men or women 40-80 years of age
  • HAMD-17 scores > 14 at screen visit
  • Score of 25 or greater on the Mini-Mental Status Examination
  • Willing to come to MGH for screening and study participation

Exclusion Criteria:

Patients meeting any of the following criteria are to be excluded from the study:

  • Subjects who, in the investigator's judgment, pose a current, serious suicidal or homicidal risk
  • Patients who would not be appropriate for a delayed CBT control due to the severity of their depression based on clinical judgment as well as HAMD-17 scores > 28
  • The following DSM-IV diagnoses: 1) substance use disorders, including alcohol dependence, active within the last 3 months; 2) schizophrenia; 3) delusional disorder; 4) psychotic disorders not elsewhere classified; 5) bipolar disorder; 6) MDD with psychotic features
  • Subjects who meet DSM-IV criteria for dementia
  • Severe, unstable concurrent medical conditions (determined by his/her physician) that are likely to require hospitalization within six months from study entry (e.g., a patient with severe congestive heart failure who has a history of recent hospital admissions)
  • Subjects may not be receiving a psychosocial intervention that is specific for depression; psychosocial interventions not specific for depression (e.g., couples counseling) and established for three or more months before screen visit are allowed

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Patients randomized to the immediate arm will be given 12 weeks of CBT starting one week after randomization
Behavioral: Cognitive Behavioral Therapy
12 weeks of Cognitive Behavioral Therapy designed for adults with Parkinson's Disease and comorbid Depression
Other Names:
  • CBT
  • Psychosocial Intervention
  • Therapy
  • Cognitive Therapy
Active Comparator: 2
Patients in the delayed arm will receive 12 weeks of CBT, starting 12 weeks after randomization.
Behavioral: Cognitive Behavioral Therapy
12 weeks of Cognitive Behavioral Therapy designed for adults with Parkinson's Disease and comorbid Depression
Other Names:
  • CBT
  • Psychosocial Intervention
  • Therapy
  • Cognitive Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response according to the Hamilton Rating Scale for Depression, 17 items (HAM-D 17).
Time Frame: screen, week 4, week 8, week 12; if applicable, week 16, week 20, week 24
screen, week 4, week 8, week 12; if applicable, week 16, week 20, week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amy Farabaugh, PhD

Collaborators

Beth Israel Deaconess Medical Center
Brigham and Women's Hospital

Investigators

  • Principal Investigator: Amy Farabaugh, PhD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Anticipated)

April 1, 2013

Study Completion (Anticipated)

April 1, 2013

Study Registration Dates

First Submitted

February 27, 2009

First Submitted That Met QC Criteria

February 27, 2009

First Posted (Estimate)

March 2, 2009

Study Record Updates

Last Update Posted (Estimate)

November 16, 2012

Last Update Submitted That Met QC Criteria

November 15, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MH076037-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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