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Official Study Title: Psychosocial Treatment of Depression in Parkinson's Disease
Sponsor: Massachusetts General Hospital
Clinicaltrials.gov ID: NCT00853346
Study ID: MH076037-01

Summary

The purpose of the study is to examine the effects of a form of talk therapy  TherapyAnother word for “treatment”. called cognitive  CognitiveRelated to mental activities having to do with perception, memory, judgment, and reasoning. behavior therapy (CBT) in the treatment of major depression in individuals with Parkinson's disease  Parkinson's DiseaseA chronic, slowly progressive disease of the nervous system characterized by the combination of tremor, rigidity, bradykinesia and stooped posture, among other symptoms. (PD). 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 the investigators to believe that this type of therapy may help people with PD cope with their depression.

Study Phase

Not Applicable
What is a study phase?

Symptoms Addressed: Non-movement Symptoms

Depression

Time Commitment

• Less than six months
• Once per week, actively receiving CBT for 12 weeks

Eligibility

• Minimum Age: 40
• Maximum Age: 80
• Gender(s) Accepted: Either

Inclusion Criteria

In addition to the diagnostic criteria for major depressive disorder, the following conditions must be met for participant eligibility:

• Written informed consent
• People with a primary diagnosis of PD who are also currently diagnosed with Major Depressive Disorder, minor depression or dysthymia
• Participants must be stable on their anti-Parkinson treatment, as defined by no medication changes over the past six weeks
• Participants may be taking an antidepressant as long as they have had a stable dose for up to six weeks and do not alter the dosage during the course of the study
• Willing to come to MGH (Mass. General Hospital) for screening  ScreeningPeriod of selection of clinical trial participants based on ELIGIBILITY CRITERIA. and study participation
  

Exclusion Criteria

• People who, in the investigator's judgment, pose a current, serious suicidal or homicidal risk
• People who would not be appropriate for a delayed CBT control due to the severity of their depression based on clinical  ClinicalDealing with or based on observation and treatment of people, as opposed to basic science carried out in the laboratory or in animals. judgment
• The following diagnoses: 1) substance use disorders, including alcohol dependence, active within the last three months; 2) schizophrenia; 3) delusional disorder; 4) psychotic disorders not elsewhere classified; 5) bipolar disorder; 6) Major depressive disorder with psychotic features
• People who meet the clinical criteria for dementia  DementiaA decline in higher-level brain functions, such as memory, reasoning and personality.
• 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 person with severe congestive heart failure who has a history of recent hospital admissions)
• People 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
  

Enrollment

Expected Enrollment: 80 (US)
Date Enrollment Began: Apr 2007
Date Enrollment Ends: Apr 2011
Last Updated Date: Apr 20 2009
Trial Post Date: Apr 08 2009
Website: http://clinicaltrials.gov/ct2/show/NCT00853346?term=NCT00853346&rank=1

Primary Contacts and Locations

Massachusetts

• Amy Farabaugh, PhD — Principal Investigator
  afarabaugh@partners.org
  Phone: (617) 726-1629
  Massachusetts General Hospital
  Boston, MA 02114
  USA
  
• Daniel P Johnson, BA — Study Coordinator
  djohnson31@partners.org
  Phone: (617) 724-3673
  Massachusetts General Hospital
  Boston, MA 02114
  USA