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| Sponsor: | Amy Farabaugh, PhD |
|---|---|
| Collaborators: |
Brigham and Women's Hospital Beth Israel Deaconess Medical Center |
| Information provided by (Responsible Party): | Amy Farabaugh, PhD, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00853346 |
Purpose
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).
| Condition | Intervention |
|---|---|
|
Major Depressive Disorder Parkinson's Disease |
Behavioral: Cognitive Behavioral Therapy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Psychosocial Treatment of Depression in Parkinson's Disease |
| Estimated Enrollment: | 80 |
| Study Start Date: | April 2007 |
| Estimated Study Completion Date: | April 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
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Active Comparator: 2
Patients in the delayed arm will receive 12 weeks of CBT, starting 12 weeks after randomization.
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Behavioral: Cognitive Behavioral Therapy
12 weeks of Cognitive Behavioral Therapy designed for adults with Parkinson's Disease and comorbid Depression
Other Names:
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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.
Eligibility| Ages Eligible for Study: | 40 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
In addition to the DSM-IV diagnostic criteria for major depressive disorder, the following conditions must be met for patient eligibility:
Exclusion Criteria:
Patients meeting any of the following criteria are to be excluded from the study:
Contacts and Locations| Contact: Amy Farabaugh, PhD | 617-726-1629 | afarabaugh@partners.org |
| Contact: Daniel P Johnson, BA | 617-724-3673 | djohnson31@partners.org |
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Amy Farabaugh, PhD 617-726-1629 afarabaugh@partners.org | |
| Contact: Daniel P Johnson, BA 617-724-3673 djohnson31@partners.org | |
| Principal Investigator: Amy Farabaugh, PhD | |
| Principal Investigator: | Amy Farabaugh, PhD | Massachusetts General Hospital |
More Information
| Responsible Party: | Amy Farabaugh, PhD, Director, Psychotherapy Research, Depression Clinical & Research Program, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00853346 History of Changes |
| Other Study ID Numbers: | MH076037-01 |
| Study First Received: | February 27, 2009 |
| Last Updated: | May 2, 2012 |
| Health Authority: | United States: Institutional Review Board |
|
Depression Parkinson's Disease Major Depression Cognitive Behavioral Therapy |
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Depression Depressive Disorder Parkinson Disease Depressive Disorder, Major Behavioral Symptoms Mood Disorders Mental Disorders |
Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases |