Psychosocial Treatment of Depression in Parkinson's Disease
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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 |
- 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 ] [ Designated as safety issue: No ]
| 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:
|
|
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:
|
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.
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:
- 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
Contacts and Locations| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Principal Investigator: | Amy Farabaugh, PhD | Massachusetts General Hospital |
More Information
Additional Information:
No publications provided
| 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: | November 15, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Massachusetts General Hospital:
|
Depression Parkinson's Disease Major Depression Cognitive Behavioral Therapy |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on May 22, 2013