This trial is active, not recruiting.

Conditions major depressive disorder, parkinson's disease
Treatments cognitive behavioral therapy
Sponsor Amy Farabaugh, PhD
Collaborator Brigham and Women's Hospital
Start date April 2007
End date April 2013
Trial size 80 participants
Trial identifier NCT00853346, MH076037-01


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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Patients randomized to the immediate arm will be given 12 weeks of CBT starting one week after randomization
cognitive behavioral therapy CBT
12 weeks of Cognitive Behavioral Therapy designed for adults with Parkinson's Disease and comorbid Depression
(Active Comparator)
Patients in the delayed arm will receive 12 weeks of CBT, starting 12 weeks after randomization.
cognitive behavioral therapy CBT
12 weeks of Cognitive Behavioral Therapy designed for adults with Parkinson's Disease and comorbid Depression

Primary Outcomes

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

Eligibility Criteria

Male or female participants from 40 years up to 80 years old.

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

Additional Information

Official title Psychosocial Treatment of Depression in Parkinson's Disease
Principal investigator Amy Farabaugh, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2012.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.