Coping With Depression in Parkinson's Disease
The purpose of this study is to evaluate the efficacy of a cognitive-behavioral treatment, that includes a caregiver-focused social support intervention, for depression in persons with Parkinson's disease.
Individuals who are unable to travel to the study site, but are interested in participating and meet all other eligibility requirements, will be allowed to participate over the phone.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Treating Depression in Parkinson's Disease: A New Method|
- Hamilton Rating Scale for Depression. [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
- Several secondary outcomes to assess depression, anxiety, sleep, quality of life, social support, caregiver distress, and neuropsychological functioning. [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||April 2007|
|Study Completion Date:||March 2013|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Behavioral: cognitive-behavioral therapy
The therapy will consist of 10 weekly individual cognitive-behavioral treatment sessions, lasting 1 hour each and modified to meet the unique needs of each individual with PD.
No Intervention: 2
standard medical care
Depression is the most common emotional problem found in persons with Parkinson's disease (PD). It causes immense personal suffering and is associated with increased disability and burden to caregivers. Despite the adverse consequences of depression in PD, there are virtually no studies to guide clinical treatment. Several studies are currently examining the effectiveness of antidepressant medication for depression in PD. However, there have been no studies to examine the effectiveness of non-medication approaches, such as cognitive-behavioral therapy, despite the success of these techniques in other populations. Cognitive-behavioral therapy teaches people with PD to become more aware of their thoughts and feelings and to change thinking patterns and behaviors that may be related to symptoms of depression.
The purpose of this study is to determine if cognitive-behavioral therapy—-with a caregiver-focused social support intervention—-is effective in treating depression in persons with PD. This study will enroll 160 persons—80 with PD and 80 caregivers. Forty participants with PD will be randomly chosen to receive the study treatment in addition to standard medical care. The other 40 will only receive standard medical care and will have the option to receive the study treatment after completing all study assessments (4 months after the initial evaluation).
The study treatment will consist of 10 weekly individual cognitive-behavioral treatment sessions, lasting 1 hour each and modified to meet the unique needs of each individual with PD. Caregivers will attend 4 separate educational sessions—lasting 30 minutes each—-designed to provide them with the tools needed to reinforce and supplement the material presented in the cognitive-behavioral sessions. Duration of the study for participants is 15 weeks.
This is the first study to evaluate the impact of a cognitive-behavioral treatment for PD depression in a randomized controlled trial. Information gained from this study may be beneficial in treating depression in persons with PD.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00464464
|United States, New Jersey|
|University of Medicine and Dentistry of New Jersey (UMDNJ), Robert Wood Johnson Medical School, 675 Hoes Lane, Room D-317|
|Piscataway, New Jersey, United States, 08854|
|Principal Investigator:||Roseanne D Dobkin, PhD||Associate Professor of Psychiatry UMDNJ-Robert Wood Johnson Medical School|
|Principal Investigator:||Matthew Menza, MD||Professor and Chair, Department of Psychiatry, UMDNJ- Robert Wood Johnson Medical School (Primary Mentor)|