Study Rationale:
Anxiety disorders occur in up to 35 percent of people with Parkinson's disease and can have a negative impact on gait, involuntary movements, motor fluctuations and quality of life. With this study we intend to develop a treatment module for anxiety in patients with Parkinson's disease based on cognitive behavioral therapy methods and assess its efficacy in reducing anxiety symptoms. We also want to study what biological changes occur in the brain during this treatment.
Hypothesis:
We hypothesize that after therapy, patients will be better able to manage their anxiety symptoms, and as a result will experience less anxiety symptoms. We also expect that treatment will restore the reduced connections between frontal brain areas and the deeper brain structures involved in the regulation of anxiety.
Study Design:
This study is a clinical trial in which 60 patients will be randomized to cognitive behavioral therapy or usual care. Treatment will consist of eight to 10 weekly sessions and will involve the partner or caregiver. Those patients randomized to usual care will be offered the module at the end of the study follow-up period (six months). At the beginning and end of the study, we will conduct MRI scans to assess the connections between frontal brain areas and certain deeper brain structures.
Impact on Diagnosis/Treatment of Parkinson's Disease:
If proven effective, cognitive behavioral therapy will provide patients with anxiety management techniques that can give lasting benefits, not only on anxiety symptoms but also potentially on motor symptoms. The MRI analysis may provide an explanation on the underlying biological mechanisms.
Next Steps for Development:
If proven effective, our focus will be on dissemination of the module. The treatment module will be made available for use without further cost. Adaptations for specific patient groups, such as those diagnosed with comorbid depression, those diagnosed with Lewy body disease or those treated with deep brain stimulation, may be made.