Study Rationale:
There is a critical need for treatments that address depression and barriers to care among the approximately 5 million people living with Parkinson’s disease (PD) worldwide. The purpose of this research is to test a new treatment (Telephone-Administered Cognitive Behavioral Therapy or T-CBT) for depression in PD. The treatment does not involve medication but teaches people to change thinking patterns and behaviors related to depressive symptoms. The treatment has been tailored to address the unique needs of people with Parkinson’s and is delivered by telephone, so that patients may receive informed mental health care independent of geographic location and disability status.
Hypothesis:
We hypothesize that people with Parkinson’s receiving T-CBT will report greater improvements in depression, anxiety, negative thoughts and quality of life than those receiving enhanced usual care. Caregivers in the T-CBT group will report greater reductions in burden vs. usual care. We believe there may be effects of T-CBT on motor disability as well.
Study Design:
This is a randomized-controlled trial. Half of the study participants will begin the treatment program immediately. The other half will continue to receive their routine medical treatment under the supervision of their personal doctors (e.g., neurologists, psychiatrists) and will receive the new depression treatment six months later. The groups will be determined randomly, and people with PD from across the United States may participate.
The treatment teaches participants coping skills needed to manage their emotional reactions to the numerous challenges they face daily. Specifically, the treatment targets negative thoughts (e.g., I have no control, I am helpless) and behaviors (e.g., avoiding friends and family, lack of exercise, poor sleep habits, excessive worry). It also trains care-partners to help people with Parkinson’s practice healthy habits at home.
Impact on Diagnosis/Treatment of Parkinson’s Disease:
This project has the potential to significantly improve the management of depression in Parkinson’s disease. The study addresses several barriers to effective mental health care in PD, including the lack of PD-specific depression treatments, limited access to specialty care, physical disability, lack of transportation and geographic location. As depression is associated with increased rates of physical, cognitive and functional decline, the improved treatment of depression may also enhance the overall quality and impact of all aspects of PD care.
Next Steps for Development:
If results should prove promising, T-CBT will be made widely available to people with Parkinson’s across the United States. Positive results will allow for highly specialized doctors and therapists to be concentrated in few locations, yet provide specialty depression care across the country with the use of the telephone or internet. Treatment manuals may also be translated for international use.
Trial Phase: II