N/A
N=174
Telehealth Cognitive Behavioral Therapy for Depression in Parkinson's Disease (PD)
Depression · Parkinson's Disease
Bottom Line
View on ClinicalTrials.gov: NCT02475954 ↗Enrolled (actual)
174
Serious AEs
12.1%
Results posted
Apr 2021
Primary outcome: Primary: Hamilton Depression Rating Scale — 16.46; 21.37; 16.35; 20.70 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- TH-CBT (Behavioral); Standard Care (Other)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hamilton Depression Rating Scale |
16.46; 21.37; 16.35; 20.70 | — |
Summary
When Veterans with Parkinson's disease (PD) suffer from depression, they are more likely to experience disease complications, interpersonal difficulties with caregivers, and poorer quality of life. Unfortunately, depression in Veterans with PD is inadequately treated at the current time. Treatment for depressed Veterans with PD will require the elimination of geographical barriers to care and approaches that address the unique aspects of PD. The proposed study will be the first to explore a novel and innovative, PD-informed psychotherapy package for depressed Veterans with PD and their Caregivers, delivered through video-to-home telehealth. If the results of this proposal are promising, a much needed treatment can be made available to Veterans with PD and their Caregivers across the country, regardless of geographical location.
Eligibility Criteria
Inclusion Criteria
- Confirmed PD diagnosis in the VA medical record
- Primary Major Depression, Dysthymia, or Depression Not Otherwise Specified (NOS) of at least moderate severity per the Structured Clinical Interview (SCID) for Diagnostic and Statistical Manual of Mental Disorders (DSM5) Disorders.
- Access to a computer/tablet with high-speed internet access. primary
- Ages 35-85
- Stable medication and mental health regimen greater than or equal to 6 weeks, including:
- applicable antidepressants
- other psychotropic agents
- movement disorder drugs
- clinic-based psychotherapies
- Willingness to involve a family member or friend to participate
Exclusion Criteria
- Possible dementia or marked cognitive impairment [Montreal Cognitive
- Assessment Score (MoCA) less than 21
- Motor fluctuations greater than or equal to 50% of the day
- Suicidal plans or intent (determined by clinical interview)
- Unstable medical conditions
Data sourced from ClinicalTrials.gov (NCT02475954). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.