Telehealth Cognitive Behavioral Therapy for Depression in Parkinson's Disease (PD)



Status:Active, not recruiting
Conditions:Depression, Depression, Parkinsons Disease
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:35 - 85
Updated:2/10/2019
Start Date:July 15, 2016
End Date:June 30, 2020

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Telehealth Cognitive-Behavioral Therapy for Depression in Parkinson's Disease

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.

Objective: There is a critical need for treatments that address depression and barriers to
mental health care among the nearly 100,000 Veterans with Parkinson's Disease (PD) served by
the VA. Depression in PD (dPD) is a major complicating factor in the movement disorder,
affecting several key functional outcomes such as motor disability, cognitive status, quality
of life, and caregiving relationships. The challenge to meeting the treatment needs of
Veterans with dPD centers on the lack of clinicians who are knowledgeable about the
interactions of PD and depression, the considerable transportation barriers faced by this
population, combined with the geographical dispersion of specialized services within the VA,
and the paucity of effectiveness research that informs treatments for dPD. The proposed study
seeks to overcome these challenges by using a telehealth delivery platform (i.e.,
video-to-home) to test the effectiveness of a 10-session cognitive-behavioral treatment (CBT)
package that has been tailored to address the unique needs of depressed Veterans with PD. The
proposed treatment package also provides support and skills-training to the Veteran's
Caregiver (3 sessions). This HSR&D proposal will be the first to: 1) to evaluate the
effectiveness of TH-CBT for improving Veteran outcomes in dPD, 2) to examine the impact of
TH-CBT for dPD on a variety of Caregiver outcomes, and 3) to assess Veteran and Caregiver
perspectives on TH-CBT using a mixed-methods sequential explanatory design.

Method: A PD-informed, telehealth-administered cognitive behavioral therapy package (TH-CBT)
for dPD will be evaluated in a clinical effectiveness trial. 180 participants (90 Veterans
and 90 Caregivers) will be enrolled. Half of the sample will receive the study treatment
package (TH-CBT), in addition to their standard medical care. The other half will only
receive standard medical care. The two groups will be compared at baseline, midpoint (week
5), endpoint (week 10), and 1 and 6 months post treatment. Veterans will be assessed with
standard measures of depression, anxiety, quality of life, and motor function, while
Caregivers will be evaluated with measures of caregiver burden, empowerment, and
communication.

Impact: Given the public health impact of improved depression treatment in Veterans with
Parkinson's disease, the knowledge to be gained may be significant and the project could
directly impact clinical practice. The data gleaned from this study will guide the wide-scale
implementation of this remote care model within the VA for meeting the specialized needs of
Veterans with PD. Towards this goal, successful results for the proposed study will
facilitate a multisite initiative to further examine issues of dissemination, implementation,
and effectiveness, using a hybrid research design. Ultimately, these HSR&D data may support
the development of a centralized care model, in which highly specialized dPD providers,
concentrated in a few locations, provide specialty care to Veterans and Caregivers across the
country.

Inclusion Criteria:

- Confirmed PD diagnosis in the VA medical record

- Primary Major Depression, Dysthymia, or Depression NOS of at least moderate severity
per the SCID

- 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
We found this trial at
1
site
Lyons, New Jersey 07939
Principal Investigator: Alejandro Interian, PhD
Phone: 908-647-0180
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mi
from
Lyons, NJ
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