Clinical trial NCT02475954: Telehealth Cognitive Behavioral Therapy for Depression in Parkinson's Disease (PD)
Official title: Telehealth Cognitive-Behavioral Therapy for Depression in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Parkinson's Disease
Keywords: Depression
Telehealth
Parkinson's Disease
Veterans
Care-partners
Cognitive-Behavioral Therapy
Caregiver
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Department of Veterans Affairs, New Jersey
name: Rutgers Robert Wood Johnson Medical School
First posted: 2015-06-19
Enrollment: 174
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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 Health Science Research \& Development (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.

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

Primary outcomes:
measure: Hamilton Depression Rating Scale
timeFrame: 10 weeks (endpoint) and 6 months post-treatment
Secondary outcomes:
Other outcomes:
measure: Family Empowerment Scale
timeFrame: 10 weeks (endpoint) and 6 months post-treatment
Locations:
city: Lyons
country: United States
facility: Lyons Campus of the VA New Jersey Health Care System, Lyons, NJ
state: New Jersey
Study officials:
affiliation: Lyons Campus of the VA New Jersey Health Care System, Lyons, NJ
name: Alejandro Interian, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pontone GM, Dissanayaka N, Dobkin RD, Mari L, Marsh L, Vernaleo BA, Weintraub D, Mari Z. Integration and Extension of Specialty Mental Healthcare Services to Community Practice in Parkinson Disease. Am J Geriatr Psychiatry. 2019 Jul;27(7):712-719. doi: 10.1016/j.jagp.2019.03.005. Epub 2019 Mar 13.
citation: Dobkin RD, Mann SL, Weintraub D, Rodriguez KM, Miller RB, St Hill L, King A, Gara MA, Interian A. Innovating Parkinson's Care: A Randomized Controlled Trial of Telemedicine Depression Treatment. Mov Disord. 2021 Nov;36(11):2549-2558. doi: 10.1002/mds.28548. Epub 2021 Mar 12.