Telehealth Cognitive Behavioral Therapy for Depression in Parkinson's Disease (PD)
Condition: Depression; Parkinson's Disease
MeSH terms: Parkinson Disease; Depression; Depressive Disorder
Study type: Interventional

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.
    

Intervention name(s): TH-CBT; Standard Care
Intervention type(s): Behavioral; Other
Intervention description(s): The TH-CBT group will receive the study intervention and standard care. The study treatment has been previously manualized and modified for remote administration, as described in the introduction to the revised application.12 PD Veterans will receive 10 weekly individual sessions (60 minutes each) of CBT, delivered via Video-to-Home (V2H).; Standard Care is defined as medical and psychiatric treatment provided by patients' personal doctors (e.g., neurologists, psychiatrists, therapists). Veterans will continue to receive routine clinical care and will remain on all depression treatments that they were receiving prior to their study (e.g., stable anti-depressant medications, established psychotherapy, clinical monitoring).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Depression; Telehealth; Parkinson's Disease; Veterans; Care-partners; Cognitive-Behavioral Therapy; Caregiver