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

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ClinicalTrials.gov Identifier: NCT02475954
Recruitment Status : Recruiting
First Posted : June 19, 2015
Last Update Posted : September 3, 2018
Sponsor:
Collaborators:
Department of Veterans Affairs, New Jersey
Rutgers Robert Wood Johnson Medical School
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Depression Parkinson's Disease Behavioral: TH-CBT Other: Standard Care Not Applicable

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 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Telehealth Cognitive-Behavioral Therapy for Depression in Parkinson's Disease
Actual Study Start Date : July 15, 2016
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: TH-CBT + Standard Care
Cognitive-behavioral therapy delivered via telehealth with a focus on decreasing depressive symptoms in Parkinson's Disease (PD).
Behavioral: TH-CBT
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 V2H.

Other: Standard Care
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 ADMs, established psychotherapy, clinical monitoring).

Standard Care
VA standard care depression in Parkinson's Disease (PD)
Other: Standard Care
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 ADMs, established psychotherapy, clinical monitoring).




Primary Outcome Measures :
  1. Hamilton Depression Rating Scale [ Time Frame: Change from baseline at 5 weeks (midpoint), 10 weeks (endpoint), 1 month post-treatment, 6 months post-treatment ]
    This measure uses the Hamilton Depression Rating Scale (HDRS) to express the average severity of depressive symptoms, with higher scores indicating greater depression.


Other Outcome Measures:
  1. Family Empowerment Scale [ Time Frame: Change from baseline at 10 weeks (endpoint), 1 month post-treatment, 6 months post-treatment ]
    The Family Empowerment scale measures the degree to which caregivers feel empowered to help care for their Veteran.



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02475954


Contacts
Contact: Alejandro Interian, PhD (908) 647-0180 ext 4617 alejandro.interian@va.gov
Contact: Roseanne Dobkin, PhD (732) 235-4051 dobkinro@rutgers.edu

Locations
United States, New Jersey
Lyons Campus of the VA New Jersey Health Care System, Lyons, NJ Recruiting
Lyons, New Jersey, United States, 07939
Contact: Alejandro Interian, PhD    908-647-0180 ext 4617    alejandro.interian@va.gov   
Contact: Roseanne Dobkin, PhD    (732) 235-4051    dobkinro@rutgers.edu   
Principal Investigator: Alejandro Interian, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Department of Veterans Affairs, New Jersey
Rutgers Robert Wood Johnson Medical School
Investigators
Principal Investigator: Alejandro Interian, PhD Lyons Campus of the VA New Jersey Health Care System, Lyons, NJ

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02475954     History of Changes
Other Study ID Numbers: IIR 14-353
First Posted: June 19, 2015    Key Record Dates
Last Update Posted: September 3, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
Depression
Telehealth
Parkinson's Disease
Veterans
Care-partners
Cognitive-Behavioral Therapy
Caregiver

Additional relevant MeSH terms:
Depression
Depressive Disorder
Parkinson Disease
Behavioral Symptoms
Mood Disorders
Mental Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases