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

Depression Clinical Trial

— TH-CBT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02475954
• Other study ID #: IIR 14-353
• Status: Completed
• Phase: N/A
• Start date: July 15, 2016
• Est. completion date: December 10, 2019

Study information

• Verified date: July 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: December 10, 2019
• Est. primary completion date: December 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Parkinson Disease
• Parkinson's Disease

Intervention

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 Video-to-Home (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 anti-depressant medications, established psychotherapy, clinical monitoring).

Locations

Country	Name	City	State
United States	Lyons Campus of the VA New Jersey Health Care System, Lyons, NJ	Lyons	New Jersey

Sponsors (3)

Lead Sponsor	Collaborator
VA Office of Research and Development	Department of Veterans Affairs, New Jersey, Rutgers Robert Wood Johnson Medical School

Country where clinical trial is conducted

United States, 

References & Publications (2)

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.2854 — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Family Empowerment Scale	The Family Empowerment scale measures the degree to which caregivers feel empowered to help care for their Veteran. To obtain a score for each area, sum the item responses where "Not at all" is scoring as 1, "Mostly not true" is scored as 2, "Somewhat true" is scored as 3, "Mostly true" is scored as 4, and "Very true" is scored as 5 to produce a score ranging from 12-60. The items are scored in the same direction, i.e., no item scores are reversed, and a higher score indicates relatively more empowerment in each respective area. Higher scores mean a better outcome.	10 weeks (endpoint) and 6 months post-treatment
Primary	Hamilton Depression Rating Scale	This measure uses the Hamilton Depression Rating Scale (HDRS) to express the average severity of depressive symptoms, with higher scores indicating greater depression. Hamilton Depression Rating Scale (HAMD) Score Min:0 and Max: 52. Higher scores mean a worse outcome.	10 weeks (endpoint) and 6 months post-treatment