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| Name | Class |
|---|---|
| Department of Veterans Affairs, New Jersey | FED |
| Rutgers Robert Wood Johnson Medical School | OTHER |
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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TH-CBT + Standard Care | Active Comparator | Cognitive-behavioral therapy delivered via telehealth with a focus on decreasing depressive symptoms in Parkinson's Disease (PD). |
|
| Standard Care | Other | VA standard care depression in Parkinson's Disease (PD) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TH-CBT | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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:
Willingness to involve a family member or friend to participate
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alejandro Interian, PhD | Lyons Campus of the VA New Jersey Health Care System, Lyons, NJ | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lyons Campus of the VA New Jersey Health Care System, Lyons, NJ | Lyons | New Jersey | 07939 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30955991 | Result | 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. | |
| 33710659 | Result |
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| ID | Title | Description |
|---|---|---|
| FG000 | TH-CBT + Standard Care | Cognitive-behavioral therapy delivered via telehealth with a focus on decreasing depressive symptoms in Parkinson's Disease (PD). 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. 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 antidepressant medication, established psychotherapy, clinical monitoring). |
| FG001 | Standard Care | VA standard care depression in Parkinson's Disease (PD) 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). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TH-CBT + Standard Care | Cognitive-behavioral therapy delivered via telehealth with a focus on decreasing depressive symptoms in Parkinson's Disease (PD). 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. 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 antidepressant medication, established psychotherapy, clinical monitoring). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | This assessment was only given to veterans not care partners. | Posted | Mean | Standard Deviation | score on a scale | 10 weeks (endpoint) and 6 months post-treatment |
|
2.5 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TH-CBT + Standard Care | Cognitive-behavioral therapy delivered via telehealth with a focus on decreasing depressive symptoms in Parkinson's Disease (PD). 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. 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 antidepressant medication, established psychotherapy, clinical monitoring). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac related | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Muscle related | Musculoskeletal and connective tissue disorders | Systematic Assessment |
This study has several limitations that merit comment. This sample was 100% male, which may limit the generalizability of findings to females. In order to provide direct policy guidance on the additive value of V-CBT to VA's current standard of PD care, we utilized an existing-practice control (TAU). It is not possible to fully disaggregate effects of this V-CBT intervention from nonspecific factors (e.g., therapeutic relationship, attention) that contribute to all psychotherapy outcomes.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roseanne D. Dobkin | Rutgers - Robert Wood Johnson Medical School | 732-235-4051 | dobkinro@rutgers.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 18, 2015 | Mar 4, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 9, 2017 | Mar 4, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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|
| Standard Care | Other | 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). |
|
| 10 weeks (endpoint) and 6 months post-treatment |
| 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. |
| Death |
|
| BG001 | Standard Care | VA standard care depression in Parkinson's Disease (PD) 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 antidepressant medication, established psychotherapy, clinical monitoring). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | One person had missing data. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Missing data | Count of Participants | Participants |
|
| Race (NIH/OMB) | Missing data | Count of Participants | Participants |
|
| Hamilton Depression Rating Scale | Hamilton Depression Rating Scale Scores: Min:0 and Max: 52. Higher scores mean a worse outcome. | Hamilton Depression Rating Scale was only given to veterans not care partners. | Mean | Standard Deviation | units on a scale |
|
| Hamilton Anxiety Rating Scale | Hamilton Anxiety Rating Scale Scores: Min:0 and Max: 56. Higher scores mean a worse outcome. | Hamilton Anxiety Rating Scale was only given to veterans, not care partners. | Mean | Standard Deviation | units on a scale |
|
| Montreal Cognitive Assessment | Montreal Cognitive Assessment Scores: Min:0 and Max: 30. Higher scores mean a better outcome. | This assessment was only given to veterans not care partners. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Standard Care | VA standard care depression in Parkinson's Disease (PD) 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 antidepressant medication, established psychotherapy, clinical monitoring). |
|
|
| Other Pre-specified | 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. | This assessment was only given to care partners not veterans. Some care partners did not complete the Family Empowerment Scale at 6-months post treatment. | Posted | Mean | Standard Deviation | score on a scale | 10 weeks (endpoint) and 6 months post-treatment |
|
|
|
| 1 |
| 87 |
| 9 |
| 87 |
| 9 |
| 87 |
| EG001 | Standard Care | VA standard care depression in Parkinson's Disease (PD) 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 antidepressant medication, established psychotherapy, clinical monitoring). | 1 | 87 | 12 | 87 | 9 | 87 |
| Endocrine related | Endocrine disorders | Systematic Assessment |
|
| GI related | Gastrointestinal disorders | Systematic Assessment |
|
| General disorders related | General disorders | Systematic Assessment |
|
| Infection related | Infections and infestations | Systematic Assessment |
|
| Nervous system related | Nervous system disorders | Systematic Assessment |
|
| Renal related | Renal and urinary disorders | Systematic Assessment |
|
| Muscle related | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Cancer related | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Nervous system related | Nervous system disorders | Systematic Assessment |
|
| Cardiac related | Cardiac disorders | Systematic Assessment |
|
| GI related | Gastrointestinal disorders | Systematic Assessment |
|
| Urinary related | Renal and urinary disorders | Systematic Assessment |
|
| General disorders related | General disorders | Systematic Assessment |
|
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| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 6 months post-treatment |
|
|