Depression, Parkinson's Disease
Conditions
Keywords
Depression, Telehealth, Parkinson's Disease, Veterans, Care-partners, Cognitive-Behavioral Therapy, Caregiver
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.
Interventions
BEHAVIORALTH-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).
OTHERStandard 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).
Sponsors
Department of Veterans Affairs, New Jersey
Rutgers Robert Wood Johnson Medical School
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Depression Rating Scale | 10 weeks (endpoint) and 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. Hamilton Depression Rating Scale (HAMD) Score Min:0 and Max: 52. Higher scores mean a worse outcome. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Family Empowerment Scale | 10 weeks (endpoint) and 6 months post-treatment | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 87 |
| 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). | 87 |
| Total | 174 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 1 |
| Overall Study | Lost to Follow-up | 11 | 9 |
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | TH-CBT + Standard Care | Standard Care | Total |
|---|---|---|---|
| Age, Continuous | 67.27 years STANDARD_DEVIATION 7.79 | 66.42 years STANDARD_DEVIATION 9.51 | 66.84 years STANDARD_DEVIATION 8.65 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 4 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 75 Participants | 82 Participants | 157 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Hamilton Anxiety Rating Scale | 23.49 units on a scale STANDARD_DEVIATION 4.57 | 24.16 units on a scale STANDARD_DEVIATION 4.14 | 23.82 units on a scale STANDARD_DEVIATION 4.35 |
| Hamilton Depression Rating Scale | 21.60 units on a scale STANDARD_DEVIATION 4.3 | 22.49 units on a scale STANDARD_DEVIATION 3.85 | 22.04 units on a scale STANDARD_DEVIATION 4.08 |
| Montreal Cognitive Assessment | 25.17 units on a scale STANDARD_DEVIATION 2.72 | 25.00 units on a scale STANDARD_DEVIATION 2.43 | 25.08 units on a scale STANDARD_DEVIATION 2.57 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 4 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 75 Participants | 80 Participants | 155 Participants |
| Sex: Female, Male Female | 41 Participants | 39 Participants | 80 Participants |
| Sex: Female, Male Male | 46 Participants | 47 Participants | 93 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 87 | 1 / 87 |
| other Total, other adverse events | 9 / 87 | 9 / 87 |
| serious Total, serious adverse events | 9 / 87 | 12 / 87 |
Outcome results
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.
Time frame: 10 weeks (endpoint) and 6 months post-treatment
Population: This assessment was only given to veterans not care partners.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TH-CBT + Standard Care | Hamilton Depression Rating Scale | 10 weeks (endpoint) | 16.46 score on a scale | Standard Deviation 5.18 |
| TH-CBT + Standard Care | Hamilton Depression Rating Scale | 6 months post-treatment | 16.35 score on a scale | Standard Deviation 4.97 |
| Standard Care | Hamilton Depression Rating Scale | 10 weeks (endpoint) | 21.37 score on a scale | Standard Deviation 5.27 |
| Standard Care | Hamilton Depression Rating Scale | 6 months post-treatment | 20.70 score on a scale | Standard Deviation 5.47 |
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.
Time frame: 10 weeks (endpoint) and 6 months post-treatment
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TH-CBT + Standard Care | Family Empowerment Scale | 10 weeks (endpoint) | 49.82 score on a scale | Standard Deviation 6.2 |
| TH-CBT + Standard Care | Family Empowerment Scale | 6 months post-treatment | 49.66 score on a scale | Standard Deviation 7.47 |
| Standard Care | Family Empowerment Scale | 10 weeks (endpoint) | 44.06 score on a scale | Standard Deviation 9.12 |
| Standard Care | Family Empowerment Scale | 6 months post-treatment | 45.31 score on a scale | Standard Deviation 7.04 |