DepressionTH-CBTNCT02475954
Telehealth Cognitive Behavioral Therapy for Depression in Parkinson's Disease (PD)
A study testing TH-CBT in people with Depression and Parkinson's Disease, run by VA Office of Research and Development at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Depression, Parkinson's Disease
- What is being tested?
- TH-CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2016to 10 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- other psychotropic agents
- movement disorder drugs
- clinic-based psychotherapies
- Willingness to involve a family member or friend to participate
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Lyons Campus of the VA New Jersey Health Care System, Lyons, NJ
Lyons, New Jersey, 07939
About this study
Official title: Telehealth Cognitive-Behavioral Therapy for Depression in Parkinson's Disease
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.
Read the 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.
- Conditions
- Depression, Parkinson's Disease
- Being tested
- TH-CBT, Standard Care
- Keywords
- Depression, Telehealth, Parkinson's Disease, Veterans, Care-partners, Cognitive-Behavioral Therapy, Caregiver
- Medical subject headings
- Depression, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TH-CBTBehavioural
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 CareOther
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).
| Study group | Role | What they receive |
|---|---|---|
| TH-CBT + Standard Care | Active comparator | Cognitive-behavioral therapy delivered via telehealth with a focus on decreasing depressive symptoms in Parkinson's Disease (PD). Receives: Behavioral: TH-CBT; Other: Standard Care |
| Standard Care | Other | VA standard care depression in Parkinson's Disease (PD) Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 weeks (endpoint) and 6 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2015 (estimated)
- Study start15 Jul 2016
- Primary completion10 Dec 2019
- Study completion10 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Department of Veterans Affairs, New Jersey, Rutgers Robert Wood Johnson Medical School
- Responsible party
- Sponsor
- Investigators
- Alejandro Interian, PhD, Principal investigator, Lyons Campus of the VA New Jersey Health Care System, Lyons, NJ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02475954
- Sponsor's protocol ID
- IIR 14-353
- Acronym
- TH-CBT
- Status last verified
- Jul 2023
- First submitted
- 17 Jun 2015
- Last updated
- 28 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30955991Dobkin 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.
PubMed 33710659
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telehealth Cognitive-Behavioral Therapy for Depression in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02475954
- Acronym / sponsor ID
- TH-CBT / IIR 14-353
- Conditions
- Depression, Parkinson's Disease
- Keywords
- Depression, Telehealth, Parkinson's Disease, Veterans, Care-partners, Cognitive-Behavioral Therapy, Caregiver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Department of Veterans Affairs, New Jersey, Rutgers Robert Wood Johnson Medical School
- Study start
- 15 Jul 2016 (actual)
- Primary completion
- 10 Dec 2019 (actual)
- Study completion
- 10 Dec 2019 (actual)
- First posted
- 19 Jun 2015 (estimated)
- Results
- Posted 1 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TH-CBT + Standard Care | Active comparator | Behavioral: TH-CBT, Other: Standard CareCognitive-behavioral therapy delivered via telehealth with a focus on decreasing depressive symptoms in Parkinson's Disease (PD). |
| Standard Care | Other | Other: Standard CareVA standard care depression in Parkinson's Disease (PD) |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TH-CBTThe 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). | Behavioural | TH-CBT + Standard Care |
| Standard CareStandard 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). | Other | Standard Care, TH-CBT + Standard Care |
Primary outcome
Hamilton Depression Rating Scale
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 30955991Pontone 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.
- Results publication: PubMed 33710659Dobkin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alejandro Interian, PhD principal investigator
Lyons Campus of the VA New Jersey Health Care System, Lyons, NJ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TH-CBT in people with Depression and Parkinson's Disease, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Depression Rating Scale (time frame: 10 weeks (endpoint) and 6 months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02475954, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2023.