NCT02475954

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
174

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Jul 2016

Typical duration for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 19, 2015

Completed
1.1 years until next milestone

Study Start

First participant enrolled

July 15, 2016

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2019

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

April 1, 2021

Completed
Last Updated

July 28, 2023

Status Verified

July 1, 2023

Enrollment Period

3.4 years

First QC Date

June 17, 2015

Results QC Date

February 4, 2021

Last Update Submit

July 19, 2023

Conditions

DepressionParkinson's Disease

Keywords

DepressionTelehealthParkinson's DiseaseVeteransCare-partnersCognitive-Behavioral TherapyCaregiver

Outcome Measures

Primary Outcomes (1)

  • 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

Other Outcomes (1)

  • Family Empowerment Scale

    10 weeks (endpoint) and 6 months post-treatment

Study Arms (2)

TH-CBT + Standard Care

ACTIVE COMPARATOR

Cognitive-behavioral therapy delivered via telehealth with a focus on decreasing depressive symptoms in Parkinson's Disease (PD).

Behavioral: TH-CBTOther: Standard Care

Standard Care

OTHER

VA standard care depression in Parkinson's Disease (PD)

Other: Standard Care

Interventions

TH-CBTBEHAVIORAL

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).

TH-CBT + Standard Care
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).

Standard CareTH-CBT + Standard Care

Eligibility Criteria

Age35 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lyons Campus of the VA New Jersey Health Care System, Lyons, NJ

Lyons, New Jersey, 07939, United States

Location

Related Publications (2)

  • 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.

    PMID: 30955991RESULT

  • 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.

    PMID: 33710659RESULT

MeSH Terms

Conditions

DepressionParkinson Disease

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorParkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Limitations and Caveats

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.

Results Point of Contact

Title
Roseanne D. Dobkin
Organization
Rutgers - Robert Wood Johnson Medical School
dobkinro@rutgers.edu
732-235-4051

Study Officials

  • Alejandro Interian, PhD

    Lyons Campus of the VA New Jersey Health Care System, Lyons, NJ

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2015

First Posted

June 19, 2015

Study Start

July 15, 2016

Primary Completion

December 10, 2019

Study Completion

December 10, 2019

Last Updated

July 28, 2023

Results First Posted

April 1, 2021

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)