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A Trial of Neurocognitive and Supportive Therapy Interventions for Individuals With Parkinson's Disease

Primary Purpose

Parkinson's Disease, Mild Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Memory and Problem-Solving Intervention
Supportive Therapy
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson Disease, Mild Cognitive Impairment, Cognition, Executive Function, Learning, Memory, Problem Solving

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of Parkinson's Disease
  • Clinical diagnosis of Mild Cognitive Impairment

Exclusion Criteria:

  • Clinical diagnosis of Dementia
  • Clinical diagnosis of other Parkinson's Disease-associated comorbid conditions (e.g., severe anxiety, depression, excessive daytime sleepiness, or psychosis) that significantly influence cognitive testing

Sites / Locations

  • VCU Parkinson's and Movement Disorders Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Supportive Therapy

Memory and Problem-Solving Intervention

Arm Description

The supportive therapy offers patients and support persons the opportunity to discuss and reflect upon both Parkinson's Disease and non-Parkinson's Disease related problems.

The memory and problem solving training consists of a day calendar manual and note taking system and problem solving techniques. The neurocognitive memory intervention was adapted from a 6-week manualized day calendar and note taking system previously evaluated in an amnestic MCI sample and a brain tumor sample. The problem solving intervention was adapted from an originally 12-week intervention, which was later adapted into a 6-week brain tumor sample.

Outcomes

Primary Outcome Measures

California Verbal Learning Test-II Long Delay Free Recall Scaled Score Change Over 10 Weeks
Change in California Verbal Learning Test-II Long Delay Free Recall Scaled Score from Baseline and 10 weeks

Secondary Outcome Measures

Linear Analog Scale Assessment Overall Well Being Raw Score Change Over 10 Weeks
Change in Linear Analog Scale Assessment Overall Well Being Raw Score from Baseline and 10 weeks

Full Information

First Posted
July 13, 2012
Last Updated
January 6, 2016
Sponsor
Virginia Commonwealth University
Collaborators
Michael J. Fox Foundation for Parkinson's Research
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1. Study Identification

Unique Protocol Identification Number
NCT01646333
Brief Title
A Trial of Neurocognitive and Supportive Therapy Interventions for Individuals With Parkinson's Disease
Official Title
A Randomized Controlled Trial of Neurocognitive and Supportive Therapy Interventions for Individuals With Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
Michael J. Fox Foundation for Parkinson's Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This randomized, controlled trial (RCT) evaluates the benefits of memory and problem solving training compared to supportive therapy in individuals with Parkinson's Disease with Mild Cognitive Impairment (MCI) and their support persons. Participants will be randomly assigned to receive memory and problem solving training or supportive therapy for 2-months. A 6-month follow up evaluation will establish if benefits remain over time. Impact of these therapies on thinking abilities, physical health, and patient and support person ratings of thinking skills, mood and quality of life will be evaluated. The memory and problem solving training is hypothesized to result in greater improvements and/or stability of function on neuropsychological tests of attention, working memory, learning, and memory skills compared to the supportive therapy condition. Both conditions are hypothesized to result in improved mood and quality of life ratings. Results from this study will determine whether memory and problem solving therapies and supportive therapy are easily used by and beneficial for individuals with Parkinson's Disease and Mild Cognitive Impairment. If positive benefit is observed, information from this study will be used to further optimize these therapies for larger trials designed to evaluate the value of the therapies for individuals with Parkinson's Disease and their support persons.
Detailed Description
The memory and problem solving training consists of a day calendar manual and note taking system and problem solving techniques. The supportive therapy offers patients and support persons the opportunity to discuss and reflect upon both Parkinson's Disease and non-Parkinson's Disease related problems.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, Mild Cognitive Impairment
Keywords
Parkinson Disease, Mild Cognitive Impairment, Cognition, Executive Function, Learning, Memory, Problem Solving

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supportive Therapy
Arm Type
Active Comparator
Arm Description
The supportive therapy offers patients and support persons the opportunity to discuss and reflect upon both Parkinson's Disease and non-Parkinson's Disease related problems.
Arm Title
Memory and Problem-Solving Intervention
Arm Type
Experimental
Arm Description
The memory and problem solving training consists of a day calendar manual and note taking system and problem solving techniques. The neurocognitive memory intervention was adapted from a 6-week manualized day calendar and note taking system previously evaluated in an amnestic MCI sample and a brain tumor sample. The problem solving intervention was adapted from an originally 12-week intervention, which was later adapted into a 6-week brain tumor sample.
Intervention Type
Behavioral
Intervention Name(s)
Memory and Problem-Solving Intervention
Intervention Description
8 weekly 1 hour sessions of memory compensation and problem-solving strategies
Intervention Type
Behavioral
Intervention Name(s)
Supportive Therapy
Intervention Description
8 weekly 1 hour sessions of non-directive supportive therapy.
Primary Outcome Measure Information:
Title
California Verbal Learning Test-II Long Delay Free Recall Scaled Score Change Over 10 Weeks
Description
Change in California Verbal Learning Test-II Long Delay Free Recall Scaled Score from Baseline and 10 weeks
Time Frame
Change from Baseline in California Verbal Learning Test-II Long Delay Free Recall Scaled Score at 10 weeks
Secondary Outcome Measure Information:
Title
Linear Analog Scale Assessment Overall Well Being Raw Score Change Over 10 Weeks
Description
Change in Linear Analog Scale Assessment Overall Well Being Raw Score from Baseline and 10 weeks
Time Frame
Change from Baseline in Linear Analog Scale Assessment Overall Well Being Raw Score at 10 weeks
Other Pre-specified Outcome Measures:
Title
California Verbal Learning Test-II Long Delay Free Recall Scaled Score Change Over 6 Months
Description
Change in California Verbal Learning Test-II Long Delay Free Recall Scaled Score from Baseline and 6 months
Time Frame
Change from Baseline in California Verbal Learning Test-II Long Delay Free Recall Scaled Score at 6 months
Title
Linear Analog Scale Assessment Overall Well Being Raw Score Change Over 6 Months
Description
Change in Linear Analog Scale Assessment Overall Well Being Raw Score from Baseline and 6 months
Time Frame
Change from Baseline in Linear Analog Scale Assessment Overall Well Being Raw Score at 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of Parkinson's Disease Clinical diagnosis of Mild Cognitive Impairment Exclusion Criteria: Clinical diagnosis of Dementia Clinical diagnosis of other Parkinson's Disease-associated comorbid conditions (e.g., severe anxiety, depression, excessive daytime sleepiness, or psychosis) that significantly influence cognitive testing
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah K Lageman, Ph.D.
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James P Bennett, Jr., M.D., Ph.D.
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Study Chair
Facility Information:
Facility Name
VCU Parkinson's and Movement Disorders Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Trial of Neurocognitive and Supportive Therapy Interventions for Individuals With Parkinson's Disease

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