Text Size

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

This study is currently recruiting participants.
Verified July 2012 by Virginia Commonwealth University
Sponsor:
Collaborator:
Michael J. Fox Foundation for Parkinson's Research
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01646333
First received: July 13, 2012
Last updated: July 18, 2012
Last verified: July 2012
History of Changes
  Purpose

This RCT evaluates the benefits of memory and problem solving training compared to supportive therapy in individuals with Parkinson's Disease with Mild Cognitive Impairment 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.


Condition Intervention
Parkinson's Disease
Mild Cognitive Impairment
 Behavioral: Memory and Problem-Solving Intervention
Behavioral: Supportive Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Neurocognitive and Supportive Therapy Interventions for Individuals With Parkinson's Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • California Verbal Learning Test-II Long Delay Free Recall Scaled Score Change Over 10 Weeks [ Time Frame: Change from Baseline in California Verbal Learning Test-II Long Delay Free Recall Scaled Score at 10 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Change from Baseline in Linear Analog Scale Assessment Overall Well Being Raw Score at 10 weeks ] [ Designated as safety issue: No ]
    Change in Linear Analog Scale Assessment Overall Well Being Raw Score from Baseline and 10 weeks


Other Outcome Measures:
  • California Verbal Learning Test-II Long Delay Free Recall Scaled Score Change Over 6 Months [ Time Frame: Change from Baseline in California Verbal Learning Test-II Long Delay Free Recall Scaled Score at 6 months ] [ Designated as safety issue: No ]
    Change in California Verbal Learning Test-II Long Delay Free Recall Scaled Score from Baseline and 6 months

  • Linear Analog Scale Assessment Overall Well Being Raw Score Change Over 6 Months [ Time Frame: Change from Baseline in Linear Analog Scale Assessment Overall Well Being Raw Score at 6 months ] [ Designated as safety issue: No ]
    Change in Linear Analog Scale Assessment Overall Well Being Raw Score from Baseline and 6 months


Estimated Enrollment: 30
Study Start Date: July 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Supportive Therapy
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.
 Behavioral: Supportive Therapy
8 weekly 1 hour sessions of non-directive supportive therapy.
Experimental: Memory and Problem-Solving Intervention
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.
 Behavioral: Memory and Problem-Solving Intervention
8 weekly 1 hour sessions of memory compensation and problem-solving strategies

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01646333

Contacts
Contact: Sarah K Lageman, Ph.D. 804-828-3747 pdcenter@vcu.edu

Locations
United States, Virginia
VCU Parkinson's and Movement Disorders Center Recruiting
Richmond, Virginia, United States, 23230
Contact: Andrea M Perseghin, M.Ed.     804-828-0819     aperseghin@vcu.edu    
Sponsors and Collaborators
Virginia Commonwealth University
Michael J. Fox Foundation for Parkinson's Research
Investigators
Principal Investigator: Sarah K Lageman, Ph.D. Virginia Commonwealth University
Study Chair: James P Bennett, Jr., M.D., Ph.D. Virginia Commonwealth University
  More Information

No publications provided

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01646333     History of Changes
Other Study ID Numbers: PT107964
Study First Received: July 13, 2012
Last Updated: July 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:
Parkinson Disease
Mild Cognitive Impairment
Cognition
Executive Function
 Learning
Memory
Problem Solving

Additional relevant MeSH terms:
Parkinson Disease
Cognition Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013