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

January 6, 2016 updated by: Virginia Commonwealth University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23230
        • VCU Parkinson's and Movement Disorders Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change in California Verbal Learning Test-II Long Delay Free Recall Scaled Score from Baseline and 10 weeks
Change from Baseline in California Verbal Learning Test-II Long Delay Free Recall Scaled Score at 10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change in Linear Analog Scale Assessment Overall Well Being Raw Score from Baseline and 10 weeks
Change from Baseline in Linear Analog Scale Assessment Overall Well Being Raw Score at 10 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change in California Verbal Learning Test-II Long Delay Free Recall Scaled Score from Baseline and 6 months
Change from Baseline in California Verbal Learning Test-II Long Delay Free Recall Scaled Score at 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
Change in Linear Analog Scale Assessment Overall Well Being Raw Score from Baseline and 6 months
Change from Baseline in Linear Analog Scale Assessment Overall Well Being Raw Score at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Commonwealth University

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

July 13, 2012

First Submitted That Met QC Criteria

July 18, 2012

First Posted (Estimate)

July 20, 2012

Study Record Updates

Last Update Posted (Estimate)

January 8, 2016

Last Update Submitted That Met QC Criteria

January 6, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PT107964

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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