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Completed

NCT Number: NCT01646333

A 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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Mental Disorders Mild Cognitive Impairment Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VCU Parkinson's and Movement Disorders Center

Richmond, Virginia, 23230, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Memory and Problem-Solving Intervention

Behavioral

8 weekly 1 hour sessions of memory compensation and problem-solving strategies

Supportive Therapy

Behavioral

8 weekly 1 hour sessions of non-directive supportive therapy.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Other outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • Michael J. Fox Foundation for Parkinson's Research

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jul 20, 2012
Registry last updated
Jan 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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