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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Parkinson's Disease, Mild Cognitive Impairment

Intervention / Treatment
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* Behavioral: Memory and Problem-Solving Intervention
* Behavioral: Supportive Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Supportive Therapy<br>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<br>* 8 weekly 1 hour sessions of non-directive supportive therapy.<br>|
| Experimental: Memory and Problem-Solving Intervention<br>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<br>* 8 weekly 1 hour sessions of memory compensation and problem-solving strategies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson Disease, Mild Cognitive Impairment, Cognition, Executive Function, Learning, Memory, Problem Solving