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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01646333
• Other study ID #: PT107964
• Status: Completed
• Phase: N/A
• First received: July 13, 2012
• Last updated: January 6, 2016
• Start date: July 2012
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cognition Disorders
• Mild Cognitive Impairment
• Parkinson Disease
• Parkinson's Disease

Intervention

Behavioral:
• Memory and Problem-Solving Intervention
8 weekly 1 hour sessions of memory compensation and problem-solving strategies
• Supportive Therapy
8 weekly 1 hour sessions of non-directive supportive therapy.

Locations

Country	Name	City	State
United States	VCU Parkinson's and Movement Disorders Center	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	Michael J. Fox Foundation for Parkinson's Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	California Verbal Learning Test-II Long Delay Free Recall Scaled Score Change Over 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	No
Other	Linear Analog Scale Assessment Overall Well Being Raw Score Change Over 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	No
Primary	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	No
Secondary	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	No