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

NCT01646333 | Completed

• 1 other identifier: PT107964
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson's Disease; Mild Cognitive Impairment

Keywords

Parkinson Disease; Mild Cognitive Impairment; Cognition; Executive Function; Learning; Memory; Problem Solving

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Linear Analog Scale Assessment Overall Well Being Raw Score Change Over 10 Weeks

  Change from Baseline in Linear Analog Scale Assessment Overall Well Being Raw Score at 10 weeks

Other Outcomes (2)

• California Verbal Learning Test-II Long Delay Free Recall Scaled Score Change Over 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

  Change from Baseline in Linear Analog Scale Assessment Overall Well Being Raw Score at 6 months

Study Arms (2)

Supportive Therapy

ACTIVE COMPARATOR

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

Memory and Problem-Solving Intervention

EXPERIMENTAL

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

Interventions

Memory and Problem-Solving Intervention BEHAVIORAL

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

Memory and Problem-Solving Intervention

Supportive Therapy BEHAVIORAL

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

Supportive Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of Parkinson's Disease
• Clinical diagnosis of Mild Cognitive Impairment

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• Michael J. Fox Foundation for Parkinson's Research: collaborator

Study Sites (1)

VCU Parkinson's and Movement Disorders Center

Richmond, Virginia, 23230, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Cognitive Dysfunction

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Sarah K Lageman, Ph.D.

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

• James P Bennett, Jr., M.D., Ph.D.

  Virginia Commonwealth University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2012
• First Posted: July 20, 2012
• Study Start: July 1, 2012
• Primary Completion: October 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 8, 2016

Record last verified: 2016-01

Locations

US (1)