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出境医 / 临床实验 / Mindfulness Based Stress Reduction for Parkinson's Disease: A Longitudinal Study (MBSR)
Mindfulness Based Stress Reduction for Parkinson's Disease: A Longitudinal Study (MBSR)
Study Description
Brief Summary:
To investigate the efficacy of Mindfulness-based Stress Reduction (MBSR),to improve HRQoL, cognition, and mood, as well as to determine the longevity of the treatment response in individuals with Parkinson's disease (PD).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Parkinson's Disease Mindfulness Based Stress Reduction Quality of Life | Behavioral: Mindfulness Based Stress Reduction Radiation: Creative Education Care | Not Applicable |
Detailed Description:
Eligible study participants will be randomly assigned to one of two interventions: 1) Mindfulness Based Stress Reduction for Parkinson's disease; MBSR-PD or 2) Creative Education Care (CEC). Study visits may be held remotely, via online video format (Webex). Interventions are held within a group format consisting of approximately 6-10 individuals with PD. Groups will meet once per week for over a 9-week period. All participants will be administered a battery of neuropsychological tests to measure HRQoL, cognition (e.g., executive function, attention, memory), and mood (i.e., anxiety, depression, and apathy), as well as motor symptoms, disease severity, and mindfulness engagement/practice. Tests will be administered at baseline, 9 weeks (post-treatment), and 6- and 12-months (follow-up assessments) by an examiner blinded to group assignment.
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 88 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Investigator, Outcomes Assessor) |
| Masking Description: | Investigator and Assessor are blinded to group assignment. |
| Primary Purpose: | Treatment |
| Official Title: | Mindfulness Based Stress Reduction for Parkinson's Disease: A Longitudinal Study |
| Actual Study Start Date : | January 1, 2020 |
| Estimated Primary Completion Date : | November 1, 2024 |
| Estimated Study Completion Date : | November 1, 2024 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: Mindfulness Based Stress Reduction
MBSR consists of 6-10 individuals with PD and led by a trained instructor who is not involved in the clinical care or assessment of these participants.
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Behavioral: Mindfulness Based Stress Reduction
MBSR consists of 6-10 individuals with PD and led by a trained instructor who is not involved in the clinical care or assessment of these participants.
Other Name: MBSR
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Placebo Comparator: Creative Education Care
Creative Education Care consists of 6-10 individuals with PD and led by a trained instructor who is not involved in the clinical care or assessment of these participants.
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Radiation: Creative Education Care
Creative Education Care consists of 6-10 individuals with PD and led by a trained instructor who is not involved in the clinical care or assessment of these participants.
Other Name: control group
|
Outcome Measures
Primary Outcome Measures :
- Change in Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index [ Time Frame: 0-9 weeks and 0-62 weeks ]Parkinson's disease Quality of Life (self-report); range = 0-156. Higher scores = poorer quality of life.
- Change in Wechsler Adult Intelligence Scale-IV (WAIS-IV) Matrix Reasoning Test total score [ Time Frame: 0-9 weeks and 0-62 weeks ]Objective measure of executive function; range = 0-26; higher scores = better executive function
- Change in State-Trait Anxiety Inventory (STAI) total score [ Time Frame: 0-9 weeks and 0-62 weeks ]Measure of anxiety; range of possible scores from 20-80; "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).
Eligibility Criteria
| Ages Eligible for Study: | 41 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Clinical diagnosis of PD based on UK Brain Bank Criteria
- >40 years of age
Exclusion Criteria:
- Secondary causes of Parkinsonism (e.g. corticobasal degeneration, progressive supranuclear palsy, drug-induced parkinsonism)
- Other neurological conditions (e.g. stroke)
- Clinical diagnosis of dementia based on any previous neuropsychological testing
- Psychosis, antipsychotic treatment or treatment for substance abuse
- Uncorrected vision or hearing to adequately participate in the intervention
- Prior formal training in MBSR or regular current MBSR practice
- Recent or new participation in a psychological/behavioral treatment, such as Cognitive Behavioral Therapy (CBT)
- Active/current suicidal ideation
Contacts and Locations
Contacts
| Contact: Nicole M Whiteley, BS | (858) 552-8585 ext 3517 | Nicole.Whiteley@va.gov | |
| Contact: Dawn M Schiehser, PhD | Dawn.Schiehser@va.gov |
Locations
| United States, California | |
| VA San Diego Healthcare System, San Diego, CA | Recruiting |
| San Diego, California, United States, 92161 | |
| Contact: Patricia A Franklin, AA BS 858-552-8585 ext 7441 patricia.franklin2@va.gov | |
| Principal Investigator: Dawn M. Schiehser, PhD | |
Sponsors and Collaborators
VA Office of Research and Development
Investigators
| Principal Investigator: | Dawn M. Schiehser, PhD | VA San Diego Healthcare System, San Diego, CA |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 24, 2019 | ||||||||
| First Posted Date ICMJE | June 26, 2019 | ||||||||
| Last Update Posted Date | April 5, 2021 | ||||||||
| Actual Study Start Date ICMJE | January 1, 2020 | ||||||||
| Estimated Primary Completion Date | November 1, 2024 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Mindfulness Based Stress Reduction for Parkinson's Disease: A Longitudinal Study | ||||||||
| Official Title ICMJE | Mindfulness Based Stress Reduction for Parkinson's Disease: A Longitudinal Study | ||||||||
| Brief Summary | To investigate the efficacy of Mindfulness-based Stress Reduction (MBSR),to improve HRQoL, cognition, and mood, as well as to determine the longevity of the treatment response in individuals with Parkinson's disease (PD). | ||||||||
| Detailed Description | Eligible study participants will be randomly assigned to one of two interventions: 1) Mindfulness Based Stress Reduction for Parkinson's disease; MBSR-PD or 2) Creative Education Care (CEC). Study visits may be held remotely, via online video format (Webex). Interventions are held within a group format consisting of approximately 6-10 individuals with PD. Groups will meet once per week for over a 9-week period. All participants will be administered a battery of neuropsychological tests to measure HRQoL, cognition (e.g., executive function, attention, memory), and mood (i.e., anxiety, depression, and apathy), as well as motor symptoms, disease severity, and mindfulness engagement/practice. Tests will be administered at baseline, 9 weeks (post-treatment), and 6- and 12-months (follow-up assessments) by an examiner blinded to group assignment. | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Investigator, Outcomes Assessor) Masking Description: Investigator and Assessor are blinded to group assignment. Primary Purpose: Treatment
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
88 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | November 1, 2024 | ||||||||
| Estimated Primary Completion Date | November 1, 2024 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 41 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03998462 | ||||||||
| Other Study ID Numbers ICMJE | D3154-R | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | VA Office of Research and Development | ||||||||
| Study Sponsor ICMJE | VA Office of Research and Development | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| PRS Account | VA Office of Research and Development | ||||||||
| Verification Date | March 2021 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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