- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03747848
Treatment Protocol for PD Fatigue Management With CBT
A Treatment Protocol for Management of Fatigue in Parkinson's Disease Using Cognitive Behavioral Therapy
Study Overview
Detailed Description
PD is the second most common neurodegenerative disorder in the United States. Although PD is typically classified as a movement disorder, the non-motor symptoms (NMS) also have a negative impact on quality of life. Among the NMS, fatigue is one of the most reported and bothersome symptoms, even at the early stage of the disease. Currently there are not any clear pharmacological or rehabilitative recommendations for managing PD related fatigue.
The purpose of this study is to evaluate the feasibility and effectiveness of a developed treatment protocol specifically adapted to the Parkinson's population to address fatigue symptoms based on the best available evidence. This is a one-group, pre-post, feasibility study. It is hypothesized that an establishment of a proper sleep hygiene routine and a moderate- to intensive-exercise routine three times a week will decrease Parkinson's disease (PD) related fatigue and improve health-related quality of life. The treatment protocol focuses on assisting individuals with PD experiencing fatigue to improve sleep hygiene habits and establish physical exercise routine using cognitive behavioral therapy in a group format. Through this study, the designed program will be evaluated to determine if it will decrease self-perceived fatigue level and to improve health-related quality of life among community dwelling people with PD.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
Old Westbury, New York, United States, 11568
- New York Institute of Technology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All subjects must be diagnosed with PD, without the diagnosis of Lewy Body dementia. Atypical parkinsonism such as Progressive Supranuclear Palsy, Corticobasal Degeneration, and Multiple System Atrophy are excluded.
- All participants of the program are community dwelling.
- Subjects must age between 21 and 80. There is no gender limitation.
- All subjects report feeling sense of fatigue.
- Because the intervention involves encouraging individuals to participate in highly-intense physical exercise or multimodal moderately-intense physical exercise, cardiovascular clearance from each participant's physician (either primary care, internist, or cardiologist) is required. See attachment for cardiovascular clearance letter.
- Because cognitive behavioral therapy will be used in the interventions, and safety judgment is required when choosing an appropriate physical exercise during interventions, participants must present with adequate cognitive capacity. The Montreal Cognitive Assessment (MoCA) will be used to determine if the individual meets the cognitive criteria. MoCA score must be 24 or above, or 21 to 23 with an accompany of a caregiver to participate (MoCA total score is 30). In PD, individuals with mild neurocognitive disorder (NCD), with MoCA score 21 to 23, are able to perform everyday activities independently, although with greater effort, compensatory strategies, or accommodation
Exclusion Criteria:
- MoCA score 22 or below
- Unable to obtain physician clearance for exercise participation
- Diagnosis of Lewy Body dementia. Atypical parkinsonism
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CBT group
Subjects will participate in group treatment sessions (once a week for six weeks).
|
Each interested individual will complete eligibility screening, consent form, and pre-intervention assessment.
Demographic information such as gender, age, and number of years since diagnosis of PD will be collected.
This investigator will implement the treatment program by meeting with the participants in groups, once a week, for six weeks.
Group meetings will encourage interaction and support among group participants.
Program content includes encouraging physical exercise with higher intensity, changing poor sleeping hygiene habits, stress management, and encouraging utilization of social support.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Modified Fatigue Impact Scale (MFIS)
Time Frame: 0-week, 6-week, 12-week. This is to measure the change between three points. 0-week indicates pre-treatment status; 6-week indicates post-treatment status immediately; and 12-week indicates long-term status
|
Measurement of self-report fatigue level. There are 21 items on a 5-point scale- subjects rate from "Never"=0, "Rarely"=1, "Sometimes"=2, "Often"=3, to "Always"=4. MFIS can be aggregated into three subscales: physical, cognitive, and psychosocial. Total scores range from 0 to 84 (physical subscale: 0-36, cognitive subscale: 0-40, psychosocial subscale 0-8), with a higher score representing a greater impact of fatigue on a person's activities.) |
0-week, 6-week, 12-week. This is to measure the change between three points. 0-week indicates pre-treatment status; 6-week indicates post-treatment status immediately; and 12-week indicates long-term status
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sleep Hygiene Index (SHI)
Time Frame: 0-week, 6-week, 12-week. This is to measure the change between three points. 0-week indicates pre-treatment status; 6-week indicates post-treatment status immediately; and 12-week indicates long-term status
|
Measurement of self-report sleep hygiene behavior. There are 13-item, on a five-point scale ranging from "never"=0, "rarely"=1, "sometimes"=2, "frequent"=3, to "always"=4. Total scores range from 0 to 52, with a higher score representing poorer sleep hygiene. |
0-week, 6-week, 12-week. This is to measure the change between three points. 0-week indicates pre-treatment status; 6-week indicates post-treatment status immediately; and 12-week indicates long-term status
|
Parkinson's Sleep Scale (PDSS-2)
Time Frame: 0-week, 6-week, 12-week. This is to measure the change between three points. 0-week indicates pre-treatment status; 6-week indicates post-treatment status immediately; and 12-week indicates long-term status
|
Measurement of self-report quality of sleep. There are 15 items about various sleep and nocturnal disturbance; rated on a 5-point scale ranging from "never"=0, occasional"=1, "sometimes"=2, "often"=3 to "very often"=4. Total scores range from 0 to 60, with a higher score representing poorer sleep quality. |
0-week, 6-week, 12-week. This is to measure the change between three points. 0-week indicates pre-treatment status; 6-week indicates post-treatment status immediately; and 12-week indicates long-term status
|
Parkinson's Disease Quality of Life Questionnaire (PDQ-39)
Time Frame: 0-week, 6-week, 12-week. This is to measure the change between three points. 0-week indicates pre-treatment status; 6-week indicates post-treatment status immediately; and 12-week indicates long-term status.
|
Measurement of self-report health-related quality of life. There are 39 items, grouped in 8 subscales: Mobility (10 items), Activities of daily living (6 items), Emotional well-being (6 items), Stigma (4 items), Social support (3 items), Cognitions (4 items), Communication (3 items), Bodily discomfort (3 items). Total score is calculated for outcome. Subjects rated on a 5-point scale, ranging from "Never"=0, "occasionally"=1, "sometimes"=2, "often"=3 to "always"=4. Each dimension total scores range from 0-100, with a higher score representing worse quality of life. Dimension score is sum of scores of each item in the dimension divided by the maximum possible score of all the items in the dimension, multiplied by 100. |
0-week, 6-week, 12-week. This is to measure the change between three points. 0-week indicates pre-treatment status; 6-week indicates post-treatment status immediately; and 12-week indicates long-term status.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ling Wan-Albert, MS, New York Institute of Technology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BHS-1401
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Parkinson Disease
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedParkinson Disease 6, Early-Onset | Parkinson Disease (Autosomal Recessive, Early Onset) 7, Human | Parkinson Disease Autosomal Recessive, Early Onset | Parkinson Disease, Autosomal Recessive Early-Onset, Digenic, Pink1/Dj1United States
-
ProgenaBiomeRecruitingParkinson Disease | Parkinsons Disease With Dementia | Parkinson-Dementia Syndrome | Parkinson Disease 2 | Parkinson Disease 3 | Parkinson Disease 4United States
-
King's College LondonGlaxoSmithKlineCompletedParkinson Disease | Idiopathic Parkinson Disease | Parkinson Disease, PARK8United Kingdom
-
Ohio State UniversityCompletedParkinson's Disease | Parkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease | Parkinson Disease, Idiopathic | Parkinson's Disease, IdiopathicUnited States
-
National Yang Ming UniversityUnknownEarly Onset Parkinson Disease | Early Stage Parkinson Disease
-
Michele Tagliati, MDRecruitingREM Sleep Behavior Disorder | Symptomatic Parkinson Disease | Pre-motor Parkinson DiseaseUnited States
-
Cedars-Sinai Medical CenterEnrolling by invitationREM Sleep Behavior Disorder | Symptomatic Parkinson Disease | Pre-motor Parkinson DiseaseUnited States
-
Mahatma Gandhi Institute of Medical SciencesCompletedStroke, Parkinson' s Disease, Neurological Impairments, Tele-rehabilitationIndia
-
Merck Sharp & Dohme LLCCompletedParkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease
-
University of DeustoCompletedPARKINSON DISEASE (Disorder)Spain
Clinical Trials on CBT group
-
University of California, San FranciscoCompletedDepressionUnited States
-
Mersin UniversityNot yet recruitingMental Health IssueTurkey
-
Florida International UniversityNational Institute of Mental Health (NIMH)CompletedAnxiety DisordersUnited States
-
University of CopenhagenUniversity of Exeter; The University of Western AustraliaCompletedDepression | Recurrent DepressionDenmark
-
Icahn School of Medicine at Mount SinaiNational Institute of Mental Health (NIMH)RecruitingClinical High Risk for Psychosis (CHR)United States
-
University of MinnesotaNational Institute of Mental Health (NIMH)Completed
-
University of AlbertaAlberta Health servicesTerminated
-
National Bureau of Economic Research, Inc.National Institute on Aging (NIA); Abdul Latif Jameel Poverty Action LabNot yet recruiting
-
The University of Hong KongCompletedChronic InsomniaHong Kong
-
Karolinska InstitutetCompleted