Back to resultsTreatment Protocol for PD Fatigue Management With CBT
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CBT group
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring fatigue, cognitive behavioral therapy
Eligibility Criteria
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
Sites / Locations
- New York Institute of Technology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CBT group
Arm Description
Subjects will participate in group treatment sessions (once a week for six weeks).
Outcomes
Primary Outcome Measures
Modified Fatigue Impact Scale (MFIS)
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.)
Secondary Outcome Measures
Sleep Hygiene Index (SHI)
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.
Parkinson's Sleep Scale (PDSS-2)
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.
Parkinson's Disease Quality of Life Questionnaire (PDQ-39)
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.
Full Information
NCT ID
NCT03747848
First Posted
October 31, 2018
Last Updated
January 25, 2022
Sponsor
New York Institute of Technology
1. Study Identification
Unique Protocol Identification Number
NCT03747848
Brief Title
Treatment Protocol for PD Fatigue Management With CBT
Official Title
A Treatment Protocol for Management of Fatigue in Parkinson's Disease Using Cognitive Behavioral Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
October 19, 2018 (Actual)
Primary Completion Date
October 18, 2019 (Actual)
Study Completion Date
October 18, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York Institute of Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Fatigue affects more than half of people living with Parkinson's disease. Despite its prevalence, treatment options remain limited. To improve patient outcome, a group treatment protocol was developed for PD fatigue management primarily using cognitive behavioral therapy. The program focuses on assisting individuals with PD who experience fatigue to establish proper sleep hygiene habits and a physical exercise routine to meet the end goal of reducing fatigue. The aim of the group is to change negative thoughts and behavior regarding changing sleep hygiene habits and exercise behavior into positive ones. This is a feasibility project that aims to explore the feasibility of this protocol as well as to produce a treatment protocol that is able to be replicated by other occupational therapists and health professionals who serve the PD population.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
fatigue, cognitive behavioral therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CBT group
Arm Type
Experimental
Arm Description
Subjects will participate in group treatment sessions (once a week for six weeks).
Intervention Type
Behavioral
Intervention Name(s)
CBT group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Modified Fatigue Impact Scale (MFIS)
Description
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.)
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
Secondary Outcome Measure Information:
Title
Sleep Hygiene Index (SHI)
Description
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.
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
Title
Parkinson's Sleep Scale (PDSS-2)
Description
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.
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
Title
Parkinson's Disease Quality of Life Questionnaire (PDQ-39)
Description
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.
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ling Wan-Albert, MS
Organizational Affiliation
New York Institute of Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York Institute of Technology
City
Old Westbury
State/Province
New York
ZIP/Postal Code
11568
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Treatment Protocol for PD Fatigue Management With CBT
We'll reach out to this number within 24 hrs