Treatment Protocol for PD Fatigue Management With CBT

NCT ID: NCT03747848

Last Updated: 2022-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-19
• Study Completion Date: 2019-10-18

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CBT group

Subjects will participate in group treatment sessions (once a week for six weeks).

Group Type: EXPERIMENTAL

CBT group

Intervention Type: BEHAVIORAL

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.

Interventions

CBT group

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. 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.

2. All participants of the program are community dwelling.

3. Subjects must age between 21 and 80. There is no gender limitation.

4. All subjects report feeling sense of fatigue.

5. 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.

6. 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

1. MoCA score 22 or below

2. Unable to obtain physician clearance for exercise participation

3. Diagnosis of Lewy Body dementia. Atypical parkinsonism

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

New York Institute of Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ling Wan-Albert, MS

Role: PRINCIPAL_INVESTIGATOR

New York Institute of Technology

Locations

New York Institute of Technology

Old Westbury, New York, United States

Countries

United States

Other Identifiers

BHS-1401

Identifier Type: -

Identifier Source: org_study_id