Clinical Trials Directory

Trials / Completed

CompletedNCT03747848

Treatment Protocol for PD Fatigue Management With CBT

A Treatment Protocol for Management of Fatigue in Parkinson's Disease Using Cognitive Behavioral Therapy

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
14 (actual)
Sponsor
New York Institute of Technology · Academic / Other
Sex
All
Age
21 Years – 80 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
BEHAVIORALCBT groupEach 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.

Timeline

Start date
2018-10-19
Primary completion
2019-10-18
Completion
2019-10-18
First posted
2018-11-20
Last updated
2022-01-27

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03747848. Inclusion in this directory is not an endorsement.