Clinical trial NCT04903769: Stress Management and Resiliency Training Program for Parkinson's Disease
Official title: Stress Management and Resiliency Training Program for Parkinson's Disease Patients and Their Caregivers (SMART-PD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Stony Brook University
Sponsor class: OTHER
Collaborators: name: Parkinson's Disease Foundation
First posted: 2021-05-27
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will receive the SMART-PD intervention and will take baseline and follow-up assessments to determine the impact of the program
Primary purpose: SUPPORTIVE_CARE

Brief summary: SMART-PD is an 8-session program designed to decrease the physiological, emotional, cognitive and behavioral effects of stress in participants with Parkinson's disease and their caregivers by teaching cognitive-behavioral techniques and relaxation skills to help participants learn to elicit the relaxation response, alter cognitive appraisals, improve healthy lifestyle behaviors and access social support. The SMART program has been shown to be effective for reducing mental health symptoms such as depression and anxiety as well as physical symptoms such as pain and in promoting positive health behaviors.

Detailed description: This is an interventional study sponsored by the Parkinson's Foundation designed to measure the feasibility, acceptability, and initial impact of the SMART-PD program on participants with a recent (less than five years) diagnosis of Parkinson's disease and their caregivers. This program provides information and tools to help patients and their caregivers cope with the new PD diagnosis and manage the stress and negative mental health symptoms (such as anxiety and depression) associated with the diagnosis.

SMART-PD is a manualized 8-week intervention that teaches cognitive-behavioral techniques and relaxation skills to help participants learn to elicit the relaxation response, alter cognitive appraisals, improve healthy lifestyle behaviors (i.e., sleep, nutrition, physical activity) and access social support.

Participants will take baseline and follow-up questionnaires to ascertain the impact of the program on outcomes such as quality of life, emotional health, coping skills, and healthy lifestyle behaviors.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Parkinson's Disease within the past three years or caregiver of someone with a recent diagnosis of Parkinson's disease
* Ability to participate in 8 weekly program sessions via Microsoft Teams or in-person (as available)
* Ability to provide informed consent

Exclusion Criteria:

* Previous participation in the SMART program

Primary outcomes:
measure: Enrollment and participation
timeFrame: One year
measure: SMART Group Feedback Form
timeFrame: Eight weeks
measure: Change from Baseline General Quality of Life at 1-week post-intervention
timeFrame: 1-week post-intervention
measure: Change from Baseline Parkinson's disease Quality of Life at 1-week post-intervention
timeFrame: 1-week post-intervention
measure: Change from Baseline Healthy Lifestyle Behaviors at 1-week post-intervention
timeFrame: 1-week post-intervention
measure: Change from Baseline Caregiver Burden at 1-week post-intervention
timeFrame: 1-week post-intervention
measure: Change from Baseline cognitive functioning at 1-week post-intervention
timeFrame: 1-week post-intervention
measure: Change from Baseline Coping at 1-week post-intervention
timeFrame: 1-week post-intervention
measure: Change from Baseline Depression Symptoms at 1-week post-intervention
timeFrame: 1-week post-intervention
measure: Change from Baseline Anxiety Symptoms at 1-week post-intervention
timeFrame: 1-week post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Stony Brook Medical Center
state: New York
Study officials:
affiliation: Stony Brook Medical Center
name: Adam Gonzalez, PhD
role: PRINCIPAL_INVESTIGATOR
References: