Stress Management and Resiliency Training Program for Parkinson's Disease

NCT ID: NCT04903769

Last Updated: 2021-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-03

Study Completion Date

2022-01-31

Brief Summary

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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

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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.

Conditions

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Parkinson Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All participants will receive the SMART-PD intervention and will take baseline and follow-up assessments to determine the impact of the program
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Parkinson's Patients and Caregivers

Will participate in the 8-session SMART-PD program as a participant with Parkinson's disease or as a caregiver of a participant with Parkinson's disease

Group Type OTHER

Stress Management and Resiliency Training Program for Parkinson's Disease (SMART-PD)

Intervention Type BEHAVIORAL

SMART-PD is a manualized 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.

Interventions

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Stress Management and Resiliency Training Program for Parkinson's Disease (SMART-PD)

SMART-PD is a manualized 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Parkinson's Disease Foundation

OTHER

Sponsor Role collaborator

Stony Brook University

OTHER

Sponsor Role lead

Responsible Party

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Adam Gonzalez

Associate Professor of Psychiatry & Behavioral Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Adam Gonzalez, PhD

Role: PRINCIPAL_INVESTIGATOR

Stony Brook Medical Center

Locations

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Stony Brook Medical Center

Stony Brook, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Lucero Molina

Role: CONTACT

631-632-3797

Sandra Skinner, PhD

Role: CONTACT

631-444-7513

Other Identifiers

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663519

Identifier Type: -

Identifier Source: org_study_id

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