Parkinson DiseaseSMART-PDNCT04903769
Stress Management and Resiliency Training Program for Parkinson's Disease
A study testing Stress Management and Resiliency Training Program for Parkinson's Disease (SMART-PD) in people with Parkinson Disease, run by Stony Brook University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Stress Management and Resiliency Training Program for Parkinson's Disease (SMART-PD)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2020to 25 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Previous participation in the SMART program
Trial locations and contacts
1 site in 1 country.
United States1 site
Stony Brook Medical Center
Stony Brook, New York, 11794
About this study
Official title: Stress Management and Resiliency Training Program for Parkinson's Disease Patients and Their Caregivers (SMART-PD)
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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- Stress Management and Resiliency Training Program for Parkinson's Disease (SMART-PD)
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress Management and Resiliency Training Program for Parkinson's Disease (SMART-PD)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's Patients and Caregivers | Other | 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 Receives: Behavioral: Stress Management and Resiliency Training Program for Parkinson's Disease (SMART-PD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment and participation
The number of participants who enroll and fully participate in the program will be used to measure the feasibility of using SMART-PD for patients with Parkinson's disease and their caregivers.
Measured: One year
SMART Group Feedback Form
Designed to assess the accessibility of the SMART-PD program, The SMART Group Feedback form contains six Likert-scale questions such as, "On a 10-point scale, how would you rate the following items: helpfulness/effectiveness of SMART group" and four open-ended questions such as, "What has been the most helpful part of the group for you?"
Measured: Eight weeks
Change from Baseline General Quality of Life at 1-week post-intervention
The Short Form Health Survey (SF-36) is a quality of life measure that assesses eight aspects of health through the use of 36 multiple choice, yes/no, and Likert-scale items. An example question is, "Compared to one year ago, how would you rate your health in general now?" The SF-36 consists of eight scales (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health). Scores are converted into z-scores with a scale of 0-100 with 0 indicating the greatest level of disability and 100 the least.
Measured: 1-week post-intervention
Change from Baseline Parkinson's disease Quality of Life at 1-week post-intervention
The Parkinson's Disease Quality of Life Questionnaire (PDQ-39) consists of 39 Likert-scale questions asking how often in the last month the participant experienced something due to having Parkinson's disease. An example question is, "Had difficulty doing leisure activities which you would like to do?" with response options for all questions being "never", "occasionally", "sometimes", "Often", and "always or cannot do at all". The overall score from the PDQ-39 can be used for a global assessment, and scores can also be broken down into the following individual scales: mobility, activities of daily living, emotional well-being, stigma, social support, cognitions, communications and bodily discomfort.
Measured: 1-week post-intervention
Change from Baseline Healthy Lifestyle Behaviors at 1-week post-intervention
The Lifestyle Profile II contains 52 Likert-scale items pertaining to healthy lifestyle behaviors in the areas of healthy eating, physical activity, spirituality, stress management, health responsibility, and interpersonal relations. Respondents are asked to indicate the frequency with which they engage in behaviors with the response options of "Never", "Sometimes", "Often", and "Routinely". An example question is, "Take some time for relaxation each day." Scores range from 52-208 and fall into the categories of poor (52-90), moderate (91-129), good (130-168), an excellent (169-208).
Measured: 1-week post-intervention
Change from Baseline Caregiver Burden at 1-week post-intervention
The Zarit Burden Interview Short Form (ZBI-12) is designed to measure caregiver burden and consists of 12 Likert-scale items that ask respondents to if they feel a certain way "Never", "Rarely", "Sometimes", "Quite Frequently" or "Nearly Always". An example question is, "That because of the time you spend with your relative that you don't have enough time for yourself?" Scores range from 0-48 and are grouped into the categories of mild burden (0-10), mild to moderate burden (10-20), and high burden (>20).
Measured: 1-week post-intervention
Change from Baseline cognitive functioning at 1-week post-intervention
The Montreal Cognitive Assessment (MoCA) is a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. Examples of questions include drawing a clock at ten past eleven and serial subtraction starting at 100. Scores on the MoCA range form 0-30 with a score of 26 or higher generally considered normal.
Measured: 1-week post-intervention
Change from Baseline Coping at 1-week post-intervention
Ways of Coping is a 66 Likert-scale item instrument that assesses behaviors used to cope with everyday stressful encounters. Response options are "Not Used", "Used Somewhat", "Used Quite A Bit", and "Used A Great Deal". Respondents are asked to describe a stressful situation they experienced in the past week and to respond to each item asking to what extent they used that way of coping in that situation. Examples of items are, "Turned to work or substitute activity to take my mind off things" and "Found new faith". The items comprise eight scales: confrontive coping, distancing, self-controlling, seeking social support, accepting responsibility, escape-avoidance, planful problem solving, and positive reappraisal.
Measured: 1-week post-intervention
Change from Baseline Depression Symptoms at 1-week post-intervention
The Patient Health Questionnaire (PHQ-9) is used to measure depressive symptoms. The nine Likert-scale items have response options of, "Not at all", "Several days", "More than half the days", and "Nearly every day" and include questions such as, "Little interest or pleasure in doing things" and "Poor appetite or overeating." Scores range from 0-27 with 0 indicating no depression and five bands of scores ranges indicating minimal (1-4), mild (5-9), moderate (10-14), moderately severe (15-19), and severe depression (20-27).
Measured: 1-week post-intervention
Change from Baseline Anxiety Symptoms at 1-week post-intervention
The Generalized Anxiety Disorder (GAD-7) consists of seven Likert-scale items designed to measure anxiety. Response options are, "Not at all", "Several Days", "More than half the days", and "Nearly every day" and item examples are, "Trouble relaxing" and "Becoming easily annoyed or irritated". Scores range form 0-21 with scores of 8 or higher indicating a probable anxiety disorder.
Measured: 1-week post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start3 Aug 2020
- Primary completion25 Jan 2022
- Study completion25 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Collaborators
- Parkinson's Disease Foundation
- Responsible party
- Principal investigator, Adam Gonzalez, Stony Brook University
- Investigators
- Adam Gonzalez, PhD, Principal investigator, Stony Brook Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04903769
- Sponsor's protocol ID
- 663519
- Acronym
- SMART-PD
- Status last verified
- Mar 2025
- First submitted
- 24 May 2021
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Management and Resiliency Training Program for Parkinson's Disease Patients and Their Caregivers (SMART-PD)
- ClinicalTrials.gov ID
- NCT04903769
- Acronym / sponsor ID
- SMART-PD / 663519
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Collaborators
- Parkinson's Disease Foundation
- Study start
- 3 Aug 2020 (actual)
- Primary completion
- 25 Jan 2022 (actual)
- Study completion
- 25 Jan 2022 (actual)
- First posted
- 27 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| Parkinson's Patients and Caregivers | Other | Behavioral: Stress Management and Resiliency Training Program for Parkinson's Disease (SMART-PD)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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Previous participation in the SMART program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Parkinson's Patients and Caregivers |
Primary outcome
Enrollment and participation
Time frame: One year
The number of participants who enroll and fully participate in the program will be used to measure the feasibility of using SMART-PD for patients with Parkinson's disease and their caregivers.
SMART Group Feedback Form
Time frame: Eight weeks
Designed to assess the accessibility of the SMART-PD program, The SMART Group Feedback form contains six Likert-scale questions such as, "On a 10-point scale, how would you rate the following items: helpfulness/effectiveness of SMART group" and four open-ended questions such as, "What has been the most helpful part of the group for you?"
Change from Baseline General Quality of Life at 1-week post-intervention
Time frame: 1-week post-intervention
The Short Form Health Survey (SF-36) is a quality of life measure that assesses eight aspects of health through the use of 36 multiple choice, yes/no, and Likert-scale items. An example question is, "Compared to one year ago, how would you rate your health in general now?" The SF-36 consists of eight scales (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health). Scores are converted into z-scores with a scale of 0-100 with 0 indicating the greatest level of disability and 100 the least.
Change from Baseline Parkinson's disease Quality of Life at 1-week post-intervention
Time frame: 1-week post-intervention
The Parkinson's Disease Quality of Life Questionnaire (PDQ-39) consists of 39 Likert-scale questions asking how often in the last month the participant experienced something due to having Parkinson's disease. An example question is, "Had difficulty doing leisure activities which you would like to do?" with response options for all questions being "never", "occasionally", "sometimes", "Often", and "always or cannot do at all". The overall score from the PDQ-39 can be used for a global assessment, and scores can also be broken down into the following individual scales: mobility, activities of daily living, emotional well-being, stigma, social support, cognitions, communications and bodily discomfort.
Change from Baseline Healthy Lifestyle Behaviors at 1-week post-intervention
Time frame: 1-week post-intervention
The Lifestyle Profile II contains 52 Likert-scale items pertaining to healthy lifestyle behaviors in the areas of healthy eating, physical activity, spirituality, stress management, health responsibility, and interpersonal relations. Respondents are asked to indicate the frequency with which they engage in behaviors with the response options of "Never", "Sometimes", "Often", and "Routinely". An example question is, "Take some time for relaxation each day." Scores range from 52-208 and fall into the categories of poor (52-90), moderate (91-129), good (130-168), an excellent (169-208).
Change from Baseline Caregiver Burden at 1-week post-intervention
Time frame: 1-week post-intervention
The Zarit Burden Interview Short Form (ZBI-12) is designed to measure caregiver burden and consists of 12 Likert-scale items that ask respondents to if they feel a certain way "Never", "Rarely", "Sometimes", "Quite Frequently" or "Nearly Always". An example question is, "That because of the time you spend with your relative that you don't have enough time for yourself?" Scores range from 0-48 and are grouped into the categories of mild burden (0-10), mild to moderate burden (10-20), and high burden (>20).
Change from Baseline cognitive functioning at 1-week post-intervention
Time frame: 1-week post-intervention
The Montreal Cognitive Assessment (MoCA) is a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. Examples of questions include drawing a clock at ten past eleven and serial subtraction starting at 100. Scores on the MoCA range form 0-30 with a score of 26 or higher generally considered normal.
Change from Baseline Coping at 1-week post-intervention
Time frame: 1-week post-intervention
Ways of Coping is a 66 Likert-scale item instrument that assesses behaviors used to cope with everyday stressful encounters. Response options are "Not Used", "Used Somewhat", "Used Quite A Bit", and "Used A Great Deal". Respondents are asked to describe a stressful situation they experienced in the past week and to respond to each item asking to what extent they used that way of coping in that situation. Examples of items are, "Turned to work or substitute activity to take my mind off things" and "Found new faith". The items comprise eight scales: confrontive coping, distancing, self-controlling, seeking social support, accepting responsibility, escape-avoidance, planful problem solving, and positive reappraisal.
Change from Baseline Depression Symptoms at 1-week post-intervention
Time frame: 1-week post-intervention
The Patient Health Questionnaire (PHQ-9) is used to measure depressive symptoms. The nine Likert-scale items have response options of, "Not at all", "Several days", "More than half the days", and "Nearly every day" and include questions such as, "Little interest or pleasure in doing things" and "Poor appetite or overeating." Scores range from 0-27 with 0 indicating no depression and five bands of scores ranges indicating minimal (1-4), mild (5-9), moderate (10-14), moderately severe (15-19), and severe depression (20-27).
Change from Baseline Anxiety Symptoms at 1-week post-intervention
Time frame: 1-week post-intervention
The Generalized Anxiety Disorder (GAD-7) consists of seven Likert-scale items designed to measure anxiety. Response options are, "Not at all", "Several Days", "More than half the days", and "Nearly every day" and item examples are, "Trouble relaxing" and "Becoming easily annoyed or irritated". Scores range form 0-21 with scores of 8 or higher indicating a probable anxiety disorder.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam Gonzalez, PhD principal investigator
Stony Brook Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress Management and Resiliency Training Program for Parkinson's Disease (SMART-PD) in people with Parkinson Disease, run by Stony Brook University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment and participation (time frame: One year). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.