- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03776890
DeStress for Health: Partnering With Granville and Vance Counties to Reduce Stress and Cancer Risk
March 3, 2023 updated by: Duke University
The purpose of this research study is to determine whether a positive psychology intervention paired with a health behavior intervention is successful in decreasing perceived stress and increasing positive affect in residents of Vance and Granville County.
Participants will attend 4 classes that occur once a week.
The first class will focus on nutrition, the second class will focus on exercise, the 3rd class will focus on tobacco use, and the 4th class that will review the previous 3 classes and help participants incorporate the strategies taught in the Destress for Health Program into their everyday lives.
The duration of each class is 1 hour and the classes will be held once a week for a total of 4 weeks.
Participants in this research study will be asked to complete 2 surveys.
The first survey will occur during class 1, and will ask participants about their demographic information, health behaviors, stress levels, emotions, and behaviors.
The second survey will be conducted over the phone and will occur 30-days after the final class and will ask participants about their health behaviors, stress levels, emotions, behaviors and also about whether or not they felt the classes they attended were useful to them.
Total study duration is about 2 months.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
29
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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North Carolina
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Oxford, North Carolina, United States, 27565
- Granville Vance Public Health Department
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Live in Granville or Vance Counties;
- >18 years old;
- Interested in participating a stress reduction study
- Speak English
Exclusion Criteria:
- Does Not Live in Granville or Vance Counties
- Under 18 years of age
- Not interested in participating in a stress reduction study
- Does not speak English
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: DeStress for Health Program Participants
Rural residents 18 years and older of Granville and Vance counties (n=30) will be recruited to participate.
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The program will consist of 4 in person sessions that are based on empirically supported Positive Psychosocial Well-Being PPWB components including Optimism, Mindfulness, Positive Reprisal as well as Strengths-based Cognitive Behavioral Therapy (SBCBT) to improve behavioral self-regulation towards health-related goals.
Research staff will conduct face-to-face surveys with participants at baseline and at end of program.
Finally, we will conduct a phone-based survey 30 days after program completion to assess sustainability of intervention effects.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Recruited in a 6-Month Time-frame
Time Frame: 6 Months
|
Measured via subject enrollment log
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6 Months
|
Percentage of Participants That Stay in Study for Duration
Time Frame: 3 Months
|
Measured via subject enrollment log
|
3 Months
|
Percentage of Participants That Attend All Intervention Sessions
Time Frame: 3 Months
|
Measured via subject enrollment log
|
3 Months
|
Percent of Participants Rating Intervention as Useful
Time Frame: 3 Months
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Measured on a scale from 1-5 with 1 being "Not Useful at All" and 5 being "Extremely Useful".
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3 Months
|
Percent of Participants Recommending Intervention to Friend
Time Frame: 3 Months
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Measured on a scale from 1-5 with 1 being "Not at All" and 5 being "Extremely".
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3 Months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Stress Self Regulation As Measured By a Survey
Time Frame: Baseline, 3 Months
|
Baseline, 3 Months
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Change in Positive Emotion As Measured by a Survey
Time Frame: Baseline, 3 Months
|
Baseline, 3 Months
|
Change in Behavioral Self Regulation As Measured by a Survey
Time Frame: Baseline, 3 Months
|
Baseline, 3 Months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2019
Primary Completion (Actual)
February 6, 2020
Study Completion (Actual)
February 6, 2020
Study Registration Dates
First Submitted
December 13, 2018
First Submitted That Met QC Criteria
December 13, 2018
First Posted (Actual)
December 17, 2018
Study Record Updates
Last Update Posted (Estimate)
March 6, 2023
Last Update Submitted That Met QC Criteria
March 3, 2023
Last Verified
March 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- Pro00100183
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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