Stress ReductionNCT03776890
DeStress for Health: Partnering With Granville and Vance Counties to Reduce Stress and Cancer Risk
A study testing DeStress for Health Program in people with Stress Reduction, run by Duke University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress Reduction
- What is being tested?
- DeStress for Health Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2019to 6 Feb 2020
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Live in Granville or Vance Counties;
- >18 years old;
- Interested in participating a stress reduction study
- Speak English
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Granville Vance Public Health Department
Oxford, North Carolina, 27565
About this study
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.
- Conditions
- Stress Reduction
- Being tested
- DeStress for Health Program
- Keywords
- stress reduction, rural, health behaviors, north carolina
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeStress for Health ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| DeStress for Health Program Participants | Experimental | Rural residents 18 years and older of Granville and Vance counties (n=30) will be recruited to participate. Receives: Behavioral: DeStress for Health Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Recruited in a 6-Month Time-frame
Measured via subject enrollment log
Measured: 6 Months
Percentage of Participants That Stay in Study for Duration
Measured via subject enrollment log
Measured: 3 Months
Percentage of Participants That Attend All Intervention Sessions
Measured via subject enrollment log
Measured: 3 Months
Percent of Participants Rating Intervention as Useful
Measured on a scale from 1-5 with 1 being "Not Useful at All" and 5 being "Extremely Useful".
Measured: 3 Months
Percent of Participants Recommending Intervention to Friend
Measured on a scale from 1-5 with 1 being "Not at All" and 5 being "Extremely".
Measured: 3 Months
Secondary outcomes (3)
Change in Stress Self Regulation As Measured By a Survey
Measured: Baseline, 3 Months
Change in Positive Emotion As Measured by a Survey
Measured: Baseline, 3 Months
Change in Behavioral Self Regulation As Measured by a Survey
Measured: Baseline, 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2018
- Study start1 Mar 2019
- Primary completion6 Feb 2020
- Study completion6 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress ReductionStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Devon Noonan, Ph.D, Principal investigator, Duke School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03776890
- Sponsor's protocol ID
- Pro00100183
- Status last verified
- Mar 2020
- First submitted
- 13 Dec 2018
- Last updated
- 6 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Noonan D, Muhirwa A, Sang E, Calhoun N, Crews A, Peter K, Crews H, Mercer L, Harrison LM, Guthrie SL, Pollak KI. Pilot study of the DeStress for Health Program: a community-engaged stress reduction and cancer prevention intervention for rural communities. Pilot Feasibility Stud. 2026 Apr 10;12(1):75. doi: 10.1186/s40814-026-01811-z.
PubMed 41964035
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DeStress for Health: Partnering With Granville and Vance Counties to Reduce Stress and Cancer Risk
- ClinicalTrials.gov ID
- NCT03776890
- Acronym / sponsor ID
- Pro00100183
- Conditions
- Stress Reduction
- Keywords
- stress reduction, rural, health behaviors, north carolina
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 6 Feb 2020 (actual)
- Study completion
- 6 Feb 2020 (actual)
- First posted
- 17 Dec 2018 (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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DeStress for Health Program Participants | Experimental | Behavioral: DeStress for Health ProgramRural residents 18 years and older of Granville and Vance counties (n=30) will be recruited to participate. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Live in Granville or Vance Counties;
- >18 years old;
- Interested in participating a stress reduction study
- Speak English
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| DeStress for Health ProgramThe 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. | Behavioural | DeStress for Health Program Participants |
Primary outcome
Number of Participants Recruited in a 6-Month Time-frame
Time frame: 6 Months
Measured via subject enrollment log
Percentage of Participants That Stay in Study for Duration
Time frame: 3 Months
Measured via subject enrollment log
Percentage of Participants That Attend All Intervention Sessions
Time frame: 3 Months
Measured via subject enrollment log
Percent of Participants Rating Intervention as Useful
Time frame: 3 Months
Measured on a scale from 1-5 with 1 being "Not Useful at All" and 5 being "Extremely Useful".
Percent of Participants Recommending Intervention to Friend
Time frame: 3 Months
Measured on a scale from 1-5 with 1 being "Not at All" and 5 being "Extremely".
3 secondary outcomes
Change in Stress Self Regulation As Measured By a Survey
Time frame: Baseline, 3 Months
Change in Positive Emotion As Measured by a Survey
Time frame: Baseline, 3 Months
Change in Behavioral Self Regulation As Measured by a Survey
Time frame: Baseline, 3 Months
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 6 Mar 2023.
- Derived from this study: PubMed 41964035Noonan D, Muhirwa A, Sang E, Calhoun N, Crews A, Peter K, Crews H, Mercer L, Harrison LM, Guthrie SL, Pollak KI. Pilot study of the DeStress for Health Program: a community-engaged stress reduction and cancer prevention intervention for rural communities. Pilot Feasibility Stud. 2026 Apr 10;12(1):75. doi: 10.1186/s40814-026-01811-z.
- 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.
Devon Noonan, Ph.D principal investigator
Duke School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DeStress for Health Program in people with Stress Reduction, run by Duke 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 4 inclusion and 4 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 6 Mar 2023. 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?
Number of Participants Recruited in a 6-Month Time-frame (time frame: 6 Months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03776890, which also lists 1 linked publication.
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 6 Mar 2023.