Stress ReductionNCT05469334
DeStress for Health: Partnering With Granville and Vance Counties to Reduce Stress and Cancer Risk (Part 2)
A study testing DeStress for Health Program Participants 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.The program will consist of 4 in person / zoom sessions that… 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 Participants
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2022to 19 Aug 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 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
Official title: DeStress for Health: Partnering With Granville and Vance Counties to Reduce Stress and Cancer Risk
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.The program will consist of 4 in person / zoom sessions that are based on empirically supported PPWB components including Optimism, Gratitude, Mindfulness and Positive Savoring to improve behavioral self-regulation towards health-related goals with an additional class five as a check in that will be used for survey completion. Specifically, principal investigator will provide participants with instruction on positive psychology exercises that can do on their own and counseling around increased fruit and vegetable intake, physical activity and smoking cessation. Participants will then be asked to create a SMART goal to work on each week of the program for one of the behaviors. Research staff will conduct surveys with participants at baseline and at end of program. Feasibility and acceptability measures of the intervention will be collected at the end of the program. Research team will also collect informal feedback from participants at the end of each of the class sessions. Classes will be delivered in person and broadcasted via zoom via a password protected zoom link. Participant who choose to remain remote and participate via Zoom will be mailed binders of study materials with information on who to call if participants have questions. Participants who attend live events will receive their materials in person. Pre- and post-intervention surveys will be sent to participants via email. This is Part 2 of study (NCT03776890)
- Conditions
- Stress Reduction
- Being tested
- DeStress for Health Program Participants
- Keywords
- Stress Reduction, Rural, North Carolina, Health Behaviors
- 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 Program ParticipantsBehavioural
Behavioral: DeStress for Health Program 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, with an additional class five as a check in that will be used for survey completion. 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 |
|---|---|---|
| Experimental: DeStress for Health Program Participants | Experimental | Rural residents 18 years and older of Granville and Vance counties (n=40) will be recruited to participate. Receives: Behavioral: DeStress for Health Program Participants |
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: 2 months
Percentage of Participants That Attend All Intervention Sessions
Measured via subject enrollment log
Measured: 2 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: 2 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: 2 months
Secondary outcomes (3)
Change in Stress Self Regulation As Measured By a Survey
qualitative scale I agree a lot I agree a little I neither agree nor disagree I disagree a little I disagree a lot
Measured: 2 months
Change in Positive Emotion As Measured by a Survey
qualitative scale I agree a lot I agree a little I neither agree nor disagree I disagree a little I disagree a lot
Measured: 2 months
Change in Behavioral Self Regulation As Measured by a Survey
qualitative scale I agree a lot I agree a little I neither agree nor disagree I disagree a little I disagree a lot
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study start14 Jul 2022
- Primary completion19 Aug 2022
- Study completion19 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 14 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
- NCT05469334
- Sponsor's protocol ID
- Pro00100183_1
- Status last verified
- May 2023
- First submitted
- 19 Jul 2022
- Last updated
- 6 May 2023
- 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 6 May 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
- NCT05469334
- Acronym / sponsor ID
- Pro00100183_1
- Conditions
- Stress Reduction
- Keywords
- Stress Reduction, Rural, North Carolina, Health Behaviors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 14 Jul 2022 (actual)
- Primary completion
- 19 Aug 2022 (actual)
- Study completion
- 19 Aug 2022 (actual)
- First posted
- 21 Jul 2022 (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.The program will consist of 4 in person / zoom sessions that are based on empirically supported PPWB components including Optimism, Gratitude, Mindfulness and Positive Savoring to improve behavioral self-regulation towards health-related goals with an additional class five as a check in that will be used for survey completion. Specifically, principal investigator will provide participants with instruction on positive psychology exercises that can do on their own and counseling around increased fruit and vegetable intake, physical activity and smoking cessation. Participants will then be asked to create a SMART goal to work on each week of the program for one of the behaviors. Research staff will conduct surveys with participants at baseline and at end of program. Feasibility and acceptability measures of the intervention will be collected at the end of the program. Research team will also collect informal feedback from participants at the end of each of the class sessions. Classes will be delivered in person and broadcasted via zoom via a password protected zoom link. Participant who choose to remain remote and participate via Zoom will be mailed binders of study materials with information on who to call if participants have questions. Participants who attend live events will receive their materials in person. Pre- and post-intervention surveys will be sent to participants via email. This is Part 2 of study (NCT03776890)
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: DeStress for Health Program Participants | Experimental | Behavioral: DeStress for Health Program ParticipantsRural residents 18 years and older of Granville and Vance counties (n=40) 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 Program ParticipantsBehavioral: DeStress for Health Program 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, with an additional class five as a check in that will be used for survey completion. 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 | Experimental: 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: 2 months
Measured via subject enrollment log
Percentage of Participants That Attend All Intervention Sessions
Time frame: 2 months
Measured via subject enrollment log
Percent of Participants Rating Intervention as Useful
Time frame: 2 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: 2 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: 2 months
Change in Positive Emotion As Measured by a Survey
Time frame: 2 months
Change in Behavioral Self Regulation As Measured by a Survey
Time frame: 2 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 May 2023.
- 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 Participants 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 May 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?
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 May 2023.