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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in United States

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.

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 groups in NCT03776890
Study groupRoleWhat they receive
DeStress for Health Program ParticipantsExperimentalRural 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.

  1. Number of Participants Recruited in a 6-Month Time-frame

    Measured via subject enrollment log

    Measured: 6 Months

  2. Percentage of Participants That Stay in Study for Duration

    Measured via subject enrollment log

    Measured: 3 Months

  3. Percentage of Participants That Attend All Intervention Sessions

    Measured via subject enrollment log

    Measured: 3 Months

  4. 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

  5. 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)
  1. Change in Stress Self Regulation As Measured By a Survey

    Measured: Baseline, 3 Months

  2. Change in Positive Emotion As Measured by a Survey

    Measured: Baseline, 3 Months

  3. 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.

  1. First posted17 Dec 2018
  2. Study start1 Mar 2019
  3. Primary completion6 Feb 2020
  4. Study completion6 Feb 2020

Resources

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)
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

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.

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