DeStress for Health: Partnering With Granville and Vance Counties to Reduce Stress and Cancer Risk

Sponsor
Duke University (Other)
Overall Status
Completed
CT.gov ID
NCT03776890
Collaborator
(none)
28
1
1
11.2
2.5

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: DeStress for Health Program
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
28 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
DeStress for Health: Partnering With Granville and Vance Counties to Reduce Stress and Cancer Risk
Actual Study Start Date :
Mar 1, 2019
Actual Primary Completion Date :
Feb 6, 2020
Actual Study Completion Date :
Feb 6, 2020

Arms and Interventions

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.

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. 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.

Outcome Measures

Primary Outcome Measures

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

    Measured via subject enrollment log

  2. Percentage of Participants That Stay in Study for Duration [3 Months]

    Measured via subject enrollment log

  3. Percentage of Participants That Attend All Intervention Sessions [3 Months]

    Measured via subject enrollment log

  4. Percent of Participants Rating Intervention as Useful [3 Months]

    Measured on a scale from 1-5 with 1 being "Not Useful at All" and 5 being "Extremely Useful".

  5. Percent of Participants Recommending Intervention to Friend [3 Months]

    Measured on a scale from 1-5 with 1 being "Not at All" and 5 being "Extremely".

Secondary Outcome Measures

  1. Change in Stress Self Regulation As Measured By a Survey [Baseline, 3 Months]

  2. Change in Positive Emotion As Measured by a Survey [Baseline, 3 Months]

  3. Change in Behavioral Self Regulation As Measured by a Survey [Baseline, 3 Months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Granville Vance Public Health Department Oxford North Carolina United States 27565

Sponsors and Collaborators

  • Duke University

Investigators

  • Principal Investigator: Devon Noonan, Ph.D, Duke School of Nursing

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Duke University
ClinicalTrials.gov Identifier:
NCT03776890
Other Study ID Numbers:
  • Pro00100183
First Posted:
Dec 17, 2018
Last Update Posted:
Mar 10, 2020
Last Verified:
Mar 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Duke University

Study Results

No Results Posted as of Mar 10, 2020