DeStress for Health: Partnering With Granville and Vance Counties to Reduce Stress and Cancer Risk (Part 2)

Sponsor
Duke University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05469334
Collaborator
(none)
40
1
1
10
4

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.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, we 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. We 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 they 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)

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 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
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Apr 29, 2023
Anticipated Study Completion Date :
Apr 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental: DeStress for Health Program Participants

Rural residents 18 years and older of Granville and Vance counties (n=40) will be recruited to participate.

Behavioral: DeStress for Health Program Participants
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.

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 [2 months]

    Measured via subject enrollment log

  3. Percentage of Participants That Attend All Intervention Sessions [2 months]

    Measured via subject enrollment log

  4. Percent of Participants Rating Intervention as Useful [2 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 [2 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 [2 months]

  2. Change in Positive Emotion As Measured by a Survey [2 months]

  3. Change in Behavioral Self Regulation As Measured by a Survey [2 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:
NCT05469334
Other Study ID Numbers:
  • Pro00100183_1
First Posted:
Jul 21, 2022
Last Update Posted:
Jul 21, 2022
Last Verified:
Jul 1, 2022
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 Jul 21, 2022