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

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)

Study Overview

• Status: Completed
• Conditions: Stress Reduction
• Intervention / Treatment: Behavioral: DeStress for Health Program Participants

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Oxford, North Carolina, United States, 27565
      • Granville Vance Public Health Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Recruited in a 6-Month Time-frame	Measured via subject enrollment log	6 months
Percentage of Participants That Stay in Study for Duration	Measured via subject enrollment log	2 months
Percentage of Participants That Attend All Intervention Sessions	Measured via subject enrollment log	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".	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".	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	2 months

Collaborators and Investigators

• Sponsor: Duke University

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2022
• Primary Completion (Actual): August 19, 2022
• Study Completion (Actual): August 19, 2022

Study Registration Dates

• First Submitted: July 19, 2022
• First Submitted That Met QC Criteria: July 19, 2022
• First Posted (Actual): July 21, 2022

Study Record Updates

• Last Update Posted (Estimate): May 5, 2023
• Last Update Submitted That Met QC Criteria: May 4, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Rural; Stress Reduction; Health Behaviors; North Carolina
• Other Study ID Numbers: Pro00100183_1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No