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

Stress Reduction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05469334
• Other study ID #: Pro00100183_1
• Status: Completed
• Phase: N/A
• Start date: July 14, 2022
• Est. completion date: August 19, 2022

Study information

• Verified date: May 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: August 19, 2022
• Est. primary completion date: August 19, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stress Reduction

Intervention

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.

Locations

Country	Name	City	State
United States	Granville Vance Public Health Department	Oxford	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Recruited in a 6-Month Time-frame	Measured via subject enrollment log	6 months
Primary	Percentage of Participants That Stay in Study for Duration	Measured via subject enrollment log	2 months
Primary	Percentage of Participants That Attend All Intervention Sessions	Measured via subject enrollment log	2 months
Primary	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
Primary	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	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
Secondary	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
Secondary	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