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

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: NCT03776890
• Other study ID #: Pro00100183
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: February 6, 2020

Study information

• Verified date: March 2020
• 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: February 6, 2020
• Est. primary completion date: February 6, 2020
• 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
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.

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	3 Months
Primary	Percentage of Participants That Attend All Intervention Sessions	Measured via subject enrollment log	3 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".	3 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".	3 Months
Secondary	Change in Stress Self Regulation As Measured By a Survey		Baseline, 3 Months
Secondary	Change in Positive Emotion As Measured by a Survey		Baseline, 3 Months
Secondary	Change in Behavioral Self Regulation As Measured by a Survey		Baseline, 3 Months