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

Study Overview
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Brief Summary
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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)

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

Conditions
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Stress Reduction

Intervention / Treatment
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* Behavioral: DeStress for Health Program Participants


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: DeStress for Health Program Participants<br>Rural residents 18 years and older of Granville and Vance counties (n=40) will be recruited to participate. | Behavioral: DeStress for Health Program Participants<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stress Reduction, Rural, North Carolina, Health Behaviors