DeStress for Health: Partnering With Granville and Vance Counties to Reduce Stress and Cancer Risk (Part 2)
1 other identifier
interventional
14
1 country
1
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, 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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 14, 2022
CompletedFirst Submitted
Initial submission to the registry
July 19, 2022
CompletedFirst Posted
Study publicly available on registry
July 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 19, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 19, 2022
CompletedMay 6, 2023
May 1, 2023
1 month
July 19, 2022
May 4, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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 Outcomes (3)
Change in Stress Self Regulation As Measured By a Survey
2 months
Change in Positive Emotion As Measured by a Survey
2 months
Change in Behavioral Self Regulation As Measured by a Survey
2 months
Study Arms (1)
Experimental: DeStress for Health Program Participants
EXPERIMENTALRural residents 18 years and older of Granville and Vance counties (n=40) will be recruited to participate.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Live in Granville or Vance Counties;
- \>18 years old;
- Interested in participating a stress reduction study
- Speak English
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
Study Sites (1)
Granville Vance Public Health Department
Oxford, North Carolina, 27565, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Devon Noonan, Ph.D
Duke School of Nursing
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2022
First Posted
July 21, 2022
Study Start
July 14, 2022
Primary Completion
August 19, 2022
Study Completion
August 19, 2022
Last Updated
May 6, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share