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Completed

NCT Number: NCT05469334

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

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)

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Granville Vance Public Health Department

Oxford, North Carolina, 27565, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DeStress for Health Program Participants

Behavioral

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.

Primary outcomes

  1. Number of Participants Recruited in a 6-Month Time-frame

    Time frame: 6 months

    Measured via subject enrollment log

  2. Percentage of Participants That Stay in Study for Duration

    Time frame: 2 months

    Measured via subject enrollment log

  3. Percentage of Participants That Attend All Intervention Sessions

    Time frame: 2 months

    Measured via subject enrollment log

  4. Percent of Participants Rating Intervention as Useful

    Time frame: 2 months

    Measured on a scale from 1-5 with 1 being "Not Useful at All" and 5 being "Extremely Useful".

  5. Percent of Participants Recommending Intervention to Friend

    Time frame: 2 months

    Measured on a scale from 1-5 with 1 being "Not at All" and 5 being "Extremely".

Secondary outcomes

  1. Change in Stress Self Regulation As Measured By a Survey

    Time frame: 2 months

    qualitative scale I agree a lot I agree a little I neither agree nor disagree I disagree a little I disagree a lot

  2. Change in Positive Emotion As Measured by a Survey

    Time frame: 2 months

    qualitative scale I agree a lot I agree a little I neither agree nor disagree I disagree a little I disagree a lot

  3. Change in Behavioral Self Regulation As Measured by a Survey

    Time frame: 2 months

    qualitative scale I agree a lot I agree a little I neither agree nor disagree I disagree a little I disagree a lot

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 21, 2022
Registry last updated
May 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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