NCT03776890

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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

December 13, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 17, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2020

Completed
Last Updated

March 6, 2023

Status Verified

March 1, 2020

Enrollment Period

11 months

First QC Date

December 13, 2018

Last Update Submit

March 3, 2023

Conditions

Keywords

stress reductionruralhealth behaviorsnorth carolina

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

    3 Months

  • Percentage of Participants That Attend All Intervention Sessions

    Measured via subject enrollment log

    3 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".

    3 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".

    3 Months

Secondary Outcomes (3)

  • Change in Stress Self Regulation As Measured By a Survey

    Baseline, 3 Months

  • Change in Positive Emotion As Measured by a Survey

    Baseline, 3 Months

  • Change in Behavioral Self Regulation As Measured by a Survey

    Baseline, 3 Months

Study Arms (1)

DeStress for Health Program Participants

EXPERIMENTAL

Rural residents 18 years and older of Granville and Vance counties (n=30) will be recruited to participate.

Behavioral: DeStress for Health Program

Interventions

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.

DeStress for Health Program Participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

Granville Vance Public Health Department

Oxford, North Carolina, 27565, United States

Location

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Devon Noonan, Ph.D

    Duke School of Nursing

    PRINCIPAL INVESTIGATOR

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

December 13, 2018

First Posted

December 17, 2018

Study Start

March 1, 2019

Primary Completion

February 6, 2020

Study Completion

February 6, 2020

Last Updated

March 6, 2023

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations