NCT05469334

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

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 14, 2022

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 21, 2022

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 19, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 19, 2022

Completed
Last Updated

May 6, 2023

Status Verified

May 1, 2023

Enrollment Period

1 month

First QC Date

July 19, 2022

Last Update Submit

May 4, 2023

Conditions

Keywords

Stress ReductionRuralNorth CarolinaHealth Behaviors

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

EXPERIMENTAL

Rural residents 18 years and older of Granville and Vance counties (n=40) will be recruited to participate.

Behavioral: DeStress for Health Program Participants

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.

Experimental: 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

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

Locations