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Occupational StressNCT04932018

Exploring an Incubator to Decrease Stress in Farmers Occupational Stress and Depression in Beginning Kentucky Farmers

A study testing Virtual Community of Support and Mentorship Incubator in people with Occupational Stress and Depression, run by Martha Biddle at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this 6- month study is to determine the feasibility of a start-up incubator intervention designed to decrease occupational stress and depression for beginning Kentucky farmers. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Occupational Stress, Depression
What is being tested?
Virtual Community of Support and Mentorship Incubator
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
17 participants
Where
1 siteUnited States
Study dates
1 Apr 2021to 30 Sep 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • classified as a beginning farmer by the USDA criteria
  • has the ability to read and speak English;
  • access to wi-fi or smartphone technology.
  • primary residence or farm in Washington, Anderson, Franklin, Henry, Scott, Harrison, Woodford or Owen County, Kentucky

Who cannot join

  • less than 18 years of age.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Kentucky

    Lexington, Kentucky, 40507

Other trials in United States

About this study

Official title: Exploring the Feasibility of a Start-up Incubator to Decrease Occupational Stress and Depression in Beginning Kentucky Farmers

The purpose of this 6- month study is to determine the feasibility of a start-up incubator intervention designed to decrease occupational stress and depression for beginning Kentucky farmers. The objectives are to: #1) test the feasibility of a mentorship and start-up incubator intervention on depression in beginning Kentucky farmers using questionnaires administered prestudy, mid-study, and post-study; #2) explore associations between mentorship, occupational stress and depression in beginning Kentucky farmers using specific survey questionnaires to guide future research. This study's results will provide valuable data to agriculture and occupational health researchers. The data will illustrate the impact of mentorship and community support on improving depression and occupational stress of beginning Kentucky farmers.

Read the detailed description

A suicide rate in farmers which is higher than the general population (rate 17.3/100,000) should remind occupational health professionals that the important work of agriculture is creating an emotional burden resulting in preventable death. Given the high incidence of suicide in the farming population, it is imperative that we explore the agrarian culture to guide the development of interventions to reduce occupational stress and depression in beginning Kentucky farmers. The isolating nature of rural farming, a leading risk factor for depression, creates an urgency to develop interventions to protect our Kentucky farmers from occupational stress and depression, which are leading risk factors for suicide. Interventions developed to reduce occupational stress and depression are an essential strategy to improve mental health before the devastating outcome of suicide. To address a gap in the management of occupational stress and depression in beginning farmers in Kentucky, novel interventions must address the unique agrarian culture, rural isolation, peer influence and social stigma of depression. Interventions must be available at little to no expense and without extensive time commitment; must be accessible in rural areas and provide mentorship and community support. The concept of a start-up incubator for beginning farmers is one type of intervention that combines the accessibility of a virtual program with mentorship by farming experts, peer and community support, with a mental health curriculum provided by occupational health nurses is our proposed intervention to address occupational stress and depression in the beginning Kentucky farmer. The curriculums of several existing programs related to occupational stress and depression guide the development of this incubator intervention. Incubator curriculums are designed to address failures and mitigate conditions to support future success. Rural Resilience, Farm Aid, and Farm Stress are training programs that address stress, depression, and suicide in farmers, these programs use components of an incubator model to fit the constructs of agrarian business and culture. The start-up incubator model in this proposal utilizes mentorship and community support to form a strategic alliance between mentors and beginner farmers.

Mentorship and community support are social capital that can be utilized through networking opportunities which may eliminate the structural barriers identified by beginning farmers. The impact of mentorship and community support in the context of healthcare, business, and farming has consistently been supported in research. Uncomfortable topics of occupational stressors and depression have only recently been included in initiatives to help farmers, however available mentorship programs in Kentucky are currently focused on farm management knowledge deficits. Results from this proposed study have the potential to guide future research related to the effectiveness for occupational stress, depression and suicide reduction in beginning Kentucky farmers. This proposal will address a major mental health objective of Healthy People 2020: Reducing the rising national suicide rate, specifically by addressing the vulnerable population of farmworkers considered to be at high risk (https://www.healthypeople.gov/node/4804/data_details). The The purpose of this study is to determine the feasibility of a start-up incubator intervention designed to decrease occupational stress and depression for beginning Kentucky farmers. The central hypothesis is: A start-up incubator intervention will be feasible and acceptable to the beginning farmer population. Specific Aim #1: To test the feasibility of a start-up incubator intervention on occupational stress and depression in beginning Kentucky farmers. Hypothesis #1: Compared to an attention control group, individuals assigned to the incubator intervention (6 month curriculum) group will have a lower incidence of occupational stress and depression at three and six months from baseline.

Specific Aim #2: To explore associations between mentorship, occupational stress and depression in beginning Kentucky farmers to guide future research. Hypothesis #2: Associations exist between mentorship, occupational stress and depression that will guide future research focused on prioritizing efforts to advance farmer health and well-being.

Study Design. The design is that of a two-group intervention study. Subjects (N=48) will be assigned to 1 of 2 groups (intervention group or attention control group based on county of residence; randomization will occur at the county level). Subjects will be recruited from eight central Kentucky counties: Washington, Anderson, Franklin, Henry, Scott, Harrison, Woodford and Owen. The intervention group will participate in a round table educational session with a study facilitator/mentor farmer and occupational health nurse plus receive an invitation to participate in an interactive virtual community providing ongoing resources and support from community farmers and agriculture experts. The second group (attention control) will receive an invitation to participate in the virtual community without mentor interaction. Data collection for both groups will occur at baseline, 3 months, and 6-months.

Sample and Setting. Subjects will be referred by county extension agents located in Washington, Anderson, Franklin, Henry, Scott, Harrison, Woodford and Owen counties in Kentucky that have contact with "beginning farmers", as defined by the United States Department of Agriculture (USDA). Subjects will be contacted via email or personal contact by County Extension agents, or via CCTS recruitment services, potential interested parties will be given the PI's email, name and phone to contact for pre-screening of eligibility into the study. A total of 48 subjects meeting inclusion criteria will be assigned to one of two groups. Based on USDA estimates of beginning farmer characteristics, the planned enrollment in this study is 60% men, 95% Caucasian, and 5% Black or African American (demographic survey will include a question regarding Hispanic ethnicity).

Being tested
Virtual Community of Support, Mentorship Incubator
Medical subject headings
Occupational Stress, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual Community of SupportBehavioural

    The 6-month virtual community will consist of self-directed learning modules that will vary in content from worker and family relationships, collaboration and skill acquisition to self-care habits; problem-solving; monthly sessions will include a positive psychology exercise.

  • Mentorship IncubatorBehavioural

    The 6-month incubator intervention will consist of monthly interactive time with an assigned study facilitator/farmer mentor.

Study groups in NCT04932018
Study groupRoleWhat they receive
InterventionalExperimentalThe intervention group will participate in a round table educational session with a study facilitator/mentor farmer and occupational health nurse plus receive an invitation to participate in an interactive virtual community providing ongoing resources and support from community farmers and agriculture experts.
Receives: Behavioral: Virtual Community of Support; Behavioral: Mentorship Incubator
Attention ControlSham comparatorThe second group (attention control) will receive an invitation to participate in the virtual community without mentor interaction.
Receives: Behavioral: Virtual Community of Support

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occupational Stress

    Psychological stress as result of farming measured with the Farm Stressors Inventory, a 37 item self-report survey measuring potentially prevalent farm stressors. Items from the following categories of stressors are addressed in the assessment tool: personal finances, weather, regulatory climate, workload and other job demands, physical environment, control and ambiguity, interpersonal issues, and job and retirement security. The tool is comprised of a 1-5 likert scale of 37 items, higher scores indicating higher occupational stress related to farming.

    Measured: Change from baseline occupational stress at 6 months

  2. Depressive symptoms

    Depressive symptoms as measured with the 10-item short Beck Depression Inventory to detect moderate and severe depressive episodes. High sensitivity and negative predictive value (NPV) were obtained with a cut-off score of 9/10 (sensitivity = 100%, specificity = 83.1%, NPV = 100%). High sensitivity and positive predictive value (PPV) were obtained with a cut-off score of 13/14 (sensitivity = 93.5%, specificity = 96%, PPV = 85.3%). The area under the ROC curve was 98.4% (95% Confidence Interval = 0.97-1.00). This tool includes 10 items, each including four alternative statements ranging in order of severity from zero to three. For the short form ,higher scores indicate higher depression.

    Measured: Change from baseline depressive symptoms at 6 months

Secondary outcomes (2)
  1. Self-Efficacy

    Self-efficacy will be measured with the John Henry Active Coping Scale, a 12 item self-report survey measuring coping strategies associated with sustained cognitive and emotional stressors. The scale includes twelve items answered on a Likert Scale with responses ranging from 1 "completely false" to 5 "completely true." Sample items include, "hard work has really helped me to get ahead"; "it's not always easy, but I manage to find a way to do the things I really need to get done"; and "once I make up my mind to do something, I stay with it until the job is completely done." The items were summed, with higher scores indicating a higher degree of high-effort coping

    Measured: Change from baseline self-efficacy at 6 months

  2. Adherence to Intervention

    Intervention fidelity will be monitored by the PI, who will ensure all research assistants and study facilitators follow the study protocol. Study participants assigned to the intervention will have adherence monitored by participation in the virtual community and at the face to face meeting.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2021
  2. Study start1 Apr 2021
  3. Primary completion30 Sep 2022
  4. Study completion30 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized Controlled Trial
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04932018
Sponsor's protocol ID
61320
Status last verified
Nov 2022
First submitted
10 Jun 2021
Last updated
18 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Olson KR, Schellenberg RP. Farm stressors. Am J Community Psychol. 1986 Oct;14(5):555-69. doi: 10.1007/BF00935358.

    PubMed 3799552
  • Cuthbertson C, Brennan A, Shutske J, Zierl L, Bjornestad A, Macy K, Schallhorn P, Shelle G, Dellifield J, Leatherman J, Lin E, Skidmore M. Developing and Implementing Farm Stress Training to Address Agricultural Producer Mental Health. Health Promot Pract. 2022 Jan;23(1):8-10. doi: 10.1177/1524839920931849. Epub 2020 Jun 9.

    PubMed 32517517
  • Gerrard N. An application of a community psychology approach to dealing with farm stress. Can J Commun Ment Health. 2000 Fall;19(2):89-100. doi: 10.7870/cjcmh-2000-0017.

    PubMed 11381740
  • Hoyt DR, Conger RD, Valde JG, Weihs K. Psychological distress and help seeking in rural America. Am J Community Psychol. 1997 Aug;25(4):449-70. doi: 10.1023/a:1024655521619.

    PubMed 9338954
  • Peterson C, Stone DM, Marsh SM, Schumacher PK, Tiesman HM, McIntosh WL, Lokey CN, Trudeau AT, Bartholow B, Luo F. Suicide Rates by Major Occupational Group - 17 States, 2012 and 2015. MMWR Morb Mortal Wkly Rep. 2018 Nov 16;67(45):1253-1260. doi: 10.15585/mmwr.mm6745a1.

    PubMed 30439869
  • Cassitto MG, Gilioli R. [Emerging aspects of occupational stress]. Med Lav. 2003 Jan-Feb;94(1):108-13. Italian.

    PubMed 12768962
  • Oatley K, Bolton W. A social-cognitive theory of depression in reaction to life events. Psychol Rev. 1985 Jul;92(3):372-88. No abstract available.

    PubMed 4023147
  • Rudolphi JM, Berg RL, Parsaik A. Depression, Anxiety and Stress Among Young Farmers and Ranchers: A Pilot Study. Community Ment Health J. 2020 Jan;56(1):126-134. doi: 10.1007/s10597-019-00480-y. Epub 2019 Oct 3.

    PubMed 31583619
  • Frey LM, Hans JD, Cerel J. Perceptions of Suicide Stigma. Crisis. 2016 Mar;37(2):95-103. doi: 10.1027/0227-5910/a000358. Epub 2015 Dec 23.

    PubMed 26695868
  • Kris-Etherton PM, Petersen KS, Hibbeln JR, Hurley D, Kolick V, Peoples S, Rodriguez N, Woodward-Lopez G. Nutrition and behavioral health disorders: depression and anxiety. Nutr Rev. 2021 Feb 11;79(3):247-260. doi: 10.1093/nutrit/nuaa025.

    PubMed 32447382
  • Logstein B. Farm-Related Concerns and Mental Health Status Among Norwegian Farmers. J Agromedicine. 2016;21(4):316-26. doi: 10.1080/1059924X.2016.1211055.

    PubMed 27420178
  • Hammen C. Stress and depression. Annu Rev Clin Psychol. 2005;1:293-319. doi: 10.1146/annurev.clinpsy.1.102803.143938.

    PubMed 17716090
  • Truchot D, Andela M. Burnout and hopelessness among farmers: The Farmers Stressors Inventory. Soc Psychiatry Psychiatr Epidemiol. 2018 Aug;53(8):859-867. doi: 10.1007/s00127-018-1528-8. Epub 2018 May 3.

    PubMed 29725701
  • Fernander AF, Duran RE, Saab PG, Llabre MM, Schneiderman N. Assessing the reliability and validity of the John Henry Active Coping Scale in an urban sample of African Americans and white Americans. Ethn Health. 2003 May;8(2):147-61. doi: 10.1080/13557850303563.

    PubMed 14671768

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Community of Support and Mentorship Incubator in people with Occupational Stress and Depression, run by Martha Biddle at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occupational Stress (time frame: Change from baseline occupational stress at 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04932018, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2022.

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