Well-Being, PsychologicalNCT06058949
Health Protection and Promotion of Sign Language Interpreters Through Implementation of Total Worker Health®
A study testing Health Protection and Promotion and General Health Program in people with Well-Being, Psychological, run by University of Rochester at 1 site in United States.
Trial summary
Using mixed-methods and a clinical efficacy trial design, the overall objective of this study will employ implementation strategies to adapt and evaluate a previous integrated Total Worker Health® (TWH®) program and pilot test its efficacy on sign language interpreter well-being. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Well-Being, Psychological
- What is being tested?
- Health Protection and Promotion and General Health Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2024to 31 Aug 2026
- 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
- Bilingual in English and American Sign Language
- Certified sign language interpreter working at least 10 hours/week in any interpreter setting.
- Apparently healthy
Who cannot join
- Less than 18 year old
- Not yet certified as a sign language interpreter
- Unable to provide consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Using mixed-methods and a clinical efficacy trial design, the overall objective of this study will employ implementation strategies to adapt and evaluate a previous integrated Total Worker Health® (TWH®) program and pilot test its efficacy on sign language interpreter well-being. The central hypothesis is that interpreters in the health protection and promotion program (intervention) will demonstrate significantly improved well-being compared to those in a general health program (control).
- Conditions
- Well-Being, Psychological
- Being tested
- Health Protection and Promotion, General Health Program
- Keywords
- sign language interpreters, Total Worker Health®
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Protection and PromotionBehavioural
An adaptive integrated Total Worker Health® program. Virtual 8-week program that's been contextualized to the physical and mental health needs of sign language interpreters. It will examine biomechanics, sleep hygiene, vicarious trauma and burnout, demand-control schema, physical activity, emotional management strategies, proper nutrition and examination of worksite.
General Health ProgramBehavioural
Virtual 8-week program that addresses participant sleep hygiene, physical activity and proper nutrition.
| Study group | Role | What they receive |
|---|---|---|
| Health Protection and Promotion Program | Experimental | Not described Receives: Behavioral: Health Protection and Promotion |
| General Health Program | Active comparator | Not described Receives: Behavioral: General Health Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean change in acceptability using the Training Acceptability Rating Scale-1 (TARS-1)
TARS-1 measures acceptability using six items (1=strongly disagree; 6=strongly agree) and demonstrates good test-retest reliability, internal consistency, and construct and concurrent validity. The scale ranges from 6 to 36 with higher scores indicating better acceptability.
Measured: 15 to 24 months
mean change in acceptability using the Training Acceptability Rating Scale-2 (TARS-2)
TARS-2 assesses perceived impact with eight items (0=not at all; 3=a great deal) and demonstrates good face and concurrent validity. Of particular interest, TARS-2 also includes three qualitative items asking about the most helpful part of the program and any recommended changes and invites other comments. The scale ranges from 0-24 with higher scores indicating better outcomes.
Measured: 15 to 24 months
mean change in Acceptability, Feasibility, and Appropriateness Scale
This acceptability (six items), feasibility (three items), and appropriateness (five items) instrument will be used to assess whether or not the intervention efforts were successful. The 14 total items across three subscales demonstrate good to excellent internal consistency and are rated on a five-point scale (1=not at all; 5=extremely). High scores of 30, 15, and 25 and low scores of 6, 3, and 5 indicate excellent and poor acceptability, feasibility, and appropriateness, respectively.
Measured: 15 to 24 months
mean change in the National Institute of Occupational Safety and Health's Worker Well-Being Questionnaire- work evaluation and experience
Work evaluation and experience is the first of five domains in this comprehensive measure of worker well-being and has 16 total questions. Total summed scores within this section range from 23-128 with higher scores indicating better outcomes (accounting for inverse scoring on negative items).
Measured: baseline to post intervention (approximately 15-24 months)
mean change in the National Institute of Occupational Safety and Health's Worker Well-Being Questionnaire- work evaluation and experience
Work evaluation and experience is the first of five domains in this comprehensive measure of worker well-being and has 16 total questions. Total scores within this section range from 23-128 with higher scores indicating better outcomes (accounting for inverse scoring on negative items).
Measured: baseline to 6 months post intervention (approximately 21-30 months)
mean change in the National Institute of Occupational Safety and Health's Worker Well-Being Questionnaire- workplace policies and culture
Workplace policies and culture is the second of five domains in this comprehensive measure of worker well-being and has 14 total questions. Total scores within this section range from 12-75 with higher scores indicating better outcomes (accounting for inverse scoring on negative items).
Measured: baseline to post intervention (approximately 15-24 months)
mean change in the National Institute of Occupational Safety and Health's Worker Well-Being Questionnaire- workplace policies and culture
Workplace policies and culture is the second of five domains in this comprehensive measure of worker well-being and has 14 total questions. Total scores within this section range from 12-75 with higher scores indicating better outcomes (accounting for inverse scoring on negative items).
Measured: baseline to 6 months post intervention (approximately 21-30 months)
mean change in the National Institute of Occupational Safety and Health's Worker Well-Being Questionnaire- workplace physical environment and safety climate
Workplace physical environment and safety climate is the third of five domains in this comprehensive measure of worker well-being and has 10 total questions. Total scores within this section range from 14-60 with higher scores indicating better outcomes (accounting for inverse scoring on negative items).
Measured: baseline to post intervention (approximately 15-24 months)
mean change in the National Institute of Occupational Safety and Health's Worker Well-Being Questionnaire- workplace physical environment and safety climate
Workplace physical environment and safety climate is the third of five domains in this comprehensive measure of worker well-being and has 10 total questions. Total scores within this section range from 14-60 with higher scores indicating better outcomes (accounting for inverse scoring on negative items).
Measured: baseline to 6 months post intervention (approximately 21-30 months)
mean change in the National Institute of Occupational Safety and Health's Worker Well-Being Questionnaire- health status
Health status is the fourth of five domains in this comprehensive measure of worker well-being and has 23 total questions. There are five open text box items within this section (i.e. asking for the number of days the respondent gets high intensity physical activity). Otherwise, total scores of the Likert scale items within this section range from 24-146 with higher scores indicating better outcomes (accounting for inverse scoring on negative items).
Measured: baseline to post intervention (approximately 15-24 months)
mean change in the National Institute of Occupational Safety and Health's Worker Well-Being Questionnaire- health status
Health status is the fourth of five domains in this comprehensive measure of worker well-being and has 23 total questions. There are five open text box items within this section (i.e. asking for the number of days the respondent gets high intensity physical activity). Otherwise, total scores of the Likert scale items within this section range from 24-146 with higher scores indicating better outcomes (accounting for inverse scoring on negative items).
Measured: baseline to 6 months post intervention (approximately 21-30 months)
mean change in the National Institute of Occupational Safety and Health's Worker Well-Being Questionnaire- home, community, and society
Home, community, and society is the final domain in this comprehensive measure of worker well-being and has 5 total questions. Total scores within this section range from 11-65 with higher scores indicating better outcomes (accounting for inverse scoring on negative items).
Measured: baseline to post intervention (approximately 15-24 months)
mean change in the National Institute of Occupational Safety and Health's Worker Well-Being Questionnaire- home, community, and society
Home, community, and society is the final domain in this comprehensive measure of worker well-being and has 5 total questions. Total scores within this section range from 11-65 with higher scores indicating better outcomes (accounting for inverse scoring on negative items).
Measured: baseline to 6 months post intervention (approximately 21-30 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start1 May 2024
- Primary completion15 Aug 2026
- Study completion31 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Well-Being, PsychologicalStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Gretchen Roman, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06058949
- Sponsor's protocol ID
- STUDY00008720
- Other IDs
- K01OH012441
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2023
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Eriksen HR, Ihlebaek C, Mikkelsen A, Gronningsaeter H, Sandal GM, Ursin H. Improving subjective health at the worksite: a randomized controlled trial of stress management training, physical exercise and an integrated health programme. Occup Med (Lond). 2002 Oct;52(7):383-91. doi: 10.1093/occmed/52.7.383.
PubMed 12422025Tveito TH, Eriksen HR. Integrated health programme: a workplace randomized controlled trial. J Adv Nurs. 2009 Jan;65(1):110-9. doi: 10.1111/j.1365-2648.2008.04846.x. Epub 2008 Nov 14.
PubMed 19032505
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Protection and Promotion of Sign Language Interpreters Through Implementation of Total Worker Health®
- ClinicalTrials.gov ID
- NCT06058949
- Acronym / sponsor ID
- STUDY00008720
- Conditions
- Well-Being, Psychological
- Keywords
- sign language interpreters, Total Worker Health®
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 1 May 2024 (actual)
- Primary completion
- 15 Aug 2026 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Using mixed-methods and a clinical efficacy trial design, the overall objective of this study will employ implementation strategies to adapt and evaluate a previous integrated Total Worker Health® (TWH®) program and pilot test its efficacy on sign language interpreter well-being. The central hypothesis is that interpreters in the health protection and promotion program (intervention) will demonstrate significantly improved well-being compared to those in a general health program (control).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health Protection and Promotion Program | Experimental | Behavioral: Health Protection and Promotion |
| General Health Program | Active comparator | Behavioral: General Health Program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Bilingual in English and American Sign Language
- Certified sign language interpreter working at least 10 hours/week in any interpreter setting.
- Apparently healthy
Key exclusion criteria (3 listed)
- Less than 18 year old
- Not yet certified as a sign language interpreter
- Unable to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health Protection and PromotionAn adaptive integrated Total Worker Health® program. Virtual 8-week program that's been contextualized to the physical and mental health needs of sign language interpreters. It will examine biomechanics, sleep hygiene, vicarious trauma and burnout, demand-control schema, physical activity, emotional management strategies, proper nutrition and examination of worksite. | Behavioural | Health Protection and Promotion Program |
| General Health ProgramVirtual 8-week program that addresses participant sleep hygiene, physical activity and proper nutrition. | Behavioural | General Health Program |
Primary outcome
mean change in acceptability using the Training Acceptability Rating Scale-1 (TARS-1)
Time frame: 15 to 24 months
TARS-1 measures acceptability using six items (1=strongly disagree; 6=strongly agree) and demonstrates good test-retest reliability, internal consistency, and construct and concurrent validity. The scale ranges from 6 to 36 with higher scores indicating better acceptability.
mean change in acceptability using the Training Acceptability Rating Scale-2 (TARS-2)
Time frame: 15 to 24 months
TARS-2 assesses perceived impact with eight items (0=not at all; 3=a great deal) and demonstrates good face and concurrent validity. Of particular interest, TARS-2 also includes three qualitative items asking about the most helpful part of the program and any recommended changes and invites other comments. The scale ranges from 0-24 with higher scores indicating better outcomes.
mean change in Acceptability, Feasibility, and Appropriateness Scale
Time frame: 15 to 24 months
This acceptability (six items), feasibility (three items), and appropriateness (five items) instrument will be used to assess whether or not the intervention efforts were successful. The 14 total items across three subscales demonstrate good to excellent internal consistency and are rated on a five-point scale (1=not at all; 5=extremely). High scores of 30, 15, and 25 and low scores of 6, 3, and 5 indicate excellent and poor acceptability, feasibility, and appropriateness, respectively.
mean change in the National Institute of Occupational Safety and Health's Worker Well-Being Questionnaire- work evaluation and experience
Time frame: baseline to post intervention (approximately 15-24 months)
Work evaluation and experience is the first of five domains in this comprehensive measure of worker well-being and has 16 total questions. Total summed scores within this section range from 23-128 with higher scores indicating better outcomes (accounting for inverse scoring on negative items).
mean change in the National Institute of Occupational Safety and Health's Worker Well-Being Questionnaire- work evaluation and experience
Time frame: baseline to 6 months post intervention (approximately 21-30 months)
Work evaluation and experience is the first of five domains in this comprehensive measure of worker well-being and has 16 total questions. Total scores within this section range from 23-128 with higher scores indicating better outcomes (accounting for inverse scoring on negative items).
mean change in the National Institute of Occupational Safety and Health's Worker Well-Being Questionnaire- workplace policies and culture
Time frame: baseline to post intervention (approximately 15-24 months)
Workplace policies and culture is the second of five domains in this comprehensive measure of worker well-being and has 14 total questions. Total scores within this section range from 12-75 with higher scores indicating better outcomes (accounting for inverse scoring on negative items).
mean change in the National Institute of Occupational Safety and Health's Worker Well-Being Questionnaire- workplace policies and culture
Time frame: baseline to 6 months post intervention (approximately 21-30 months)
Workplace policies and culture is the second of five domains in this comprehensive measure of worker well-being and has 14 total questions. Total scores within this section range from 12-75 with higher scores indicating better outcomes (accounting for inverse scoring on negative items).
mean change in the National Institute of Occupational Safety and Health's Worker Well-Being Questionnaire- workplace physical environment and safety climate
Time frame: baseline to post intervention (approximately 15-24 months)
Workplace physical environment and safety climate is the third of five domains in this comprehensive measure of worker well-being and has 10 total questions. Total scores within this section range from 14-60 with higher scores indicating better outcomes (accounting for inverse scoring on negative items).
mean change in the National Institute of Occupational Safety and Health's Worker Well-Being Questionnaire- workplace physical environment and safety climate
Time frame: baseline to 6 months post intervention (approximately 21-30 months)
Workplace physical environment and safety climate is the third of five domains in this comprehensive measure of worker well-being and has 10 total questions. Total scores within this section range from 14-60 with higher scores indicating better outcomes (accounting for inverse scoring on negative items).
mean change in the National Institute of Occupational Safety and Health's Worker Well-Being Questionnaire- health status
Time frame: baseline to post intervention (approximately 15-24 months)
Health status is the fourth of five domains in this comprehensive measure of worker well-being and has 23 total questions. There are five open text box items within this section (i.e. asking for the number of days the respondent gets high intensity physical activity). Otherwise, total scores of the Likert scale items within this section range from 24-146 with higher scores indicating better outcomes (accounting for inverse scoring on negative items).
mean change in the National Institute of Occupational Safety and Health's Worker Well-Being Questionnaire- health status
Time frame: baseline to 6 months post intervention (approximately 21-30 months)
Health status is the fourth of five domains in this comprehensive measure of worker well-being and has 23 total questions. There are five open text box items within this section (i.e. asking for the number of days the respondent gets high intensity physical activity). Otherwise, total scores of the Likert scale items within this section range from 24-146 with higher scores indicating better outcomes (accounting for inverse scoring on negative items).
mean change in the National Institute of Occupational Safety and Health's Worker Well-Being Questionnaire- home, community, and society
Time frame: baseline to post intervention (approximately 15-24 months)
Home, community, and society is the final domain in this comprehensive measure of worker well-being and has 5 total questions. Total scores within this section range from 11-65 with higher scores indicating better outcomes (accounting for inverse scoring on negative items).
mean change in the National Institute of Occupational Safety and Health's Worker Well-Being Questionnaire- home, community, and society
Time frame: baseline to 6 months post intervention (approximately 21-30 months)
Home, community, and society is the final domain in this comprehensive measure of worker well-being and has 5 total questions. Total scores within this section range from 11-65 with higher scores indicating better outcomes (accounting for inverse scoring on negative items).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Background: PubMed 12422025Eriksen HR, Ihlebaek C, Mikkelsen A, Gronningsaeter H, Sandal GM, Ursin H. Improving subjective health at the worksite: a randomized controlled trial of stress management training, physical exercise and an integrated health programme. Occup Med (Lond). 2002 Oct;52(7):383-91. doi: 10.1093/occmed/52.7.383.
- Background: PubMed 19032505Tveito TH, Eriksen HR. Integrated health programme: a workplace randomized controlled trial. J Adv Nurs. 2009 Jan;65(1):110-9. doi: 10.1111/j.1365-2648.2008.04846.x. Epub 2008 Nov 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Protection and Promotion and General Health Program in people with Well-Being, Psychological, run by University of Rochester 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 3 inclusion and 3 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 22 Sep 2026. 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. 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?
mean change in acceptability using the Training Acceptability Rating Scale-1 (TARS-1) (time frame: 15 to 24 months). The study lists 13 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 NCT06058949, which also lists 2 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 22 Sep 2026.