Well-Being, PsychologicalNCT06813495
Eastern Principles Acceptance and Commitment Therapy For Injury Prevention Among Nurses and Nursing Aides
A study testing Eastern Principles Acceptance and Commitment Therapy for Nurses and Nursing Aids (EPACT NNA) and Acceptance and Commitment Therapy for Nurses and Nursing Aids (ACT NNA) in people with Well-Being, Psychological and Work Injury, run by Bowling Green State University at 1 site in United States.
Trial summary
This clinical trial will evaluate the effectivness of an Eastern Principles Acceptance and Commitment Therapy intervention (EPACT) relative to an estabished traditional Western-based Acceptance and Commitment Therapy intervention (ACT) and a no treatment control group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Well-Being, Psychological, Work Injury, Musculoskeletal Pain
- What is being tested?
- Eastern Principles Acceptance and Commitment Therapy for Nurses and Nursing Aids (EPACT NNA) and Acceptance and Commitment Therapy for Nurses and Nursing Aids (ACT NNA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 255 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2023to 1 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- USA: Employed as a nurse or nursing aide in a long-term care facility within a 120 mile radius of Bowling Green, Ohio.
- Thailand: Employed as a nurse or nursing aide in Chiang Mai, Thailand or Krung Thep Bangkok), Thailand.
- At least 18 years of age.
- Able to attend scheduled assessment and intervention appointments.
Who cannot join
- There are no a-priori exclusion criteria. However, if a participant reports significant psychological distress or a diagnosable mental health condition at the baseline assessment, they will be referred for an alternative treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Bowling Green State University
Bowling Green, Ohio, 43402
William H O'Brien, Ph.D., 419-372-2974, wobrien@bgsu.edu
William H O'Brien, Ph.D.
About this study
Official title: Prevention of Injuries Among Nurses and Nursing Aides Using Eastern Principles Acceptance and Commitment Therapy: Clinical Trial and Dissemination Research
This clinical trial will evaluate the effectivness of an Eastern Principles Acceptance and Commitment Therapy intervention (EPACT) relative to an estabished traditional Western-based Acceptance and Commitment Therapy intervention (ACT) and a no treatment control group. The participants for the study will be nurses and nursing aides (NNAs) who work in long-term care settings in the USA and Thailand. The primary dependent variables are work-related injuries, work stress and burnout, wellbeing, musculoskeletal symptoms, time off from work due to injury. High frequency heart rate variability will also be investigated as a predictor of responsiveness to the interventions.
The study has three primary aims:
Read more
- To compare the EPACT NNA intervention to an established traditional Western ACT NNA intervention and a no-treatment control group.
- To identify predictors of ACT NNA and EPACT NNA responsiveness to the interventions and injury likelihood across time.
- To assess EPACT NNA's feasibility and effectiveness across cultures.
USA participants working in Ohio will be randomly assigned to one of three groups: EPACT NNA (n = 80), ACT NNA (n = 80), or a no treatment control group (n = 80). All participants will participate in an assessment session where study questnnaires are completed and a baseline high frequency HRV measurement is collected. Subsequent to the assessment, the EPACT NNA and ACT NNA participants will attend two 2.5 hour sessions spaced one week apart. The control group will have no further in-person meetings with the researchers. One-month after completing the intervention (4 weeks after the baseline assessment) a follow-up survey will be sent to participants for the first follow-up. Three months after baseline, the second follow-up survey will be sent to participants.
The surveys assess demographic characteristics, organizational variables, work-related injuries, work stress, and well-being.
A second RCT study will be conducted in Thailand comparing EPACT NNA (n = 40) to a no-treatment control group (n = 40) among nurses and nursing aides working in healthcare settings. The same outcome measures and procedures will be used.
This research aims to develop a culturally-informed, evidence-based intervention that integrates both Western and Eastern mindfulness principles to address the high rates of work-related injuries among NNAs.
Read the detailed description
Nurses and nursing aides (NNAs) in healthcare settings are a diverse, vulnerable group who experience high rates of psychological and physical injuries. Addressing work-related injuries among NNAs is crucial for health, social, economic, and humanitarian reasons.
Research has shown that mindfulness predicts injuries among Ohio NNAs. A mindfulness-based intervention (Acceptance and Commitment Therapy, ACT) was effective in reducing injury-related absences and improving psychological wellbeing. However, Western mindfulness interventions may miss critical Eastern elements. It has been argued that Western "McMindfulness" interventions lack essential Eastern teachings, potentially reducing effectiveness, especially for healthcare workers.
Acceptance of suffering, self-compassion/loving-kindness, acceptance of impermanence, letting go of stress, nonself-attachment, and a common humanity are Eastern elements missing in Western mindfulness interventions. In collaboration with Thai mindfulness scholars, the researchers developed the Eastern Perspectives-added Acceptance and Commitment Therapy (EPACT NNA) for NNAs, integrating Eastern theories into an existing ACT protocol for NNAs. We hypothesize that EPACT NNA will more effectively reduce psychological and physical injuries, improve psychophysiological well-being, and shorten recovery times compared to conventional Western interventions or no treatment.
Specific Aim 1: Conduct a randomized clinical trial to evaluate EPACT NNA's effectiveness against traditional ACT for NNAs and a no-treatment control group. Outcome variables include: Psychological distress, injuries, well-being, work stress, burnout, compassion, psychological flexibility, and behavioral outcomes.
Specific Aim 2: Predict the responsiveness to EPACT NNA and the likelihood of psychological and physical injuries using on baseline measures of psychological and physiological functioning.
Specific Aim 3: Evaluate the feasibility and effectiveness of EPACT NNA in healthcare settings in Ohio and Thailand.
These aims align with NIH and Ohio BWC goals for preventing musculoskeletal and related injuries, integrating health and wellness into occupational safety, and improving mental health among workers. Additionally, this project acknowledges the Eastern origins of mindfulness practices.
The EPACT intervention will be group-based with 5-10 participants per group. The EPACT protocol is comprised of two 2.5-hour sessions spaced one week apart. The ACT for NNA intervention has been previously tested for NNAs. It contains only the six core processes identified above and omits the added EPACT components of acceptance of suffering, common humanity, impermanence, self- and other-compassion, and non-self- attachment. It will be delivered in a similar group-based format of 5-10 participants in two 2.5-hour sessions.
Control group participants will complete measures at the same time points as the EPACT and ACT groups. The researchers opted to use a no-treatment control group to allow for measurement of the durability of treatment gains across a 3-month follow-up period without an expectation for treatment.
All NNAs agreeing to participate will be asked to complete the informed consent and the pretreatment measures. The first EPACT and ACT for NNAs sessions will follow the pretreatment assessment. The control group will have not further in-person contact with researchers but will receive text and email messages. The following week, the ACT NNA and EPACT NNA participants will attend the second session. Exposure to violence, injury, musculoskeletal symptoms, burnout, mindfulness, and compassion measures will be completed at pretreatment, post-treatment, and three-months follow-up. Participants will complete these measures online. Heart rate variability will be assessed at pretreatment.
- Conditions
- Well-Being, Psychological, Work Injury, Musculoskeletal Pain, High Frequency Heart Rate Variability, Burnout, Mindfulness
- Being tested
- Eastern Principles Acceptance and Commitment Therapy for Nurses and Nursing Aids (EPACT NNA), Acceptance and Commitment Therapy for Nurses and Nursing Aids (ACT NNA)
- Medical subject headings
- Psychological Well-Being, Musculoskeletal Pain, Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eastern Principles Acceptance and Commitment Therapy for Nurses and Nursing Aids (EPACT NNA)Behavioural
The EPACT intervention will be group-based with 5-10 participants per group. The group-based format has been shown to be an effective delivery method for NNAs (O'Brien, et al., 2019b). The EPACT protocol is comprised of two 2.5-hour sessions spaced one week apart.
Acceptance and Commitment Therapy for Nurses and Nursing Aids (ACT NNA)Behavioural
The ACT for NNA intervention has been previously tested for NNAs. It contains only the six core processes identified above and omits the added EPACT components of acceptance of suffering, common humanity, impermanence, self- and other-compassion, and non-self-attachment. It will be delivered in a similar group-based format of 5-10 participants in two 2.5 -hour sessions.
| Study group | Role | What they receive |
|---|---|---|
| Eastern Principles Acceptance and Commitment Therapy for Nurss and Nursing Aids (EPACT NNA) | Active comparator | The EPACT intervention is designed to promote psychological flexibility (Hayes, et al., 2006), compassion, a recognition of impermanence, common humanity, and non-self-attachment. Psychological flexibility has six core processes: acceptance, cognitive defusion, present moment awareness, self-as-context, values, committed action. The EPACT NNA intervention will be group-based with 5-10 participants per group. The group-based format has been shown to be an effective delivery method for NNAs (O'Brien, et al., 2019b). The EPACT NNA protocol is comprised of two 2.5-hour sessions spaced one week apart. Receives: Behavioral: Eastern Principles Acceptance and Commitment Therapy for Nurses and Nursing Aids (EPACT NNA) |
| Acceptance and Commitment Therapy for Nurses and Nursing Aids (ACT NNA) | Active comparator | The ACT NNA intervention has been previously tested for NNAs. It contains the six core processes identified above and omits the added EPACT components of acceptance of suffering, common humanity, impermanence, self- and other-compassion, and non-self- attachment. It will be delivered in a similar group-based format of 5-10 participants in three 2.5 - hour sessions. Receives: Behavioral: Acceptance and Commitment Therapy for Nurses and Nursing Aids (ACT NNA) |
| Control Group | No intervention | Control group participants will complete measures at the same time points as the EPACT NNA and ACT NNA groups. We opted to use a no-treatment control group to allow for measurement of the durability of treatment gains across a 3-month follow-up period without an expectation for treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Organizational and Work Characteristics Associated with Injury
The Risk for Nursing Aide Injury Inventory (RNAII) contains 6 items measuring demographic variables, 9 items measuring job characteristics (e.g., tenure, hours per week, hours per shift, etc.) and 120 items assessing individual and organizational characteristics (e.g., staffing, space, training, physical environment characteristics, organizational constraints, incivility, family-work conflict, lifting device availability, organizational safety climate, supervisor relationships, and worker respect).
Measured: Measured at baseline (pretreatment), 1 month, and 3 months
Exposure to Violence
The Workplace Violence Tool is used to measure exposure to assault and abuse of NNAs. The workplace violence tool consists of 7 items that assess the occurrence of: (a) threat of assault, (b) emotional abuse (e.g., hurtful remarks), (c) physical abuse (e.g., spit, kick, punch), (d) verbal sexual harassment, (e) sexual assault (e.g., touching, groping), and (f) forced sexual intercourse. Bostrom et al. (2011) modified the original measure to include information about the source of assault or abuse (resident, family member, coworker, other).
Measured: Measured at baseline (pretreatment), 1 month, and 3 months
Work-related Injuries and Days Missed Due to Injury
The National Nursing Assistant Survey (NNAS) will be used to measure NNA injuries. The NNAS was developed by the Centers for Disease Control (Squillace, et al., 2007). The NNAS contains 6 items assessing musculoskeletal injuries, strains and muscle pulls, bites, scratches, wounds, cuts, bruising, and other types of injuries. Additionally, the NNAS measures the type of injury, cause of injury, days unable to work due to injury, and restricted activity due to injury.
Measured: Measured at baseline, 1 month, and 3 months
Musculoskeletal Symptoms
Musculoskeletal symptoms will be measured a scale developed by Kuorinka et al. (1987). This scale asks participants how often they experienced any of 9 common musculoskeletal complaints, on a scale from "never" to "very often." The 9 complaints included in this scale adequately represent the musculoskeletal symptoms identified in our prior research with nursing aides (O'Brien et al., 2019a).
Measured: Measured at baseline (pretreatment), 1 month, and 3 months
Burnout
Copenhagen Burnout Inventory (Kristensen, et al., 2005) will be used to measure burnout. The 18 items on the inventory form three subscales: personal burnout, work-related burnout, and client-related burnout. The scale has demonstrated strong reliability, consistency, and validity in prior research investigations.
Measured: Measured at baseline (pretreatment), 1 month, and 3 months
Acceptance, present-moment awareness, self-as-context, defusion, values, and committed action
The Multidimensional Psychological Flexibility Inventory (MPFI) is a 60-item measure that was developed by Rolffs et al., (2018). The MPFI includes six subscales that measure psychological flexibility: acceptance, defusion, values, committed action, present-moment-awareness, self-as-context, and experiential avoidance. Six other subscales represent psychological inflexibility: experiential avoidance, fusion, lack of values, inaction, noncontact with the present moment, and self-as-content.
Measured: Measured at baseline (pretreatment), 1 month, and 3 months
Self-compassion and other compassion
The Self-Compassion Scale (SCS) is a 26 item self-report measure that was developed by Neff (2003) to measure the extent to which a person may report a perspective towards the suffering of self that reflects kindness versus judgement, common humanity versus isolation, and mindfulness versus overidentification.
The SCS yields 6 subscales: Self-Kindness, Common Humanity, Mindfulness, Self-Judgement, Isolation, and Over-Identified. The Compassion scale (CS) is a 16-item inventory measuring compassion for others. It has four subscales: kindness, common humanity, mindfulness, and lessened indifference.
Measured: Measured at baseline (pretreatment), 1 month, and 3 months
Ubiquity of suffering, impermanence, common humanity, nonattachment to self.
The Mindfulness Insight Scale (MIS) is a 16-item measure that assesses the three characteristics of existence (inevitability of suffering, impermanence, and nonself-attachment/interconnectedness) from an Eastern and Buddhist perspective. Each item (e.g., "No living creature can escape suffering," "With or without noticing, change constantly occurs to everything," "I try not to get caught up in "Who I am.") is rated from 1 (very untrue) to 5 (very true).
Measured: Measured at baseline (pretreatment), 1 month, and 3 months
High Frequency Heart Rate Variability (HF-HRV)
Resting HF-HRV levels will be collected from participants at their worksites. The resting HF-HRV will be recorded across a 10-minute interval while the participants are seated comfortably in a private room at each site. ECG data will be collected with a Biopac MP150 interfaced with Biopac Acqknowledge 4.3 software. ECG electrodes will be attached to participants using a lead II configuration. The ECG signal will be sampled at a rate of 1000Hz, which exceeds the minimum recommended sampling rate of 500Hz (Allen, et al., 2007). Once recorded, ECG signals will be replayed and visually inspected by researchers to detect and remove artifacts. The cleaned ECG data will then be analyzed using Kubios software (Tarvainen, et al., 2014).
Measured: Measured at baseline (pretreatment), 1 month, and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start1 May 2023
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (79)Papers the sponsor has linked to this study.
- Other trials for Well-Being, PsychologicalStudies of the same condition, open and under way.
- 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
- 255 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bowling Green State University
- Sponsor type
- University, hospital or other
- Collaborators
- Ohio Bureau of Workers Compensation
- Responsible party
- Principal investigator, Willliam H. O'Brien, Bowling Green State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06813495
- Sponsor's protocol ID
- 10011559
- Status last verified
- Feb 2025
- First submitted
- 9 Oct 2024
- Last updated
- 7 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Yes
Publications
Ahola K, Salminen S, Toppinen-Tanner S, Koskinen A, Vaananen A. Occupational burnout and severe injuries: an eight-year prospective cohort study among Finnish forest industry workers. J Occup Health. 2013;55(6):450-7. doi: 10.1539/joh.13-0021-oa. Epub 2013 Oct 26.
PubMed 24162145Baer RA, Smith GT, Hopkins J, Krietemeyer J, Toney L. Using self-report assessment methods to explore facets of mindfulness. Assessment. 2006 Mar;13(1):27-45. doi: 10.1177/1073191105283504.
PubMed 16443717Bernal D, Campos-Serna J, Tobias A, Vargas-Prada S, Benavides FG, Serra C. Work-related psychosocial risk factors and musculoskeletal disorders in hospital nurses and nursing aides: a systematic review and meta-analysis. Int J Nurs Stud. 2015 Feb;52(2):635-48. doi: 10.1016/j.ijnurstu.2014.11.003. Epub 2014 Nov 15.
PubMed 25480459Blignault I, Ponzio V, Rong Y, Eisenbruch M. A qualitative study of barriers to mental health services utilisation among migrants from mainland China in south-east Sydney. Int J Soc Psychiatry. 2008 Mar;54(2):180-90. doi: 10.1177/0020764007085872.
PubMed 18488410Bohlmeijer E, ten Klooster PM, Fledderus M, Veehof M, Baer R. Psychometric properties of the five facet mindfulness questionnaire in depressed adults and development of a short form. Assessment. 2011 Sep;18(3):308-20. doi: 10.1177/1073191111408231. Epub 2011 May 17.
PubMed 21586480Bos EH, Krol B, Van Der Star A, Groothoff JW. The effects of occupational interventions on reduction of musculoskeletal symptoms in the nursing profession. Ergonomics. 2006 Jun 10;49(7):706-23. doi: 10.1080/00140130600578005.
PubMed 16720530Bostrom AM, Squires JE, Mitchell A, Sales AE, Estabrooks CA. Workplace aggression experienced by frontline staff in dementia care. J Clin Nurs. 2012 May;21(9-10):1453-65. doi: 10.1111/j.1365-2702.2011.03924.x. Epub 2011 Dec 12.
PubMed 22151034Brown, R. L., & Moloney, M. E. (2018). Intersectionality, Work, and Well-Being: The Effects of Gender and Disability. Gender & Society, 33(1), 94-122. doi.org/10.1177/0891243218800636
Burton A, Burgess C, Dean S, Koutsopoulou GZ, Hugh-Jones S. How Effective are Mindfulness-Based Interventions for Reducing Stress Among Healthcare Professionals? A Systematic Review and Meta-Analysis. Stress Health. 2017 Feb;33(1):3-13. doi: 10.1002/smi.2673. Epub 2016 Feb 25.
PubMed 26916333Chang YJ, Kwon YC, Lee WJ, Do YR, Seok LK, Kim HT, Park SR, Hong YS, Chung IJ, Yun YH. Burdens, needs and satisfaction of terminal cancer patients and their caregivers. Asian Pac J Cancer Prev. 2013;14(1):209-16. doi: 10.7314/apjcp.2013.14.1.209.
PubMed 23534725Chen Y, Yang X, Wang L, Zhang X. A randomized controlled trial of the effects of brief mindfulness meditation on anxiety symptoms and systolic blood pressure in Chinese nursing students. Nurse Educ Today. 2013 Oct;33(10):1166-72. doi: 10.1016/j.nedt.2012.11.014. Epub 2012 Dec 20.
PubMed 23260618Cohen, A., & Golan, R. (2007). Predicting absenteeism and turnover intentions by past absenteeism and work attitudes. Career Development International, 12(5), 416-432. doi.org/10.1108/13620430710773745
Cohen-Katz J, Wiley SD, Capuano T, Baker DM, Kimmel S, Shapiro S. The effects of mindfulness-based stress reduction on nurse stress and burnout, Part II: A quantitative and qualitative study. Holist Nurs Pract. 2005 Jan-Feb;19(1):26-35. doi: 10.1097/00004650-200501000-00008.
PubMed 15736727Crenshaw, K. (1989) Demarginalizing the Intersection of Race and Sex: A Black Feminist Critique of Antidiscrimination Doctrine, Feminist Theory and Antiracist Politics, University of Chicago Legal Forum: Vol. 1989: Iss. 1, Article 8.
Dantas EM, Sant'Anna ML, Andreao RV, Goncalves CP, Morra EA, Baldo MP, Rodrigues SL, Mill JG. Spectral analysis of heart rate variability with the autoregressive method: what model order to choose? Comput Biol Med. 2012 Feb;42(2):164-70. doi: 10.1016/j.compbiomed.2011.11.004. Epub 2011 Dec 2.
PubMed 22136799
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Injuries Among Nurses and Nursing Aides Using Eastern Principles Acceptance and Commitment Therapy: Clinical Trial and Dissemination Research
- ClinicalTrials.gov ID
- NCT06813495
- Acronym / sponsor ID
- 10011559
- Conditions
- Well-Being, Psychological, Work Injury, Musculoskeletal Pain, High Frequency Heart Rate Variability, Burnout, Mindfulness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 255 participants (estimated)
- Lead sponsor
- Bowling Green State UniversityUniversity, hospital or other
- Collaborators
- Ohio Bureau of Workers Compensation
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 7 Feb 2025 (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.
This clinical trial will evaluate the effectivness of an Eastern Principles Acceptance and Commitment Therapy intervention (EPACT) relative to an estabished traditional Western-based Acceptance and Commitment Therapy intervention (ACT) and a no treatment control group. The participants for the study will be nurses and nursing aides (NNAs) who work in long-term care settings in the USA and Thailand. The primary dependent variables are work-related injuries, work stress and burnout, wellbeing, musculoskeletal symptoms, time off from work due to injury. High frequency heart rate variability will also be investigated as a predictor of responsiveness to the interventions.
The study has three primary aims:
- To compare the EPACT NNA intervention to an established traditional Western ACT NNA intervention and a no-treatment control group.
- To identify predictors of ACT NNA and EPACT NNA responsiveness to the interventions and injury likelihood across time.
- To assess EPACT NNA's feasibility and effectiveness across cultures.
USA participants working in Ohio will be randomly assigned to one of three groups: EPACT NNA (n = 80), ACT NNA (n = 80), or a no treatment control group (n = 80). All participants will participate in an assessment session where study questnnaires are completed and a baseline high frequency HRV measurement is collected. Subsequent to the assessment, the EPACT NNA and ACT NNA participants will attend two 2.5 hour sessions spaced one week apart. The control group will have no further in-person meetings with the researchers. One-month after completing the intervention (4 weeks after the baseline assessment) a follow-up survey will be sent to participants for the first follow-up. Three months after baseline, the second follow-up survey will be sent to participants.
The surveys assess demographic characteristics, organizational variables, work-related injuries, work stress, and well-being.
A second RCT study will be conducted in Thailand comparing EPACT NNA (n = 40) to a no-treatment control group (n = 40) among nurses and nursing aides working in healthcare settings. The same outcome measures and procedures will be used.
This research aims to develop a culturally-informed, evidence-based intervention that integrates both Western and Eastern mindfulness principles to address the high rates of work-related injuries among NNAs.
Detailed description
Nurses and nursing aides (NNAs) in healthcare settings are a diverse, vulnerable group who experience high rates of psychological and physical injuries. Addressing work-related injuries among NNAs is crucial for health, social, economic, and humanitarian reasons.
Research has shown that mindfulness predicts injuries among Ohio NNAs. A mindfulness-based intervention (Acceptance and Commitment Therapy, ACT) was effective in reducing injury-related absences and improving psychological wellbeing. However, Western mindfulness interventions may miss critical Eastern elements. It has been argued that Western "McMindfulness" interventions lack essential Eastern teachings, potentially reducing effectiveness, especially for healthcare workers.
Acceptance of suffering, self-compassion/loving-kindness, acceptance of impermanence, letting go of stress, nonself-attachment, and a common humanity are Eastern elements missing in Western mindfulness interventions. In collaboration with Thai mindfulness scholars, the researchers developed the Eastern Perspectives-added Acceptance and Commitment Therapy (EPACT NNA) for NNAs, integrating Eastern theories into an existing ACT protocol for NNAs. We hypothesize that EPACT NNA will more effectively reduce psychological and physical injuries, improve psychophysiological well-being, and shorten recovery times compared to conventional Western interventions or no treatment.
Specific Aim 1: Conduct a randomized clinical trial to evaluate EPACT NNA's effectiveness against traditional ACT for NNAs and a no-treatment control group. Outcome variables include: Psychological distress, injuries, well-being, work stress, burnout, compassion, psychological flexibility, and behavioral outcomes.
Specific Aim 2: Predict the responsiveness to EPACT NNA and the likelihood of psychological and physical injuries using on baseline measures of psychological and physiological functioning.
Specific Aim 3: Evaluate the feasibility and effectiveness of EPACT NNA in healthcare settings in Ohio and Thailand.
These aims align with NIH and Ohio BWC goals for preventing musculoskeletal and related injuries, integrating health and wellness into occupational safety, and improving mental health among workers. Additionally, this project acknowledges the Eastern origins of mindfulness practices.
The EPACT intervention will be group-based with 5-10 participants per group. The EPACT protocol is comprised of two 2.5-hour sessions spaced one week apart. The ACT for NNA intervention has been previously tested for NNAs. It contains only the six core processes identified above and omits the added EPACT components of acceptance of suffering, common humanity, impermanence, self- and other-compassion, and non-self- attachment. It will be delivered in a similar group-based format of 5-10 participants in two 2.5-hour sessions.
Control group participants will complete measures at the same time points as the EPACT and ACT groups. The researchers opted to use a no-treatment control group to allow for measurement of the durability of treatment gains across a 3-month follow-up period without an expectation for treatment.
All NNAs agreeing to participate will be asked to complete the informed consent and the pretreatment measures. The first EPACT and ACT for NNAs sessions will follow the pretreatment assessment. The control group will have not further in-person contact with researchers but will receive text and email messages. The following week, the ACT NNA and EPACT NNA participants will attend the second session. Exposure to violence, injury, musculoskeletal symptoms, burnout, mindfulness, and compassion measures will be completed at pretreatment, post-treatment, and three-months follow-up. Participants will complete these measures online. Heart rate variability will be assessed at pretreatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Eastern Principles Acceptance and Commitment Therapy for Nurss and Nursing Aids (EPACT NNA) | Active comparator | Behavioral: Eastern Principles Acceptance and Commitment Therapy for Nurses and Nursing Aids (EPACT NNA)The EPACT intervention is designed to promote psychological flexibility (Hayes, et al., 2006), compassion, a recognition of impermanence, common humanity, and non-self-attachment. Psychological flexibility has six core processes: acceptance, cognitive defusion, present moment awareness, self-as-context, values, committed action. The EPACT NNA intervention will be group-based with 5-10 participants per group. The group-based format has been shown to be an effective delivery method for NNAs (O'Brien, et al., 2019b). The EPACT NNA protocol is comprised of two 2.5-hour sessions spaced one week apart. |
| Acceptance and Commitment Therapy for Nurses and Nursing Aids (ACT NNA) | Active comparator | Behavioral: Acceptance and Commitment Therapy for Nurses and Nursing Aids (ACT NNA)The ACT NNA intervention has been previously tested for NNAs. It contains the six core processes identified above and omits the added EPACT components of acceptance of suffering, common humanity, impermanence, self- and other-compassion, and non-self- attachment. It will be delivered in a similar group-based format of 5-10 participants in three 2.5 - hour sessions. |
| Control Group | No intervention | –Control group participants will complete measures at the same time points as the EPACT NNA and ACT NNA groups. We opted to use a no-treatment control group to allow for measurement of the durability of treatment gains across a 3-month follow-up period without an expectation for treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- USA: Employed as a nurse or nursing aide in a long-term care facility within a 120 mile radius of Bowling Green, Ohio.
- Thailand: Employed as a nurse or nursing aide in Chiang Mai, Thailand or Krung Thep Bangkok), Thailand.
- At least 18 years of age.
- Able to attend scheduled assessment and intervention appointments.
Key exclusion criteria (1 listed)
- There are no a-priori exclusion criteria. However, if a participant reports significant psychological distress or a diagnosable mental health condition at the baseline assessment, they will be referred for an alternative treatment.
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 |
|---|---|---|
| Eastern Principles Acceptance and Commitment Therapy for Nurses and Nursing Aids (EPACT NNA)The EPACT intervention will be group-based with 5-10 participants per group. The group-based format has been shown to be an effective delivery method for NNAs (O'Brien, et al., 2019b). The EPACT protocol is comprised of two 2.5-hour sessions spaced one week apart. | Behavioural | Eastern Principles Acceptance and Commitment Therapy for Nurss and Nursing Aids (EPACT NNA) |
| Acceptance and Commitment Therapy for Nurses and Nursing Aids (ACT NNA)The ACT for NNA intervention has been previously tested for NNAs. It contains only the six core processes identified above and omits the added EPACT components of acceptance of suffering, common humanity, impermanence, self- and other-compassion, and non-self-attachment. It will be delivered in a similar group-based format of 5-10 participants in two 2.5 -hour sessions. | Behavioural | Acceptance and Commitment Therapy for Nurses and Nursing Aids (ACT NNA) |
Primary outcome
Organizational and Work Characteristics Associated with Injury
Time frame: Measured at baseline (pretreatment), 1 month, and 3 months
The Risk for Nursing Aide Injury Inventory (RNAII) contains 6 items measuring demographic variables, 9 items measuring job characteristics (e.g., tenure, hours per week, hours per shift, etc.) and 120 items assessing individual and organizational characteristics (e.g., staffing, space, training, physical environment characteristics, organizational constraints, incivility, family-work conflict, lifting device availability, organizational safety climate, supervisor relationships, and worker respect).
Exposure to Violence
Time frame: Measured at baseline (pretreatment), 1 month, and 3 months
The Workplace Violence Tool is used to measure exposure to assault and abuse of NNAs. The workplace violence tool consists of 7 items that assess the occurrence of: (a) threat of assault, (b) emotional abuse (e.g., hurtful remarks), (c) physical abuse (e.g., spit, kick, punch), (d) verbal sexual harassment, (e) sexual assault (e.g., touching, groping), and (f) forced sexual intercourse. Bostrom et al. (2011) modified the original measure to include information about the source of assault or abuse (resident, family member, coworker, other).
Work-related Injuries and Days Missed Due to Injury
Time frame: Measured at baseline, 1 month, and 3 months
The National Nursing Assistant Survey (NNAS) will be used to measure NNA injuries. The NNAS was developed by the Centers for Disease Control (Squillace, et al., 2007). The NNAS contains 6 items assessing musculoskeletal injuries, strains and muscle pulls, bites, scratches, wounds, cuts, bruising, and other types of injuries. Additionally, the NNAS measures the type of injury, cause of injury, days unable to work due to injury, and restricted activity due to injury.
Musculoskeletal Symptoms
Time frame: Measured at baseline (pretreatment), 1 month, and 3 months
Musculoskeletal symptoms will be measured a scale developed by Kuorinka et al. (1987). This scale asks participants how often they experienced any of 9 common musculoskeletal complaints, on a scale from "never" to "very often." The 9 complaints included in this scale adequately represent the musculoskeletal symptoms identified in our prior research with nursing aides (O'Brien et al., 2019a).
Burnout
Time frame: Measured at baseline (pretreatment), 1 month, and 3 months
Copenhagen Burnout Inventory (Kristensen, et al., 2005) will be used to measure burnout. The 18 items on the inventory form three subscales: personal burnout, work-related burnout, and client-related burnout. The scale has demonstrated strong reliability, consistency, and validity in prior research investigations.
Acceptance, present-moment awareness, self-as-context, defusion, values, and committed action
Time frame: Measured at baseline (pretreatment), 1 month, and 3 months
The Multidimensional Psychological Flexibility Inventory (MPFI) is a 60-item measure that was developed by Rolffs et al., (2018). The MPFI includes six subscales that measure psychological flexibility: acceptance, defusion, values, committed action, present-moment-awareness, self-as-context, and experiential avoidance. Six other subscales represent psychological inflexibility: experiential avoidance, fusion, lack of values, inaction, noncontact with the present moment, and self-as-content.
Self-compassion and other compassion
Time frame: Measured at baseline (pretreatment), 1 month, and 3 months
The Self-Compassion Scale (SCS) is a 26 item self-report measure that was developed by Neff (2003) to measure the extent to which a person may report a perspective towards the suffering of self that reflects kindness versus judgement, common humanity versus isolation, and mindfulness versus overidentification. The SCS yields 6 subscales: Self-Kindness, Common Humanity, Mindfulness, Self-Judgement, Isolation, and Over-Identified. The Compassion scale (CS) is a 16-item inventory measuring compassion for others. It has four subscales: kindness, common humanity, mindfulness, and lessened indifference.
Ubiquity of suffering, impermanence, common humanity, nonattachment to self.
Time frame: Measured at baseline (pretreatment), 1 month, and 3 months
The Mindfulness Insight Scale (MIS) is a 16-item measure that assesses the three characteristics of existence (inevitability of suffering, impermanence, and nonself-attachment/interconnectedness) from an Eastern and Buddhist perspective. Each item (e.g., "No living creature can escape suffering," "With or without noticing, change constantly occurs to everything," "I try not to get caught up in "Who I am.") is rated from 1 (very untrue) to 5 (very true).
High Frequency Heart Rate Variability (HF-HRV)
Time frame: Measured at baseline (pretreatment), 1 month, and 3 months
Resting HF-HRV levels will be collected from participants at their worksites. The resting HF-HRV will be recorded across a 10-minute interval while the participants are seated comfortably in a private room at each site. ECG data will be collected with a Biopac MP150 interfaced with Biopac Acqknowledge 4.3 software. ECG electrodes will be attached to participants using a lead II configuration. The ECG signal will be sampled at a rate of 1000Hz, which exceeds the minimum recommended sampling rate of 500Hz (Allen, et al., 2007). Once recorded, ECG signals will be replayed and visually inspected by researchers to detect and remove artifacts. The cleaned ECG data will then be analyzed using Kubios software (Tarvainen, et al., 2014).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Background: PubMed 24162145Ahola K, Salminen S, Toppinen-Tanner S, Koskinen A, Vaananen A. Occupational burnout and severe injuries: an eight-year prospective cohort study among Finnish forest industry workers. J Occup Health. 2013;55(6):450-7. doi: 10.1539/joh.13-0021-oa. Epub 2013 Oct 26.
- Background: PubMed 16443717Baer RA, Smith GT, Hopkins J, Krietemeyer J, Toney L. Using self-report assessment methods to explore facets of mindfulness. Assessment. 2006 Mar;13(1):27-45. doi: 10.1177/1073191105283504.
- Background: PubMed 25480459Bernal D, Campos-Serna J, Tobias A, Vargas-Prada S, Benavides FG, Serra C. Work-related psychosocial risk factors and musculoskeletal disorders in hospital nurses and nursing aides: a systematic review and meta-analysis. Int J Nurs Stud. 2015 Feb;52(2):635-48. doi: 10.1016/j.ijnurstu.2014.11.003. Epub 2014 Nov 15.
- Background: PubMed 18488410Blignault I, Ponzio V, Rong Y, Eisenbruch M. A qualitative study of barriers to mental health services utilisation among migrants from mainland China in south-east Sydney. Int J Soc Psychiatry. 2008 Mar;54(2):180-90. doi: 10.1177/0020764007085872.
- Background: PubMed 21586480Bohlmeijer E, ten Klooster PM, Fledderus M, Veehof M, Baer R. Psychometric properties of the five facet mindfulness questionnaire in depressed adults and development of a short form. Assessment. 2011 Sep;18(3):308-20. doi: 10.1177/1073191111408231. Epub 2011 May 17.
- Background: PubMed 16720530Bos EH, Krol B, Van Der Star A, Groothoff JW. The effects of occupational interventions on reduction of musculoskeletal symptoms in the nursing profession. Ergonomics. 2006 Jun 10;49(7):706-23. doi: 10.1080/00140130600578005.
- Background: PubMed 22151034Bostrom AM, Squires JE, Mitchell A, Sales AE, Estabrooks CA. Workplace aggression experienced by frontline staff in dementia care. J Clin Nurs. 2012 May;21(9-10):1453-65. doi: 10.1111/j.1365-2702.2011.03924.x. Epub 2011 Dec 12.
- BackgroundBrown, R. L., & Moloney, M. E. (2018). Intersectionality, Work, and Well-Being: The Effects of Gender and Disability. Gender & Society, 33(1), 94-122. doi.org/10.1177/0891243218800636
- Background: PubMed 26916333Burton A, Burgess C, Dean S, Koutsopoulou GZ, Hugh-Jones S. How Effective are Mindfulness-Based Interventions for Reducing Stress Among Healthcare Professionals? A Systematic Review and Meta-Analysis. Stress Health. 2017 Feb;33(1):3-13. doi: 10.1002/smi.2673. Epub 2016 Feb 25.
- Background: PubMed 23534725Chang YJ, Kwon YC, Lee WJ, Do YR, Seok LK, Kim HT, Park SR, Hong YS, Chung IJ, Yun YH. Burdens, needs and satisfaction of terminal cancer patients and their caregivers. Asian Pac J Cancer Prev. 2013;14(1):209-16. doi: 10.7314/apjcp.2013.14.1.209.
- Background: PubMed 23260618Chen Y, Yang X, Wang L, Zhang X. A randomized controlled trial of the effects of brief mindfulness meditation on anxiety symptoms and systolic blood pressure in Chinese nursing students. Nurse Educ Today. 2013 Oct;33(10):1166-72. doi: 10.1016/j.nedt.2012.11.014. Epub 2012 Dec 20.
- BackgroundCohen, A., & Golan, R. (2007). Predicting absenteeism and turnover intentions by past absenteeism and work attitudes. Career Development International, 12(5), 416-432. doi.org/10.1108/13620430710773745
- Individual participant dataSharing planned: Undecided. Yes
Related trials for Well-Being, Psychological
Active, not recruitingObservational study
Gulf Long-Term Follow-Up Study
Cardiovascular Disease, Hematologic Diseases
Not yet recruitingObservational study
A Natural History of Cardiometabolic Disease Among US Bhutanese: Developing the Cross-Sectional Bhutanese Community of Central Ohio Health Study to Understand Acculturation as Synergizing Socioenvironmental and Biobehavioral Risk Factors Propagating ...
Cardiometabolic Risk Factors, Mental Health
Not yet recruiting
Supporting Health and Empowerment Through Contingency Management and Affect Regulation
HIV Risk
Not yet recruiting
A Hybrid Effectiveness-Implementation and Cost-Utility Evaluation of a Support Programme for Informal Carers of People With Dementia in Primary Care (EsCuidar2)
Quality of Life
Not yet recruiting
Pilot Study to Co-create and Implement a Multicomponent Intervention to Reduce Mental Health Stigma in Primary Care
Mental Health, Stigma of Mental Illness
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eastern Principles Acceptance and Commitment Therapy for Nurses and Nursing Aids (EPACT NNA) and Acceptance and Commitment Therapy for Nurses and Nursing Aids (ACT NNA) in people with Well-Being, Psychological and Work Injury, run by Bowling Green State University 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: looking for participants now, as of the sponsor's last update on 7 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Organizational and Work Characteristics Associated with Injury (time frame: Measured at baseline (pretreatment), 1 month, and 3 months). The study lists 9 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 NCT06813495, which also lists 79 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 7 Feb 2025; AzTrials last refreshed its copy on 26 Oct 2026.