Menu
Recruiting NCT06813495

Eastern Principles Acceptance and Commitment Therapy For Injury Prevention Among Nurses and Nursing Aides

No phase Interventional Well-Being, Psychological Work Injury Musculoskeletal Pain High Frequency Heart Rate Variability

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Eastern Principles Acceptance and Commitment Therapy for Nurses and Nursing Aids (EPACT NNA), Acceptance and Commitment Therapy for Nurses and Nursing Aids (ACT NNA).
Who it may be relevant to
Registry conditions: Well-Being, Psychological, Work Injury, Musculoskeletal Pain, High Frequency Heart Rate Variability. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Prevention of Injuries Among Nurses and Nursing Aides Using Eastern Principles Acceptance and Commitment Therapy: Clinical Trial and Dissemination Research

Overview

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: 1. To compare the EPACT NNA intervention to an established traditional Western ACT NNA intervention and a no-treatment control group. 2. To identify predictors of ACT NNA and EPACT NNA responsiveness to the interventions and injury likelihood across time. 3. 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.

Interventions

  • Behavioral 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.
  • Behavioral 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.

Primary outcome measures

  • Organizational and Work Characteristics Associated with Injury [Time frame: Measured at baseline (pretreatment), 1 month, and 3 months]
  • Exposure to Violence [Time frame: Measured at baseline (pretreatment), 1 month, and 3 months]
  • Work-related Injuries and Days Missed Due to Injury [Time frame: Measured at baseline, 1 month, and 3 months]
  • Musculoskeletal Symptoms [Time frame: Measured at baseline (pretreatment), 1 month, and 3 months]
  • Burnout [Time frame: Measured at baseline (pretreatment), 1 month, and 3 months]
  • Acceptance, present-moment awareness, self-as-context, defusion, values, and committed action [Time frame: Measured at baseline (pretreatment), 1 month, and 3 months]
  • Self-compassion and other compassion [Time frame: Measured at baseline (pretreatment), 1 month, and 3 months]
  • Ubiquity of suffering, impermanence, common humanity, nonattachment to self. [Time frame: Measured at baseline (pretreatment), 1 month, and 3 months]
  • High Frequency Heart Rate Variability (HF-HRV) [Time frame: Measured at baseline (pretreatment), 1 month, and 3 months]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Bowling Green State University — Bowling Green

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. PMID 24162145
  • Baer 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. PMID 16443717
  • Bernal 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. PMID 25480459
  • Blignault 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. PMID 18488410
  • Bohlmeijer 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. PMID 21586480
  • Bos 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. PMID 16720530
  • Bostrom 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. PMID 22151034
  • Brown, 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

Identifiers

NCT: NCT06813495 · 10011559

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗