Clinical trial NCT06813495: Eastern Principles Acceptance and Commitment Therapy For Injury Prevention Among Nurses and Nursing Aides
Official title: Prevention of Injuries Among Nurses and Nursing Aides Using Eastern Principles Acceptance and Commitment Therapy: Clinical Trial and Dissemination Research
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Well-Being, Psychological
Work Injury
Musculoskeletal Pain
High Frequency Heart Rate Variability
Burnout
Mindfulness
Self-Compassion
Acceptance and Commitment Therapy
Heart Rate Variability
Lead sponsor: Bowling Green State University
Sponsor class: OTHER
Collaborators: name: Ohio Bureau of Workers Compensation
First posted: 2025-02-07
Enrollment: 255
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

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.

Primary outcomes:
measure: Organizational and Work Characteristics Associated with Injury
timeFrame: Measured at baseline (pretreatment), 1 month, and 3 months
measure: Exposure to Violence
timeFrame: Measured at baseline (pretreatment), 1 month, and 3 months
measure: Work-related Injuries and Days Missed Due to Injury
timeFrame: Measured at baseline, 1 month, and 3 months
measure: Musculoskeletal Symptoms
timeFrame: Measured at baseline (pretreatment), 1 month, and 3 months
measure: Burnout
timeFrame: Measured at baseline (pretreatment), 1 month, and 3 months
measure: Acceptance, present-moment awareness, self-as-context, defusion, values, and committed action
timeFrame: Measured at baseline (pretreatment), 1 month, and 3 months
measure: Self-compassion and other compassion
timeFrame: Measured at baseline (pretreatment), 1 month, and 3 months
measure: Ubiquity of suffering, impermanence, common humanity, nonattachment to self.
timeFrame: Measured at baseline (pretreatment), 1 month, and 3 months
measure: High Frequency Heart Rate Variability (HF-HRV)
timeFrame: Measured at baseline (pretreatment), 1 month, and 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bowling Green
country: United States
facility: Bowling Green State University
state: Ohio
Study officials:
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