NCT06813495 · Bowling Green State University
Eastern Principles Acceptance and Commitment Therapy For Injury Prevention Among Nurses and Nursing Aides
What this study is about
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.
View original scientific description
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.
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
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Bowling Green, Ohio
Collaborators
Ohio Bureau of Workers Compensation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 7, 2025 · Source of record for eligibility and locations