Ignite Creation Date:
2025-12-24 @ 1:20 PM
Ignite Modification Date:
2025-12-27 @ 12:08 AM
Study NCT ID:
NCT06813495
Status:
RECRUITING
Last Update Posted:
2025-02-07
First Post:
2024-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Eastern Principles Acceptance and Commitment Therapy For Injury Prevention Among Nurses and Nursing Aides
Sponsor:
Organization:
Raw JSON
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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).'}, {'measure': 'Work-related Injuries and Days Missed Due to Injury', 'timeFrame': 'Measured at baseline, 1 month, and 3 months', 'description': '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.'}, {'measure': 'Musculoskeletal Symptoms', 'timeFrame': 'Measured at baseline (pretreatment), 1 month, and 3 months', 'description': '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).'}, {'measure': 'Burnout', 'timeFrame': 'Measured at baseline (pretreatment), 1 month, and 3 months', 'description': '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.'}, {'measure': 'Acceptance, present-moment awareness, self-as-context, defusion, values, and committed action', 'timeFrame': 'Measured at baseline (pretreatment), 1 month, and 3 months', 'description': '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.'}, {'measure': 'Self-compassion and other compassion', 'timeFrame': 'Measured at baseline (pretreatment), 1 month, and 3 months', 'description': '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.\n\nThe 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.'}, {'measure': 'Ubiquity of suffering, impermanence, common humanity, nonattachment to self.', 'timeFrame': 'Measured at baseline (pretreatment), 1 month, and 3 months', 'description': '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).'}, {'measure': 'High Frequency Heart Rate Variability (HF-HRV)', 'timeFrame': 'Measured at baseline (pretreatment), 1 month, and 3 months', 'description': '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).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Well-Being, Psychological', 'Work Injury', 'Musculoskeletal Pain', 'High Frequency Heart Rate Variability', 'Burnout', 'Mindfulness', 'Self-Compassion', 'Acceptance and Commitment Therapy', 'Heart Rate Variability']}, 'referencesModule': {'references': [{'pmid': '24162145', 'type': 'BACKGROUND', 'citation': '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': '16443717', 'type': 'BACKGROUND', 'citation': 'Baer RA, Smith GT, Hopkins J, Krietemeyer J, Toney L. Using self-report assessment methods to explore facets of mindfulness. 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The Wiley handbook of contextual behavioral science. John Wiley & Sons.'}, {'type': 'BACKGROUND', 'citation': 'Zhao, J.-B., Ji, J.-L., Yang, X.-L., Yang, Z.-Z., Hou, Y.-F., & Zhang, X.-Y. (2011). National survey of ethical practices among Chinese psychotherapists. Professional Psychology: Research and Practice, 42(5), 375-381. https://doi.org/10.1037/a0025138'}]}, 'descriptionModule': {'briefSummary': "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.\n\nThe study has three primary aims:\n\n1. To compare the EPACT NNA intervention to an established traditional Western ACT NNA intervention and a no-treatment control group.\n2. To identify predictors of ACT NNA and EPACT NNA responsiveness to the interventions and injury likelihood across time.\n3. To assess EPACT NNA's feasibility and effectiveness across cultures.\n\nUSA 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.\n\nThe surveys assess demographic characteristics, organizational variables, work-related injuries, work stress, and well-being.\n\nA 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.\n\nThis 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.", 'detailedDescription': '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.\n\nResearch 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.\n\nAcceptance 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.\n\nSpecific 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.\n\nSpecific 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.\n\nSpecific Aim 3: Evaluate the feasibility and effectiveness of EPACT NNA in healthcare settings in Ohio and Thailand.\n\nThese 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.\n\nThe 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.\n\nControl 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.\n\nAll 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* USA: Employed as a nurse or nursing aide in a long-term care facility within a 120 mile radius of Bowling Green, Ohio.\n* Thailand: Employed as a nurse or nursing aide in Chiang Mai, Thailand or Krung Thep Bangkok), Thailand.\n* At least 18 years of age.\n* Able to attend scheduled assessment and intervention appointments.\n\nExclusion Criteria:\n\n• 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.'}, 'identificationModule': {'nctId': 'NCT06813495', 'briefTitle': 'Eastern Principles Acceptance and Commitment Therapy For Injury Prevention Among Nurses and Nursing Aides', 'organization': {'class': 'OTHER', 'fullName': 'Bowling Green State University'}, 'officialTitle': 'Prevention of Injuries Among Nurses and Nursing Aides Using Eastern Principles Acceptance and Commitment Therapy: Clinical Trial and Dissemination Research', 'orgStudyIdInfo': {'id': '10011559'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Eastern Principles Acceptance and Commitment Therapy for Nurss and Nursing Aids (EPACT NNA)', 'description': "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.", 'interventionNames': ['Behavioral: Eastern Principles Acceptance and Commitment Therapy for Nurses and Nursing Aids (EPACT NNA)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Acceptance and Commitment Therapy for Nurses and Nursing Aids (ACT NNA)', 'description': '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.', 'interventionNames': ['Behavioral: Acceptance and Commitment Therapy for Nurses and Nursing Aids (ACT NNA)']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': '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.'}], 'interventions': [{'name': 'Eastern Principles Acceptance and Commitment Therapy for Nurses and Nursing Aids (EPACT NNA)', 'type': 'BEHAVIORAL', 'description': "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.", 'armGroupLabels': ['Eastern Principles Acceptance and Commitment Therapy for Nurss and Nursing Aids (EPACT NNA)']}, {'name': 'Acceptance and Commitment Therapy for Nurses and Nursing Aids (ACT NNA)', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Acceptance and Commitment Therapy for Nurses and Nursing Aids (ACT NNA)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43402', 'city': 'Bowling Green', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': "William H O'Brien, Ph.D.", 'role': 'CONTACT', 'email': 'wobrien@bgsu.edu', 'phone': '419-372-2974'}, {'name': "William H O'Brien, Ph.D.", 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Daniel Maitland-Mohandes, Ph.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jennifer Chavanovanich, Ph.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Eric Cooke, Ph.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Teerawan Teerapong, Ph.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Tanaphong Uthayaratana, Ph.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Bowling Green State University', 'geoPoint': {'lat': 41.37477, 'lon': -83.65132}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Yes'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bowling Green State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ohio Bureau of Workers Compensation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor at Department of Psychology', 'investigatorFullName': "Willliam H. O'Brien", 'investigatorAffiliation': 'Bowling Green State University'}}}}