Recruiting

Acceptance and Commitment Therapy

Sponsor:

Bowling Green State University

Code:

NCT06813495

Conditions

Well-Being, Psychological

Work Injury

Musculoskeletal Pain

High Frequency Heart Rate Variability

Burnout

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Eastern Principles Acceptance and Commitment Therapy for Nurses and Nursing Aids (EPACT NNA)

Acceptance and Commitment Therapy for Nurses and Nursing Aids (ACT NNA)

Study Details

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.

Conditions

Well-Being, Psychological

Work Injury

Musculoskeletal Pain

High Frequency Heart Rate Variability

Burnout

Study ID

NCT06813495

Start date

May 1, 2023

Status verified date

Feb, 2025

Completion date

May 1, 2026

Anticipated

Primary completion date

May 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

255 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Eastern Principles Acceptance and Commitment Therapy for Nurss 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.

active comparator: 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.

no intervention: Control Group

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

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.

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 measure

  • 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 ]

Central Contacts and Locations

Locations

Bowling Green State University

Recruiting

Bowling Green, Ohio, United States, 43402

Contacts

William H O'Brien, Ph.D.

419-372-2974wobrien@bgsu.edu

Principal Investigator:

William H O'Brien, Ph.D.

More Information

Sponsor

Bowling Green State University

Last update posted

Feb 7, 2025

Last verified

Feb, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Bowling Green State University on 2025-02-07.