Nurse Health Pilot: Feasibility and Acceptability of a Virtual ACT-intervention in Nurses During COVID-19 (NHP)

May 27, 2021 updated by: Prof. Dr. Andrew Gloster

Feasibility and Acceptability of a Virtual ACT-intervention in Nurses Working During the COVID-19 Pandemic (Pilot Study)

Frontline nurses increasingly face challenges between executing their jobs to the best of their ability and caring for their own physical and mental health. Such a stressful and fast-changing work environment impacts the nurses' psychological wellbeing, resulting in high levels of stress and burnout, which in turn negatively affects patient care and outcomes.

The aim of this study is to investigate whether a short virtual intervention, based on Acceptance and Commitment Therapy (ACT) and adapted to caregivers, can lead to a reduction in psychological distress that may be associated with caregiving during the COVID-19 pandemic.

The intervention will be held online in a group setting during two half-day workshops using a conference application (e.g. Zoom).

Note: This study is part of an international joint research project "Nurse Health" between the Faculty of Psychology (University of Basel) and the Nethersole School of Nursing (Chinese University of Hong Kong), funded by the Swiss State Secretariat for Education, Research and Innovation (SERI), with the Leading House for the Bilateral Science and Technology Cooperation Programme with Asia at ETH Zürich (Project No. COV_09_062020).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • at least 18 years of age
  • degree in nursing
  • working 40% or higher in a team of nurses in the somatic area
  • currently or previously in contact with COVID-19 patients
  • working in Switzerland

Exclusion Criteria:

  • working in non-somatic areas (e.g. psychiatry)
  • working in non-hospital environments (e.g. home treatment)
  • not owning an electronic device
  • unable to understand and speak German

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ACT

A digitally-based ACT program will be conducted in two half-day workshops via meeting software (e.g. Zoom) consisting of:

  1. mindfulness exercises, for stress reduction and to guide nurses to observe their painful thoughts and feelings that they are attempting to avoid;
  2. ACT-metaphors, to let nurses realize the cost of struggling with psychological distress often create more distress;
  3. experiential exercises, to guide nurses to notice their own experiences in providing nursing care throughout their nursing career and explore any special qualities;
  4. explore the nurses' values with respect to different areas in their lives.
Behavioral: ACT
Acceptance and Commitment Therapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Perceived Stress Scale (PSS-10)
Time Frame: 8 weeks
Assessment of the perception of psychological stress (10 items)
8 weeks
General Anxiety Disorder Scale (GAD-7)
Time Frame: 8 weeks
Assessment of the severity of anxiety (7 items)
8 weeks
Patient Health Questionnaire (PHQ-9)
Time Frame: 8 weeks
Assessment of the severity of depression (9 items)
8 weeks
Maslach Burnout Inventory - Human Services Survey (MBI-HSS)
Time Frame: 8 weeks
Assessment of the severity of burnout (22 items)
8 weeks
Mental Health Continuum Short Form (MHC-SF)
Time Frame: 8 weeks
Assessment of perceived emotional wellbeing (14 items)
8 weeks
Psychological Flexibility Questionnaire (PsyFlex)
Time Frame: 8 weeks
Assessment of psychological flexibility (6 items)
8 weeks
Valued Living Questionnaire (VLQ)
Time Frame: 8 weeks
Assessment of the extent of valued living (10 items)
8 weeks
Mueller and McCloskey Satisfaction Scale (MMSS)
Time Frame: 8 weeks
Assessment of nurses' job satisfaction (31 items)
8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Program Attendance/ Attrition Rate
Time Frame: 8 weeks
Percentage of program attendance
8 weeks
Homework Completion
Time Frame: 8 weeks
Percentage of completed homework
8 weeks
Program Satisfaction
Time Frame: 8 weeks
Rate of nurses' satisfaction with the program
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Prof. Dr. Andrew Gloster

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
ETH Zurich (Switzerland)
State Secretariat for Education Research and Innovation, Switzerland

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Andrew T Gloster, Prof. Dr., Division of Clinical Psychology & Intervention Science, University of Basel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 26, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 29, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 2, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NHP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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