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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

Prof. Dr. Andrew Gloster

Collaborators

ETH Zurich (Switzerland)
State Secretariat for Education Research and Innovation, Switzerland

Investigators

  • 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)

June 1, 2021

Primary Completion (Anticipated)

July 1, 2021

Study Completion (Anticipated)

August 1, 2021

Study Registration Dates

First Submitted

March 26, 2021

First Submitted That Met QC Criteria

March 26, 2021

First Posted (Actual)

March 29, 2021

Study Record Updates

Last Update Posted (Actual)

June 2, 2021

Last Update Submitted That Met QC Criteria

May 27, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID 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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