NCT04821037

Brief Summary

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 29, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

June 2, 2021

Status Verified

May 1, 2021

Enrollment Period

1 month

First QC Date

March 26, 2021

Last Update Submit

May 27, 2021

Conditions

Keywords

stressresiliencewellbeing

Outcome Measures

Primary Outcomes (8)

  • Perceived Stress Scale (PSS-10)

    Assessment of the perception of psychological stress (10 items)

    8 weeks

  • General Anxiety Disorder Scale (GAD-7)

    Assessment of the severity of anxiety (7 items)

    8 weeks

  • Patient Health Questionnaire (PHQ-9)

    Assessment of the severity of depression (9 items)

    8 weeks

  • Maslach Burnout Inventory - Human Services Survey (MBI-HSS)

    Assessment of the severity of burnout (22 items)

    8 weeks

  • Mental Health Continuum Short Form (MHC-SF)

    Assessment of perceived emotional wellbeing (14 items)

    8 weeks

  • Psychological Flexibility Questionnaire (PsyFlex)

    Assessment of psychological flexibility (6 items)

    8 weeks

  • Valued Living Questionnaire (VLQ)

    Assessment of the extent of valued living (10 items)

    8 weeks

  • Mueller and McCloskey Satisfaction Scale (MMSS)

    Assessment of nurses' job satisfaction (31 items)

    8 weeks

Secondary Outcomes (3)

  • Program Attendance/ Attrition Rate

    8 weeks

  • Homework Completion

    8 weeks

  • Program Satisfaction

    8 weeks

Study Arms (1)

ACT

EXPERIMENTAL

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

Interventions

ACTBEHAVIORAL

Acceptance and Commitment Therapy

ACT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Psychology, University of Basel

Basel, Canton of Basel-City, 4055, Switzerland

RECRUITING

Study Officials

  • Andrew T Gloster, Prof. Dr.

    Division of Clinical Psychology & Intervention Science, University of Basel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eveline Frey, M Sc.

CONTACT

Fabio Coviello, B Sc.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Andrew Gloster

Study Record Dates

First Submitted

March 26, 2021

First Posted

March 29, 2021

Study Start

June 1, 2021

Primary Completion

July 1, 2021

Study Completion

August 1, 2021

Last Updated

June 2, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations