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RECHARGE: A Brief Psychological Intervention to Build Resilience in Healthcare Workers During COVID-19

Primary Purpose

Stress, Burnout, Anxiety

Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
RECHARGE
Self Study
Sponsored by
Naser Morina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stress focused on measuring Health Care Workers, Stress, Anxiety, Depression, Burnout, Work Load, COVID-19, Resilience, Brief Psychological Intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Anxiety and depression checklist (K10) score of 16 or higher
  • Healthcare worker
  • Sufficient German language comprehension
  • Access to teleconferencing platform

Exclusion Criteria:

  • Currently participating in a similar study
  • Currently in psychotherapeutic treatment / coaching
  • Currently on sick leave for more than 2 weeks

Sites / Locations

  • Klinik für Konsiliarpsychiatrie und PsychosomatikRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

RECHARGE

Online self-study of stress management strategies

Arm Description

4 1-hour sessions of RECHARGE are delivered online using Skype for Business within 2 weeks.

Self study during 2 weeks.

Outcomes

Primary Outcome Measures

Change from Baseline in psychological distress Kessler Psychological Distress Scale (K10) at Week 5 and Week 13
HCWs in the intervention condition (RECHARGE) demonstrate a lower level of distress after the intervention and at 2-month follow-up than HCWs in the active control condition.

Secondary Outcome Measures

Fewer worries in intervention group than in active control group
HCWs in the intervention condition demonstrate fewer worries after the intervention and at 2-month follow-up than HCWs in the active control condition. Worries are measured using the Generalized Anxiety Disorder Assessment (GAD-7)
Less anxiety symptoms in intervention group than in active control group
HCWs in the intervention condition demonstrate less anxiety after the intervention and at 2-month follow-up than HCWs in the active control condition. Anxiety is measured using the Hospital Anxiety and Depression Scale (HADS).
Fewer depression symptoms in intervention group than in active control group
HCWs in the intervention condition demonstrate fewer symptoms of depression after the intervention and at 2-month follow-up than HCWs in the active control condition. Depression is measured using the Hospital Anxiety and Depression Scale (HADS).
Lower level of burnout in intervention group than in active control group
HCWs in the intervention condition demonstrate a lower level of burnout after the intervention and at 2-month follow-up than HCWs in the active control condition. Burnout is measured using the Maslach Burnout Inventory (MBI).
Less traumatic stress in intervention group than in active control group
HCWs in the intervention condition demonstrate less traumatic stress after the intervention and at 2-month follow-up than HCWs in the active control condition. Traumatic stress is measured using the PTSD Checklist (PCL-5).
Lower level of distress due to perceived moral injury in intervention group than in active control group
HCWs in the intervention condition demonstrate a lower level of distress due to perceived moral injury after the intervention and at 2-month follow-up than HCWs in the active control condition. Distress due to perceived moral injury is measured using Moral Injury Appraisals (MI).
Higher work performance in intervention group than in active control group
HCWs in the intervention condition demonstrate a higher work performance after the intervention and at 2-month follow-up than HCWs in the active control condition. Work performance is measured using the Work Ability Index (WAI).

Full Information

First Posted
August 26, 2020
Last Updated
October 14, 2020
Sponsor
Naser Morina
Collaborators
The University of New South Wales
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1. Study Identification

Unique Protocol Identification Number
NCT04531774
Brief Title
RECHARGE: A Brief Psychological Intervention to Build Resilience in Healthcare Workers During COVID-19
Official Title
RECHARGE: A Brief Psychological Intervention to Build Resilience in Healthcare Workers During COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 28, 2020 (Actual)
Primary Completion Date
June 1, 2021 (Anticipated)
Study Completion Date
June 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Naser Morina
Collaborators
The University of New South Wales

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The healthcare industry is inherently demanding, stressful, and, at times, emotionally draining. On a typical day, many workers must make rapid and critical decisions, manage numerous demands, team conflicts, and challenging situations with patients and their families. For some health care workers (HCW), the current pandemic - COVID-19 - has also exacerbated these challenges. Providing psychological support is key in alleviating stress among HCWs, yet the situation does not require therapy because HCWs do not principally suffer from a mental disorder. RECHARGE was specifically developed for HCWs and is an abbreviated online version of Problem Management Plus, an evidence-based intervention that helps to cope with stress in times of crisis. As a brief psychological intervention for adults affected by adversity emerging from stress exposure, RECHARGE teaches people three well-documented strategies to manage acute stress (a: managing stress, b: managing worry, c: meaningful activity). It includes psychoeducation, arousal reduction techniques, managing worries and problem-solving skills, behavioral activation, and enhancement of meaningful activities, which are all based on the principles of cognitive-behavioral therapy. The aim of this study is to evaluate the efficacy of RECHARGE to reduce stress in HCWs and enhance their work performance. Participants in this randomized controlled trial (RCT) study are randomly assigned to either RECHARGE or the active control group. To this end, stress including symptoms of burnout, worries, anxiety, depression, PTSD, and work performance will be measured at baseline, post-intervention, and at a 2 and 6 month follow up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Burnout, Anxiety, Depression, Covid19
Keywords
Health Care Workers, Stress, Anxiety, Depression, Burnout, Work Load, COVID-19, Resilience, Brief Psychological Intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RECHARGE
Arm Type
Experimental
Arm Description
4 1-hour sessions of RECHARGE are delivered online using Skype for Business within 2 weeks.
Arm Title
Online self-study of stress management strategies
Arm Type
Active Comparator
Arm Description
Self study during 2 weeks.
Intervention Type
Behavioral
Intervention Name(s)
RECHARGE
Intervention Description
RECHARGE is an abbreviated and adapted version of Problem Management Plus (PM+), an evidence-based intervention that helps to cope with stress in times of crisis. Recharge is specifically developed for HCWs as a brief psychological intervention for adults affected by adversity emerging from stress exposure and teaches people three well-documented strategies to manage acute stress. The strategies are: a) managing stress, b) managing worry, c) meaningful activity. It includes psychoeducation, arousal reduction techniques, managing worries and problem-solving skills, behavioural activation, enhancement of meaningful activities, and relapse prevention, which are all based on the principles of cognitive-behavioural therapy. RECHARGE is delivered online in a 1 to 1 setting between coach and participant. Trained peers (medical doctors, nurses, psychologists) act as coaches.
Intervention Type
Behavioral
Intervention Name(s)
Self Study
Intervention Description
HCWs are referred to a few recommended webpages that outline well-validated, adaptive coping strategies for managing stress.
Primary Outcome Measure Information:
Title
Change from Baseline in psychological distress Kessler Psychological Distress Scale (K10) at Week 5 and Week 13
Description
HCWs in the intervention condition (RECHARGE) demonstrate a lower level of distress after the intervention and at 2-month follow-up than HCWs in the active control condition.
Time Frame
Baseline (Week 1), post-intervention (Week 5) and 2 month follow-up (Week 13)
Secondary Outcome Measure Information:
Title
Fewer worries in intervention group than in active control group
Description
HCWs in the intervention condition demonstrate fewer worries after the intervention and at 2-month follow-up than HCWs in the active control condition. Worries are measured using the Generalized Anxiety Disorder Assessment (GAD-7)
Time Frame
post-intervention (Week 5) and 2 month follow-up (Week 13)
Title
Less anxiety symptoms in intervention group than in active control group
Description
HCWs in the intervention condition demonstrate less anxiety after the intervention and at 2-month follow-up than HCWs in the active control condition. Anxiety is measured using the Hospital Anxiety and Depression Scale (HADS).
Time Frame
post-intervention (Week 5) and 2 month follow-up (Week 13)
Title
Fewer depression symptoms in intervention group than in active control group
Description
HCWs in the intervention condition demonstrate fewer symptoms of depression after the intervention and at 2-month follow-up than HCWs in the active control condition. Depression is measured using the Hospital Anxiety and Depression Scale (HADS).
Time Frame
post-intervention (Week 5) and 2 month follow-up (Week 13)
Title
Lower level of burnout in intervention group than in active control group
Description
HCWs in the intervention condition demonstrate a lower level of burnout after the intervention and at 2-month follow-up than HCWs in the active control condition. Burnout is measured using the Maslach Burnout Inventory (MBI).
Time Frame
post-intervention (Week 5) and 2 month follow-up (Week 13)
Title
Less traumatic stress in intervention group than in active control group
Description
HCWs in the intervention condition demonstrate less traumatic stress after the intervention and at 2-month follow-up than HCWs in the active control condition. Traumatic stress is measured using the PTSD Checklist (PCL-5).
Time Frame
post-intervention (Week 5) and 2 month follow-up (Week 13)
Title
Lower level of distress due to perceived moral injury in intervention group than in active control group
Description
HCWs in the intervention condition demonstrate a lower level of distress due to perceived moral injury after the intervention and at 2-month follow-up than HCWs in the active control condition. Distress due to perceived moral injury is measured using Moral Injury Appraisals (MI).
Time Frame
post-intervention (Week 5) and 2 month follow-up (Week 13)
Title
Higher work performance in intervention group than in active control group
Description
HCWs in the intervention condition demonstrate a higher work performance after the intervention and at 2-month follow-up than HCWs in the active control condition. Work performance is measured using the Work Ability Index (WAI).
Time Frame
post-intervention (Week 5) and 2 month follow-up (Week 13)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Anxiety and depression checklist (K10) score of 16 or higher Healthcare worker Sufficient German language comprehension Access to teleconferencing platform Exclusion Criteria: Currently participating in a similar study Currently in psychotherapeutic treatment / coaching Currently on sick leave for more than 2 weeks
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Naser Morina, PhD
Phone
+41442555280
Email
naser.morina@usz.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Sonja Weilenmann, PhD
Phone
+41 44 255 52 52
Email
sonja.weilenmann@usz.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naser Morina, PhD
Organizational Affiliation
University of Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinik für Konsiliarpsychiatrie und Psychosomatik
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naser Morina, PhD
Phone
+41 44 255 52 80
Email
naser.morina@usz.ch

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
We follow open science practices and will use open access journals and repositories to publish results, anonymized original data, and meta-data describing the data and procedures (e.g., study protocol, statistical codes, instructions concerning the use of the data) to ensure full transparency and reproducibility.
IPD Sharing Time Frame
One year after conclusion of the study.
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RECHARGE: A Brief Psychological Intervention to Build Resilience in Healthcare Workers During COVID-19

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