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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04531774
Recruitment Status : Recruiting
First Posted : August 28, 2020
Last Update Posted : October 19, 2020
Sponsor:
Collaborator:
The University of New South Wales
Information provided by (Responsible Party):
Naser Morina, University of Zurich

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.

Condition or disease Intervention/treatment Phase
Stress Burnout Anxiety Depression Covid19 Behavioral: RECHARGE Behavioral: Self Study Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: RECHARGE: A Brief Psychological Intervention to Build Resilience in Healthcare Workers During COVID-19
Actual Study Start Date : August 28, 2020
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: RECHARGE
4 1-hour sessions of RECHARGE are delivered online using Skype for Business within 2 weeks.
Behavioral: RECHARGE

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.


Active Comparator: Online self-study of stress management strategies
Self study during 2 weeks.
Behavioral: Self Study
HCWs are referred to a few recommended webpages that outline well-validated, adaptive coping strategies for managing stress.




Primary Outcome Measures :
  1. Change from Baseline in psychological distress Kessler Psychological Distress Scale (K10) at Week 5 and Week 13 [ Time Frame: Baseline (Week 1), post-intervention (Week 5) and 2 month follow-up (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 :
  1. Fewer worries in intervention group than in active control group [ Time Frame: post-intervention (Week 5) and 2 month follow-up (Week 13) ]

    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)


  2. Less anxiety symptoms in intervention group than in active control group [ Time Frame: post-intervention (Week 5) and 2 month follow-up (Week 13) ]

    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).


  3. Fewer depression symptoms in intervention group than in active control group [ Time Frame: post-intervention (Week 5) and 2 month follow-up (Week 13) ]

    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).


  4. Lower level of burnout in intervention group than in active control group [ Time Frame: post-intervention (Week 5) and 2 month follow-up (Week 13) ]
    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).

  5. Less traumatic stress in intervention group than in active control group [ Time Frame: post-intervention (Week 5) and 2 month follow-up (Week 13) ]

    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).


  6. Lower level of distress due to perceived moral injury in intervention group than in active control group [ Time Frame: post-intervention (Week 5) and 2 month follow-up (Week 13) ]
    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).

  7. Higher work performance in intervention group than in active control group [ Time Frame: post-intervention (Week 5) and 2 month follow-up (Week 13) ]
    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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04531774


Contacts
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Contact: Naser Morina, PhD +41442555280 naser.morina@usz.ch
Contact: Sonja Weilenmann, PhD +41 44 255 52 52 sonja.weilenmann@usz.ch

Locations
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Switzerland
Klinik für Konsiliarpsychiatrie und Psychosomatik Recruiting
Zürich, Switzerland, 8091
Contact: Naser Morina, PhD    +41 44 255 52 80    naser.morina@usz.ch   
Sponsors and Collaborators
Naser Morina
The University of New South Wales
Investigators
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Principal Investigator: Naser Morina, PhD University of Zurich
Additional Information:
Publications:

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Responsible Party: Naser Morina, PD Dr. Naser Morina, University of Zurich
ClinicalTrials.gov Identifier: NCT04531774    
Other Study ID Numbers: BASEC-Nr.2020-00796
First Posted: August 28, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: One year after conclusion of the study.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Naser Morina, University of Zurich:
Health Care Workers
Stress
Anxiety
Depression
Burnout
Work Load
COVID-19
Resilience
Brief Psychological Intervention
Additional relevant MeSH terms:
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Depression
Burnout, Psychological
Behavioral Symptoms
Stress, Psychological