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

October 14, 2020 updated by: Naser Morina
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

160

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 Locations

  • Switzerland
      • Zürich, Switzerland, 8091
        • Recruiting
        • Klinik für Konsiliarpsychiatrie und Psychosomatik

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:

  • 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

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (Week 1), post-intervention (Week 5) and 2 month follow-up (Week 13)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
post-intervention (Week 5) and 2 month follow-up (Week 13)
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).
post-intervention (Week 5) and 2 month follow-up (Week 13)
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).
post-intervention (Week 5) and 2 month follow-up (Week 13)
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).
post-intervention (Week 5) and 2 month follow-up (Week 13)
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).
post-intervention (Week 5) and 2 month follow-up (Week 13)
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).
post-intervention (Week 5) and 2 month follow-up (Week 13)
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).
post-intervention (Week 5) and 2 month follow-up (Week 13)

Collaborators and Investigators

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

Sponsor

Naser Morina

Collaborators

The University of New South Wales

Investigators

  • Principal Investigator: Naser Morina, PhD, University of Zurich

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.

General Publications

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 (Actual)

August 28, 2020

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

August 26, 2020

First Submitted That Met QC Criteria

August 27, 2020

First Posted (Actual)

August 28, 2020

Study Record Updates

Last Update Posted (Actual)

October 19, 2020

Last Update Submitted That Met QC Criteria

October 14, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BASEC-Nr.2020-00796

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

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.

Clinical Trials on Depression

Clinical Trials on RECHARGE

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cambodia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe