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

Study Overview
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Brief Summary
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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.

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

Conditions
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Stress, Burnout, Anxiety, Depression, Covid19

Intervention / Treatment
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* Behavioral: RECHARGE
* Behavioral: Self Study


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RECHARGE<br>4 1-hour sessions of RECHARGE are delivered online using Skype for Business within 2 weeks. | Behavioral: RECHARGE<br>* 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.<br>|
| Active Comparator: Online self-study of stress management strategies<br>Self study during 2 weeks. | Behavioral: Self Study<br>* HCWs are referred to a few recommended webpages that outline well-validated, adaptive coping strategies for managing stress.<br>|

What is the study measuring?
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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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Health Care Workers, Stress, Anxiety, Depression, Burnout, Work Load, COVID-19, Resilience, Brief Psychological Intervention