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| Name | Class |
|---|---|
| The University of New South Wales | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RECHARGE | Experimental | 4 1-hour sessions of RECHARGE are delivered online using Skype for Business within 2 weeks. |
|
| Online self-study of stress management strategies | Active Comparator | Self study during 2 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RECHARGE | Behavioral | 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. |
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Naser Morina, PhD | Contact | +41442555280 | naser.morina@usz.ch | |
| Sonja Weilenmann, PhD | Contact | +41 44 255 52 52 | sonja.weilenmann@usz.ch |
| Name | Affiliation | Role |
|---|---|---|
| Naser Morina, PhD | University of Zurich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik für Konsiliarpsychiatrie und Psychosomatik | Recruiting | Zurich | 8091 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15697046 | Background | Tam CW, Pang EP, Lam LC, Chiu HF. Severe acute respiratory syndrome (SARS) in Hong Kong in 2003: stress and psychological impact among frontline healthcare workers. Psychol Med. 2004 Oct;34(7):1197-204. doi: 10.1017/s0033291704002247. | |
| 14993174 | Background | Nickell LA, Crighton EJ, Tracy CS, Al-Enazy H, Bolaji Y, Hanjrah S, Hussain A, Makhlouf S, Upshur RE. Psychosocial effects of SARS on hospital staff: survey of a large tertiary care institution. CMAJ. 2004 Mar 2;170(5):793-8. doi: 10.1503/cmaj.1031077. |
| Label | URL |
|---|---|
| Declaration of Helsinki | View source |
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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.
One year after conclusion of the study.
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| ID | Term |
|---|---|
| D000077062 | Burnout, Psychological |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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|
| Self Study | Behavioral | HCWs are referred to a few recommended webpages that outline well-validated, adaptive coping strategies for managing stress. |
|
| 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) |
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| International Conference on Harmonization (ICH) E6(R2) Guideline for Good Clinical Practice | View source |
| D011024 |
| Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |