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

NCT04531774 | Unknown

• 1 other identifier: BASEC-Nr.2020-00796
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress; Burnout; Anxiety; Depression; Covid19

Keywords

Health Care Workers; Stress; Anxiety; Depression; Burnout; Work Load; COVID-19; Resilience; Brief Psychological Intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Fewer worries in intervention group than in active control group

  post-intervention (Week 5) and 2 month follow-up (Week 13)

• Less anxiety symptoms in intervention group than in active control group

  post-intervention (Week 5) and 2 month follow-up (Week 13)

• Fewer depression symptoms in intervention group than in active control group

  post-intervention (Week 5) and 2 month follow-up (Week 13)

• Lower level of burnout in intervention group than in active control group

  post-intervention (Week 5) and 2 month follow-up (Week 13)

• Less traumatic stress in intervention group than in active control group

  post-intervention (Week 5) and 2 month follow-up (Week 13)

Study Arms (2)

RECHARGE

EXPERIMENTAL

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

Behavioral: RECHARGE

Online self-study of stress management strategies

ACTIVE COMPARATOR

Self study during 2 weeks.

Behavioral: Self Study

Interventions

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.

RECHARGE

Self Study BEHAVIORAL

HCWs are referred to a few recommended webpages that outline well-validated, adaptive coping strategies for managing stress.

Online self-study of stress management strategies

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Naser Morina: lead
• The University of New South Wales: collaborator

Study Sites (1)

Klinik für Konsiliarpsychiatrie und Psychosomatik

Zurich, 8091, Switzerland

RECRUITING

Related Publications (32)

• 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.

  PMID: 15697046 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.

  PMID: 14993174 BACKGROUND

• Grace SL, Hershenfield K, Robertson E, Stewart DE. Factors affecting perceived risk of contracting severe acute respiratory syndrome among academic physicians. Infect Control Hosp Epidemiol. 2004 Dec;25(12):1111-3. doi: 10.1086/502352.

  PMID: 15636301 BACKGROUND

• Ho SM, Kwong-Lo RS, Mak CW, Wong JS. Fear of severe acute respiratory syndrome (SARS) among health care workers. J Consult Clin Psychol. 2005 Apr;73(2):344-9. doi: 10.1037/0022-006X.73.2.344.

  PMID: 15796643 BACKGROUND

• Maunder RG, Lancee WJ, Rourke S, Hunter JJ, Goldbloom D, Balderson K, Petryshen P, Steinberg R, Wasylenki D, Koh D, Fones CS. Factors associated with the psychological impact of severe acute respiratory syndrome on nurses and other hospital workers in Toronto. Psychosom Med. 2004 Nov-Dec;66(6):938-42. doi: 10.1097/01.psy.0000145673.84698.18.

  PMID: 15564361 BACKGROUND

• Bai Y, Lin CC, Lin CY, Chen JY, Chue CM, Chou P. Survey of stress reactions among health care workers involved with the SARS outbreak. Psychiatr Serv. 2004 Sep;55(9):1055-7. doi: 10.1176/appi.ps.55.9.1055.

  PMID: 15345768 BACKGROUND

• Styra R, Hawryluck L, Robinson S, Kasapinovic S, Fones C, Gold WL. Impact on health care workers employed in high-risk areas during the Toronto SARS outbreak. J Psychosom Res. 2008 Feb;64(2):177-83. doi: 10.1016/j.jpsychores.2007.07.015.

  PMID: 18222131 BACKGROUND

• Marjanovic Z, Greenglass ER, Coffey S. The relevance of psychosocial variables and working conditions in predicting nurses' coping strategies during the SARS crisis: an online questionnaire survey. Int J Nurs Stud. 2007 Aug;44(6):991-8. doi: 10.1016/j.ijnurstu.2006.02.012. Epub 2006 Apr 17.

  PMID: 16618485 BACKGROUND

• Brooks SK, Webster RK, Smith LE, Woodland L, Wessely S, Greenberg N, Rubin GJ. The psychological impact of quarantine and how to reduce it: rapid review of the evidence. Lancet. 2020 Mar 14;395(10227):912-920. doi: 10.1016/S0140-6736(20)30460-8. Epub 2020 Feb 26.

  PMID: 32112714 BACKGROUND

• The Lancet. COVID-19: protecting health-care workers. Lancet. 2020 Mar 21;395(10228):922. doi: 10.1016/S0140-6736(20)30644-9. No abstract available.

  PMID: 32199474 BACKGROUND

• Remuzzi A, Remuzzi G. COVID-19 and Italy: what next? Lancet. 2020 Apr 11;395(10231):1225-1228. doi: 10.1016/S0140-6736(20)30627-9. Epub 2020 Mar 13.

  PMID: 32178769 BACKGROUND

• Su TP, Lien TC, Yang CY, Su YL, Wang JH, Tsai SL, Yin JC. Prevalence of psychiatric morbidity and psychological adaptation of the nurses in a structured SARS caring unit during outbreak: a prospective and periodic assessment study in Taiwan. J Psychiatr Res. 2007 Jan-Feb;41(1-2):119-30. doi: 10.1016/j.jpsychires.2005.12.006. Epub 2006 Feb 7.

  PMID: 16460760 BACKGROUND

• Maunder RG, Leszcz M, Savage D, Adam MA, Peladeau N, Romano D, Rose M, Schulman B. Applying the lessons of SARS to pandemic influenza: an evidence-based approach to mitigating the stress experienced by healthcare workers. Can J Public Health. 2008 Nov-Dec;99(6):486-8. doi: 10.1007/BF03403782.

  PMID: 19149392 BACKGROUND

• Maunder RG, Lancee WJ, Balderson KE, Bennett JP, Borgundvaag B, Evans S, Fernandes CM, Goldbloom DS, Gupta M, Hunter JJ, McGillis Hall L, Nagle LM, Pain C, Peczeniuk SS, Raymond G, Read N, Rourke SB, Steinberg RJ, Stewart TE, VanDeVelde-Coke S, Veldhorst GG, Wasylenki DA. Long-term psychological and occupational effects of providing hospital healthcare during SARS outbreak. Emerg Infect Dis. 2006 Dec;12(12):1924-32. doi: 10.3201/eid1212.060584.

  PMID: 17326946 BACKGROUND

• Shanafelt TD, Noseworthy JH. Executive Leadership and Physician Well-being: Nine Organizational Strategies to Promote Engagement and Reduce Burnout. Mayo Clin Proc. 2017 Jan;92(1):129-146. doi: 10.1016/j.mayocp.2016.10.004. Epub 2016 Nov 18.

  PMID: 27871627 BACKGROUND

• Panagioti M, Geraghty K, Johnson J, Zhou A, Panagopoulou E, Chew-Graham C, Peters D, Hodkinson A, Riley R, Esmail A. Association Between Physician Burnout and Patient Safety, Professionalism, and Patient Satisfaction: A Systematic Review and Meta-analysis. JAMA Intern Med. 2018 Oct 1;178(10):1317-1331. doi: 10.1001/jamainternmed.2018.3713.

  PMID: 30193239 BACKGROUND

• Scheepers RA, Boerebach BC, Arah OA, Heineman MJ, Lombarts KM. A Systematic Review of the Impact of Physicians' Occupational Well-Being on the Quality of Patient Care. Int J Behav Med. 2015 Dec;22(6):683-98. doi: 10.1007/s12529-015-9473-3.

  PMID: 25733349 BACKGROUND

• Wallace JE, Lemaire JB, Ghali WA. Physician wellness: a missing quality indicator. Lancet. 2009 Nov 14;374(9702):1714-21. doi: 10.1016/S0140-6736(09)61424-0.

  PMID: 19914516 BACKGROUND

• Zhu Z, Xu S, Wang H, Liu Z, Wu J, Li G, Miao J, Zhang C, Yang Y, Sun W, Zhu S, Fan Y, Chen Y, Hu J, Liu J, Wang W. COVID-19 in Wuhan: Sociodemographic characteristics and hospital support measures associated with the immediate psychological impact on healthcare workers. EClinicalMedicine. 2020 Jun 24;24:100443. doi: 10.1016/j.eclinm.2020.100443. eCollection 2020 Jul.

  PMID: 32766545 BACKGROUND

• Liu CY, Yang YZ, Zhang XM, Xu X, Dou QL, Zhang WW, Cheng ASK. The prevalence and influencing factors in anxiety in medical workers fighting COVID-19 in China: a cross-sectional survey. Epidemiol Infect. 2020 May 20;148:e98. doi: 10.1017/S0950268820001107.

  PMID: 32430088 BACKGROUND

• Lai J, Ma S, Wang Y, Cai Z, Hu J, Wei N, Wu J, Du H, Chen T, Li R, Tan H, Kang L, Yao L, Huang M, Wang H, Wang G, Liu Z, Hu S. Factors Associated With Mental Health Outcomes Among Health Care Workers Exposed to Coronavirus Disease 2019. JAMA Netw Open. 2020 Mar 2;3(3):e203976. doi: 10.1001/jamanetworkopen.2020.3976.

  PMID: 32202646 BACKGROUND

• Maunder R. The experience of the 2003 SARS outbreak as a traumatic stress among frontline healthcare workers in Toronto: lessons learned. Philos Trans R Soc Lond B Biol Sci. 2004 Jul 29;359(1447):1117-25. doi: 10.1098/rstb.2004.1483.

  PMID: 15306398 BACKGROUND

• Chan AO, Huak CY. Psychological impact of the 2003 severe acute respiratory syndrome outbreak on health care workers in a medium size regional general hospital in Singapore. Occup Med (Lond). 2004 May;54(3):190-6. doi: 10.1093/occmed/kqh027.

  PMID: 15133143 BACKGROUND

• Dawson KS, Bryant RA, Harper M, Kuowei Tay A, Rahman A, Schafer A, van Ommeren M. Problem Management Plus (PM+): a WHO transdiagnostic psychological intervention for common mental health problems. World Psychiatry. 2015 Oct;14(3):354-7. doi: 10.1002/wps.20255. No abstract available.

  PMID: 26407793 BACKGROUND

• Rahman A, Hamdani SU, Awan NR, Bryant RA, Dawson KS, Khan MF, Azeemi MM, Akhtar P, Nazir H, Chiumento A, Sijbrandij M, Wang D, Farooq S, van Ommeren M. Effect of a Multicomponent Behavioral Intervention in Adults Impaired by Psychological Distress in a Conflict-Affected Area of Pakistan: A Randomized Clinical Trial. JAMA. 2016 Dec 27;316(24):2609-2617. doi: 10.1001/jama.2016.17165.

  PMID: 27837602 BACKGROUND

• Rahman A, Khan MN, Hamdani SU, Chiumento A, Akhtar P, Nazir H, Nisar A, Masood A, Din IU, Khan NA, Bryant RA, Dawson KS, Sijbrandij M, Wang D, van Ommeren M. Effectiveness of a brief group psychological intervention for women in a post-conflict setting in Pakistan: a single-blind, cluster, randomised controlled trial. Lancet. 2019 Apr 27;393(10182):1733-1744. doi: 10.1016/S0140-6736(18)32343-2. Epub 2019 Apr 1.

  PMID: 30948286 BACKGROUND

• Bryant RA, Schafer A, Dawson KS, Anjuri D, Mulili C, Ndogoni L, Koyiet P, Sijbrandij M, Ulate J, Harper Shehadeh M, Hadzi-Pavlovic D, van Ommeren M. Effectiveness of a brief behavioural intervention on psychological distress among women with a history of gender-based violence in urban Kenya: A randomised clinical trial. PLoS Med. 2017 Aug 15;14(8):e1002371. doi: 10.1371/journal.pmed.1002371. eCollection 2017 Aug.

  PMID: 28809935 BACKGROUND

• Kessler RC, Barker PR, Colpe LJ, Epstein JF, Gfroerer JC, Hiripi E, Howes MJ, Normand SL, Manderscheid RW, Walters EE, Zaslavsky AM. Screening for serious mental illness in the general population. Arch Gen Psychiatry. 2003 Feb;60(2):184-9. doi: 10.1001/archpsyc.60.2.184.

  PMID: 12578436 BACKGROUND

• Slade T, Grove R, Burgess P. Kessler Psychological Distress Scale: normative data from the 2007 Australian National Survey of Mental Health and Wellbeing. Aust N Z J Psychiatry. 2011 Apr;45(4):308-16. doi: 10.3109/00048674.2010.543653. Epub 2011 Feb 21.

  PMID: 21332432 BACKGROUND

• Price M, Szafranski DD, van Stolk-Cooke K, Gros DF. Investigation of abbreviated 4 and 8 item versions of the PTSD Checklist 5. Psychiatry Res. 2016 May 30;239:124-30. doi: 10.1016/j.psychres.2016.03.014. Epub 2016 Mar 8.

  PMID: 27137973 BACKGROUND

• Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

  PMID: 6880820 BACKGROUND

• Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

  PMID: 16717171 BACKGROUND

Related Links

• Declaration of Helsinki
• Human Research Act (HRA)
• International Conference on Harmonization (ICH) E6(R2) Guideline for Good Clinical Practice
• Ordinance on Clinical Trials in Human Research (ClinO)

MeSH Terms

Conditions

Burnout, Psychological; Anxiety Disorders; Depression; COVID-19

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior; Mental Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Naser Morina, PhD

  University of Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Naser Morina, PhD

CONTACT

+41442555280; naser.morina@usz.ch

Sonja Weilenmann, PhD

CONTACT

+41 44 255 52 52; sonja.weilenmann@usz.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PD Dr. Naser Morina

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: August 28, 2020
• Study Start: August 28, 2020
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: October 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: One year after conclusion of the study.

Locations

CH (1)