StressNCT04531774
RECHARGE: A Brief Psychological Intervention to Build Resilience in Healthcare Workers During COVID-19
A study testing RECHARGE and Self Study in people with Stress and Burnout, run by Naser Morina at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- RECHARGE and Self Study
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteSwitzerland
- Study dates
- 28 Aug 2020to 1 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Anxiety and depression checklist (K10) score of 16 or higher
- Healthcare worker
- Sufficient German language comprehension
- Access to teleconferencing platform
Who cannot join
- Currently participating in a similar study
- Currently in psychotherapeutic treatment / coaching
- Currently on sick leave for more than 2 weeks
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Klinik für Konsiliarpsychiatrie und Psychosomatik
Zurich, 8091
Naser Morina, PhD, +41 44 255 52 80, naser.morina@usz.ch
About this study
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
- Being tested
- RECHARGE, Self Study
- Keywords
- Health Care Workers, Stress, Anxiety, Depression, Burnout, Work Load, COVID-19, Resilience, Brief Psychological Intervention
- Medical subject headings
- Burnout, Psychological, Anxiety Disorders, Depression, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RECHARGEBehavioural
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.
Self StudyBehavioural
HCWs are referred to a few recommended webpages that outline well-validated, adaptive coping strategies for managing stress.
| Study group | Role | What they receive |
|---|---|---|
| RECHARGE | Experimental | 4 1-hour sessions of RECHARGE are delivered online using Skype for Business within 2 weeks. Receives: Behavioral: RECHARGE |
| Online self-study of stress management strategies | Active comparator | Self study during 2 weeks. Receives: Behavioral: Self Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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)
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: post-intervention (Week 5) and 2 month follow-up (Week 13)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start28 Aug 2020
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Naser Morina
- Sponsor type
- University, hospital or other
- Collaborators
- The University of New South Wales
- Responsible party
- Sponsor-investigator, Naser Morina, University of Zurich
- Investigators
- Naser Morina, PhD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04531774
- Sponsor's protocol ID
- BASEC-Nr.2020-00796
- Status last verified
- Oct 2020
- First submitted
- 26 Aug 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 15697046Nickell 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.
PubMed 14993174Grace 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.
PubMed 15636301Ho 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.
PubMed 15796643Maunder 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.
PubMed 15564361Bai 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.
PubMed 15345768Styra 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.
PubMed 18222131Marjanovic 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.
PubMed 16618485Brooks 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.
PubMed 32112714The 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.
PubMed 32199474Remuzzi 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.
PubMed 32178769Su 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.
PubMed 16460760Maunder 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.
PubMed 19149392Maunder 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.
PubMed 17326946Shanafelt 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.
PubMed 27871627
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RECHARGE: A Brief Psychological Intervention to Build Resilience in Healthcare Workers During COVID-19
- ClinicalTrials.gov ID
- NCT04531774
- Acronym / sponsor ID
- BASEC-Nr.2020-00796
- Conditions
- Stress, Burnout, Anxiety, Depression, Covid19
- Keywords
- Health Care Workers, Stress, Anxiety, Depression, Burnout, Work Load, COVID-19, Resilience
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Naser MorinaUniversity, hospital or other
- Collaborators
- The University of New South Wales
- Study start
- 28 Aug 2020 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 28 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RECHARGE | Experimental | Behavioral: RECHARGE4 1-hour sessions of RECHARGE are delivered online using Skype for Business within 2 weeks. |
| Online self-study of stress management strategies | Active comparator | Behavioral: Self StudySelf study during 2 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Anxiety and depression checklist (K10) score of 16 or higher
- Healthcare worker
- Sufficient German language comprehension
- Access to teleconferencing platform
Key exclusion criteria (3 listed)
- Currently participating in a similar study
- Currently in psychotherapeutic treatment / coaching
- Currently on sick leave for more than 2 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RECHARGERECHARGE 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. | Behavioural | RECHARGE |
| Self StudyHCWs are referred to a few recommended webpages that outline well-validated, adaptive coping strategies for managing stress. | Behavioural | Online self-study of stress management strategies |
Primary outcome
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.
7 secondary outcomes
Fewer worries in intervention group than in active control group
Time frame: 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)
Fewer depression symptoms in intervention group than in active control group
Time frame: 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)
Less traumatic stress in intervention group than in active control group
Time frame: 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)
Higher work performance in intervention group than in active control group
Time frame: post-intervention (Week 5) and 2 month follow-up (Week 13)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Background: PubMed 15697046Tam 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.
- Background: PubMed 14993174Nickell 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.
- Background: PubMed 15636301Grace 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.
- Background: PubMed 15796643Ho 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.
- Background: PubMed 15564361Maunder 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.
- Background: PubMed 15345768Bai 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.
- Background: PubMed 18222131Styra 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.
- Background: PubMed 16618485Marjanovic 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.
- Background: PubMed 32112714Brooks 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.
- Background: PubMed 32199474The 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.
- Background: PubMed 32178769Remuzzi 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.
- Background: PubMed 16460760Su 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.
- Declaration of HelsinkiLink provided by the sponsor.
- International Conference on Harmonization (ICH) E6(R2) Guideline for Good Clinical PracticeLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naser Morina, PhD principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RECHARGE and Self Study in people with Stress and Burnout, run by Naser Morina at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Naser Morina, PhD (+41442555280, naser.morina@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04531774, which also lists 32 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.