ResilienceNCT05812716
"resiLIR Healthcare Professionals": A Psychological Online Intervention to Enhance Resilience in Healthcare Professionals
A study testing resiLIR Healthcare Professionals in people with Resilience, run by Leibniz-Institut für Resilienzforschung (LIR) gGmbH at 1 site in Germany.
Trial summary
The goal of this clinical trial is to evaluate an online resilience intervention with healthcare professionals. Participants will receive a 6-week online intervention addressing resilience and stress with a specific focus on self-care and self-compassion. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Resilience
- What is being tested?
- resiLIR Healthcare Professionals
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteGermany
- Study dates
- 20 Jun 2023to 4 Jul 2024
- 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
- Age 18 years or older
- Fluent in German language
- Access to web-enabled devices (tablet/laptop/computer)
- Smartphone with internet access
- Trained and employed as health care professionals
Who cannot join
- Acute mental health crisis (e.g., suicidality)
- Psychiatric/psychotherapeutic treatment
- Neurodegenerative disease(s)
- Diagnosis of schizophrenia or other psychotic disorders, bipolar disorder, post-traumatic stress disorder
Trial locations and contacts
1 site in 1 country.
Germany1 site
Leibniz Institute for Resilience Research gGmbH
Mainz, Rhineland-Palatinate, 55122
About this study
Official title: A Randomized Controlled Study to Evaluate the Feasibility and Efficacy of an Online Resilience Intervention for Healthcare Professionals ("resiLIR Healthcare Professionals")
The goal of this clinical trial is to evaluate an online resilience intervention with healthcare professionals. Participants will receive a 6-week online intervention addressing resilience and stress with a specific focus on self-care and self-compassion. The main question is whether the intervention is effective in increasing resilience.
Read the detailed description
Background: Healthcare professionals often experience challenging working conditions, e.g., demanding physical work or time-sensitive tasks, which leads to a high risk of stress-associated disorders or burnout. Especially the COVID-19 pandemic as an additional stressor for healthcare highlighted the role of resilience, that is, the ability to maintain or return to good mental health during stress exposure. To promote mental health and resilience in healthcare professionals, previous studies point to self-care and self-compassion as promising factors.
Objectives: The aim of the study therefore is to examine the feasibility and efficacy of a newly developed online intervention with a focus on self-care and self-compassion to foster resilience in healthcare professionals.
Methods: In a waitlist control design, 240 healthcare professionals will take part in the 6-week resilience intervention "resiLIR Healthcare Professionals". The online intervention contains a theoretical part conveying psychoeducational material as well as a training phase including practical exercises and mini-interventions in everyday life. Participants will assess resilience, burnout, and several resilience factors in online surveys pre-, during and post-intervention as well as 3, 6 and 12 months after completion as follow-up assessments.
Implications: The study will contribute to stress and burnout prevention in healthcare professionals through offering a feasible and evidence-based online intervention.
- Conditions
- Resilience
- Being tested
- resiLIR Healthcare Professionals
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resiLIR Healthcare ProfessionalsBehavioural
Weeks 1 and 2: Theoretical part on stress, resilience, self-care, and self-compassion
Weeks 3 to 6: Training phase of a weekly introduced practical exercise (reflection on living with ease, self-compassionate body scan, planning of positive activities, self-compassionate letter). This phase additionally includes smartphone reminders to apply the exercises in everyday life.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants in the intervention group will gain access to the 6-week online resilience intervention "resiLIR Healthcare Professionals". Receives: Behavioral: resiLIR Healthcare Professionals |
| Waitlist control group | No intervention | Participants will receive the intervention after the first follow up-assessment (3 months post-intervention of the intervention group). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Resilience measured with stressor reactivity score (Kalisch et al., 2015, 2021)
Stressor reactivity score (Kalisch et al., 2015, 2021): Stressor reactivity can be approximated by relating self-reported mental-health problems to the corresponding stressor exposure within the same timeframe (for scales for mental health problems and stressor exposure, see secondary outcomes). The stressor reactivity (SR) score will be computed as an individual score against normal stressor reactivity (see Kalisch et al., 2021), where normal stressor reactivity is the regression line of average mental health problems against average stressor exposure across all time points in the trial population and one's individual SR score at any time point is the distance to the regression line. The inverse of the SR score is considered an approximative index of outcome-based resilience. Therefore, a lower SR score indicates higher resilience. Change calculated between time points named in time frame, for details, see statistical analysis plan.
Measured: baseline (pre), 4 weeks (intermediate), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
Secondary outcomes (32)
Change in Resilience measured with Brief Resilience Scale (BRS; Chmitorz et al., 2018)
Brief Resilience Scale (BRS; Chmitorz et al., 2018):
Participants rate different items on a scale from 1 to 5. Items 2, 4 and 6 are inverted; scale mean is formed. Higher scores indicate higher resilience. Change calculated between time points named in time frame, for details, see statistical analysis plan.
Measured: baseline (pre), 4 weeks (intermediate), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
Change in Mental Health measured with General Health Questionnaire (GHQ-12; Schrnitz et al., 1999)
General Health Questionnaire (GHQ-12; Schrnitz et al., 1999):
Participants rate different items on a scale from 0 to 3. Items 14, 15, 10, 16, 18 and 19 are inverted; sum score is formed. Higher scores indicate lower mental health. Change calculated between time points named in time frame, for details, see statistical analysis plan.
Measured: baseline (pre), 4 weeks (intermediate), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
Change in Stress measured with Perceived Stress Scale (PSS-2+2; Schäfer et al., in preparation)
Perceived Stress Scale (PSS-2+2; Schäfer et al., in preparation):
Participants rate different items on a scale from 1 to 5. Items 1 and 2 are inverted; scale mean is formed. Higher scores indicate higher stress. Change calculated between time points named in time frame, for details, see statistical analysis plan.
Measured: baseline (pre), 4 weeks (intermediate), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
Change in Well-being measured with WHO-5 Well-Being Index (Brähler et al., 2007)
WHO-5 Well-Being Index (Brähler et al., 2007):
Participants rate different items on a scale from 1 to 6. Sum score is formed. Higher scores indicate higher well-being. Change calculated between time points named in time frame, for details, see statistical analysis plan.
Measured: baseline (pre), 4 weeks (intermediate), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
Change in Anxiety measured with Generalized Anxiety Disorder-7 (GAD-7; Löwe et al., 2002)
Generalized Anxiety Disorder-7 (GAD-7; Löwe et al., 2002):
Participants rate different items on a scale from 0 to 3. Sum score is formed. Higher scores indicate higher anxiety. Change calculated between time points named in time frame, for details, see statistical analysis plan.
Measured: baseline (pre), 4 weeks (intermediate), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
Change in Depression measured with Patient Health Questionnaire-9 (PHQ-9; Löwe et al., 2002)
Patient Health Questionnaire-9 (PHQ-9; Löwe et al., 2002):
Participants rate different items on a scale from 0 to 3. Sum score is formed. Higher scores indicate higher depression. Change calculated between time points named in time frame, for details, see statistical analysis plan.
Measured: baseline (pre), 4 weeks (intermediate), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
Change in Self Compassion measured with Self-Compassion Scale Deutsch (SCS-D; Hupfeld & Ruffieux, 2011)
Self-Compassion Scale Deutsch (SCS-D; Hupfeld \& Ruffieux, 2011):
Participants rate different items on a scale from 1 to 5. Items 1, 2, 4, 6, 8, 11, 13, 16, 18, 20, 21, 24 and 25 are inverted; scale mean is formed. Higher scores indicate higher self compassion. Change calculated between time points named in time frame, for details, see statistical analysis plan.
Measured: baseline (pre), 4 weeks (intermediate), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
Change in Self-care measured with Hamburg Self-Care Survey (Harfst et al., 2009)
Hamburg Self-Care Survey (Harfst et al., 2009):
Participants rate different items on a scale from 1 to 5. Scale mean is formed. Higher scores indicate higher self-care. Change calculated between time points named in time frame, for details, see statistical analysis plan.
Measured: baseline (pre), 4 weeks (intermediate), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
Change in Mindfulness measured with Mindful Attention and Awareness Scale (MAAS-Short; Höfling et al., 2011)
Mindful Attention and Awareness Scale (MAAS-Short; Höfling et al., 2011):
Participants rate different items on a scale from 1 to 6. Items 1, 2, 3, 4 and 5 are inverted; scale mean is formed. Higher scores indicate higher mindfulness. Change calculated between time points named in time frame, for details, see statistical analysis plan.
Measured: baseline (pre), 4 weeks (intermediate), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
Change in Work-Life Balance measured with Trier Short Scale for Assessing Work-life-balance (TKS-WLB; Syrek et al., 2011)
Trier Short Scale for Assessing Work-life-balance (TKS-WLB; Syrek et al., 2011) Participants rate different items on a scale from 1 to 5. Item 2 is inverted. Higher scores indicate higher work-life-balance. Change calculated between time points named in time frame, for details, see statistical analysis plan.
Measured: baseline (pre), 4 weeks (intermediate), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
Change in Burnout measured with Maslach Burnout Inventory (MBI-D; Büssing & Perrar, 1992)
Maslach Burnout Inventory (MBI-D; Büssing \& Perrar, 1992):
Participants rate different items on a scale from 0 to 6. Items 4, 7, 9, 12, 17, 18, 19, 21, 23 and 24 are inverted. Higher scores indicate higher burnout. Change calculated between time points named in time frame, for details, see statistical analysis plan.
Measured: baseline (pre), 4 weeks (intermediate), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
Change in Optimism measured with Optimism-Pessimism-Scale (SOP-2; Kemper et al., 2014)
Optimism-Pessimism-Scale (SOP-2; Kemper et al., 2014):
Participants rate different items on a scale from 1 to 7. Item 2 is inverted, scale mean is formed. Higher scores indicate higher optimism. Change calculated between time points named in time frame.
Measured: baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
Change in Sense of Coherence measured with Sense of Coherence Scale-29 (SOC-29; Singer et al., 2007)
Sense of Coherence Scale-29 (SOC-29; Singer et al., 2007):
Participants rate different items on a scale from 1 to 7. Item 2, 5, 6, 7, 8, 12, 14, 15, 17, 21, 24 and 28 are inverted, scale mean is formed. Higher scores indicate higher sense of coherence. Change calculated between time points named in time frame.
Measured: baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
Change in Meaning and Purpose measured with Subscale of Comprehensive Inventory of Thriving (CIT; Hausler et al., 2017)
Subscale of Comprehensive Inventory of Thriving (CIT; Hausler et al., 2017):
Participants rate different items on a scale from 1 to 5. Scale mean is formed. Higher scores indicate higher meaning. Change calculated between time points named in time frame.
Measured: baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
Change in Acceptance measured with Subscale of Cognitive Emotion Regulation Questionnaire (CERQ; Loch et al., 2011)
Subscale of Cognitive Emotion Regulation Questionnaire (CERQ; Loch et al., 2011):
Participants rate different items on a scale from 1 to 6. Scale mean is formed. Higher scores indicate higher acceptance. Change calculated between time points named in time frame.
Measured: baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
Change in Positive Reappraisal measured with Subscale of Cognitive Emotion Regulation Questionnaire (CERQ; Loch et al., 2011)
Subscale of Cognitive Emotion Regulation Questionnaire (CERQ; Loch et al., 2011):
Participants rate different items on a scale from 1 to 6. Scale mean is formed. Higher scores indicate higher positive reappraisal. Change calculated between time points named in time frame.
Measured: baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
Change in Self-Efficacy measured with German Version of Self-Efficacy Short Scale (ASKU; Beierlein et al., 2014)
German Version of Self-Efficacy Short Scale (ASKU; Beierlein et al., 2014):
Participants rate different items on a scale from 1 to 5. Scale mean is formed. Higher scores indicate higher self-efficacy. Change calculated between time points named in time frame.
Measured: baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
Change in Social Support measured with Oslo Social Support Scale (OSS-3; Kocalevent et al., 2018)
Oslo Social Support Scale (OSS-3; Kocalevent et al., 2018):
Participants rate different items on a scale from 1 to 4/ 1 to 5. Sum score is formed. Higher scores indicate higher social support. Change calculated between time points named in time frame.
Measured: baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
Change in Positive Appraisal Style (content aspects) measured with Positive Appraisal Style Content (PASS-content) (no publication, pre-version in Petri-Romao et al., 2021)
Positive Appraisal Style Content (PASS-content; no publication, pre-version in Petri-Romao et al., 2021) Participants rate different items on a scale from 1 to 4. Scale mean is formed. Higher scores indicate higher positive appraisal (content aspects). Change calculated between time points named in time frame.
Measured: baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
Change in Positive Appraisal Style (procedural aspects) measured with Positive Appraisal Style Content (PASS-process) (no publication, pre-version in Petri-Romao et al., 2021)
Positive Appraisal Style Content (PASS-process) (no publication, pre-version in Petri-Romao et al., 2021) Participants rate different items on a scale from 1 to 5. Scale mean is formed. Higher scores indicate higher positive appraisal (procedural aspects). Change calculated between time points named in time frame.
Measured: baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
Change in Internal and External Locus of Control measured with Internal-External Locus of Control Short Scale-4 (IE-4; Kovaleva et al., 2014)
Internal-External Locus of Control Short Scale-4 (IE-4; Kovaleva et al., 2014):
Participants rate different items on two subscales from 1 to 5. Scale mean for each subscale is formed. Higher scores on the first subscale indicate higher internal locus of control, higher scores on the second subscale indicate higher external locus of control. Change calculated between time points named in time frame.
Measured: baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
Change in Coping measured with Coping Orientation to Problems Experienced Inventory (Brief-COPE; Knoll et al., 2005)
Coping Orientation to Problems Experienced Inventory (Brief-COPE; Knoll et al., 2005):
Participants rate different items on two subscales from 1 to 4. Scale mean for each subscale is formed. Higher scores on the first subscale indicate higher adaptive coping, higher scores on the second subscale indicate higher maladaptive coping. Change calculated between time points named in time frame.
Measured: baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
Change of Self-Esteem measured with German Single-Item Self-Esteem Scale (G-SISE; Brailovskaia & Margraf, 2020)
German Single-Item Self-Esteem Scale (G-SISE; Brailovskaia \& Margraf, 2020):
Participants rate one item on a scale from 1 to 5. Higher scores indicate higher self-esteem. Change calculated between time points named in time frame.
Measured: baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
Positive Affect measured with Subscale of Positive and Negative Affect Schedule (PANAS; Breyer & Bluemke, 2016)
Subscale of Positive and Negative Affect Schedule (PANAS; Breyer \& Bluemke, 2016) Participants rate 10 items on a scale from 1 to 5. Scale mean is formed. Higher scores indicate higher positive affect. Change calculated between time points named in time frame.
Measured: baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
Satisfaction with Life measured with Satisfaction with Life Scale (SWLS; Janke & Glöckner-Rist, 2012)
Satisfaction with Life Scale (SWLS; Janke \& Glöckner-Rist, 2012):
Participants rate 5 items on a scale from 1 to 7. Sum score is formed. Higher scores indicate higher satisfaction with life. Change calculated between time points named in time frame.
Measured: baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
Functioning measured with World Health Organization Disability Assessment Schedule (WHODAS 2.0; Üstün et al., 2010)
World Health Organization Disability Assessment Schedule (WHODAS 2.0; Üstün et al., 2010):
Participants rate 12 items on a scale from 1 to 5. Sum score is formed. Higher scores indicate lower functionality. Change calculated between time points named in time frame.
Measured: baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
Coping Flexibility measured with Coping Flexibility Questionnaire Revised (CFQ-R; Kato, 2020)
Coping Flexibility Questionnaire Revised (CFQ-R; Kato, 2020):
Participants rate 12 items on a scale from 1 to 4. There are three sub scales. Scale mean is formed, respectively. Higher scores indicate higher flexibility. Change calculated between time points named in time frame.
Measured: baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
Satisfaction with Intervention (only for the intervention group) measured with Client Satisfaction Questionnaire-Intervention (CSQ-I; Boß et al., 2016)
Client Satisfaction Questionnaire-Intervention (CSQ-I; Boß et al., 2016):
Participants rate 8 items on a scale from 1 to 4. Scale mean is formed. Higher scores indicate higher client satisfaction.
Measured: 6-8 weeks (post)
Adverse Effects (only for the intervention group) measured with Inventory of Negative Effects of Psychotherapy for Online-Interventions (INEP-ON; Ladwig et al., 2014)
Inventory of Negative Effects of Psychotherapy for Online-Interventions (INEP-ON; Ladwig et al., 2014): Participants rate in total 23 items. Of these, items 1 to 11 are rated on a 7-point scale ranging from 3 (positive outcome, like "better" or "supportive") to -3 (negative outcome, like "worse" or "disturbing"); items 12 to 21 are rated on a 4-point scale ranging from 0 (fully disagree) to 3 (fully agree) and then rated if a possible change is attributed to the intervention or life circumstances. Items 22 and 23 are also rated on a 4-point scale ranging from 0 (fully disagree) to 3 (fully agree).
We are not sure whether the questionnaire can be evaluated with a sum score or mean, we have contacted the author about it to receive instructions.
Measured: 6-8 weeks (post)
Relationship to Intervention (only for the intervention group) measured with Mobile Agnew Relationship Measure (mARM; von Wulffen et al., 2022)
Mobile Agnew Relationship Measure (mARM; von Wulffen et al., 2022): Participants rate 24 items on a scale from 1 to 7. Items 4, 8, 16, and 18 are reverse coded. There are 5 sub scales. Scale mean is formed, respectively. Higher scores indicate higher bond/ confidence/ openness/ relationship/ client initiative.
Measured: 6-8 weeks (post)
Work Engagement measured with Utrecht Work Engagement Scale (UWES-9; Schaufeli et al., 2006)
Utrecht Work Engagement Scale (UWES-9; Schaufeli et al., 2006): The UWES-9 consists of 9 items which are rated on a 7-point scale ranging from 0 (never) to 6 (always). There are 3 subscales. Scale mean is formed, respectively. Higher scores indicate higher vigor / dedication / absorption. Change calculated between time points named in time frame.
Measured: baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
Perceived Occupational Stress measured with Perceived Occupational Stress Scale (Marcatto et al., 2021)
Perceived Occupational Stress Scale (POS; Marcatto et al., 2021): The POS scale presents four items which are self-reported along a 5-point Likert scale, ranging from 1 (strongly disagree) to 5 (strongly agree). Their answers are averaged. Higher scores indicate higher perceived occupational stress. Change calculated between time points named in time frame.
Measured: baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 12 months (second-follow up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start20 Jun 2023
- Primary completion4 Jul 2024
- Study completion4 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ResilienceStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Waitlist control design
- Masking
- None (open label)
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leibniz-Institut für Resilienzforschung (LIR) gGmbH
- Sponsor type
- University, hospital or other
- Collaborators
- European Regional Development Fund, Ministry of Science and Health of Rhineland-Palatinate, Germany, Fraunhofer Institute for Industrial Mathematics ITWM
- Responsible party
- Sponsor
- Investigators
- Oliver Tüscher, Principal investigator, Leibniz Institute of Resilience Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05812716
- Sponsor's protocol ID
- 01_resiLIR_HCP
- Status last verified
- Oct 2024
- First submitted
- 27 Feb 2023
- Last updated
- 23 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
von Boros L, Schafer SK, Werner T, Pank C, Koehler F, Zappala F, Wirth BE, Zimmermann T, Moos M, Gottfriedsen L, Scherrer A, Helmreich I, Lieb K, Wessa M, Tuscher O. resiLIR HCP: A self-guided digital resilience intervention for healthcare professionals focusing on self-care and self-compassion - A randomized controlled trial. Internet Interv. 2026 Oct 6;46:101010. doi: 10.1016/j.invent.2026.101010. eCollection 2026 Dec.
PubMed 42889731
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study to Evaluate the Feasibility and Efficacy of an Online Resilience Intervention for Healthcare Professionals ("resiLIR Healthcare Professionals")
- ClinicalTrials.gov ID
- NCT05812716
- Acronym / sponsor ID
- 01_resiLIR_HCP
- Conditions
- Resilience
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Leibniz-Institut für Resilienzforschung (LIR) gGmbHUniversity, hospital or other
- Collaborators
- European Regional Development Fund, Ministry of Science and Health of Rhineland-Palatinate, Germany, Fraunhofer Institute for Industrial Mathematics ITWM
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- 4 Jul 2024 (actual)
- Study completion
- 4 Jul 2024 (actual)
- First posted
- 14 Apr 2023 (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 goal of this clinical trial is to evaluate an online resilience intervention with healthcare professionals. Participants will receive a 6-week online intervention addressing resilience and stress with a specific focus on self-care and self-compassion. The main question is whether the intervention is effective in increasing resilience.
Detailed description
Background: Healthcare professionals often experience challenging working conditions, e.g., demanding physical work or time-sensitive tasks, which leads to a high risk of stress-associated disorders or burnout. Especially the COVID-19 pandemic as an additional stressor for healthcare highlighted the role of resilience, that is, the ability to maintain or return to good mental health during stress exposure. To promote mental health and resilience in healthcare professionals, previous studies point to self-care and self-compassion as promising factors.
Objectives: The aim of the study therefore is to examine the feasibility and efficacy of a newly developed online intervention with a focus on self-care and self-compassion to foster resilience in healthcare professionals.
Methods: In a waitlist control design, 240 healthcare professionals will take part in the 6-week resilience intervention "resiLIR Healthcare Professionals". The online intervention contains a theoretical part conveying psychoeducational material as well as a training phase including practical exercises and mini-interventions in everyday life. Participants will assess resilience, burnout, and several resilience factors in online surveys pre-, during and post-intervention as well as 3, 6 and 12 months after completion as follow-up assessments.
Implications: The study will contribute to stress and burnout prevention in healthcare professionals through offering a feasible and evidence-based online intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Waitlist control design
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: resiLIR Healthcare ProfessionalsParticipants in the intervention group will gain access to the 6-week online resilience intervention "resiLIR Healthcare Professionals". |
| Waitlist control group | No intervention | –Participants will receive the intervention after the first follow up-assessment (3 months post-intervention of the intervention group). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or older
- Fluent in German language
- Access to web-enabled devices (tablet/laptop/computer)
- Smartphone with internet access
- Trained and employed as health care professionals
Key exclusion criteria (4 listed)
- Acute mental health crisis (e.g., suicidality)
- Psychiatric/psychotherapeutic treatment
- Neurodegenerative disease(s)
- Diagnosis of schizophrenia or other psychotic disorders, bipolar disorder, post-traumatic stress disorder
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 |
|---|---|---|
| resiLIR Healthcare ProfessionalsWeeks 1 and 2: Theoretical part on stress, resilience, self-care, and self-compassion Weeks 3 to 6: Training phase of a weekly introduced practical exercise (reflection on living with ease, self-compassionate body scan, planning of positive activities, self-compassionate letter). This phase additionally includes smartphone reminders to apply the exercises in everyday life. | Behavioural | Intervention |
Primary outcome
Change of Resilience measured with stressor reactivity score (Kalisch et al., 2015, 2021)
Time frame: baseline (pre), 4 weeks (intermediate), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
Stressor reactivity score (Kalisch et al., 2015, 2021): Stressor reactivity can be approximated by relating self-reported mental-health problems to the corresponding stressor exposure within the same timeframe (for scales for mental health problems and stressor exposure, see secondary outcomes). The stressor reactivity (SR) score will be computed as an individual score against normal stressor reactivity (see Kalisch et al., 2021), where normal stressor reactivity is the regression line of average mental health problems against average stressor exposure across all time points in the trial population and one's individual SR score at any time point is the distance to the regression line. The inverse of the SR score is considered an approximative index of outcome-based resilience. Therefore, a lower SR score indicates higher resilience. Change calculated between time points named in time frame, for details, see statistical analysis plan.
32 secondary outcomes
Change in Resilience measured with Brief Resilience Scale (BRS; Chmitorz et al., 2018)
Time frame: baseline (pre), 4 weeks (intermediate), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
Change in Mental Health measured with General Health Questionnaire (GHQ-12; Schrnitz et al., 1999)
Time frame: baseline (pre), 4 weeks (intermediate), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
Change in Stress measured with Perceived Stress Scale (PSS-2+2; Schäfer et al., in preparation)
Time frame: baseline (pre), 4 weeks (intermediate), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
Change in Well-being measured with WHO-5 Well-Being Index (Brähler et al., 2007)
Time frame: baseline (pre), 4 weeks (intermediate), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
Change in Anxiety measured with Generalized Anxiety Disorder-7 (GAD-7; Löwe et al., 2002)
Time frame: baseline (pre), 4 weeks (intermediate), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
Change in Depression measured with Patient Health Questionnaire-9 (PHQ-9; Löwe et al., 2002)
Time frame: baseline (pre), 4 weeks (intermediate), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
Change in Self Compassion measured with Self-Compassion Scale Deutsch (SCS-D; Hupfeld & Ruffieux, 2011)
Time frame: baseline (pre), 4 weeks (intermediate), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
Change in Self-care measured with Hamburg Self-Care Survey (Harfst et al., 2009)
Time frame: baseline (pre), 4 weeks (intermediate), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
Change in Mindfulness measured with Mindful Attention and Awareness Scale (MAAS-Short; Höfling et al., 2011)
Time frame: baseline (pre), 4 weeks (intermediate), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
Change in Work-Life Balance measured with Trier Short Scale for Assessing Work-life-balance (TKS-WLB; Syrek et al., 2011)
Time frame: baseline (pre), 4 weeks (intermediate), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
Change in Burnout measured with Maslach Burnout Inventory (MBI-D; Büssing & Perrar, 1992)
Time frame: baseline (pre), 4 weeks (intermediate), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
Change in Optimism measured with Optimism-Pessimism-Scale (SOP-2; Kemper et al., 2014)
Time frame: baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
Change in Sense of Coherence measured with Sense of Coherence Scale-29 (SOC-29; Singer et al., 2007)
Time frame: baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
Change in Meaning and Purpose measured with Subscale of Comprehensive Inventory of Thriving (CIT; Hausler et al., 2017)
Time frame: baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
Change in Acceptance measured with Subscale of Cognitive Emotion Regulation Questionnaire (CERQ; Loch et al., 2011)
Time frame: baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
Change in Positive Reappraisal measured with Subscale of Cognitive Emotion Regulation Questionnaire (CERQ; Loch et al., 2011)
Time frame: baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
Change in Self-Efficacy measured with German Version of Self-Efficacy Short Scale (ASKU; Beierlein et al., 2014)
Time frame: baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
Change in Social Support measured with Oslo Social Support Scale (OSS-3; Kocalevent et al., 2018)
Time frame: baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
Change in Positive Appraisal Style (content aspects) measured with Positive Appraisal Style Content (PASS-content) (no publication, pre-version in Petri-Romao et al., 2021)
Time frame: baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
Change in Positive Appraisal Style (procedural aspects) measured with Positive Appraisal Style Content (PASS-process) (no publication, pre-version in Petri-Romao et al., 2021)
Time frame: baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
Change in Internal and External Locus of Control measured with Internal-External Locus of Control Short Scale-4 (IE-4; Kovaleva et al., 2014)
Time frame: baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
Change in Coping measured with Coping Orientation to Problems Experienced Inventory (Brief-COPE; Knoll et al., 2005)
Time frame: baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
Change of Self-Esteem measured with German Single-Item Self-Esteem Scale (G-SISE; Brailovskaia & Margraf, 2020)
Time frame: baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
Positive Affect measured with Subscale of Positive and Negative Affect Schedule (PANAS; Breyer & Bluemke, 2016)
Time frame: baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
Satisfaction with Life measured with Satisfaction with Life Scale (SWLS; Janke & Glöckner-Rist, 2012)
Time frame: baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
Functioning measured with World Health Organization Disability Assessment Schedule (WHODAS 2.0; Üstün et al., 2010)
Time frame: baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
Coping Flexibility measured with Coping Flexibility Questionnaire Revised (CFQ-R; Kato, 2020)
Time frame: baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
Satisfaction with Intervention (only for the intervention group) measured with Client Satisfaction Questionnaire-Intervention (CSQ-I; Boß et al., 2016)
Time frame: 6-8 weeks (post)
Adverse Effects (only for the intervention group) measured with Inventory of Negative Effects of Psychotherapy for Online-Interventions (INEP-ON; Ladwig et al., 2014)
Time frame: 6-8 weeks (post)
Relationship to Intervention (only for the intervention group) measured with Mobile Agnew Relationship Measure (mARM; von Wulffen et al., 2022)
Time frame: 6-8 weeks (post)
Work Engagement measured with Utrecht Work Engagement Scale (UWES-9; Schaufeli et al., 2006)
Time frame: baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
Perceived Occupational Stress measured with Perceived Occupational Stress Scale (Marcatto et al., 2021)
Time frame: baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 12 months (second-follow up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Derived from this study: PubMed 42889731von Boros L, Schafer SK, Werner T, Pank C, Koehler F, Zappala F, Wirth BE, Zimmermann T, Moos M, Gottfriedsen L, Scherrer A, Helmreich I, Lieb K, Wessa M, Tuscher O. resiLIR HCP: A self-guided digital resilience intervention for healthcare professionals focusing on self-care and self-compassion - A randomized controlled trial. Internet Interv. 2026 Oct 6;46:101010. doi: 10.1016/j.invent.2026.101010. eCollection 2026 Dec.
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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.
Oliver Tüscher principal investigator
Leibniz Institute of Resilience Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing resiLIR Healthcare Professionals in people with Resilience, run by Leibniz-Institut für Resilienzforschung (LIR) gGmbH at 1 site in Germany.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 23 Oct 2024. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Resilience measured with stressor reactivity score (Kalisch et al., 2015, 2021) (time frame: baseline (pre), 4 weeks (intermediate), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)). 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 NCT05812716, which also lists 1 linked publication.
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 23 Oct 2024.