resiLIR Healthcare Professionals: A Psychological Online Intervention to Enhance Resilience in Healthcare Professionals

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Controlled Study to Evaluate the Feasibility and Efficacy of an Online Resilience Intervention for Healthcare Professionals (resiLIR Healthcare Professionals)

Conditions
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Resilience

Intervention / Treatment
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* Behavioral: resiLIR Healthcare Professionals


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Waitlist control design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Participants in the intervention group will gain access to the 6-week online resilience intervention resiLIR Healthcare Professionals. | Behavioral: resiLIR Healthcare Professionals<br>* 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.<br>|
| No Intervention: Waitlist control group<br>Participants will receive the intervention after the first follow up-assessment (3 months post-intervention of the intervention group). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 12 months (second-follow up) |