Clinical trial NCT05812716: "resiLIR Healthcare Professionals": A Psychological Online Intervention to Enhance Resilience in Healthcare Professionals
Official title: A Randomized Controlled Study to Evaluate the Feasibility and Efficacy of an Online Resilience Intervention for Healthcare Professionals ("resiLIR Healthcare Professionals")
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Resilience
Lead sponsor: Leibniz-Institut für Resilienzforschung (LIR) gGmbH
Sponsor class: OTHER
Collaborators: name: European Regional Development Fund
name: Ministry of Science and Health of Rhineland-Palatinate, Germany
name: Fraunhofer Institute for Industrial Mathematics ITWM
First posted: 2023-04-14
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Waitlist control design
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of Resilience measured with stressor reactivity score (Kalisch et al., 2015, 2021)
timeFrame: 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:
measure: Change in Resilience measured with Brief Resilience Scale (BRS; Chmitorz et al., 2018)
timeFrame: baseline (pre), 4 weeks (intermediate), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
measure: Change in Mental Health measured with General Health Questionnaire (GHQ-12; Schrnitz et al., 1999)
timeFrame: baseline (pre), 4 weeks (intermediate), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
measure: Change in Stress measured with Perceived Stress Scale (PSS-2+2; Schäfer et al., in preparation)
timeFrame: baseline (pre), 4 weeks (intermediate), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
measure: Change in Well-being measured with WHO-5 Well-Being Index (Brähler et al., 2007)
timeFrame: baseline (pre), 4 weeks (intermediate), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
measure: Change in Anxiety measured with Generalized Anxiety Disorder-7 (GAD-7; Löwe et al., 2002)
timeFrame: baseline (pre), 4 weeks (intermediate), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
measure: Change in Depression measured with Patient Health Questionnaire-9 (PHQ-9; Löwe et al., 2002)
timeFrame: baseline (pre), 4 weeks (intermediate), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
measure: Change in Self Compassion measured with Self-Compassion Scale Deutsch (SCS-D; Hupfeld & Ruffieux, 2011)
timeFrame: baseline (pre), 4 weeks (intermediate), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
measure: Change in Self-care measured with Hamburg Self-Care Survey (Harfst et al., 2009)
timeFrame: baseline (pre), 4 weeks (intermediate), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
measure: Change in Mindfulness measured with Mindful Attention and Awareness Scale (MAAS-Short; Höfling et al., 2011)
timeFrame: baseline (pre), 4 weeks (intermediate), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
measure: Change in Work-Life Balance measured with Trier Short Scale for Assessing Work-life-balance (TKS-WLB; Syrek et al., 2011)
timeFrame: baseline (pre), 4 weeks (intermediate), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
measure: Change in Burnout measured with Maslach Burnout Inventory (MBI-D; Büssing & Perrar, 1992)
timeFrame: baseline (pre), 4 weeks (intermediate), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
measure: Change in Optimism measured with Optimism-Pessimism-Scale (SOP-2; Kemper et al., 2014)
timeFrame: baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
measure: Change in Sense of Coherence measured with Sense of Coherence Scale-29 (SOC-29; Singer et al., 2007)
timeFrame: baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
measure: Change in Meaning and Purpose measured with Subscale of Comprehensive Inventory of Thriving (CIT; Hausler et al., 2017)
timeFrame: baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
measure: Change in Acceptance measured with Subscale of Cognitive Emotion Regulation Questionnaire (CERQ; Loch et al., 2011)
timeFrame: baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
measure: Change in Positive Reappraisal measured with Subscale of Cognitive Emotion Regulation Questionnaire (CERQ; Loch et al., 2011)
timeFrame: baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
measure: Change in Self-Efficacy measured with German Version of Self-Efficacy Short Scale (ASKU; Beierlein et al., 2014)
timeFrame: baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
measure: Change in Social Support measured with Oslo Social Support Scale (OSS-3; Kocalevent et al., 2018)
timeFrame: baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
measure: 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)
timeFrame: baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
measure: 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)
timeFrame: baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
measure: Change in Internal and External Locus of Control measured with Internal-External Locus of Control Short Scale-4 (IE-4; Kovaleva et al., 2014)
timeFrame: baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
measure: Change in Coping measured with Coping Orientation to Problems Experienced Inventory (Brief-COPE; Knoll et al., 2005)
timeFrame: baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
measure: Change of Self-Esteem measured with German Single-Item Self-Esteem Scale (G-SISE; Brailovskaia & Margraf, 2020)
timeFrame: baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
measure: Positive Affect measured with Subscale of Positive and Negative Affect Schedule (PANAS; Breyer & Bluemke, 2016)
timeFrame: baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
measure: Satisfaction with Life measured with Satisfaction with Life Scale (SWLS; Janke & Glöckner-Rist, 2012)
timeFrame: baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
measure: Functioning measured with World Health Organization Disability Assessment Schedule (WHODAS 2.0; Üstün et al., 2010)
timeFrame: baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
measure: Coping Flexibility measured with Coping Flexibility Questionnaire Revised (CFQ-R; Kato, 2020)
timeFrame: baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
measure: Satisfaction with Intervention (only for the intervention group) measured with Client Satisfaction Questionnaire-Intervention (CSQ-I; Boß et al., 2016)
timeFrame: 6-8 weeks (post)
measure: Adverse Effects (only for the intervention group) measured with Inventory of Negative Effects of Psychotherapy for Online-Interventions (INEP-ON; Ladwig et al., 2014)
timeFrame: 6-8 weeks (post)
measure: Relationship to Intervention (only for the intervention group) measured with Mobile Agnew Relationship Measure (mARM; von Wulffen et al., 2022)
timeFrame: 6-8 weeks (post)
measure: Work Engagement measured with Utrecht Work Engagement Scale (UWES-9; Schaufeli et al., 2006)
timeFrame: baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
measure: Perceived Occupational Stress measured with Perceived Occupational Stress Scale (Marcatto et al., 2021)
timeFrame: baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 12 months (second-follow up)
Other outcomes:
measure: Attitudes towards Psychological Online Interventions measured with Attitudes towards Psychological Online Interventions Questionnaire (APOI; Schröder et al., 2015)
timeFrame: baseline (pre)
measure: Personality measured with Big Five Inventory-10 (BFI-10; Rammstedt et al., 2017)
timeFrame: baseline (pre)
measure: Sociodemographic Variables
timeFrame: baseline (pre)
measure: Socioeconomic Variables
timeFrame: baseline (pre)
measure: Change of belief Towards Mental Illness measured with Belief Towards Mental Illness Scale (Hirai & Clum, 2018)
timeFrame: baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
measure: Change of help-seeking Behavior measured with General Help Seeking Scale (Rickwood et al., 2005)
timeFrame: baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
measure: Change of help-seeking Behavior measured with Attitudes Toward Seeking Professional Psychological Help (Kessler et al., 2015)
timeFrame: baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
measure: Change of Mental Health Literacy measured with Mental Health Literacy Questionnaire (Dias et al., 2018)
timeFrame: baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
measure: Change in Mental Health Literacy measured with Mental Health Literacy Scale (O'Connor & Casey, 2015)
timeFrame: baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
measure: Change in Mental Health Literacy measured with Mental Health Knowledge Schedule (Evans-Lacko et al., 2010)
timeFrame: baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
measure: Change in Mental Health Literacy measured with Health Literacy Survey EU 16 (Jordan & Hoebel, 2015)
timeFrame: baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
measure: Change in Mental Health Literacy measured with eHealth Literacy Scale (Soellner et al., 2014)
timeFrame: baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
measure: Change of Mental Health Literacy measured with Well-being Literacy Scale (Hou et al., 2021)
timeFrame: baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
measure: Change of Mental Health Literacy measured with STRESS K-10 (Giesinger et al., 2008)
timeFrame: baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
measure: Change of Knowledge of psychosocial care structures measured with Questionnaire to survey knowledge of psychosocial care structures. (Fritz, 2021, in preparation)
timeFrame: baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
measure: Work-related variables
timeFrame: baseline (pre)
measure: Occurrence of Life Events measured with Life Events Checklist-5 (LEC-5; Krüger-Gottschalk et al., 2017)
timeFrame: baseline (pre)
measure: Occurrence of Life Events measured with Life Events Checklist-5 (LEC-5; Krüger-Gottschalk et al., 2017)
timeFrame: 4 weeks (intermediate)
measure: Occurrence of Life Events measured with Life Events Checklist-5 (LEC-5; Krüger-Gottschalk et al., 2017)
timeFrame: 6-8 weeks (post)
measure: Occurrence of Life Events measured with Life Events Checklist-5 (LEC-5; Krüger-Gottschalk et al., 2017)
timeFrame: 3 months (first follow-up)
measure: Occurrence of Life Events measured with Life Events Checklist-5 (LEC-5; Krüger-Gottschalk et al., 2017)
timeFrame: 6 months (second follow-up)
measure: Occurrence of Life Events measured with Life Events Checklist-5 (LEC-5; Krüger-Gottschalk et al., 2017)
timeFrame: 12 months (third follow-up)
measure: Occurrence of Stressors measured with Mainz Inventory for Micro Stressors (MIMIS; Chmitorz et al., 2020)
timeFrame: baseline (pre)
measure: Occurrence of Stressors measured with Mainz Inventory for Micro Stressors (MIMIS; Chmitorz et al., 2020)
timeFrame: 4 weeks (intermediate)
measure: Occurrence of Stressors measured with Mainz Inventory for Micro Stressors (MIMIS; Chmitorz et al., 2020)
timeFrame: 6-8 weeks (post)
measure: Occurrence of Stressors measured with Mainz Inventory for Micro Stressors (MIMIS; Chmitorz et al., 2020)
timeFrame: 3 months (first follow-up)
measure: Occurrence of Stressors measured with Mainz Inventory for Micro Stressors (MIMIS; Chmitorz et al., 2020)
timeFrame: 6 months (second follow-up)
measure: Occurrence of Stressors measured with Mainz Inventory for Micro Stressors (MIMIS; Chmitorz et al., 2020)
timeFrame: 12 months (third follow-up)
Locations:
city: Mainz
country: Germany
facility: Leibniz Institute for Resilience Research gGmbH
state: Rhineland Palatinate
Study officials:
affiliation: Leibniz Institute of Resilience Research
name: Oliver Tüscher
role: PRINCIPAL_INVESTIGATOR
References: