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

Leibniz-Institut für Resilienzforschung (LIR) gGmbH1 site in 1 country224 target enrollmentJune 20, 2023

ConditionsResilience

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Resilience
Sponsor: Leibniz-Institut für Resilienzforschung (LIR) gGmbH
Enrollment: 224
Locations: 1
Primary Endpoint: Change of Resilience measured with stressor reactivity score (Kalisch et al., 2015, 2021)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 20, 2023

End Date

July 4, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Leibniz-Institut für Resilienzforschung (LIR) gGmbH

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

Change in Resilience measured with Brief Resilience Scale (BRS; Chmitorz et al., 2018)(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)(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)(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)(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)(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)(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)(baseline (pre), 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)(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)(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 Social Support measured with Oslo Social Support Scale (OSS-3; Kocalevent et al., 2018)(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)(baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up))
Relationship to Intervention (only for the intervention group) measured with Mobile Agnew Relationship Measure (mARM; von Wulffen et al., 2022)(6-8 weeks (post))
Work Engagement measured with Utrecht Work Engagement Scale (UWES-9; Schaufeli et al., 2006)(baseline (pre), 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)(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)(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 Acceptance measured with Subscale of Cognitive Emotion Regulation Questionnaire (CERQ; Loch et al., 2011)(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)(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)(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)(baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up))
Adverse Effects (only for the intervention group) measured with Inventory of Negative Effects of Psychotherapy for Online-Interventions (INEP-ON; Ladwig et al., 2014)(6-8 weeks (post))
Change in Well-being measured with WHO-5 Well-Being Index (Brähler et al., 2007)(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)(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 Positive Appraisal Style (procedural aspects) measured with Positive Appraisal Style Content (PASS-process) (no publication, pre-version in Petri-Romao et al., 2021)(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)(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)(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)(6-8 weeks (post))
Change in Sense of Coherence measured with Sense of Coherence Scale-29 (SOC-29; Singer et al., 2007)(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)(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)(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)(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)(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)(baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 12 months (second-follow up))