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

NCT05812716 | Completed

• 1 other identifier: 01_resiLIR_HCP
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

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.

Conditions

Resilience

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (32)

• 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 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 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)

Other Outcomes (28)

• Attitudes towards Psychological Online Interventions measured with Attitudes towards Psychological Online Interventions Questionnaire (APOI; Schröder et al., 2015)

  baseline (pre)

• Personality measured with Big Five Inventory-10 (BFI-10; Rammstedt et al., 2017)

  baseline (pre)

• Sociodemographic Variables

  baseline (pre)

Study Arms (2)

Intervention

EXPERIMENTAL

Participants in the intervention group will gain access to the 6-week online resilience intervention "resiLIR Healthcare Professionals".

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).

Interventions

resiLIR Healthcare Professionals BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Leibniz-Institut für Resilienzforschung (LIR) gGmbH: lead
• European Regional Development Fund: collaborator
• Ministry of Science and Health of Rhineland-Palatinate, Germany: collaborator
• Fraunhofer Institute for Industrial Mathematics ITWM: collaborator

Study Sites (1)

Leibniz Institute for Resilience Research gGmbH

Mainz, Rhineland-Palatinate, 55122, Germany

Location

Study Officials

• Oliver Tüscher

  Leibniz Institute of Resilience Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Waitlist control design

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: April 14, 2023
• Study Start: June 20, 2023
• Primary Completion: July 4, 2024
• Study Completion: July 4, 2024
• Last Updated: October 23, 2024

Record last verified: 2024-10

Locations

DE (1)