"resiLIR Basic": A Psychological Online Intervention to Enhance Resilience in the General Population

NCT05812729 | Completed

• 1 other identifier: 01_resiLIR_basic
• Study Type: interventional
• Target: 244
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to examine the developed online resilience intervention "resiLIR Basic" for the general population. Participants will receive a 6-week online intervention addressing resilience and stress as well as different resilience factors. The main question is whether the intervention is effective in increasing psychological 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), 3-4 weeks (intermediate), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)

Secondary Outcomes (27)

• Change of Resilience as measured by the Brief Resilience Scale (BRS; Chmitorz et al., 2018)

  baseline (pre), 3-4 weeks (intermediate), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)

• Change of Mental Health measured by the General Health Questionnaire (GHQ-12; Schrnitz et al., 1999)

  baseline (pre), 3-4 weeks (intermediate), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)

• Change of Optimism measured with Optimism-Pessimism-Scale (SOP-2; Kemper et al., 2014)

  baseline (pre), 3-4 weeks (intermediate), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)

• Change of Mindfulness measured with Mindful Attention and Awareness Scale (MAAS-Short; Höfling et al., 2011)

  baseline (pre), 3-4 weeks (intermediate), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)

• Change of Sense of Coherence measured by Sense of Coherence Scale-29 (SOC-29; Singer et al., 2007)

  baseline (pre), 3-4 weeks (intermediate), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)

Other Outcomes (29)

• Change of Self-care measured with Hamburg Self-Care Survey (Harfst et al., 2009)

  baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)

• 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)

Study Arms (2)

Intervention

EXPERIMENTAL

Participants in the intervention group will receive access to the 6-week online resilience intervention "resiLIR Basic" consisting of 8 modules of about 45-60 minutes addressing evidence-based resilience factors, such as optimism or sense of coherence.

Behavioral: resiLIR Basic

Waitlist control group

NO INTERVENTION

Participants will receive the intervention after the first follow-up assessment (3 months after post-assessment).

Interventions

resiLIR Basic BEHAVIORAL

Each module contains psychoeducational elements as well as practical exercises. Week 1: Introduction + "Stress and resilience" Week 2: "Optimism" Week 3: "Mindfulness" Week 4: "Sense of coherence and values" Week 5: "Acceptance" Week 6: "Self-compassion" + Conclusion

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
• Have access to an internet-enabled device with a large screen (tablet / laptop / computer).
• as well as that they can use at least once a week for 45 min to 1.5 hours during the study period

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 24, 2023
• First Posted: April 14, 2023
• Study Start: June 14, 2023
• Primary Completion: June 28, 2024
• Study Completion: June 28, 2024
• Last Updated: October 23, 2024

Record last verified: 2024-10

Locations

DE (1)