Clinical trial NCT05812729: "resiLIR Basic": A Psychological Online Intervention to Enhance Resilience in the General Population
Official title: A Randomized Controlled Study to Evaluate the Feasibility and Efficacy of an Online Resilience Intervention in the General Population ("resiLIR Basic")
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: 244
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 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.

Detailed description: Background: Acute and chronic stress in everyday life plays an essential role in the onset and development of several physical and mental health conditions. The ability to maintain or return to mental health during stress exposure is characterized as resilience. Especially the COVID-19 pandemic emphasized the role of resilience for mental health and pointed to the importance of easily accessible and flexible interventions to improve resilience in the general population.

Objectives: The aim of the study therefore is to examine the feasibility and efficacy of a newly developed online intervention to foster resilience in the general population.

Methods: In a waitlist control design, 240 adults will participate in the 6-week resilience intervention "resiLIR Basic". This online intervention consists of 8 modules of about 45-60 minutes length using psycho-educational elements and practical exercises to address evidence-based resilience factors, such as optimism or sense of coherence. Participants will complete online surveys on resilience, mental health, and several resilience factors 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 an evidence-based and easily accessible supply of resilience interventions supporting health promotion and stress prevention in the general population.

Eligibility criteria: Inclusion Criteria:

* 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

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), 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:
measure: Change of Resilience as measured by the Brief Resilience Scale (BRS; Chmitorz et al., 2018)
timeFrame: 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)
measure: Change of Mental Health measured by the General Health Questionnaire (GHQ-12; Schrnitz et al., 1999)
timeFrame: 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)
measure: Change of Optimism measured with Optimism-Pessimism-Scale (SOP-2; Kemper et al., 2014)
timeFrame: 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)
measure: Change of Mindfulness measured with Mindful Attention and Awareness Scale (MAAS-Short; Höfling et al., 2011)
timeFrame: 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)
measure: Change of Sense of Coherence measured by Sense of Coherence Scale-29 (SOC-29; Singer et al., 2007)
timeFrame: 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)
measure: Change of Meaning and Purpose measured by Subscale of Comprehensive Inventory of Thriving (CIT; Hausler et al., 2017)
timeFrame: 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)
measure: Change of 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 of Acceptance measured with Subscale of Cognitive Emotion Regulation Questionnaire (CERQ; Loch et al., 2011)
timeFrame: 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)
measure: Change of Self Compassion measured with Self-Compassion Scale Deutsch (SCS-D; Hupfeld & Ruffieux, 2011)
timeFrame: 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)
measure: Change of Perceived Stress measured with Perceived Stress Scale (PSS-2+2; Schäfer et al., in preparation)
timeFrame: 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)
measure: Change of Depression measured with Patient Health Questionnaire-9 (PHQ-9; Löwe et al., 2002)
timeFrame: 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)
measure: Change of Anxiety measured with Generalized Anxiety Disorder-7 (GAD-7; Löwe et al., 2002)
timeFrame: 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)
measure: Change of Well-being measured with WHO-5 Well-Being Index (Brähler et al., 2007)
timeFrame: 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)
measure: Change of 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 of 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 of 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 of 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 of 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 of 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 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: Change of 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: Change of 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: Change of 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: Change of 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 intervention group) measured with Client Satisfaction Questionnaire-Intervention (CSQ-I; Boß et al., 2016)
timeFrame: 6-8 weeks (post)
measure: Adverse effects (only 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 intervention group) measured with Mobile Agnew Relationship Measure (mARM; von Wulffen et al., 2022):
timeFrame: 6-8 weeks (post)
Other outcomes:
measure: Change of Self-care measured with Hamburg Self-Care Survey (Harfst et al., 2009)
timeFrame: baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up)
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 Attitudes towards 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 of 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 of 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 of 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 of eMental 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 Stress 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: Occurrence of Stressors within the last week measured with Mainz Inventory for Micro Stressors (MIMIS; Chmitorz et al., 2020)
timeFrame: baseline (pre)
measure: Occurrence of Stressors within the last week measured with Mainz Inventory for Micro Stressors (MIMIS; Chmitorz et al., 2020)
timeFrame: 3-4 weeks (intermediate)
measure: Occurrence of Stressors within the last week measured with Mainz Inventory for Micro Stressors (MIMIS; Chmitorz et al., 2020)
timeFrame: 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)
measure: Occurrence of Stressors within the last week measured with Mainz Inventory for Micro Stressors (MIMIS; Chmitorz et al., 2020)
timeFrame: 6-8 weeks (post)
measure: Occurrence of Stressors within the last week measured with Mainz Inventory for Micro Stressors (MIMIS; Chmitorz et al., 2020)
timeFrame: 3 months (first follow-up)
measure: Occurrence of Stressors within the last week measured with Mainz Inventory for Micro Stressors (MIMIS; Chmitorz et al., 2020)
timeFrame: 6 months (second follow-up)
measure: Occurrence of Stressors within the last week measured with Mainz Inventory for Micro Stressors (MIMIS; Chmitorz et al., 2020)
timeFrame: 12 months (third follow-up)
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: 3-4 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)
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: