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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Controlled Study to Evaluate the Feasibility and Efficacy of an Online Resilience Intervention in the General Population (resiLIR Basic)

Conditions
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Resilience

Intervention / Treatment
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* Behavioral: resiLIR Basic


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Waitlist-control design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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<br>* 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<br>|
| No Intervention: Waitlist control group<br>Participants will receive the intervention after the first follow-up assessment (3 months after post-assessment). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Resilience as measured by the Brief Resilience Scale (BRS; Chmitorz et al., 2018) | Brief Resilience Scale (BRS; Chmitorz et al., 2018): Participants rate 6 items on a scale from 1 to 5. Items 2, 4 and 6 are inverted; scale mean is formed. Higher scores indicate 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) | 
| Change of Mental Health measured by the General Health Questionnaire (GHQ-12; Schrnitz et al., 1999) | General Health Questionnaire (GHQ-12; Schrnitz et al., 1999): Participants rate 12 items on a scale from 0 to 3. Items 14, 15, 10, 16, 18 and 19 are inverted; sum score is formed. Higher scores indicate lower mental health. 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) | 
| Change of Optimism measured with Optimism-Pessimism-Scale (SOP-2; Kemper et al., 2014) | Optimism-Pessimism-Scale (SOP-2; Kemper et al., 2014): Participants rate different items on a scale from 1 to 7. Item 2 is inverted, scale mean is formed. Higher scores indicate higher optimism. 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) | 
| Change of Mindfulness measured with Mindful Attention and Awareness Scale (MAAS-Short; Höfling et al., 2011) | Mindful Attention and Awareness Scale (MAAS-Short; Höfling et al., 2011) Participants rate different items on a scale from 1 to 6. Items 1, 2, 3, 4 and 5 are inverted; scale mean is formed. Higher scores indicate higher mindfulness. 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) | 
| Change of Sense of Coherence measured by Sense of Coherence Scale-29 (SOC-29; Singer et al., 2007) | Sense of Coherence Scale-29 (SOC-29; Singer et al., 2007): Participants rate different items on a scale from 1 to 7. Item 2, 5, 6, 7, 8, 12, 14, 15, 17, 21, 24 and 28 are inverted, scale mean is formed. Higher scores indicate higher sense of coherence. 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) | 
| Change of Meaning and Purpose measured by Subscale of Comprehensive Inventory of Thriving (CIT; Hausler et al., 2017) | Subscale of Comprehensive Inventory of Thriving (CIT; Hausler et al., 2017): Participants rate different items on a scale from 1 to 5. Scale mean is formed. Higher scores indicate higher meaning. 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) | 
| Change of Positive Reappraisal measured with Subscale of Cognitive Emotion Regulation Questionnaire (CERQ; Loch et al., 2011) | Subscale of Cognitive Emotion Regulation Questionnaire (CERQ; Loch et al., 2011): Participants rate different items on a scale from 1 to 6. Scale mean is formed. Higher scores indicate higher positive reappraisal. Change calculated between time points named in time frame, for details, see statistical analysis plan. | baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up) | 
| Change of Acceptance measured with Subscale of Cognitive Emotion Regulation Questionnaire (CERQ; Loch et al., 2011) | Subscale of Cognitive Emotion Regulation Questionnaire (CERQ; Loch et al., 2011) Participants rate different items on a scale from 1 to 6. Scale mean is formed. Higher scores indicate higher acceptance. 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) | 
| Change of Self Compassion measured with Self-Compassion Scale Deutsch (SCS-D; Hupfeld & Ruffieux, 2011) | Self-Compassion Scale Deutsch (SCS-D; Hupfeld & Ruffieux, 2011): Participants rate different items on a scale from 1 to 5. Items 1, 2, 4, 6, 8, 11, 13, 16, 18, 20, 21, 24 and 25 are inverted; Scale mean is formed. Higher scores indicate higher self compassion. 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) | 
| Change of Perceived Stress measured with Perceived Stress Scale (PSS-2+2; Schäfer et al., in preparation) | Perceived Stress Scale (PSS-2+2; Schäfer et al., in preparation): Participants rate different items on a scale from 1 to 5. Items 1 and 2 are inverted; scale mean is formed. Higher scores indicate higher stress. 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) | 
| Change of Depression measured with Patient Health Questionnaire-9 (PHQ-9; Löwe et al., 2002) | Patient Health Questionnaire-9 (PHQ-9; Löwe et al., 2002): Participants rate 9 items on a scale from 0 to 3. Sum score is formed. Higher scores indicate higher depression. 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) | 
| Change of Anxiety measured with Generalized Anxiety Disorder-7 (GAD-7; Löwe et al., 2002) | Generalized Anxiety Disorder-7 (GAD-7; Löwe et al., 2002): Participants rate 7 items on a scale from 0 to 3. Sum score is formed. Higher scores indicate higher anxiety. 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) | 
| Change of Well-being measured with WHO-5 Well-Being Index (Brähler et al., 2007) | WHO-5 Well-Being Index (Brähler et al., 2007): Participants rate 5 items on a scale from 1 to 6. Sum score is formed. Higher scores indicate higher well-being. 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) | 
| Change of Self-Efficacy measured with German Version of Self-Efficacy Short Scale (ASKU; Beierlein et al., 2014) | German Version of Self-Efficacy Short Scale (ASKU; Beierlein et al., 2014): Participants rate different items on a scale from 1 to 5. Scale mean is formed. Higher scores indicate higher self-efficacy. Change calculated between time points named in time frame. | baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up) | 
| 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) | Positive Appraisal Style Content (PASS-process; no publication, pre-version in Petri-Romao et al., 2021): Participants rate different items on a scale from 1 to 5. Scale mean is formed. Higher scores indicate higher positive appraisal (procedural aspects). Change calculated between time points named in time frame. | baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up) | 
| 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) | Positive Appraisal Style Content (PASS-content; no publication, pre-version in Petri-Romao et al., 2021): Participants rate different items on a scale from 1 to 4. Scale mean is formed. Higher scores indicate higher positive appraisal (content aspects). Change calculated between time points named in time frame. | baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up) | 
| Change of Social Support measured with Oslo Social Support Scale (OSS-3; Kocalevent et al., 2018) | Oslo Social Support Scale (OSS-3; Kocalevent et al., 2018): Participants rate different items on a scale from 1 to 4/ 1 to 5. Sum score is formed. Higher scores indicate higher social support. Change calculated between time points named in time frame. | baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up) | 
| Change of Internal and External Locus of Control measured with Internal-External Locus of Control Short Scale-4 (IE-4; Kovaleva et al., 2014) | Internal-External Locus of Control Short Scale-4 (IE-4; Kovaleva et al., 2014): Participants rate different items on two subscales from 1 to 5. Scale mean for each subscale is formed. Higher scores on the first subscale indicate higher internal locus of control, higher scores on the second subscale indicate higher external locus of control. Change calculated between time points named in time frame. | baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up) | 
| Change of Coping measured with Coping Orientation to Problems Experienced Inventory (Brief-COPE; Knoll et al., 2005) | Coping Orientation to Problems Experienced Inventory (Brief-COPE; Knoll et al., 2005): Participants rate different items on two subscales from 1 to 4. Scale mean for each subscale is formed. Higher scores on the first subscale indicate higher adaptive coping, higher scores on the second subscale indicate higher maladaptive coping. Change calculated between time points named in time frame. | 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 German Single-Item Self-Esteem Scale (G-SISE; Brailovskaia & Margraf, 2020) | German Single-Item Self-Esteem Scale (G-SISE; Brailovskaia & Margraf, 2020): Participants rate one item on a scale from 1 to 5. Higher scores indicate higher self-esteem. Change calculated between time points named in time frame. | baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up) | 
| Change of Positive Affect measured with Subscale of Positive and Negative Affect Schedule (PANAS; Breyer & Bluemke, 2016) | Subscale of Positive and Negative Affect Schedule (PANAS; Breyer & Bluemke, 2016) Participants rate 10 items on a scale from 1 to 5. Scale mean is formed. Higher scores indicate higher positive affect. Change calculated between time points named in time frame. | baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up) | 
| Change of Satisfaction with Life measured with Satisfaction with Life Scale (SWLS; Janke & Glöckner-Rist, 2012) | Satisfaction with Life Scale (SWLS; Janke & Glöckner-Rist, 2012): Participants rate 5 items on a scale from 1 to 7. Sum score is formed. Higher scores indicate higher satisfaction with life. Change calculated between time points named in time frame. | baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up) | 
| Change of Functioning measured with World Health Organization Disability Assessment Schedule (WHODAS 2.0; Üstün et al., 2010) | World Health Organization Disability Assessment Schedule (WHODAS 2.0; Üstün et al., 2010): Participants rate 12 items on a scale from 1 to 5. Sum score is formed. Higher scores indicate lower functionality. Change calculated between time points named in time frame. | baseline (pre), 6-8 weeks (post), 3 months (first follow-up), 6 months (second follow-up), 12 months (third follow-up) | 
| Change of Coping Flexibility measured with Coping Flexibility Questionnaire Revised (CFQ-R; Kato, 2020) | Coping Flexibility Questionnaire Revised (CFQ-R; Kato, 2020): Participants rate 12 items on a scale from 1 to 4. There are three sub scales. Scale mean is formed, respectively. Higher scores indicate higher flexibility. Change calculated between time points named in time frame. | 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 intervention group) measured with Client Satisfaction Questionnaire-Intervention (CSQ-I; Boß et al., 2016) | Client Satisfaction Questionnaire-Intervention (CSQ-I; Boß et al., 2016): Participants rate 8 items on a scale from 1 to 4. Scale mean is formed. Higher scores indicate higher client satisfaction. | 6-8 weeks (post) | 
| Adverse effects (only intervention group) measured with Inventory of Negative Effects of Psychotherapy for Online-Interventions (INEP-ON; Ladwig et al., 2014) | Inventory of Negative Effects of Psychotherapy for Online-Interventions (INEP-ON; Ladwig et al., 2014): Participants rate in total 23 items. Of these, items 1 to 11 are rated on a 7-point scale ranging from 3 (positive outcome, like better or supportive) to -3 (negative outcome, like worse or disturbing); items 12 to 21 are rated on a 4-point scale ranging from 0 (fully disagree) to 3 (fully agree) and then rated if a possible change is attributed to the intervention or life circumstances. Items 22 and 23 are also rated on a 4-point scale ranging from 0 (fully disagree) to 3 (fully agree). We are not sure whether the questionnaire can be evaluated with a sum score or mean, we have contacted the author about it to receive instructions. | 6-8 weeks (post) | 
| Relationship to Intervention (only intervention group) measured with Mobile Agnew Relationship Measure (mARM; von Wulffen et al., 2022): | Mobile Agnew Relationship Measure (mARM; von Wulffen et al., 2022): Participants rate 24 items on a scale from 1 to 7. Items 4, 8, 16, and 18 are reverse coded. There are 5 sub scales. Scale mean is formed, respectively. Higher scores indicate higher bond/ confidence/ openness/ relationship/ client initiative. | 6-8 weeks (post) |