ResilienceNCT05812729
"resiLIR Basic": A Psychological Online Intervention to Enhance Resilience in the General Population
A study testing resiLIR Basic in people with Resilience, run by Leibniz-Institut für Resilienzforschung (LIR) gGmbH at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Resilience
- What is being tested?
- resiLIR Basic
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- 1 siteGermany
- Study dates
- 14 Jun 2023to 28 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Leibniz Institute for Resilience Research gGmbH
Mainz, Rhineland-Palatinate, 55122
About this study
Official title: A Randomized Controlled Study to Evaluate the Feasibility and Efficacy of an Online Resilience Intervention in the General Population ("resiLIR Basic")
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.
Read the 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.
- Conditions
- Resilience
- Being tested
- resiLIR Basic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resiLIR BasicBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: resiLIR Basic |
| Waitlist control group | No intervention | Participants will receive the intervention after the first follow-up assessment (3 months after post-assessment). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6-8 weeks (post)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start14 Jun 2023
- Primary completion28 Jun 2024
- Study completion28 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ResilienceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Waitlist-control design
- Masking
- None (open label)
- Enrolment
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leibniz-Institut für Resilienzforschung (LIR) gGmbH
- Sponsor type
- University, hospital or other
- Collaborators
- European Regional Development Fund, Ministry of Science and Health of Rhineland-Palatinate, Germany, Fraunhofer Institute for Industrial Mathematics ITWM
- Responsible party
- Sponsor
- Investigators
- Oliver Tüscher, Principal investigator, Leibniz Institute of Resilience Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05812729
- Sponsor's protocol ID
- 01_resiLIR_basic
- Status last verified
- Oct 2024
- First submitted
- 24 Feb 2023
- Last updated
- 23 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study to Evaluate the Feasibility and Efficacy of an Online Resilience Intervention in the General Population ("resiLIR Basic")
- ClinicalTrials.gov ID
- NCT05812729
- Acronym / sponsor ID
- 01_resiLIR_basic
- Conditions
- Resilience
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- Leibniz-Institut für Resilienzforschung (LIR) gGmbHUniversity, hospital or other
- Collaborators
- European Regional Development Fund, Ministry of Science and Health of Rhineland-Palatinate, Germany, Fraunhofer Institute for Industrial Mathematics ITWM
- Study start
- 14 Jun 2023 (actual)
- Primary completion
- 28 Jun 2024 (actual)
- Study completion
- 28 Jun 2024 (actual)
- First posted
- 14 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Waitlist-control design
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: resiLIR BasicParticipants 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. |
| Waitlist control group | No intervention | –Participants will receive the intervention after the first follow-up assessment (3 months after post-assessment). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| resiLIR BasicEach 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 | Behavioural | Intervention |
Primary outcome
Change of Resilience measured with stressor reactivity score (Kalisch et al., 2015, 2021)
Time frame: 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)
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.
27 secondary outcomes
Change of Resilience as measured by the Brief Resilience Scale (BRS; Chmitorz et al., 2018)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
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 Acceptance measured with Subscale of Cognitive Emotion Regulation Questionnaire (CERQ; Loch et al., 2011)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Time frame: 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)
Time frame: 6-8 weeks (post)
Relationship to Intervention (only intervention group) measured with Mobile Agnew Relationship Measure (mARM; von Wulffen et al., 2022):
Time frame: 6-8 weeks (post)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oliver Tüscher principal investigator
Leibniz Institute of Resilience Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing resiLIR Basic in people with Resilience, run by Leibniz-Institut für Resilienzforschung (LIR) gGmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Resilience measured with stressor reactivity score (Kalisch et al., 2015, 2021) (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2024.