Resilience Clinical Trial
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.
Status | Recruiting |
Enrollment | 240 |
Est. completion date | June 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Leibniz Institute for Resilience Research gGmbH | Mainz | Rhineland Palatinate |
Lead Sponsor | Collaborator |
---|---|
Leibniz-Institut für Resilienzforschung (LIR) gGmbH | European Regional Development Fund, Fraunhofer Institute for Industrial Mathematics ITWM, Ministry of Science and Health of Rhineland-Palatinate, Germany |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change of Self-care measured with Hamburg Self-Care Survey (Harfst et al., 2009) | Hamburg Self-Care Survey (Harfst et al., 2009): Participants rate 12 items on a scale from 1 to 5. Scale mean is formed. Higher scores indicate higher self-care. 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) | |
Other | Attitudes towards Psychological Online Interventions measured with Attitudes towards Psychological Online Interventions Questionnaire (APOI; Schröder et al., 2015) | Attitudes towards Psychological Online Interventions Questionnaire (APOI; Schröder et al., 2015):
Participants rate 16 items on a scale from 1 to 7. There are four sub scales (Scepticism and perception of Risks, Confidence in Effectiveness, Technologization Threat, Anonymity Benefits), scale mean is formed, respectively. Higher scores indicate higher Scepticism, etc.. |
baseline (pre) | |
Other | Personality measured with Big Five Inventory-10 (BFI-10; Rammstedt et al., 2017) | Big Five Inventory-10 (BFI-10; Rammstedt et al., 2017):
Participants rate 10 items on a scale from 1 to 5. There are five sub scales (Extraversion, Openness, Neuroticism, Agreeableness, Conscientiousness). Scale mean is formed, respectively. Higher scores indicate higher Extraversion, etc. |
baseline (pre) | |
Other | Sociodemographic Variables | Single Items: age, sex, education | baseline (pre) | |
Other | Socioeconomic Variables | number of people living in household, household net income, individual net income | baseline (pre) | |
Other | Change of Belief Towards Mental Illness measured with Belief Towards Mental Illness Scale (Hirai & Clum, 2018) | Belief Towards Mental Illness Scale (Hirai & Clum, 2018):
Participants rate 21 items on a scale from 1 to 6. There are three sub scales (Dangerousness, Poor social and interpersonal skills, Incurability). Scale mean is formed, respectively. Higher scores indicate higher Dangerousness, etc.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) | |
Other | Change of Help-seeking Behavior measured with General Help Seeking Scale (Rickwood et al., 2005) | General Help Seeking Scale (Rickwood et al., 2005):
Participants rate 15 items on a scale from 1 to 4. There are three sub scales (level of intention for seeking informal help, level of intention for seeking formal help, level of intention to seek help from no-one). Scale mean is formed, respectively. Higher scores indicate higher level of intention for seeking informal help, etc. 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) | |
Other | Change of Attitudes towards Help-seeking Behavior measured with Attitudes Toward Seeking Professional Psychological Help (Kessler et al., 2015) | Attitudes Toward Seeking Professional Psychological Help (Kessler et al., 2015) Participants rate 24 items on a scale from 1 to 5. Items 1, 3, 4, 6, 7, 9, 11, 12, 14, 16, 17, 18, 20, 21 and 24 are inverted. There are three sub scales (Psychological Openness, Help-Seeking Propensity, Indifference to stigma). Scale mean is formed, respectively. Higher scores indicate higher level of Psychological Openness, etc. 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) | |
Other | Change of Mental Health Literacy measured with Mental Health Literacy Questionnaire (Dias et al., 2018) | Mental Health Literacy Questionnaire (Dias et al., 2018):
Participants rate 29 items on a scale from 1 to 5. Items 6, 10, 13, 15, 21 and 23 are invertedSum score is formed. Higher scores indicate higher health literacy.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) | |
Other | Change of Mental Health Literacy measured with Mental Health Literacy Scale (O'Connor & Casey, 2015) | Mental Health Literacy Scale (O'Connor & Casey, 2015):
Participants rate 35 items on a scale from 1 to 4/5. Items 10, 12, 15, 20, 21, 22, 23, 24, 25, 26, 27, 28 are inverted. Sum score is formed. Higher scores indicate higher health literacy. 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) | |
Other | Change of Mental Health Literacy measured with Mental Health Knowledge Schedule (Evans-Lacko et al., 2010) | Mental Health Knowledge Schedule (Evans-Lacko et al., 2010) Participants rate 6 items on a scale from 1 to 6. Sum score is formed where 6 (don't know) is equalized to a score of 3. Higher scores indicate higher health literacy. 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) | |
Other | Change of Mental Health Literacy measured with Health Literacy Survey EU 16 (Jordan & Hoebel, 2015) | Health Literacy Survey EU 16 (Jordan & Hoebel, 2015) Participants rate 16 items on a scale from 1 to 4. Sum score is formed where 1/2 are summed up to a score of 1 and 3/4 are summed up to a score of 0. Higher scores indicate higher health literacy. 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) | |
Other | Change of eMental Health Literacy measured with eHealth Literacy Scale (Soellner et al., 2014) | eHealth Literacy Scale (Soellner et al., 2014): Participants rate 8 items on a scale from 1 to 5. There are two subscales (Information seeking/ Information appraisal). Scale mean is formed. Higher scores indicate higher information seeking/ information appraisal. 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) | |
Other | Change of Mental Health Literacy measured with Well-being Literacy Scale (Hou et al., 2021): | Well-being Literacy Scale (Hou et al., 2021): The scale consists of 6 items. Each item is rated on a 7-point Likert scale, from 1 (Strongly disagree) to 7 (Strongly agree). Scale mean is formed. Higher scores indicate higher mental health literacy. 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) | |
Other | Change of Stress measured with STRESS K-10 (Giesinger et al., 2008) | STRESS K-10 (Giesinger et al., 2008):
Participants rate 10 items on a scale from 1 to 5. Sum score is formed. Higher scores indicate higher stress. 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) | |
Other | Change of Knowledge of psychosocial care structures measured with Questionnaire to survey knowledge of psychosocial care structures. (Fritz, 2021, in preparation) | Questionnaire to survey knowledge of psychosocial care structures. (Fritz, 2021, in preparation) Participants rate 8 items on a scale from 1 to 3 (yes, no, I don't know). Sum score is formed. Higher scores indicate higher knowledge. 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) | |
Other | Occurrence of Stressors within the last week measured with Mainz Inventory for Micro Stressors (MIMIS; Chmitorz et al., 2020) | Mainz Inventory for Micro Stressors (MIMIS; Chmitorz et al., 2020): Participants rate different items on a scale from 1 to 7. Sum score is formed. Higher scores indicate higher number of stressors. | baseline (pre) | |
Other | Occurrence of Stressors within the last week measured with Mainz Inventory for Micro Stressors (MIMIS; Chmitorz et al., 2020) | Mainz Inventory for Micro Stressors (MIMIS; Chmitorz et al., 2020): Participants rate different items on a scale from 1 to 7. Sum score is formed. Higher scores indicate higher number of stressors. | 3-4 weeks (intermediate) | |
Other | Occurrence of Stressors within the last week measured with Mainz Inventory for Micro Stressors (MIMIS; Chmitorz et al., 2020) | Mainz Inventory for Micro Stressors (MIMIS; Chmitorz et al., 2020): Participants rate different items on a scale from 1 to 7. Sum score is formed. Higher scores indicate higher number of stressors. | 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 | Occurrence of Stressors within the last week measured with Mainz Inventory for Micro Stressors (MIMIS; Chmitorz et al., 2020) | Mainz Inventory for Micro Stressors (MIMIS; Chmitorz et al., 2020): Participants rate different items on a scale from 1 to 7. Sum score is formed. Higher scores indicate higher number of stressors. | 6-8 weeks (post) | |
Other | Occurrence of Stressors within the last week measured with Mainz Inventory for Micro Stressors (MIMIS; Chmitorz et al., 2020) | Mainz Inventory for Micro Stressors (MIMIS; Chmitorz et al., 2020): Participants rate different items on a scale from 1 to 7. Sum score is formed. Higher scores indicate higher number of stressors. | 3 months (first follow-up) | |
Other | Occurrence of Stressors within the last week measured with Mainz Inventory for Micro Stressors (MIMIS; Chmitorz et al., 2020) | Mainz Inventory for Micro Stressors (MIMIS; Chmitorz et al., 2020): Participants rate different items on a scale from 1 to 7. Sum score is formed. Higher scores indicate higher number of stressors. | 6 months (second follow-up) | |
Other | Occurrence of Stressors within the last week measured with Mainz Inventory for Micro Stressors (MIMIS; Chmitorz et al., 2020) | Mainz Inventory for Micro Stressors (MIMIS; Chmitorz et al., 2020): Participants rate different items on a scale from 1 to 7. Sum score is formed. Higher scores indicate higher number of stressors. | 12 months (third follow-up) | |
Other | Occurrence of Life Events measured with Life Events Checklist-5 (LEC-5; Krüger-Gottschalk et al., 2017) | Life Events Checklist-5 (LEC-5; Krüger-Gottschalk et al., 2017): Participants rate different items on a scale from 1 to 6. Items experienced directly are weighted by a factor of 3, items witnessed weighted with a factor of 2, items learned about or experienced at work are weighted with a factor of 1. Sum score is formed. Higher scores indicate more events experienced with closer proximity to the individual. | baseline (pre) | |
Other | Occurrence of Life Events measured with Life Events Checklist-5 (LEC-5; Krüger-Gottschalk et al., 2017) | Life Events Checklist-5 (LEC-5; Krüger-Gottschalk et al., 2017): Participants rate different items on a scale from 1 to 6. Items experienced directly are weighted by a factor of 3, items witnessed weighted with a factor of 2, items learned about or experienced at work are weighted with a factor of 1. Sum score is formed. Higher scores indicate more events experienced with closer proximity to the individual. | 3-4 weeks (intermediate) | |
Other | Occurrence of Life Events measured with Life Events Checklist-5 (LEC-5; Krüger-Gottschalk et al., 2017) | Life Events Checklist-5 (LEC-5; Krüger-Gottschalk et al., 2017): Participants rate different items on a scale from 1 to 6. Items experienced directly are weighted by a factor of 3, items witnessed weighted with a factor of 2, items learned about or experienced at work are weighted with a factor of 1. Sum score is formed. Higher scores indicate more events experienced with closer proximity to the individual. | 6-8 weeks (post) | |
Other | Occurrence of Life Events measured with Life Events Checklist-5 (LEC-5; Krüger-Gottschalk et al., 2017) | Life Events Checklist-5 (LEC-5; Krüger-Gottschalk et al., 2017): Participants rate different items on a scale from 1 to 6. Items experienced directly are weighted by a factor of 3, items witnessed weighted with a factor of 2, items learned about or experienced at work are weighted with a factor of 1. Sum score is formed. Higher scores indicate more events experienced with closer proximity to the individual. | 3 months (first follow-up) | |
Other | Occurrence of Life Events measured with Life Events Checklist-5 (LEC-5; Krüger-Gottschalk et al., 2017) | Life Events Checklist-5 (LEC-5; Krüger-Gottschalk et al., 2017): Participants rate different items on a scale from 1 to 6. Items experienced directly are weighted by a factor of 3, items witnessed weighted with a factor of 2, items learned about or experienced at work are weighted with a factor of 1. Sum score is formed. Higher scores indicate more events experienced with closer proximity to the individual. | 6 months (second follow-up) | |
Other | Occurrence of Life Events measured with Life Events Checklist-5 (LEC-5; Krüger-Gottschalk et al., 2017) | Life Events Checklist-5 (LEC-5; Krüger-Gottschalk et al., 2017): Participants rate different items on a scale from 1 to 6. Items experienced directly are weighted by a factor of 3, items witnessed weighted with a factor of 2, items learned about or experienced at work are weighted with a factor of 1. Sum score is formed. Higher scores indicate more events experienced with closer proximity to the individual. | 12 months (third follow-up) | |
Primary | 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 | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) |
Status | Clinical Trial | Phase | |
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Enrolling by invitation |
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N/A | |
Completed |
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The Effects of Resilience and Self-efficacy on Nurses' Compassion Fatigue
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Completed |
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Recalling and Anticipating Specific Positive Events to Boost Resilience in Adolescents
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N/A | |
Completed |
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Effect of #LIFEGOALS on Adolescents' Mental Health
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N/A | |
Recruiting |
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Resiliency in U.S. Air Force Personnel
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N/A | |
Completed |
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Online Mindfulness Therapy for Pandemic Fatigue and Resilience in COVID-19 Nurses
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N/A | |
Completed |
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Evaluation of Play and Care Together (PACT) Implementation
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Completed |
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Resilience Enhancement Online Training for Nurses (REsOluTioN) Trial
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N/A | |
Completed |
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An Online Compassionate Imagery Intervention for Veterinarian Mental Health
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Recruiting |
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Culturally Adapted iCBT for Arabic-speaking Refugee and Migrant Youth With Common Mental Health Problems
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N/A | |
Enrolling by invitation |
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Mind-Body Medicine Training for Incarcerated Men and Women
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N/A | |
Completed |
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Resilience Models in Adolescence and Youth With Cancer in Taiwan
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Recruiting |
NCT06286787 -
Efficacy of Mountain Craft Training at Enhancing the Resilience and Physio-psychological Well-being of Children From Low-income Families
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N/A | |
Completed |
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Learning From Excellence in a Hospital Unit
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Recruiting |
NCT06423417 -
RCT: the Effectiveness of LifeHack in Improving Mental Wellbeing in University Students.
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N/A | |
Completed |
NCT04889508 -
Investigating Differential Effects of Online Mental Training Interventions on Mental Well-being and Social Cohesion
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N/A | |
Completed |
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Enhancing Resilience in Young Stroke Survivors With Res-ET
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Completed |
NCT05588596 -
Intervention Program to Address PTSD in People Living With HIV
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N/A |