- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04165473
A Training Program for Developing Social- and Personal Resources
A Training Program for Developing Social- and Personal Resources and Its Effects on Emotional, Physical and Social Wellbeing in Adults
In this study, a new psychosocial training for social relationships for adults will be evaluated. In a 6-module course, with four 3-day modules and two 5-day modules in the timeframe of one year, participants learn ways to strengthen their personal resources to establish effective social relationships and to develop skills as a social being. In between the module courses, the participants take 5 single sessions with an instructed trainer and document 10 conversations/social situations where they successfully apply the acquired personal and social skills. For my study, I will recruit a total of 200 persons. Approx. one hundred participants for the intervention group and 100 individuals for the control group. During the course of the training, the participants are taught social and personal skills that should result in a lower perceived stress level in daily life, improved health behaviour, a decreased presence of common somatic symptoms, a higher satisfaction with their lives, improved quality of their social relationships and a higher wellbeing. Data from study participants having accomplished additional training programs with the same training provider will be used to evaluate the influence on the results compared to participants without the extra addition for this study.
The training participants will be assessed together with the controls. All study participants will be evaluated with standardized online questionnaires.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Human beings perceive stress differently and several bio-psycho-social factors, as well as personal and environmental factors influence how persons can manage and cope with stress. Concepts, such as resilience, facilitate positive attitudes towards self-management of stressful life situations. Phylogenetically, (positive) stress produced/s adequate reactions of humans in difficult or dangerous situations, like to fight or run away in the time when human beings were predominantly hunter-gatherers. However, persistent stress, as well as the inability to sufficiently cope with stress have several negative consequences for the physical and mental health of humans. Negative stress is a major contributor to chronic diseases, like cardiovascular diseases, cancer, respiratory disorders, mental diseases including depression, but also the occurrence of accidental injuries. Insufficient coping can result in a harmful health behaviour at first and in the long term to a higher overall morbidity and mortality. This means not only a personal, emotional and physical burden but also a financial burden for the society as a whole, as well as the health system of a country.
On the other hand, satisfactory social relationships were found to have a stress buffering, positive effect on how people deal with stress and are beneficial for one's own health over the course of life. Satisfactory social relationships might even lead to longevity.
The following research questions will be addressed in this study:
- What effect has a 1-year training program for social- and personal resources A) on the outcome parameters perceived stress level, health behavior, presence of common somatic symptoms, satisfaction with life, quality of social relationships, wellbeing compared to a control group? B) on the perception of the trainings aims life goals, meaning in life, sense of coherence, social- and personal resources and transcendence of the participants compared to a control group? C) and how do sociodemographic characteristics influence these effects?
- If changes occur A) what effect has the time passed since finishing the training on the outcome parameters and training aims in participants? B) what effect has the time passed since finishing the training on the outcome parameters and aims in participants compared to the control group?
- How are the perceptions of the training aims (concerning life goals, meaning in life, sense of coherence, social- and personal resources and transcendence) related to perceived stress level, health behaviour, health status, satisfaction with life, quality of social relationships, and wellbeing and how much does each of them contribute?
- What effect has the exposure to this training content (number of trainings and seminars taken) on the outcome parameters and training aims A) in training participants? B) compared to the control group?
- What kind of statistically relevant effects are present for the combination and interaction of the training aims and sociodemographic characteristics on the outcome variables?
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Vienna, Austria
- Medical Universtiy of Vienna
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- male, female, other
- fluently German speaking
- between 18-70 years of age
- given informed consent
Intervention Arm:
- having completed the "Resonanz Practitioner" training
Exclusion Criteria:
- taking too long or too little time to finish the questionnaire (> 3 standard deviations)
- wrong answer on the control question
- where no time stamp available, check for suspicious patterns and drop-out if they are present
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Intervention Group
Study participants having finished the following course in the past will be assigned to the intervention group: During a 6-module course, with four 3-day modules and two 5-day modules in the timeframe of one year, participants learn ways to strengthen their personal resources to establish effective social relationships and to develop skills as a social being.
In between the module courses, the participants take 5 single sessions with an instructed trainer and document 10 conversations/social situations where they successfully applied the new skills.
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The training-method shows how one's own resonance can be exposed in order to live the balance between one's own needs and those of others. Living one's own resonance means: more quality of life, work-life balance, holistic health through living feelings and talents, live equal, respectful and loving relationships, more personal responsibility, authentic decision making find new role models in private and professional areas. The teaching and learning methods of the trainings and seminars are implemented according to the latest state of brain research and enable new perspectives with regard to new learning strategies, goals, enthusiasm and motivation. With the Kutschera-Resonanz® method we teach and learn to consciously use this unconscious reservoir so that completely new dimensions in thinking and acting open up. In this training program the basic tools of communication and interaction according to the Kutschera-Resonanz® method are taught and experienced by the participants.
Other Names:
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Control Group
Individuals without intervention
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Perceived Stress Level
Time Frame: Assessed on Day 1
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"Perceived Stress Scale" score (PSS) difference between Intervention and Control Group, score range 0-40 where a lower score means less perceived stress
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Assessed on Day 1
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Health behavior
Time Frame: Assessed on Day 1
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Difference in "Fragebogen zur Erfassung des Gesundheitsverhaltens" (FEG) scores for health behavior between intervention and control group, score range: sleep: 10-50, physical activity: -20-26, psychosocial burden: 2-46, where higher scores mean more positive behavior
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Assessed on Day 1
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Presence of common somatic symptoms
Time Frame: Assessed on Day 1
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Difference in "Fragebogen zur Erfassung des Gesundheitsverhaltens" (FEG) scores for Presence of common somatic symptoms between intervention and control group, score range: 5-25, where a lower score means less symptoms
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Assessed on Day 1
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Wellbeing
Time Frame: Assessed on Day 1
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Difference in scores for Wellbeing (WHO-5) between intervention and control group, score range: 0-25, with higher scores meaning better wellbeing
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Assessed on Day 1
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Quality of Relationships
Time Frame: Assessed on Day 1
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Difference in scores for Quality of Relationships - Evaluation of Social Systems Scale (EVOS) and Experience in Social Systems Scale (EXIS) between intervention and control group, EVOS score range: 0-3, EXIS score range: 1-6, with higher scores meaning better Quality of Relationships
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Assessed on Day 1
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Satisfaction with Life
Time Frame: Assessed on Day 1
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Difference in Life Satisfaction Scale (LS-4) scores between intervention and control group, score range: 4-20 with higher scores meaning better satisfaction with life
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Assessed on Day 1
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christoph Janka, DI, Medical Universtiy of Vienna
Publications and helpful links
General Publications
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Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EK1592/2019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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