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Clinical Trial Summary

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.


Clinical Trial 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: 1. 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? 2. 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? 3. 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? 4. 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? 5. 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 Design


Related Conditions & MeSH terms


NCT number NCT04165473
Study type Observational
Source Medical University of Vienna
Contact
Status Suspended
Phase
Start date January 14, 2023
Completion date June 30, 2023

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