A Training Program for Developing Social- and Personal Resources

Health Behavior Clinical Trial

Official title:

A Training Program for Developing Social- and Personal Resources and Its Effects on Emotional, Physical and Social Wellbeing in Adults

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04165473
• Other study ID #: EK1592/2019
• Status: Suspended
• Start date: January 14, 2023
• Est. completion date: June 30, 2023

Study information

• Verified date: January 2023
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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?

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 200
• Est. completion date: June 30, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Family Relations
• Health Behavior
• Medically Unexplained Symptoms
• Program Evaluation
• Psychophysiology
• Satisfaction, Personal
• Somatic Symptom
• Stress, Emotional
• Stress, Psychological

Intervention

Behavioral:
• Training Program for Developing Social- and Personal Resources
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.

Locations

Country	Name	City	State
Austria	Medical Universtiy of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

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Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perceived Stress Level	"Perceived Stress Scale" score (PSS) difference between Intervention and Control Group, score range 0-40 where a lower score means less perceived stress	Assessed on Day 1
Secondary	Health behavior	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	Assessed on Day 1
Secondary	Presence of common somatic symptoms	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	Assessed on Day 1
Secondary	Wellbeing	Difference in scores for Wellbeing (WHO-5) between intervention and control group, score range: 0-25, with higher scores meaning better wellbeing	Assessed on Day 1
Secondary	Quality of Relationships	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	Assessed on Day 1
Secondary	Satisfaction with Life	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	Assessed on Day 1