How to Optimally Train Emotional and Social Skills

The goal of this clinical trial is to compare different well-being intervention components in healthy individuals. The main question it aims to answer is how an optimal emotional and social learning program should be composed. Participants will participate in one of 16 courses over 14-weeks which will have a varying combination of four components:

• emotion regulation,
• mindfulness,
• self-acceptance and
• resource activation.

For each of these components there will be a control component. Further, there will be a waitlist-control-group included.

Study Overview

• Status: Not yet recruiting
• Conditions: Mental Health
• Intervention / Treatment: Behavioral: Emotion regulation; Behavioral: Self-acceptance; Behavioral: Mindfulness; Behavioral: Resource activation; Behavioral: Control component 4_constructive conflict resolution; Behavioral: Control component 3_stress management; Behavioral: Control component 2_communication skills; Behavioral: Control component 1_social behaviors in groups

Detailed Description

Background: Social-emotional skills are of great importance for academic and professional success and are a huge protective factor of mental health.

Objectives: The aim of the study therefore is to examine the optimal combination of different well-being intervention components to foster mental health and subjective well-being in a student and trainee population. The investigators draw on current concepts like mindfulness which already proved to be empirically effective and try to compare their effectiveness and understand how they work together, whether they strengthen or complement each other.

Methods: In a factorial design trial with 16 different intervention conditions, up to 240 students or trainees will participate in a 14-week well-being-intervention. This intervention with a maximum of 15 participants per course consists of weekly 1,5h sessions plus 3 full-day appointments using psycho-educational elements, practical exercises and group discussion on various topics. Participants will complete online surveys on subjective and psychological well-being, mental health, and several resilience factors pre-, during and post-intervention as well as 5 months after completion as follow-up assessments.

Implications: The study will contribute to an evidence-based and easily accessible and scalable well-being intervention, supporting health promotion and stress prevention in the general population.

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sarah Franziska Tran-Huu, Dr.; Phone Number: +49 6131 3929082; Email: stranhuu@uni-mainz.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age 18 years or older
• Fluent in German language
• Student at a German university or trainee in vocational training

Exclusion Criteria:

• Acute mental health crisis (e.g., suicidality)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

16

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Condition 1: emotions, self, mindfulness, resources; (1) emotion regulation, (2) self-acceptance, (3) mindfulness, (4) resource activation	Behavioral: Emotion regulation; Psycho-education elements concerning the emergence and functions of emotions, progressive muscle relaxation (PMR), analysis of emotional situations and group exercises; Behavioral: Self-acceptance; Exercises and guided self-experience targeting heightened knowledge about oneself and acceptance of all personal strengths and weaknesses, exercises based on the internal family systems by R. Schwartz.; Behavioral: Mindfulness; Guided mindfulness-exercises, different meditation techniques like body scan, breathing meditation. Reflection and exchange within the group; Behavioral: Resource activation; Exercises focusing on developing positive emotions and fostering personal strengths, based on the Positive Psychology movement of Martin Seligman, working on individual values, life goals and sense of life.
Experimental: Condition 2: emotions, self, mindfulness, conflict resolution; (1) emotion regulation, (2) self-acceptance, (3) mindfulness, (4) constructive conflict resolution	Behavioral: Emotion regulation; Psycho-education elements concerning the emergence and functions of emotions, progressive muscle relaxation (PMR), analysis of emotional situations and group exercises; Behavioral: Self-acceptance; Exercises and guided self-experience targeting heightened knowledge about oneself and acceptance of all personal strengths and weaknesses, exercises based on the internal family systems by R. Schwartz.; Behavioral: Mindfulness; Guided mindfulness-exercises, different meditation techniques like body scan, breathing meditation. Reflection and exchange within the group; Behavioral: Control component 4_constructive conflict resolution; Control component for resource activation
Experimental: Condition 3: emotions, self, stress, resources; (1) emotion regulation, (2) self-acceptance, (3) stress management, (4) resource activation	Behavioral: Emotion regulation; Psycho-education elements concerning the emergence and functions of emotions, progressive muscle relaxation (PMR), analysis of emotional situations and group exercises; Behavioral: Self-acceptance; Exercises and guided self-experience targeting heightened knowledge about oneself and acceptance of all personal strengths and weaknesses, exercises based on the internal family systems by R. Schwartz.; Behavioral: Resource activation; Exercises focusing on developing positive emotions and fostering personal strengths, based on the Positive Psychology movement of Martin Seligman, working on individual values, life goals and sense of life.; Behavioral: Control component 3_stress management; Control component for mindfulness
Experimental: Condition 4: emotions, self, stress, conflict resolution; (1) emotion regulation, (2) self-acceptance, (3) stress management, (4) constructive conflict resolution	Behavioral: Emotion regulation; Psycho-education elements concerning the emergence and functions of emotions, progressive muscle relaxation (PMR), analysis of emotional situations and group exercises; Behavioral: Self-acceptance; Exercises and guided self-experience targeting heightened knowledge about oneself and acceptance of all personal strengths and weaknesses, exercises based on the internal family systems by R. Schwartz.; Behavioral: Control component 4_constructive conflict resolution; Control component for resource activation; Behavioral: Control component 3_stress management; Control component for mindfulness
Experimental: Condition 5: emotions, communication, mindfulness, resources; (1) emotion regulation, (2) communication skills, (3) mindfulness, (4) resource activation	Behavioral: Emotion regulation; Psycho-education elements concerning the emergence and functions of emotions, progressive muscle relaxation (PMR), analysis of emotional situations and group exercises; Behavioral: Mindfulness; Guided mindfulness-exercises, different meditation techniques like body scan, breathing meditation. Reflection and exchange within the group; Behavioral: Resource activation; Exercises focusing on developing positive emotions and fostering personal strengths, based on the Positive Psychology movement of Martin Seligman, working on individual values, life goals and sense of life.; Behavioral: Control component 2_communication skills; Control component for self-acceptance
Experimental: Condition 6: emotions, communication, mindfulness, conflict resolution; (1) emotion regulation, (2) communication skills, (3) mindfulness, (4) constructive conflict resolution	Behavioral: Emotion regulation; Psycho-education elements concerning the emergence and functions of emotions, progressive muscle relaxation (PMR), analysis of emotional situations and group exercises; Behavioral: Mindfulness; Guided mindfulness-exercises, different meditation techniques like body scan, breathing meditation. Reflection and exchange within the group; Behavioral: Control component 4_constructive conflict resolution; Control component for resource activation; Behavioral: Control component 2_communication skills; Control component for self-acceptance
Experimental: Condition 7: emotions, communication, stress, resources; (1) emotion regulation, (2) communication skills, (3) stress management, (4) resource activation	Behavioral: Emotion regulation; Psycho-education elements concerning the emergence and functions of emotions, progressive muscle relaxation (PMR), analysis of emotional situations and group exercises; Behavioral: Resource activation; Exercises focusing on developing positive emotions and fostering personal strengths, based on the Positive Psychology movement of Martin Seligman, working on individual values, life goals and sense of life.; Behavioral: Control component 3_stress management; Control component for mindfulness; Behavioral: Control component 2_communication skills; Control component for self-acceptance
Experimental: Condition 8: emotions, communication, stress, conflict resolution; (1) emotion regulation, (2) communication skills, (3) stress management, (4) constructive conflict resolution	Behavioral: Emotion regulation; Psycho-education elements concerning the emergence and functions of emotions, progressive muscle relaxation (PMR), analysis of emotional situations and group exercises; Behavioral: Control component 4_constructive conflict resolution; Control component for resource activation; Behavioral: Control component 3_stress management; Control component for mindfulness; Behavioral: Control component 2_communication skills; Control component for self-acceptance
Experimental: Condition 9: group dynamics, self, mindfulness, resources; (1) social behavior in groups, (2), self-acceptance, (3) mindfulness, (4) resource activation	Behavioral: Self-acceptance; Exercises and guided self-experience targeting heightened knowledge about oneself and acceptance of all personal strengths and weaknesses, exercises based on the internal family systems by R. Schwartz.; Behavioral: Mindfulness; Guided mindfulness-exercises, different meditation techniques like body scan, breathing meditation. Reflection and exchange within the group; Behavioral: Resource activation; Exercises focusing on developing positive emotions and fostering personal strengths, based on the Positive Psychology movement of Martin Seligman, working on individual values, life goals and sense of life.; Behavioral: Control component 1_social behaviors in groups; Control component for emotion regulation
Experimental: Condition 10: group dynamics, self, mindfulness, conflict resolution; (1) social behavior in groups, (2) self-acceptance, (3) mindfulness, (4) constructive conflict resolution	Behavioral: Self-acceptance; Exercises and guided self-experience targeting heightened knowledge about oneself and acceptance of all personal strengths and weaknesses, exercises based on the internal family systems by R. Schwartz.; Behavioral: Mindfulness; Guided mindfulness-exercises, different meditation techniques like body scan, breathing meditation. Reflection and exchange within the group; Behavioral: Control component 4_constructive conflict resolution; Control component for resource activation; Behavioral: Control component 1_social behaviors in groups; Control component for emotion regulation
Experimental: Condition 11: group dynamics, self, stress, resources; (1) social behavior in groups, (2) self-acceptance, (3) stress management, (4) resource activation	Behavioral: Self-acceptance; Exercises and guided self-experience targeting heightened knowledge about oneself and acceptance of all personal strengths and weaknesses, exercises based on the internal family systems by R. Schwartz.; Behavioral: Resource activation; Exercises focusing on developing positive emotions and fostering personal strengths, based on the Positive Psychology movement of Martin Seligman, working on individual values, life goals and sense of life.; Behavioral: Control component 3_stress management; Control component for mindfulness; Behavioral: Control component 1_social behaviors in groups; Control component for emotion regulation
Experimental: Condition 12: group dynamics, self, stress, conflict resolution; (1) social behavior in groups, (2) self-acceptance, (3) stress management, (4) constructive conflict resolution	Behavioral: Self-acceptance; Exercises and guided self-experience targeting heightened knowledge about oneself and acceptance of all personal strengths and weaknesses, exercises based on the internal family systems by R. Schwartz.; Behavioral: Control component 4_constructive conflict resolution; Control component for resource activation; Behavioral: Control component 3_stress management; Control component for mindfulness; Behavioral: Control component 1_social behaviors in groups; Control component for emotion regulation
Experimental: Condition 13: group dynamics, communication, mindfulness, resources; (1) social behavior in groups, (2) communication skills, (3) mindfulness, (4) resource activation	Behavioral: Mindfulness; Guided mindfulness-exercises, different meditation techniques like body scan, breathing meditation. Reflection and exchange within the group; Behavioral: Resource activation; Exercises focusing on developing positive emotions and fostering personal strengths, based on the Positive Psychology movement of Martin Seligman, working on individual values, life goals and sense of life.; Behavioral: Control component 2_communication skills; Control component for self-acceptance; Behavioral: Control component 1_social behaviors in groups; Control component for emotion regulation
Experimental: Condition 14: group dynamics, communication, mindfulness, conflict resolution; (1) social behavior in groups, (2) communication skills, (3) mindfulness, (4) constructive conflict resolution	Behavioral: Mindfulness; Guided mindfulness-exercises, different meditation techniques like body scan, breathing meditation. Reflection and exchange within the group; Behavioral: Control component 4_constructive conflict resolution; Control component for resource activation; Behavioral: Control component 2_communication skills; Control component for self-acceptance; Behavioral: Control component 1_social behaviors in groups; Control component for emotion regulation
Experimental: Condition 15: group dynamics, communication, stress, resources; (1) social behavior in groups, (2) communication skills, (3) stress management, (4) resource activation	Behavioral: Resource activation; Exercises focusing on developing positive emotions and fostering personal strengths, based on the Positive Psychology movement of Martin Seligman, working on individual values, life goals and sense of life.; Behavioral: Control component 3_stress management; Control component for mindfulness; Behavioral: Control component 2_communication skills; Control component for self-acceptance; Behavioral: Control component 1_social behaviors in groups; Control component for emotion regulation
Active Comparator: Condition 16: group dynamics, communication, stress, conflict resolution; (1) social behavior in groups, (2) communication skills, (3) stress management, (4) constructive conflict resolution	Behavioral: Control component 4_constructive conflict resolution; Control component for resource activation; Behavioral: Control component 3_stress management; Control component for mindfulness; Behavioral: Control component 2_communication skills; Control component for self-acceptance; Behavioral: Control component 1_social behaviors in groups; Control component for emotion regulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in emotional regulation, measured by self-appraisal of emotional skills	27 items in total, 3 items per 9 subscales (attention, body perception, clarity, understanding, regulation, acceptance, resilience, self support, willingness of confrontation) (German instrument: Selbsteinschätzung emotionaler Kompetenzen, SEK-27, Berking & Znoj, 2011) Scores range from 0 ("not at all") to 4 ("(almost) always").; higher scores reflect higher assessment of emotional skill.	baseline (pre), 7-8 weeks (intermediate), 14 weeks (post), 6 months (first follow-up), 9 months (second follow-up)
Change in self-efficacy, measured by scale on general self-efficacy	10 items on one-dimensional scale. (German instrument; Skala zur Allgemeinen Selbstwirksamkeitserwartung, SWE, Jerusalem & Schwarzer, 2003) Scores range from 1 ("strongly disagree") to 4 ("strongly agree"); higher scores reflect higher self-efficacy.	baseline (pre), 7-8 weeks (intermediate), 14 weeks (post), 6 months (first follow-up), 9 months (second follow-up)
Change in psychological well-being, measured by the Psychological Wellbeing Scale (German version)	6 subscales (autonomy, environmental mastery, purpose in life, personal growth, relations with others, self-acceptance) (German Version of the PWB Scale by Ryff et al. 2007; Fragebogen zum Psychologischen Wohlbefinden, Risch, Strohmayer & Stangier, 2005) Scores range from 1 ("strongly disagree") to 6 ("strongly agree"); higher scores reflect better well-being.	baseline (pre), 7-8 weeks (intermediate), 14 weeks (post), 6 months (first follow-up), 9 months (second follow-up)
Change in mindfulness, measured by the Mindfulness Attention and Awareness Scale (German Version)	15 items on one-dimensional scale (Michalak, Heidenreich, Ströhle & Nachtigall, 2011) Scores range from 1 ("almost always") to 6 ("almost never") assessing daily exercises and activities; higher scores reflect lower mindfulness.	baseline (pre), 7-8 weeks (intermediate), 14 weeks (post), 6 months (first follow-up), 9 months (second follow-up)
Change in flourishing, measured by Flourishing Scale (German version)	8 items on one-dimensional scale (Esch et al., 2013) Scores range from 1 ("stongly disagree") to 7 ("strongly agree"); higher scores reflect higher appraisal of flourishing in life.	baseline (pre), 7-8 weeks (intermediate), 14 weeks (post), 6 months (first follow-up), 9 months (second follow-up)
Change in self-compassion, measured by the Self-Compassion Scale (German version)	26 items measuring 6 scales (self-kindness, self-judgment, common humanity, isolation, mindfulness, over-identification) (Hupfeld & Ruffieux, 2011) Scores range from 1 ("very seldom") to 5 ("very often") assessing daily exercises and activities; higher scores reflect higher self-compassion.	baseline (pre), 7-8 weeks (intermediate), 14 weeks (post), 6 months (first follow-up), 9 months (second follow-up)
Change in perceived stress, measured by the Perceived Stress Scale (German version)	10 items; 6 items assessing helplessness, and 4 items assessing self-efficacy. (Schneider et al., 2020) Scores range from 1 ("never") to 5 ("very often") ; higher scores reflect higher perceived stress.	baseline (pre), 7-8 weeks (intermediate), 14 weeks (post), 6 months (first follow-up), 9 months (second follow-up)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in subjective well-being, measured by the Positive and Negative Affective Schedule (PANAS)	The scale consists of a total of 20 items, when 10 items referring to positive affect, 10 items referring to negative affect. Scores range from 1 ("not at all") to 5 ("extremely") assessing the experience of positive or negative emotional states during the past week; higher scores reflect higher experiencing of this emotion.	baseline (pre), 7-8 weeks (intermediate), 14 weeks (post), 6 months (first follow-up), 9 months (second follow-up)
Change in subjective life-satisfaction	5 items on one-dimensional scale (Schumacher 2003) Scores range from 1 ("not at all") to 7 ("extremely"); higher scores reflect higher life satisfaction.	baseline (pre), 7-8 weeks (intermediate), 14 weeks (post), 6 months (first follow-up), 9 months (second follow-up)
Change in mental health, measured by the Patient Health Questionnaire (German version, by Löwe, Zipfel & Herzog, 2002)	The sum of the PHQ-9 is used to assess general mental health. Scales concerning 1. somatic symptoms: assessing body symptoms, scores range from "not impaired" to 3 ("strongly impaired") / 2. depression: 9 items, scores from 0 "not at all" to 3 "almost every das / 3. anxiety: items assessing panic attac or other forms of anxiety, scores "Yes" or "No", respectively assessing general nervousness and anxiety from 1 ("not at all") to 3 ("on more than half days in the week"), higher scores meaning higher symptomatology / 4. eating disorder: items assessing eating difficulties and feelings of uncontrollability, (Yes vs. No"). Yes-answers on all items indicating eating disorder / 5. alcohol misuse: items assessing drinking patterns, scores "yes" vs. "no", when at least 1 item is answered with a "yes", misuse ist assessed / 6. psychosocial functionality: 1 item on the impairment of those symptomes, from 1 ("not at all impaired") to 4 ("very highly impaired")	baseline (pre), 7-8 weeks (intermediate), 14 weeks (post), 6 months (first follow-up), 9 months (second follow-up)

Collaborators and Investigators

• Sponsor: Johannes Gutenberg University Mainz
• Investigators: Study Chair: Klaus Wälde, Prof. Dr., Chair in Macroeconomics, JGU Johannes Gutenberg Universität Mainz

Publications and helpful links

Helpful Links

• Further description of the research project.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: June 25, 2023
• First Submitted That Met QC Criteria: July 6, 2023
• First Posted (Actual): July 14, 2023

Study Record Updates

• Last Update Posted (Actual): July 14, 2023
• Last Update Submitted That Met QC Criteria: July 6, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Prevention; Psychological well-being; Social-emotional learning; Subjective well-being; Factorial trial
• Other Study ID Numbers: TESKx16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized answers to questionnaires (all data)
• IPD Sharing Time Frame: as soon as results are available (expected fall 2024)
• IPD Sharing Access Criteria: on web page once paper is published
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No