How to Optimally Train Emotional and Social Skills

Mental Health Clinical Trial

Official title:

How to Optimally Train Emotional and Social Skills

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05945992
• Other study ID #: TESKx16
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2023
• Est. completion date: July 2024

Study information

• Verified date: July 2023
• Source: Johannes Gutenberg University Mainz
• Contact: Sarah Franziska Tran-Huu, Dr.
• Phone: +49 6131 3929082
• Email: stranhuu[@]uni-mainz.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: July 2024
• Est. primary completion date: July 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

• Student at a German university or trainee in vocational training

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Mental Health

Intervention

Behavioral:
• Emotion regulation
Psycho-education elements concerning the emergence and functions of emotions, progressive muscle relaxation (PMR), analysis of emotional situations and group exercises
• 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.
• Mindfulness
Guided mindfulness-exercises, different meditation techniques like body scan, breathing meditation. Reflection and exchange within the group
• 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.
• Control component 1_social behaviors in groups
Control component for emotion regulation
• Control component 2_communication skills
Control component for self-acceptance
• Control component 3_stress management
Control component for mindfulness
• Control component 4_constructive conflict resolution
Control component for resource activation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johannes Gutenberg University Mainz

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)

External Links

•   Further description of the research project.