How to Optimally Train Emotional and Social Skills

Not Applicable

Not yet recruiting

• Conditions: Mental Health

• Registration Number: NCT05945992
• Lead Sponsor: Johannes Gutenberg University Mainz

Brief 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.

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 Timeline

• Study First Submitted: 2023-06-25
• Status Verified: 2023-07
• Study Start: 2023-07
• Study First Submitted QC: 2023-07-06
• Last Update Submitted: 2023-07-06
• Study First Posted: 2023-07-14
• Last Update Posted: 2023-07-14
• Primary Completion: 2024-07
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 240

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Change in psychological well-being, measured by the Psychological Wellbeing Scale (German version)	baseline (pre), 7-8 weeks (intermediate), 14 weeks (post), 6 months (first follow-up), 9 months (second follow-up)	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.
Change in emotional regulation, measured by self-appraisal of emotional skills	baseline (pre), 7-8 weeks (intermediate), 14 weeks (post), 6 months (first follow-up), 9 months (second follow-up)	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.
Change in self-efficacy, measured by scale on general self-efficacy	baseline (pre), 7-8 weeks (intermediate), 14 weeks (post), 6 months (first follow-up), 9 months (second follow-up)	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.
Change in mindfulness, measured by the Mindfulness Attention and Awareness Scale (German Version)	baseline (pre), 7-8 weeks (intermediate), 14 weeks (post), 6 months (first follow-up), 9 months (second follow-up)	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.
Change in self-compassion, measured by the Self-Compassion Scale (German version)	baseline (pre), 7-8 weeks (intermediate), 14 weeks (post), 6 months (first follow-up), 9 months (second follow-up)	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.
Change in perceived stress, measured by the Perceived Stress Scale (German version)	baseline (pre), 7-8 weeks (intermediate), 14 weeks (post), 6 months (first follow-up), 9 months (second follow-up)	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.
Change in flourishing, measured by Flourishing Scale (German version)	baseline (pre), 7-8 weeks (intermediate), 14 weeks (post), 6 months (first follow-up), 9 months (second follow-up)	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.

Secondary Outcome Measures

Name	Time	Method
Change in mental health, measured by the Patient Health Questionnaire (German version, by Löwe, Zipfel & Herzog, 2002)	baseline (pre), 7-8 weeks (intermediate), 14 weeks (post), 6 months (first follow-up), 9 months (second follow-up)	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")
Change in subjective well-being, measured by the Positive and Negative Affective Schedule (PANAS)	baseline (pre), 7-8 weeks (intermediate), 14 weeks (post), 6 months (first follow-up), 9 months (second follow-up)	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.
Change in subjective life-satisfaction	baseline (pre), 7-8 weeks (intermediate), 14 weeks (post), 6 months (first follow-up), 9 months (second follow-up)	5 items on one-dimensional scale (Schumacher 2003); Scores range from 1 ("not at all") to 7 ("extremely"); higher scores reflect higher life satisfaction.