Clinical trial NCT05945992: How to Optimally Train Emotional and Social Skills
Official title: How to Optimally Train Emotional and Social Skills
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mental Health
Keywords: Social-emotional learning
Psychological well-being
Subjective well-being
Prevention
Factorial trial
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2023-07-14
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Every intervention of each arm will have four components, in varying combination. For each intervention component (mindfulness, self-acceptance, resource activation, emotion regulation) there will exist a control component, when this specific component is not included in the arm.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in emotional regulation, measured by self-appraisal of emotional skills
timeFrame: baseline (pre), 7-8 weeks (intermediate), 14 weeks (post), 6 months (first follow-up), 9 months (second follow-up)
measure: Change in self-efficacy, measured by scale on general self-efficacy
timeFrame: baseline (pre), 7-8 weeks (intermediate), 14 weeks (post), 6 months (first follow-up), 9 months (second follow-up)
measure: Change in psychological well-being, measured by the Psychological Wellbeing Scale (German version)
timeFrame: baseline (pre), 7-8 weeks (intermediate), 14 weeks (post), 6 months (first follow-up), 9 months (second follow-up)
measure: Change in mindfulness, measured by the Mindfulness Attention and Awareness Scale (German Version)
timeFrame: baseline (pre), 7-8 weeks (intermediate), 14 weeks (post), 6 months (first follow-up), 9 months (second follow-up)
measure: Change in flourishing, measured by Flourishing Scale (German version)
timeFrame: baseline (pre), 7-8 weeks (intermediate), 14 weeks (post), 6 months (first follow-up), 9 months (second follow-up)
measure: Change in self-compassion, measured by the Self-Compassion Scale (German version)
timeFrame: baseline (pre), 7-8 weeks (intermediate), 14 weeks (post), 6 months (first follow-up), 9 months (second follow-up)
measure: Change in perceived stress, measured by the Perceived Stress Scale (German version)
timeFrame: baseline (pre), 7-8 weeks (intermediate), 14 weeks (post), 6 months (first follow-up), 9 months (second follow-up)
Secondary outcomes:
measure: Change in subjective well-being, measured by the Positive and Negative Affective Schedule (PANAS)
timeFrame: baseline (pre), 7-8 weeks (intermediate), 14 weeks (post), 6 months (first follow-up), 9 months (second follow-up)
measure: Change in subjective life-satisfaction
timeFrame: baseline (pre), 7-8 weeks (intermediate), 14 weeks (post), 6 months (first follow-up), 9 months (second follow-up)
measure: Change in mental health, measured by the Patient Health Questionnaire (German version, by Löwe, Zipfel & Herzog, 2002)
timeFrame: baseline (pre), 7-8 weeks (intermediate), 14 weeks (post), 6 months (first follow-up), 9 months (second follow-up)
Other outcomes:
Locations:
Study officials:
affiliation: Chair in Macroeconomics, JGU Johannes Gutenberg Universität Mainz
name: Klaus Wälde, Prof. Dr.
role: STUDY_CHAIR
References: