How to Optimally Train Emotional and Social Skills

NCT05945992 | Unknown DMC

• 1 other identifier: TESKx16
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Mental Health

Keywords

Social-emotional learning; Psychological well-being; Subjective well-being; Prevention; Factorial trial

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (3)

• 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)

• Change in subjective 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)

  baseline (pre), 7-8 weeks (intermediate), 14 weeks (post), 6 months (first follow-up), 9 months (second follow-up)

Study Arms (16)

Condition 1: emotions, self, mindfulness, resources

EXPERIMENTAL

(1) emotion regulation, (2) self-acceptance, (3) mindfulness, (4) resource activation

Behavioral: Emotion regulation; Behavioral: Self-acceptance; Behavioral: Mindfulness; Behavioral: Resource activation

Condition 2: emotions, self, mindfulness, conflict resolution

EXPERIMENTAL

(1) emotion regulation, (2) self-acceptance, (3) mindfulness, (4) constructive conflict resolution

Behavioral: Emotion regulation; Behavioral: Self-acceptance; Behavioral: Mindfulness; Behavioral: Control component 4_constructive conflict resolution

Condition 3: emotions, self, stress, resources

EXPERIMENTAL

(1) emotion regulation, (2) self-acceptance, (3) stress management, (4) resource activation

Behavioral: Emotion regulation; Behavioral: Self-acceptance; Behavioral: Resource activation; Behavioral: Control component 3_stress management

Condition 4: emotions, self, stress, conflict resolution

EXPERIMENTAL

(1) emotion regulation, (2) self-acceptance, (3) stress management, (4) constructive conflict resolution

Behavioral: Emotion regulation; Behavioral: Self-acceptance; Behavioral: Control component 3_stress management; Behavioral: Control component 4_constructive conflict resolution

Condition 5: emotions, communication, mindfulness, resources

EXPERIMENTAL

(1) emotion regulation, (2) communication skills, (3) mindfulness, (4) resource activation

Behavioral: Emotion regulation; Behavioral: Mindfulness; Behavioral: Resource activation; Behavioral: Control component 2_communication skills

Condition 6: emotions, communication, mindfulness, conflict resolution

EXPERIMENTAL

(1) emotion regulation, (2) communication skills, (3) mindfulness, (4) constructive conflict resolution

Behavioral: Emotion regulation; Behavioral: Mindfulness; Behavioral: Control component 2_communication skills; Behavioral: Control component 4_constructive conflict resolution

Condition 7: emotions, communication, stress, resources

EXPERIMENTAL

(1) emotion regulation, (2) communication skills, (3) stress management, (4) resource activation

Behavioral: Emotion regulation; Behavioral: Resource activation; Behavioral: Control component 2_communication skills; Behavioral: Control component 3_stress management

Condition 8: emotions, communication, stress, conflict resolution

EXPERIMENTAL

(1) emotion regulation, (2) communication skills, (3) stress management, (4) constructive conflict resolution

Behavioral: Emotion regulation; Behavioral: Control component 2_communication skills; Behavioral: Control component 3_stress management; Behavioral: Control component 4_constructive conflict resolution

Condition 9: group dynamics, self, mindfulness, resources

EXPERIMENTAL

(1) social behavior in groups, (2), self-acceptance, (3) mindfulness, (4) resource activation

Behavioral: Self-acceptance; Behavioral: Mindfulness; Behavioral: Resource activation; Behavioral: Control component 1_social behaviors in groups

Condition 10: group dynamics, self, mindfulness, conflict resolution

EXPERIMENTAL

(1) social behavior in groups, (2) self-acceptance, (3) mindfulness, (4) constructive conflict resolution

Behavioral: Self-acceptance; Behavioral: Mindfulness; Behavioral: Control component 1_social behaviors in groups; Behavioral: Control component 4_constructive conflict resolution

Condition 11: group dynamics, self, stress, resources

EXPERIMENTAL

(1) social behavior in groups, (2) self-acceptance, (3) stress management, (4) resource activation

Behavioral: Self-acceptance; Behavioral: Resource activation; Behavioral: Control component 1_social behaviors in groups; Behavioral: Control component 3_stress management

Condition 12: group dynamics, self, stress, conflict resolution

EXPERIMENTAL

(1) social behavior in groups, (2) self-acceptance, (3) stress management, (4) constructive conflict resolution

Behavioral: Self-acceptance; Behavioral: Control component 1_social behaviors in groups; Behavioral: Control component 3_stress management; Behavioral: Control component 4_constructive conflict resolution

Condition 13: group dynamics, communication, mindfulness, resources

EXPERIMENTAL

(1) social behavior in groups, (2) communication skills, (3) mindfulness, (4) resource activation

Behavioral: Mindfulness; Behavioral: Resource activation; Behavioral: Control component 1_social behaviors in groups; Behavioral: Control component 2_communication skills

Condition 14: group dynamics, communication, mindfulness, conflict resolution

EXPERIMENTAL

(1) social behavior in groups, (2) communication skills, (3) mindfulness, (4) constructive conflict resolution

Behavioral: Mindfulness; Behavioral: Control component 1_social behaviors in groups; Behavioral: Control component 2_communication skills; Behavioral: Control component 4_constructive conflict resolution

Condition 15: group dynamics, communication, stress, resources

EXPERIMENTAL

(1) social behavior in groups, (2) communication skills, (3) stress management, (4) resource activation

Behavioral: Resource activation; Behavioral: Control component 1_social behaviors in groups; Behavioral: Control component 2_communication skills; Behavioral: Control component 3_stress management

Condition 16: group dynamics, communication, stress, conflict resolution

ACTIVE COMPARATOR

(1) social behavior in groups, (2) communication skills, (3) stress management, (4) constructive conflict resolution

Behavioral: Control component 1_social behaviors in groups; Behavioral: Control component 2_communication skills; Behavioral: Control component 3_stress management; Behavioral: Control component 4_constructive conflict resolution

Interventions

Emotion regulation BEHAVIORAL

Psycho-education elements concerning the emergence and functions of emotions, progressive muscle relaxation (PMR), analysis of emotional situations and group exercises

Condition 1: emotions, self, mindfulness, resources; Condition 2: emotions, self, mindfulness, conflict resolution; Condition 3: emotions, self, stress, resources; Condition 4: emotions, self, stress, conflict resolution; Condition 5: emotions, communication, mindfulness, resources; Condition 6: emotions, communication, mindfulness, conflict resolution; Condition 7: emotions, communication, stress, resources; Condition 8: emotions, communication, stress, conflict resolution

Self-acceptance BEHAVIORAL

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.

Condition 10: group dynamics, self, mindfulness, conflict resolution; Condition 11: group dynamics, self, stress, resources; Condition 12: group dynamics, self, stress, conflict resolution; Condition 1: emotions, self, mindfulness, resources; Condition 2: emotions, self, mindfulness, conflict resolution; Condition 3: emotions, self, stress, resources; Condition 4: emotions, self, stress, conflict resolution; Condition 9: group dynamics, self, mindfulness, resources

Mindfulness BEHAVIORAL

Guided mindfulness-exercises, different meditation techniques like body scan, breathing meditation. Reflection and exchange within the group

Condition 10: group dynamics, self, mindfulness, conflict resolution; Condition 13: group dynamics, communication, mindfulness, resources; Condition 14: group dynamics, communication, mindfulness, conflict resolution; Condition 1: emotions, self, mindfulness, resources; Condition 2: emotions, self, mindfulness, conflict resolution; Condition 5: emotions, communication, mindfulness, resources; Condition 6: emotions, communication, mindfulness, conflict resolution; Condition 9: group dynamics, self, mindfulness, resources

Resource activation BEHAVIORAL

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.

Condition 11: group dynamics, self, stress, resources; Condition 13: group dynamics, communication, mindfulness, resources; Condition 15: group dynamics, communication, stress, resources; Condition 1: emotions, self, mindfulness, resources; Condition 3: emotions, self, stress, resources; Condition 5: emotions, communication, mindfulness, resources; Condition 7: emotions, communication, stress, resources; Condition 9: group dynamics, self, mindfulness, resources

Control component 1_social behaviors in groups BEHAVIORAL

Control component for emotion regulation

Condition 10: group dynamics, self, mindfulness, conflict resolution; Condition 11: group dynamics, self, stress, resources; Condition 12: group dynamics, self, stress, conflict resolution; Condition 13: group dynamics, communication, mindfulness, resources; Condition 14: group dynamics, communication, mindfulness, conflict resolution; Condition 15: group dynamics, communication, stress, resources; Condition 16: group dynamics, communication, stress, conflict resolution; Condition 9: group dynamics, self, mindfulness, resources

Control component 2_communication skills BEHAVIORAL

Control component for self-acceptance

Condition 13: group dynamics, communication, mindfulness, resources; Condition 14: group dynamics, communication, mindfulness, conflict resolution; Condition 15: group dynamics, communication, stress, resources; Condition 16: group dynamics, communication, stress, conflict resolution; Condition 5: emotions, communication, mindfulness, resources; Condition 6: emotions, communication, mindfulness, conflict resolution; Condition 7: emotions, communication, stress, resources; Condition 8: emotions, communication, stress, conflict resolution

Control component 3_stress management BEHAVIORAL

Control component for mindfulness

Condition 11: group dynamics, self, stress, resources; Condition 12: group dynamics, self, stress, conflict resolution; Condition 15: group dynamics, communication, stress, resources; Condition 16: group dynamics, communication, stress, conflict resolution; Condition 3: emotions, self, stress, resources; Condition 4: emotions, self, stress, conflict resolution; Condition 7: emotions, communication, stress, resources; Condition 8: emotions, communication, stress, conflict resolution

Control component 4_constructive conflict resolution BEHAVIORAL

Control component for resource activation

Condition 10: group dynamics, self, mindfulness, conflict resolution; Condition 12: group dynamics, self, stress, conflict resolution; Condition 14: group dynamics, communication, mindfulness, conflict resolution; Condition 16: group dynamics, communication, stress, conflict resolution; Condition 2: emotions, self, mindfulness, conflict resolution; Condition 4: emotions, self, stress, conflict resolution; Condition 6: emotions, communication, mindfulness, conflict resolution; Condition 8: emotions, communication, stress, conflict resolution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Johannes Gutenberg University Mainz: lead

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Mindfulness; Population Groups

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Demography; Population Characteristics

Study Officials

• Klaus Wälde, Prof. Dr.

  Chair in Macroeconomics, JGU Johannes Gutenberg Universität Mainz

  STUDY CHAIR

Central Study Contacts

Sarah Franziska Tran-Huu, Dr.

CONTACT

+49 6131 3929082; stranhuu@uni-mainz.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 25, 2023
• First Posted: July 14, 2023
• Study Start: July 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: July 14, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: as soon as results are available (expected fall 2024)
• Access Criteria: on web page once paper is published