Mental HealthNCT05945992
How to Optimally Train Emotional and Social Skills
A study testing Emotion regulation, Self-acceptance and Mindfulness in people with Mental Health, run by Johannes Gutenberg University Mainz.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health
- What is being tested?
- Emotion regulation, Self-acceptance and Mindfulness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- Jul 2023to Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Fluent in German language
- Student at a German university or trainee in vocational training
Who cannot join
- Acute mental health crisis (e.g., suicidality)
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Mental Health
- Being tested
- Emotion regulation, Self-acceptance, Mindfulness, Resource activation, Control component 1_social behaviors in groups
- Keywords
- Social-emotional learning, Psychological well-being, Subjective well-being, Prevention, Factorial trial
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotion regulationBehavioural
Psycho-education elements concerning the emergence and functions of emotions, progressive muscle relaxation (PMR), analysis of emotional situations and group exercises
Self-acceptanceBehavioural
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.
MindfulnessBehavioural
Guided mindfulness-exercises, different meditation techniques like body scan, breathing meditation. Reflection and exchange within the group
Resource activationBehavioural
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 groupsBehavioural
Control component for emotion regulation
Control component 2_communication skillsBehavioural
Control component for self-acceptance
Control component 3_stress managementBehavioural
Control component for mindfulness
Control component 4_constructive conflict resolutionBehavioural
Control component for resource activation
| Study group | Role | What they receive |
|---|---|---|
| Condition 1: emotions, self, mindfulness, resources | Experimental | (1) emotion regulation, (2) self-acceptance, (3) mindfulness, (4) resource activation Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
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.
Measured: 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.
Measured: 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")
Measured: baseline (pre), 7-8 weeks (intermediate), 14 weeks (post), 6 months (first follow-up), 9 months (second follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study startJul 2023 (estimated)
- Primary completionJul 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Sarah Tran-Huu, Johannes Gutenberg University Mainz
- Investigators
- Klaus Wälde, Prof. Dr., Study chair, Chair in Macroeconomics, JGU Johannes Gutenberg Universität Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05945992
- Sponsor's protocol ID
- TESKx16
- Status last verified
- Jul 2023
- First submitted
- 25 Jun 2023
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized answers to questionnaires (all data)
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How to Optimally Train Emotional and Social Skills
- ClinicalTrials.gov ID
- NCT05945992
- Acronym / sponsor ID
- TESKx16
- Conditions
- Mental Health
- Keywords
- Social-emotional learning, Psychological well-being, Subjective well-being, Prevention, Factorial trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- Jul 2023 (estimated)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 14 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 16
- 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.
| Arm | Type | Receives |
|---|---|---|
| Condition 1: emotions, self, mindfulness, resources | Experimental | Behavioral: Emotion regulation, Behavioral: Self-acceptance, Behavioral: Mindfulness, Behavioral: Resource activation(1) emotion regulation, (2) self-acceptance, (3) mindfulness, (4) resource activation |
| Condition 2: emotions, self, mindfulness, conflict resolution | Experimental | Behavioral: Emotion regulation, Behavioral: Self-acceptance, Behavioral: Mindfulness, Behavioral: Control component 4_constructive conflict resolution(1) emotion regulation, (2) self-acceptance, (3) mindfulness, (4) constructive conflict resolution |
| Condition 3: emotions, self, stress, resources | Experimental | Behavioral: Emotion regulation, Behavioral: Self-acceptance, Behavioral: Resource activation, Behavioral: Control component 3_stress management(1) emotion regulation, (2) self-acceptance, (3) stress management, (4) resource activation |
| Condition 4: emotions, self, stress, conflict resolution | Experimental | Behavioral: Emotion regulation, Behavioral: Self-acceptance, Behavioral: Control component 3_stress management, Behavioral: Control component 4_constructive conflict resolution(1) emotion regulation, (2) self-acceptance, (3) stress management, (4) constructive conflict resolution |
| Condition 5: emotions, communication, mindfulness, resources | Experimental | Behavioral: Emotion regulation, Behavioral: Mindfulness, Behavioral: Resource activation, Behavioral: Control component 2_communication skills(1) emotion regulation, (2) communication skills, (3) mindfulness, (4) resource activation |
| Condition 6: emotions, communication, mindfulness, conflict resolution | Experimental | Behavioral: Emotion regulation, Behavioral: Mindfulness, Behavioral: Control component 2_communication skills, Behavioral: Control component 4_constructive conflict resolution(1) emotion regulation, (2) communication skills, (3) mindfulness, (4) constructive conflict resolution |
| Condition 7: emotions, communication, stress, resources | Experimental | Behavioral: Emotion regulation, Behavioral: Resource activation, Behavioral: Control component 2_communication skills, Behavioral: Control component 3_stress management(1) emotion regulation, (2) communication skills, (3) stress management, (4) resource activation |
| Condition 8: emotions, communication, stress, conflict resolution | Experimental | Behavioral: Emotion regulation, Behavioral: Control component 2_communication skills, Behavioral: Control component 3_stress management, Behavioral: Control component 4_constructive conflict resolution(1) emotion regulation, (2) communication skills, (3) stress management, (4) constructive conflict resolution |
| Condition 9: group dynamics, self, mindfulness, resources | Experimental | Behavioral: Self-acceptance, Behavioral: Mindfulness, Behavioral: Resource activation, Behavioral: Control component 1_social behaviors in groups(1) social behavior in groups, (2), self-acceptance, (3) mindfulness, (4) resource activation |
| Condition 10: group dynamics, self, mindfulness, conflict resolution | Experimental | Behavioral: Self-acceptance, Behavioral: Mindfulness, Behavioral: Control component 1_social behaviors in groups, Behavioral: Control component 4_constructive conflict resolution(1) social behavior in groups, (2) self-acceptance, (3) mindfulness, (4) constructive conflict resolution |
| Condition 11: group dynamics, self, stress, resources | Experimental | Behavioral: Self-acceptance, Behavioral: Resource activation, Behavioral: Control component 1_social behaviors in groups, Behavioral: Control component 3_stress management(1) social behavior in groups, (2) self-acceptance, (3) stress management, (4) resource activation |
| Condition 12: group dynamics, self, stress, conflict resolution | Experimental | Behavioral: Self-acceptance, Behavioral: Control component 1_social behaviors in groups, Behavioral: Control component 3_stress management, Behavioral: Control component 4_constructive conflict resolution(1) social behavior in groups, (2) self-acceptance, (3) stress management, (4) constructive conflict resolution |
| Condition 13: group dynamics, communication, mindfulness, resources | Experimental | Behavioral: Mindfulness, Behavioral: Resource activation, Behavioral: Control component 1_social behaviors in groups, Behavioral: Control component 2_communication skills(1) social behavior in groups, (2) communication skills, (3) mindfulness, (4) resource activation |
| Condition 14: group dynamics, communication, mindfulness, conflict resolution | Experimental | Behavioral: Mindfulness, Behavioral: Control component 1_social behaviors in groups, Behavioral: Control component 2_communication skills, Behavioral: Control component 4_constructive conflict resolution(1) social behavior in groups, (2) communication skills, (3) mindfulness, (4) constructive conflict resolution |
| Condition 15: group dynamics, communication, stress, resources | Experimental | Behavioral: Resource activation, Behavioral: Control component 1_social behaviors in groups, Behavioral: Control component 2_communication skills, Behavioral: Control component 3_stress management(1) social behavior in groups, (2) communication skills, (3) stress management, (4) resource activation |
| Condition 16: group dynamics, communication, stress, conflict resolution | Active comparator | 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(1) social behavior in groups, (2) communication skills, (3) stress management, (4) constructive conflict resolution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or older
- Fluent in German language
- Student at a German university or trainee in vocational training
Key exclusion criteria (1 listed)
- Acute mental health crisis (e.g., suicidality)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emotion regulationPsycho-education elements concerning the emergence and functions of emotions, progressive muscle relaxation (PMR), analysis of emotional situations and group exercises | Behavioural | 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-acceptanceExercises 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. | Behavioural | 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 |
| MindfulnessGuided mindfulness-exercises, different meditation techniques like body scan, breathing meditation. Reflection and exchange within the group | Behavioural | 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 activationExercises 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. | Behavioural | 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 groupsControl component for emotion regulation | Behavioural | 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 skillsControl component for self-acceptance | Behavioural | 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 managementControl component for mindfulness | Behavioural | 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 resolutionControl component for resource activation | Behavioural | 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 |
Primary outcome
Change in emotional regulation, measured by self-appraisal of emotional skills
Time frame: 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
Time frame: 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 psychological well-being, measured by the Psychological Wellbeing Scale (German version)
Time frame: 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 mindfulness, measured by the Mindfulness Attention and Awareness Scale (German Version)
Time frame: 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 flourishing, measured by Flourishing Scale (German version)
Time frame: 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.
Change in self-compassion, measured by the Self-Compassion Scale (German version)
Time frame: 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)
Time frame: 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.
3 secondary outcomes
Change in subjective well-being, measured by the Positive and Negative Affective Schedule (PANAS)
Time frame: baseline (pre), 7-8 weeks (intermediate), 14 weeks (post), 6 months (first follow-up), 9 months (second follow-up)
Change in subjective life-satisfaction
Time frame: 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)
Time frame: baseline (pre), 7-8 weeks (intermediate), 14 weeks (post), 6 months (first follow-up), 9 months (second follow-up)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
- Individual participant dataSharing planned: Yes. Anonymized answers to questionnaires (all data)
Related trials for Mental Health
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klaus Wälde, Prof. Dr. study chair
Chair in Macroeconomics, JGU Johannes Gutenberg Universität Mainz
Questions about this trial
What is this clinical trial studying?
A study testing Emotion regulation, Self-acceptance and Mindfulness in people with Mental Health, run by Johannes Gutenberg University Mainz.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarah Franziska Tran-Huu, Dr. (+49 6131 3929082, stranhuu@uni-mainz.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in emotional regulation, measured by self-appraisal of emotional skills (time frame: baseline (pre), 7-8 weeks (intermediate), 14 weeks (post), 6 months (first follow-up), 9 months (second follow-up)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2023.