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临床试验/NCT05945992
NCT05945992尚未招募不适用

How to Optimally Train Emotional and Social Skills

Johannes Gutenberg University Mainz0 个研究点目标入组 240 人开始时间: 2023年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
240
主要终点
Change in psychological well-being, measured by the Psychological Wellbeing Scale (German version)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Change in psychological well-being, measured by the Psychological Wellbeing Scale (German version)

时间窗: 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

时间窗: 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

时间窗: 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)

时间窗: 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)

时间窗: 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)

时间窗: 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)

时间窗: 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.

次要结局

  • 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))
  • 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))

研究者

发起方
Johannes Gutenberg University Mainz
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Sarah Tran-Huu

Principal Investigator

Johannes Gutenberg University Mainz

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