跳至主要内容
临床试验/NCT04159272
NCT04159272已完成不适用

OPEN.MIND | Can MINDfulness Help Vulnerable Youngsters to Ride a Challenging Emotional Tandem? OPENing up to Positivity While Simultaneously Accepting Negative Feelings

Prof. dr. Filip Raes11 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2019年11月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
450
试验地点
11
主要终点
Change in Emotional Distress

研究概览

简要总结

The epidemiological data are alarming. Emotional distress, and depression in particular, is highly prevalent in adolescents, it has multiple problematic consequences and, most alarming, it is on the rise. All too often, these symptoms persist and lead to long-term and severe psychiatric problems. Mindfulness training (MT) is expected to counter both the non-acceptance of negative emotions (underlying depressed (sad) mood, anxiety and stress) and the dampening of positive emotions (underlying anhedonia). Vulnerable youngsters typically do not accept their negative emotions (which paradoxically further increases negative emotions) and also dampen positive emotions, as long as there are negative emotions present: a catch-22. MT, as a low-threshold intervention, is expected to 'unlock' this catch-22 by teaching participants to become non-judgmentally aware of thoughts, feelings, and sensations, and increasing their capacity to replace automatic, habitual, and often judgmental reactions with more conscious and skillful responses. That way, MT is hypothesized to reduce depressed (sad) mood, anxiety and stress and to promote protective positive emotions. On top, MT is expected to foster a healthier discourse among youngsters on their emotional lives as an alternative to society's malignant discourse that denounces negative emotions and over-focuses on the pursuit of happiness, which now backfires on vulnerable youngsters.

The aim of the present study is to evaluate the effects of MT in adolescents on their experience of negative emotions (i.e. symptoms of stress, anxiety and depression), suppression/acceptance of negative emotions, symptoms of anhedonia (i.e. lack of pleasurable feelings), dampening of positive emotions, social expectancies towards the (non-)expression and (non-)experience of negative emotions, and on several secondary outcomes or endpoints (e.g., loneliness, repetitive negative thinking, self-compassion). Pairs of two classes will be recruited from schools in Flanders, Belgium, and all adolescents (>14 years of age) of these selected classes will be invited to participate. One class in each pair will be randomly assigned to an 8-week MT during regular school hours supported by a newly developed mindfulness app for adolescents, while the other class (control group) follows the regular school curriculum. Before randomization, post-intervention and 3 months after the intervention, participant's current experience of negative emotions, their level of suppression/acceptance of negative emotions, dampening, and anhedonia will be assessed using experience sampling methods and self-report questionnaires.

The investigators hypothesize that mindfulness can help youngsters in their school context to become more accepting of their emotions and, that this 'opening up' not only leads to less distress and anhedonia, but also to less toxic social pressure amongst peers in school not to feel and not to talk about negative emotions. That way, mindfulness can help foster a social climate that promotes a more balanced embracement of emotions which is likely beneficial for young people's well-being.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • The study is open to all adolescents (>14yrs) of participating school classes.
  • They should understand and speak Dutch.
  • Written informed consent (including informed consent from a parent for those <18yrs) after been informed on all aspects of the study.

排除标准

  • Not applicable

研究组 & 干预措施

Mindfulness Training

Experimental

The MT programme adheres to a standardized protocol developed from MBSR (Kabat-Zinn, 1990) and MBCT (Segal et al., 2012) manuals and is adjusted to an adolescent population. Adjustments are based on our ample experience with mindfulness and adolescents in different contexts. Key objectives are: (1) to increase awareness of one's present moment experience; (2) to teach an attitude of openness and acceptance (non-judging) toward one's experience. This accepting attitude changes the person's relationship with the experience, being a detached and non-reactive orientation. Participants learn to recognize entanglement with one's thoughts and emotions and there is an increased understanding of one's spontaneous reactions. If adolescents adopt these skills, their negative emotions and cognitions will no longer be reinforced, creating the opportunity to deal with problematic thoughts and feelings.

干预措施: Mindfulness Training (Behavioral)

Control

No Intervention

Participants follow their regular course curriculum.

结局指标

主要结局

Change in Emotional Distress

时间窗: Before randomisation, the week after the intervention and 3 months after the intervention; 10 times/day over 4 consecutive days

A 3-item visual analogue scale ranging from 0 to 100 with the anchors "not at all" and "very much" is used to measure feelings of anxiety, stress and depression in the present moment. The final score will be computed as the average of the individual items.

Change in (Non)Acceptance of Negative Emotions

时间窗: Before randomisation, the week after the intervention and 3 months after the intervention; 10 times/day over 4 consecutive days

A 2-item visual analogue scale ranging from 0 to 100 with the anchors "not at all" and "very much" assesses the acceptance and non-acceptance of negative emotions since the last beep. The final score will be computed as the average of the individual items.

Change in Anhedonia

时间窗: Before randomisation, the week after the intervention and 3 months after the intervention; 10 times/day over 4 consecutive days

A 3-item visual analogue scale ranging from 0 to 100 with the anchors "not at all" and "very much" measures aspects of anhedonia in the present moment. The final score will be computed as the average of the individual items.

Change in Dampening

时间窗: Before randomisation, the week after the intervention and 3 months after the intervention; 10 times/day over 4 consecutive days

A single item visual analogue scale ranging from 0 to 100 with the anchors "not at all" and "very much" is used to assess dampening of positive emotions since the last beep.

Change in Social expectancies towards the (non-) expression and (non-) experience of negative emotions

时间窗: Before randomisation, the week after the intervention and 3 months after the intervention; 10 times/day over 4 consecutive days

A single item visual analogue scale ranging from 0 to 100 with the anchors "not at all" and "very much" measures social expectancies towards the non-expression and non-experience of negative emotions since the last beep.

次要结局

  • Change in Social expectancies towards the (non-) expression and (non-) experience of positive emotions(Before randomisation, the week after the intervention and 3 months after the intervention)
  • Change in Repetitive Negative Thinking (RNT) - worry(Before randomisation, the week after the intervention and 3 months after the intervention)
  • Change in Loneliness(Before randomisation, the week after the intervention and 3 months after the intervention)
  • Change in Self-compassion(Before randomisation, the week after the intervention and 3 months after the intervention)
  • Change in Pro-social behaviour(Before randomisation, the week after the intervention and 3 months after the intervention)
  • Change in the Depression Anxiety Stress Scales (DASS-21)(Before randomisation, the week after the intervention and 3 months after the intervention)
  • Change in the Leuven Anhedonia Self-report Scale (LASS)(Before randomisation, the week after the intervention and 3 months after the intervention)
  • Change in the Dampening subscale of Responses to Positive Affect questionnaire (RPA)(Before randomisation, the week after the intervention and 3 months after the intervention)
  • Change in the Non-Acceptance and Suppression of Negative Emotions Scale (NASNES)(Before randomisation, the week after the intervention and 3 months after the intervention)
  • Change in the Adapted and extended Social Expectancies to experience Depression and Anxiety Scale (SEDAD)(Before randomisation, the week after the intervention and 3 months after the intervention)
  • Change in the Core Characteristics Subscale of the Perseverative Thinking Questionnaire (PTQ)(Before randomisation, the week after the intervention and 3 months after the intervention)
  • Change in the Self-Compassion Scale - Short Form(Before randomisation, the week after the intervention and 3 months after the intervention)
  • Change in the UCLA Loneliness Scale(Before randomisation, the week after the intervention and 3 months after the intervention)
  • Change in the Prosocial behaviour subscale of the Prosocialness Scale(Before randomisation, the week after the intervention and 3 months after the intervention)
  • Change in the Short Form of the Comprehensive Inventory of Mindfulness Experiences (CHIME-SF)(Before randomisation, the week after the intervention and 3 months after the intervention)
  • Change in the Paying Attention to Your Surroundings scale (PAYS)(Before randomisation, the week after the intervention and 3 months after the intervention)
  • Change in the Pro-Environmental Behaviour Scale (PEB)(Before randomisation, the week after the intervention and 3 months after the intervention)

研究者

发起方
Prof. dr. Filip Raes
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Prof. dr. Filip Raes

Professor

KU Leuven

研究点 (11)

Loading locations...

相似试验