Clinical trial NCT04159272: Effects of Mindfulness Training on the Emotional Experience and (Non-) Acceptance of Emotions in Adolescents
Official title: OPEN.MIND | Can MINDfulness Help Vulnerable Youngsters to Ride a Challenging Emotional Tandem? OPENing up to Positivity While Simultaneously Accepting Negative Feelings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emotional Stress
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2019-11-12
Enrollment: 450
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The intervention (MT) group receives a Mindfulness Training (MT) for 8 weeks in school, during regular school hours. The participants in the control group answer the questionnaires and complete the experience sampling assessments at the same timepoints as the intervention group, and follow the regular school curriculum.
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Not applicable

Primary outcomes:
measure: Change in Emotional Distress
timeFrame: Before randomisation, the week after the intervention and 3 months after the intervention; 10 times/day over 4 consecutive days
measure: Change in (Non)Acceptance of Negative Emotions
timeFrame: Before randomisation, the week after the intervention and 3 months after the intervention; 10 times/day over 4 consecutive days
measure: Change in Anhedonia
timeFrame: Before randomisation, the week after the intervention and 3 months after the intervention; 10 times/day over 4 consecutive days
measure: Change in Dampening
timeFrame: Before randomisation, the week after the intervention and 3 months after the intervention; 10 times/day over 4 consecutive days
measure: Change in Social expectancies towards the (non-) expression and (non-) experience of negative emotions
timeFrame: Before randomisation, the week after the intervention and 3 months after the intervention; 10 times/day over 4 consecutive days
Secondary outcomes:
measure: Change in Social expectancies towards the (non-) expression and (non-) experience of positive emotions
timeFrame: Before randomisation, the week after the intervention and 3 months after the intervention
measure: Change in Repetitive Negative Thinking (RNT) - worry
timeFrame: Before randomisation, the week after the intervention and 3 months after the intervention
measure: Change in Loneliness
timeFrame: Before randomisation, the week after the intervention and 3 months after the intervention
measure: Change in Pro-social behaviour
timeFrame: Before randomisation, the week after the intervention and 3 months after the intervention
measure: Change in Self-compassion
timeFrame: Before randomisation, the week after the intervention and 3 months after the intervention
measure: Change in the Depression Anxiety Stress Scales (DASS-21)
timeFrame: Before randomisation, the week after the intervention and 3 months after the intervention
measure: Change in the Leuven Anhedonia Self-report Scale (LASS)
timeFrame: Before randomisation, the week after the intervention and 3 months after the intervention
measure: Change in the Dampening subscale of Responses to Positive Affect questionnaire (RPA)
timeFrame: Before randomisation, the week after the intervention and 3 months after the intervention
measure: Change in the Non-Acceptance and Suppression of Negative Emotions Scale (NASNES)
timeFrame: Before randomisation, the week after the intervention and 3 months after the intervention
measure: Change in the Adapted and extended Social Expectancies to experience Depression and Anxiety Scale (SEDAD)
timeFrame: Before randomisation, the week after the intervention and 3 months after the intervention
measure: Change in the Core Characteristics Subscale of the Perseverative Thinking Questionnaire (PTQ)
timeFrame: Before randomisation, the week after the intervention and 3 months after the intervention
measure: Change in the Self-Compassion Scale - Short Form
timeFrame: Before randomisation, the week after the intervention and 3 months after the intervention
measure: Change in the UCLA Loneliness Scale
timeFrame: Before randomisation, the week after the intervention and 3 months after the intervention
measure: Change in the Prosocial behaviour subscale of the Prosocialness Scale
timeFrame: Before randomisation, the week after the intervention and 3 months after the intervention
measure: Change in the Short Form of the Comprehensive Inventory of Mindfulness Experiences (CHIME-SF)
timeFrame: Before randomisation, the week after the intervention and 3 months after the intervention
measure: Change in the Paying Attention to Your Surroundings scale (PAYS)
timeFrame: Before randomisation, the week after the intervention and 3 months after the intervention
measure: Change in the Pro-Environmental Behaviour Scale (PEB)
timeFrame: Before randomisation, the week after the intervention and 3 months after the intervention
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: GO! Atheneum Ekeren
city: Antwerpen
country: Belgium
facility: GO! KA Antwerpen
city: Deinze
country: Belgium
facility: Leiepoort campus Sint-Hendrik
city: Gent
country: Belgium
facility: Go! Lyceum Gent
city: Halle
country: Belgium
facility: Heilig-Hart&College Halle
city: Heist-op-den-Berg
country: Belgium
facility: GO! Atheneum Heist
city: Kapelle-op-den-Bos
country: Belgium
facility: KOBOS Secundaire scholen
city: Leuven
country: Belgium
facility: Heilig-Hart Instituut Heverlee
city: Merksem
country: Belgium
facility: KA Merksem
city: Oudenaarde
country: Belgium
facility: GO! atheneum Oudenaarde
city: Schoten
country: Belgium
facility: Vita et Pax Schoten
Study officials:
affiliation: KU Leuven
name: Filip Raes, Prof dr.
role: PRINCIPAL_INVESTIGATOR
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