Effects of Mindfulness Training on the Emotional Experience and (Non-) Acceptance of Emotions in Adolescents

NCT04159272 | Completed

• 2 other identifiers: s62523G049019N
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 11

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.

Conditions

Emotional Stress

Outcome Measures

Primary Outcomes (5)

• Change in Emotional Distress

  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.

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

• Change in (Non)Acceptance of Negative Emotions

  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.

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

• Change in Anhedonia

  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.

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

• Change in Dampening

  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.

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

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

  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.

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

Secondary Outcomes (17)

• 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 Pro-social behaviour

  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

Study Arms (2)

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.

Behavioral: Mindfulness Training

Control

NO INTERVENTION

Participants follow their regular course curriculum.

Interventions

Mindfulness Training BEHAVIORAL

The programme consists of 8 90-min sessions held once a week for 8 consecutive weeks. Each session consists of guided experiential mindfulness exercises, sharing of experiences of these exercises, reflections in small groups, psycho-education, and review of home practices. An overview of the core elements in each session is given in Van der Gucht et al. (2017). The in-class MT programme will be supported with a mindfulness for adolescents smartphone application to support practice at home. The curriculum is available in an open source platform. The training is supported by the use of homework assignments and audio material. The programme has already been piloted and reviewed in an expert group of mindfulness trainers and scientists working with youth in mental health care (Van der Gucht et al., 2017) and in refugee centres (Van der Gucht et al., 2019). The MT will be delivered by certified trainers (\>3 years of experience). During the trial they will receive regular supervision.

Mindfulness Training

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Not applicable

Sponsors & Collaborators

• Prof. dr. Filip Raes: lead

Study Sites (11)

GO! Atheneum Ekeren

Antwerp, Belgium

Location

GO! KA Antwerpen

Antwerp, Belgium

Location

Leiepoort campus Sint-Hendrik

Deinze, 9800, Belgium

Location

Go! Lyceum Gent

Ghent, 9000, Belgium

Location

Heilig-Hart&College Halle

Halle, 1500, Belgium

Location

GO! Atheneum Heist

Heist-op-den-Berg, Belgium

Location

KOBOS Secundaire scholen

Kapelle-op-den-Bos, 1880, Belgium

Location

Heilig-Hart Instituut Heverlee

Leuven, Belgium

Location

KA Merksem

Merksem, 2170, Belgium

Location

GO! atheneum Oudenaarde

Oudenaarde, 9700, Belgium

Location

Vita et Pax Schoten

Schoten, Belgium

Location

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MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Filip Raes, Prof dr.

  KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: November 6, 2019
• First Posted: November 12, 2019
• Study Start: November 4, 2019
• Primary Completion: June 3, 2022
• Study Completion: June 3, 2022
• Last Updated: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The coded, pseudonomized dataset will be uploaded in a csv format to OSF (in a restricted access repository) upon publication of the research results.
• Access Criteria: Coded, pseudonomized data can be shared with regulatory authorities, ethical committees, other parties that collaborate with the research team and will be shared, as mentioned above, on the OSF platform. Other researchers will only have access to the coded, pseudonomized data, and only if they agree with the confidentiality rules agreed upon within this study.

Locations

BE (11)