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

NCT ID: NCT04159272

Last Updated: 2022-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-04

Study Completion Date

2022-06-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Emotional Stress

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Mindfulness Training

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.

Group Type EXPERIMENTAL

Mindfulness Training

Intervention Type 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.

Control

Participants follow their regular course curriculum.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mindfulness Training

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Prof. dr. Filip Raes

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Prof. dr. Filip Raes

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Filip Raes, Prof dr.

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

GO! Atheneum Ekeren

Antwerp, , Belgium

Site Status

GO! KA Antwerpen

Antwerp, , Belgium

Site Status

Leiepoort campus Sint-Hendrik

Deinze, , Belgium

Site Status

Go! Lyceum Gent

Ghent, , Belgium

Site Status

Heilig-Hart&College Halle

Halle, , Belgium

Site Status

GO! Atheneum Heist

Heist-op-den-Berg, , Belgium

Site Status

KOBOS Secundaire scholen

Kapelle-op-den-Bos, , Belgium

Site Status

Heilig-Hart Instituut Heverlee

Leuven, , Belgium

Site Status

KA Merksem

Merksem, , Belgium

Site Status

GO! atheneum Oudenaarde

Oudenaarde, , Belgium

Site Status

Vita et Pax Schoten

Schoten, , Belgium

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium

References

Explore related publications, articles, or registry entries linked to this study.

Abela, J. R., & Hankin, B. L. (Eds.). (2008). Handbook of depression in children and adolescents. Guilford Press.

Reference Type BACKGROUND

Bastin M, Nelis S, Raes F, Vasey MW, Bijttebier P. Party Pooper or Life of the Party: Dampening and Enhancing of Positive Affect in a Peer Context. J Abnorm Child Psychol. 2018 Feb;46(2):399-414. doi: 10.1007/s10802-017-0296-3.

Reference Type BACKGROUND
PMID: 28391490 (View on PubMed)

Bauer DJ, Preacher KJ, Gil KM. Conceptualizing and testing random indirect effects and moderated mediation in multilevel models: new procedures and recommendations. Psychol Methods. 2006 Jun;11(2):142-63. doi: 10.1037/1082-989X.11.2.142.

Reference Type BACKGROUND
PMID: 16784335 (View on PubMed)

Benjamini, Y., & Hochberg, Y. (1995). Controlling the False Discovery Rate: A Practical and Powerful Approach to Multiple Testing. Journal of the Royal Statistical Society. Series B (Methodological), 57(1), 289-300.

Reference Type BACKGROUND

Bergomi, C., Tschacher, W., & Kupper, Z. (2014). Konstruktion und erste Validierung eines Fragebogens zur umfassenden Erfassung von Achtsamkeit. Diagnostica, 60, 111-125.doi: 10.1026/0012-1924/a000109.

Reference Type BACKGROUND

Caprara, G. V., Steca, P., Zelli, A., & Capanna, C. (2005). A new scale for measuring adults' prosocialness. European Journal of psychological assessment, 21(2), 77-89.

Reference Type BACKGROUND

Cladder-Micus, M.B., Verweij, H., van Ravesteijn, H. et al. Mindfulness (2019) 10: 1893. https://doi.org/10.1007/s12671-019-01125-7

Reference Type BACKGROUND

Crane RS, Brewer J, Feldman C, Kabat-Zinn J, Santorelli S, Williams JM, Kuyken W. What defines mindfulness-based programs? The warp and the weft. Psychol Med. 2017 Apr;47(6):990-999. doi: 10.1017/S0033291716003317. Epub 2016 Dec 29.

Reference Type BACKGROUND
PMID: 28031068 (View on PubMed)

Csikszentmihalyi M, Larson R. Validity and reliability of the Experience-Sampling Method. J Nerv Ment Dis. 1987 Sep;175(9):526-36. doi: 10.1097/00005053-198709000-00004.

Reference Type BACKGROUND
PMID: 3655778 (View on PubMed)

Dejonckheere E, Bastian B, Fried EI, Murphy SC, Kuppens P. Perceiving social pressure not to feel negative predicts depressive symptoms in daily life. Depress Anxiety. 2017 Sep;34(9):836-844. doi: 10.1002/da.22653. Epub 2017 May 12.

Reference Type BACKGROUND
PMID: 28499066 (View on PubMed)

Ehring T, Zetsche U, Weidacker K, Wahl K, Schonfeld S, Ehlers A. The Perseverative Thinking Questionnaire (PTQ): validation of a content-independent measure of repetitive negative thinking. J Behav Ther Exp Psychiatry. 2011 Jun;42(2):225-32. doi: 10.1016/j.jbtep.2010.12.003. Epub 2010 Dec 21.

Reference Type BACKGROUND
PMID: 21315886 (View on PubMed)

Gotink RA, Chu P, Busschbach JJ, Benson H, Fricchione GL, Hunink MG. Standardised mindfulness-based interventions in healthcare: an overview of systematic reviews and meta-analyses of RCTs. PLoS One. 2015 Apr 16;10(4):e0124344. doi: 10.1371/journal.pone.0124344. eCollection 2015.

Reference Type BACKGROUND
PMID: 25881019 (View on PubMed)

Goyal M, Singh S, Sibinga EM, Gould NF, Rowland-Seymour A, Sharma R, Berger Z, Sleicher D, Maron DD, Shihab HM, Ranasinghe PD, Linn S, Saha S, Bass EB, Haythornthwaite JA. Meditation programs for psychological stress and well-being: a systematic review and meta-analysis. JAMA Intern Med. 2014 Mar;174(3):357-68. doi: 10.1001/jamainternmed.2013.13018.

Reference Type BACKGROUND
PMID: 24395196 (View on PubMed)

Hofmann SG, Sawyer AT, Witt AA, Oh D. The effect of mindfulness-based therapy on anxiety and depression: A meta-analytic review. J Consult Clin Psychol. 2010 Apr;78(2):169-83. doi: 10.1037/a0018555.

Reference Type BACKGROUND
PMID: 20350028 (View on PubMed)

Hox, J. J., Moerbeek, M., & van de Schoot, R. (2010). Multilevel analysis: Techniques and applications: Routledge.

Reference Type BACKGROUND

Kabat-Zinn, J. (1990). Full catastrophe living: How to cope with stress, pain and illness using mindfulness meditation.New York: Delacorte.

Reference Type BACKGROUND

Kabat-Zinn, Jon. 1994. Wherever you go, there you are: mindfulness meditation in everyday life. New York: Hyperion.

Reference Type BACKGROUND

Khoury B, Lecomte T, Fortin G, Masse M, Therien P, Bouchard V, Chapleau MA, Paquin K, Hofmann SG. Mindfulness-based therapy: a comprehensive meta-analysis. Clin Psychol Rev. 2013 Aug;33(6):763-71. doi: 10.1016/j.cpr.2013.05.005. Epub 2013 Jun 7.

Reference Type BACKGROUND
PMID: 23796855 (View on PubMed)

Luberto CM, White C, Sears RW, Cotton S. Integrative medicine for treating depression: an update on the latest evidence. Curr Psychiatry Rep. 2013 Sep;15(9):391. doi: 10.1007/s11920-013-0391-2.

Reference Type BACKGROUND
PMID: 23943471 (View on PubMed)

Mathieu JE, Aguinis H, Culpepper SA, Chen G. Understanding and estimating the power to detect cross-level interaction effects in multilevel modeling. J Appl Psychol. 2012 Sep;97(5):951-66. doi: 10.1037/a0028380. Epub 2012 May 14.

Reference Type BACKGROUND
PMID: 22582726 (View on PubMed)

Maynard, B. R., Solis, M. R., Miller, V. L., & Brendel, K. E. (2017). Mindfulness-Based Interventions for Improving Cognition, Academic Achievement, Behavior, and Socioemotional Functioning of Primary and Secondary School Students. Campbell Systematic Reviews 2017: 5. Campbell Collaboration.

Reference Type BACKGROUND

McGuirk L, Kuppens P, Kingston R, Bastian B. Does a culture of happiness increase rumination over failure? Emotion. 2018 Aug;18(5):755-764. doi: 10.1037/emo0000322. Epub 2017 Jul 17.

Reference Type BACKGROUND
PMID: 28714701 (View on PubMed)

Merikangas KR, He JP, Burstein M, Swanson SA, Avenevoli S, Cui L, Benjet C, Georgiades K, Swendsen J. Lifetime prevalence of mental disorders in U.S. adolescents: results from the National Comorbidity Survey Replication--Adolescent Supplement (NCS-A). J Am Acad Child Adolesc Psychiatry. 2010 Oct;49(10):980-9. doi: 10.1016/j.jaac.2010.05.017. Epub 2010 Jul 31.

Reference Type BACKGROUND
PMID: 20855043 (View on PubMed)

Mojtabai R, Olfson M, Han B. National Trends in the Prevalence and Treatment of Depression in Adolescents and Young Adults. Pediatrics. 2016 Dec;138(6):e20161878. doi: 10.1542/peds.2016-1878. Epub 2016 Nov 14.

Reference Type BACKGROUND
PMID: 27940701 (View on PubMed)

Neff, K. D. (2003). Self-Compassion: An Alternative Conceptualization of a Healthy Attitude Toward Oneself. Self and Identity, 2(2), 85-101. http://dx.doi.org/10.1080/15298860309032

Reference Type BACKGROUND

Raes, F., Griffith, J. W., Van der Gucht, K., & Williams, J. M. G. (2014). School-based prevention and reduction of depression in adolescents: A cluster-randomized controlled trial of a mindfulness group program. Mindfulness, 5(5), 477-486.

Reference Type BACKGROUND

Rudolph, K. D. (2009). Adolescent depression. In I. H. Gotlib & C. L. Hammen (Eds.), Handbook of depression (pp. 444-466). New York, NY, US: The Guilford Press.

Reference Type BACKGROUND

Raes In Prep (2019)

Reference Type BACKGROUND

Bastian et al. In Prep.

Reference Type BACKGROUND

Russell D, Peplau LA, Cutrona CE. The revised UCLA Loneliness Scale: concurrent and discriminant validity evidence. J Pers Soc Psychol. 1980 Sep;39(3):472-80. doi: 10.1037//0022-3514.39.3.472.

Reference Type BACKGROUND
PMID: 7431205 (View on PubMed)

Scherbaum, C. A., & Ferreter, J. M. (2009). Estimating statistical power and required sample sizes for organizational research using multilevel modeling. Organizational Research Methods, 12(2), 347-367

Reference Type BACKGROUND

Segal, Zindel V.; Mark, J.; Williams, G.; Teasdale, John D. (2012) Mindfulness-based cognitive therapy for depression: A new approach to preventing relapse. New York, NY, US: The Guilford Press.

Reference Type BACKGROUND

Spijkerman MP, Pots WT, Bohlmeijer ET. Effectiveness of online mindfulness-based interventions in improving mental health: A review and meta-analysis of randomised controlled trials. Clin Psychol Rev. 2016 Apr;45:102-14. doi: 10.1016/j.cpr.2016.03.009. Epub 2016 Apr 1.

Reference Type BACKGROUND
PMID: 27111302 (View on PubMed)

Van der Gucht K, Takano K, Raes F, Kuppens P. Processes of change in a school-based mindfulness programme: cognitive reactivity and self-coldness as mediators. Cogn Emot. 2018 May;32(3):658-665. doi: 10.1080/02699931.2017.1310716. Epub 2017 Mar 31.

Reference Type BACKGROUND
PMID: 28361569 (View on PubMed)

Van der Gucht, K., Takano, K., Kuppens, P., & Raes, F. (2017). Potential Moderators of the Effects of School-Based Mindfulness Program on Symptoms of Depression in Adolescents. Mindfulness, 8 (3), 797-806.

Reference Type BACKGROUND

Van der Gucht K, Takano K, Labarque V, Vandenabeele K, Nolf N, Kuylen S, Cosyns V, Van Broeck N, Kuppens P, Raes F. A Mindfulness-Based Intervention for Adolescents and Young Adults After Cancer Treatment: Effects on Quality of Life, Emotional Distress, and Cognitive Vulnerability. J Adolesc Young Adult Oncol. 2017 Jun;6(2):307-317. doi: 10.1089/jayao.2016.0070. Epub 2016 Dec 21.

Reference Type BACKGROUND
PMID: 28002681 (View on PubMed)

Van der Gucht K, Dejonckheere E, Erbas Y, Takano K, Vandemoortele M, Maex E, Raes F, Kuppens P. An experience sampling study examining the potential impact of a mindfulness-based intervention on emotion differentiation. Emotion. 2019 Feb;19(1):123-131. doi: 10.1037/emo0000406. Epub 2018 Mar 26.

Reference Type BACKGROUND
PMID: 29578747 (View on PubMed)

Van der Gucht K., Glas J., De Haene L., Kuppens P., Raes F. (2019). A Mindfulness-Based Intervention for Unaccompanied Refugee Minors: A pilot study using mixed methods evaluation. Journal of Child and Family Studies, 28(4), 1084-1093.

Reference Type BACKGROUND

Vollestad J, Nielsen MB, Nielsen GH. Mindfulness- and acceptance-based interventions for anxiety disorders: a systematic review and meta-analysis. Br J Clin Psychol. 2012 Sep;51(3):239-60. doi: 10.1111/j.2044-8260.2011.02024.x. Epub 2011 Sep 9.

Reference Type BACKGROUND
PMID: 22803933 (View on PubMed)

Whitmarsh, L., & O'Neill, S. (2010). Green identity, green living? The role of pro-environmental self-identity in determining consistency across diverse pro-environmental behaviours. Journal of Environmental Psychology, 30(3), 305-314.

Reference Type BACKGROUND

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

G049019N

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

s62523

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

MIndfulness for Students
NCT03669016 UNKNOWN NA