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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04159272
Recruitment Status : Active, not recruiting
First Posted : November 12, 2019
Last Update Posted : January 23, 2020
Sponsor:
Information provided by (Responsible Party):
Prof. dr. Filip Raes, KU Leuven

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.


Condition or disease Intervention/treatment Phase
Emotional Stress Behavioral: Mindfulness Training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: OPEN.MIND | Can MINDfulness Help Vulnerable Youngsters to Ride a Challenging Emotional Tandem? OPENing up to Positivity While Simultaneously Accepting Negative Feelings
Actual Study Start Date : November 4, 2019
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Arm Intervention/treatment
Experimental: 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.
Behavioral: 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.


No Intervention: Control
Participants follow their regular course curriculum.



Primary Outcome Measures :
  1. Change in Emotional Distress [ Time Frame: 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.

  2. Change in (Non)Acceptance of Negative Emotions [ Time Frame: 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.

  3. Change in Anhedonia [ Time Frame: 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.

  4. Change in Dampening [ Time Frame: 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.

  5. Change in Social expectancies towards the (non-) expression and (non-) experience of negative emotions [ Time Frame: 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.


Secondary Outcome Measures :
  1. Change in Social expectancies towards the (non-) expression and (non-) experience of positive emotions [ Time Frame: Before randomisation, the week after the intervention and 3 months after the intervention ]
    A single item visual analogue scale ranging from 0 to 100 with the anchors "not at all" and "very much" assesses social expectancies towards the expression and experience of positive emotions since the last beep.

  2. Change in Repetitive Negative Thinking (RNT) - worry [ Time Frame: Before randomisation, the week after the intervention and 3 months after the intervention ]
    A single item visual analogue scale ranging from 0 to 100 with the anchors "not at all" and "very much" is used to measure worry since the last beep.

  3. Change in Loneliness [ Time Frame: Before randomisation, the week after the intervention and 3 months after the intervention ]
    A single item visual analogue scale ranging from 0 to 100 with the anchors "not at all" and "very much" assesses feeling of loneliness in the present moment.

  4. Change in Pro-social behaviour [ Time Frame: Before randomisation, the week after the intervention and 3 months after the intervention ]
    A single item visual analogue scale ranging from 0 to 100 with the anchors "not at all" and "very much" is used to assess pro-social behaviour since the last beep.

  5. Change in Self-compassion [ Time Frame: Before randomisation, the week after the intervention and 3 months after the intervention ]
    A single item visual analogue scale ranging from 0 to 100 with the anchors "not at all" and "very much" measures self-compassion since the last beep.

  6. Change in the Depression Anxiety Stress Scales (DASS-21) [ Time Frame: Before randomisation, the week after the intervention and 3 months after the intervention ]
    The DASS is a 21-item scale and is comprised of three sub-scales that measure symptoms of depression, anxiety and stress over the past week. Items are scored on a 4-point Likert scale ranging from "0" (did not apply to me at all) to "3" (applied to me very much or most of the time).

  7. Change in the Leuven Anhedonia Self-report Scale (LASS) [ Time Frame: Before randomisation, the week after the intervention and 3 months after the intervention ]
    The LASS is a 12-item scale designed to assess consummatory, anticipatory, and motivational aspects of anhedonia over the past two weeks. Items are scored on a 5-point Likert scale ranging from "1" (completely untrue) to "5" (completely true).

  8. Change in the Dampening subscale of Responses to Positive Affect questionnaire (RPA) [ Time Frame: Before randomisation, the week after the intervention and 3 months after the intervention ]
    The dampening subscale of the RPA is used to measure dampening responses to positive affective states using 6 items on a 4-point Likert scale ranging from "1"(almost never) to "4"(almost always).

  9. Change in the Non-Acceptance and Suppression of Negative Emotions Scale (NASNES) [ Time Frame: Before randomisation, the week after the intervention and 3 months after the intervention ]
    The NASNES is a 10-item scale designed to assess the extent of suppression vs. acceptance of negative emotions on a 7-point Likert scale ranging from "1"(not at all) to "7"(very much).

  10. Change in the Adapted and extended Social Expectancies to experience Depression and Anxiety Scale (SEDAD) [ Time Frame: Before randomisation, the week after the intervention and 3 months after the intervention ]
    The 26-item SEDAD was adapted to the class climate and extended to assess social expectancies about the (non-)experience and (non-)expression of positive thoughts and emotions on a 9-point Likert scale ranging from "1" (strongly disagree) to "9" (strongly agree).

  11. Change in the Core Characteristics Subscale of the Perseverative Thinking Questionnaire (PTQ) [ Time Frame: Before randomisation, the week after the intervention and 3 months after the intervention ]
    The core characteristics subscale of the PTQ measures the main characteristics of repetitive negative thinking, namely the repetitiveness, the intrusiveness and the difficulty of disengaging. Its 9 items are rated on a 5-point Likert scale ranging from "0" (never) to "4" (always).

  12. Change in the Self-Compassion Scale - Short Form [ Time Frame: Before randomisation, the week after the intervention and 3 months after the intervention ]
    The 12-item short form of the Self-Compassion Scale assesses the main components of self-compassion, namely self-kindness vs. self-judgment, common humanity vs. isolation and mindfulness vs. over-identification. Items are rated on a 5-point Likert scale ranging from "1" (almost never) to "5" (almost always).

  13. Change in the UCLA Loneliness Scale [ Time Frame: Before randomisation, the week after the intervention and 3 months after the intervention ]
    The 8-item Loneliness Scale measures participants' loneliness on a 5-point Likert scale ranging from "1" (completely disagree) to "5" (completely agree).

  14. Change in the Prosocial behaviour subscale of the Prosocialness Scale [ Time Frame: Before randomisation, the week after the intervention and 3 months after the intervention ]
    The Prosocialness Scale is comprised of different subscales including the prosocial behaviour subscale. Its 6-items are rated on a 5-point Likert scale ranging from "1" (never/ hardly ever true) to "5" (almost always/ always true).

  15. Change in the Short Form of the Comprehensive Inventory of Mindfulness Experiences (CHIME-SF) [ Time Frame: Before randomisation, the week after the intervention and 3 months after the intervention ]
    The 24-item CHIME-SF measures different mindfulness skills including awareness of internal experiences, awareness of external experiences, acting with awareness, accepting and non-judgmental attitude, nonreactive decentering, openness to experiences, awareness of thought's relativity, and insightful understanding using a 6-point Likert scale ranging from "1" (almost never) to "6" (almost always).

  16. Change in the Paying Attention to Your Surroundings scale (PAYS) [ Time Frame: Before randomisation, the week after the intervention and 3 months after the intervention ]
    The 13-item PAYS scale assesses participants' attention for their surroundings including nature and architecture on a 9-point Likert scale ranging from "1" (totally disagree) to "9" (totally agree).

  17. Change in the Pro-Environmental Behaviour Scale (PEB) [ Time Frame: Before randomisation, the week after the intervention and 3 months after the intervention ]
    The PEB is a 15-item scale and is comprised of four subscales: environmental citizenship, conservation, food and transportation. Its items are rated on a 4-point Likert scale ranging from "0" (never) to "3" (always).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04159272


Locations
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Belgium
Leiepoort campus Sint-Hendrik
Deinze, Belgium, 9800
Heilig-Hart&College Halle
Halle, Belgium, 1500
GO! atheneum Oudenaarde
Oudenaarde, Belgium, 9700
Sponsors and Collaborators
Prof. dr. Filip Raes
Investigators
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Principal Investigator: Filip Raes, Prof dr. KU Leuven
Publications:
Abela, J. R., & Hankin, B. L. (Eds.). (2008). Handbook of depression in children and adolescents. Guilford Press.
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.
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.
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.
Cladder-Micus, M.B., Verweij, H., van Ravesteijn, H. et al. Mindfulness (2019) 10: 1893. https://doi.org/10.1007/s12671-019-01125-7
Csikszentmihalyi, M., & Larson, R. (2014). Validity and reliability of the experience-sampling method. InFlow and the Foundations of Positive Psychology(pp. 35-54): Springer.
Hox, J. J., Moerbeek, M., & van de Schoot, R. (2010). Multilevel analysis: Techniques and applications: Routledge.
Kabat-Zinn, J. (1990). Full catastrophe living: How to cope with stress, pain and illness using mindfulness meditation.New York: Delacorte.
Kabat-Zinn, Jon. 1994. Wherever you go, there you are: mindfulness meditation in everyday life. New York: Hyperion.
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.
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
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.
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.
Raes In Prep (2019)
Bastian et al. In Prep.
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
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.
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.
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.
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.

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Responsible Party: Prof. dr. Filip Raes, Professor, KU Leuven
ClinicalTrials.gov Identifier: NCT04159272    
Other Study ID Numbers: s62523
G049019N ( Other Grant/Funding Number: Research Foundation - Flanders )
First Posted: November 12, 2019    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Moderately sensitive information including age, demographic data, all other data coming from questionnaires and experience sampling data using smartphones will be pseudo-anonymized and shared.
Supporting Materials: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stress, Psychological
Behavioral Symptoms