Emotional StressNCT04159272
Effects of Mindfulness Training on the Emotional Experience and (Non-) Acceptance of Emotions in Adolescents
A study testing Mindfulness Training in people with Emotional Stress, run by Prof. dr. Filip Raes at 11 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Emotional Stress
- What is being tested?
- Mindfulness Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 11 sitesBelgium
- Study dates
- 4 Nov 2019to 3 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Not applicable
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Belgium11 sites
GO! Atheneum Ekeren
Antwerp
GO! KA Antwerpen
Antwerp
Leiepoort campus Sint-Hendrik
Deinze, 9800
Go! Lyceum Gent
Ghent, 9000
Heilig-Hart&College Halle
Halle, 1500
GO! Atheneum Heist
Heist-op-den-Berg
KOBOS Secundaire scholen
Kapelle-op-den-Bos, 1880
Heilig-Hart Instituut Heverlee
Leuven
KA Merksem
Merksem, 2170
GO! atheneum Oudenaarde
Oudenaarde, 9700
Vita et Pax Schoten
Schoten
About this study
Official title: OPEN.MIND | Can MINDfulness Help Vulnerable Youngsters to Ride a Challenging Emotional Tandem? OPENing up to Positivity While Simultaneously Accepting Negative Feelings
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
- Being tested
- Mindfulness Training
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Mindfulness Training |
| Control | No intervention | Participants follow their regular course curriculum. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: Before randomisation, the week after the intervention and 3 months after the intervention
Change in Repetitive Negative Thinking (RNT) - worry
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.
Measured: Before randomisation, the week after the intervention and 3 months after the intervention
Change in Loneliness
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.
Measured: Before randomisation, the week after the intervention and 3 months after the intervention
Change in Pro-social behaviour
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.
Measured: Before randomisation, the week after the intervention and 3 months after the intervention
Change in Self-compassion
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.
Measured: Before randomisation, the week after the intervention and 3 months after the intervention
Change in the Depression Anxiety Stress Scales (DASS-21)
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).
Measured: Before randomisation, the week after the intervention and 3 months after the intervention
Change in the Leuven Anhedonia Self-report Scale (LASS)
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).
Measured: 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)
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).
Measured: 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)
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).
Measured: 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)
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).
Measured: 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)
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).
Measured: Before randomisation, the week after the intervention and 3 months after the intervention
Change in the Self-Compassion Scale - Short Form
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).
Measured: Before randomisation, the week after the intervention and 3 months after the intervention
Change in the UCLA Loneliness Scale
The 8-item Loneliness Scale measures participants' loneliness on a 5-point Likert scale ranging from "1" (completely disagree) to "5" (completely agree).
Measured: Before randomisation, the week after the intervention and 3 months after the intervention
Change in the Prosocial behaviour subscale of the Prosocialness Scale
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).
Measured: 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)
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).
Measured: Before randomisation, the week after the intervention and 3 months after the intervention
Change in the Paying Attention to Your Surroundings scale (PAYS)
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).
Measured: Before randomisation, the week after the intervention and 3 months after the intervention
Change in the Pro-Environmental Behaviour Scale (PEB)
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).
Measured: Before randomisation, the week after the intervention and 3 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start4 Nov 2019
- Primary completion3 Jun 2022
- Study completion3 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (40)Papers the sponsor has linked to this study.
- Other trials for Emotional StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. dr. Filip Raes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. dr. Filip Raes, KU Leuven
- Investigators
- Filip Raes, Prof dr., Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04159272
- Sponsor's protocol ID
- s62523
- Other IDs
- G049019N
- Status last verified
- Sep 2022
- First submitted
- 6 Nov 2019
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Abela, J. R., & Hankin, B. L. (Eds.). (2008). Handbook of depression in children and adolescents. Guilford Press.
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.
PubMed 28391490Bauer 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.
PubMed 16784335Benjamini, 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
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.
PubMed 28031068Csikszentmihalyi 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.
PubMed 3655778Dejonckheere 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.
PubMed 28499066Ehring 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.
PubMed 21315886Gotink 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.
PubMed 25881019Goyal 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.
PubMed 24395196Hofmann 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.
PubMed 20350028Hox, J. J., Moerbeek, M., & van de Schoot, R. (2010). Multilevel analysis: Techniques and applications: Routledge.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPEN.MIND | Can MINDfulness Help Vulnerable Youngsters to Ride a Challenging Emotional Tandem? OPENing up to Positivity While Simultaneously Accepting Negative Feelings
- ClinicalTrials.gov ID
- NCT04159272
- Acronym / sponsor ID
- s62523
- Conditions
- Emotional Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Prof. dr. Filip RaesUniversity, hospital or other
- Study start
- 4 Nov 2019 (actual)
- Primary completion
- 3 Jun 2022 (actual)
- Study completion
- 3 Jun 2022 (actual)
- First posted
- 12 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Training | Experimental | Behavioral: Mindfulness TrainingThe 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. |
| Control | No intervention | –Participants follow their regular course curriculum. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Not applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness TrainingThe 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. | Behavioural | Mindfulness Training |
Primary outcome
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.
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.
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.
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.
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.
17 secondary outcomes
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
Change in Repetitive Negative Thinking (RNT) - worry
Time frame: Before randomisation, the week after the intervention and 3 months after the intervention
Change in Loneliness
Time frame: Before randomisation, the week after the intervention and 3 months after the intervention
Change in Pro-social behaviour
Time frame: Before randomisation, the week after the intervention and 3 months after the intervention
Change in Self-compassion
Time frame: Before randomisation, the week after the intervention and 3 months after the intervention
Change in the Depression Anxiety Stress Scales (DASS-21)
Time frame: Before randomisation, the week after the intervention and 3 months after the intervention
Change in the Leuven Anhedonia Self-report Scale (LASS)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Before randomisation, the week after the intervention and 3 months after the intervention
Change in the Self-Compassion Scale - Short Form
Time frame: Before randomisation, the week after the intervention and 3 months after the intervention
Change in the UCLA Loneliness Scale
Time frame: Before randomisation, the week after the intervention and 3 months after the intervention
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
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
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
Change in the Pro-Environmental Behaviour Scale (PEB)
Time frame: Before randomisation, the week after the intervention and 3 months after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- BackgroundAbela, J. R., & Hankin, B. L. (Eds.). (2008). Handbook of depression in children and adolescents. Guilford Press.
- Background: PubMed 28391490Bastin 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.
- Background: PubMed 16784335Bauer 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.
- BackgroundBenjamini, 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.
- BackgroundBergomi, 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.
- BackgroundCaprara, 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.
- BackgroundCladder-Micus, M.B., Verweij, H., van Ravesteijn, H. et al. Mindfulness (2019) 10: 1893. https://doi.org/10.1007/s12671-019-01125-7
- Background: PubMed 28031068Crane 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.
- Background: PubMed 3655778Csikszentmihalyi 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.
- Background: PubMed 28499066Dejonckheere 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.
- Background: PubMed 21315886Ehring 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.
- Background: PubMed 25881019Gotink 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Filip Raes, Prof dr. principal investigator
KU Leuven
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Training in people with Emotional Stress, run by Prof. dr. Filip Raes at 11 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04159272, which also lists 40 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2022.