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

Emotional Stress Clinical Trial

Official title:

OPEN.MIND | Can MINDfulness Help Vulnerable Youngsters to Ride a Challenging Emotional Tandem? OPENing up to Positivity While Simultaneously Accepting Negative Feelings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04159272
• Other study ID #: s62523
• Secondary ID: G049019N
• Status: Completed
• Phase: N/A
• Start date: November 4, 2019
• Est. completion date: June 3, 2022

Study information

• Verified date: September 2022
• Source: KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: June 3, 2022
• Est. primary completion date: June 3, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emotional Stress

Intervention

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.

Locations

Country	Name	City	State
Belgium	GO! Atheneum Ekeren	Antwerpen
Belgium	GO! KA Antwerpen	Antwerpen
Belgium	Leiepoort campus Sint-Hendrik	Deinze
Belgium	Go! Lyceum Gent	Gent
Belgium	Heilig-Hart&College Halle	Halle
Belgium	GO! Atheneum Heist	Heist-op-den-Berg
Belgium	KOBOS Secundaire scholen	Kapelle-op-den-Bos
Belgium	Heilig-Hart Instituut Heverlee	Leuven
Belgium	KA Merksem	Merksem
Belgium	GO! atheneum Oudenaarde	Oudenaarde
Belgium	Vita et Pax Schoten	Schoten

Sponsors (1)

Lead Sponsor	Collaborator
Prof. dr. Filip Raes

Country where clinical trial is conducted

Belgium, 

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Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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.	Before randomisation, the week after the intervention and 3 months after the intervention
Secondary	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.	Before randomisation, the week after the intervention and 3 months after the intervention
Secondary	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.	Before randomisation, the week after the intervention and 3 months after the intervention
Secondary	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.	Before randomisation, the week after the intervention and 3 months after the intervention
Secondary	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.	Before randomisation, the week after the intervention and 3 months after the intervention
Secondary	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).	Before randomisation, the week after the intervention and 3 months after the intervention
Secondary	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).	Before randomisation, the week after the intervention and 3 months after the intervention
Secondary	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).	Before randomisation, the week after the intervention and 3 months after the intervention
Secondary	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).	Before randomisation, the week after the intervention and 3 months after the intervention
Secondary	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).	Before randomisation, the week after the intervention and 3 months after the intervention
Secondary	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).	Before randomisation, the week after the intervention and 3 months after the intervention
Secondary	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).	Before randomisation, the week after the intervention and 3 months after the intervention
Secondary	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).	Before randomisation, the week after the intervention and 3 months after the intervention
Secondary	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).	Before randomisation, the week after the intervention and 3 months after the intervention
Secondary	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).	Before randomisation, the week after the intervention and 3 months after the intervention
Secondary	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).	Before randomisation, the week after the intervention and 3 months after the intervention
Secondary	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).	Before randomisation, the week after the intervention and 3 months after the intervention