You.Mind! | Boosting First-line Mental Health Care for Youngsters Suffering From Chronic Conditions With Mindfulness

Study Overview
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Brief Summary
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Adolescents with chronic conditions often experience high levels of stress, anxiety and depression and reduced quality of life. Mindfulness-Based Interventions (MBI) have been found to improve emotional distress in clinical and non-clinical populations. Recent reviews suggest that MBIs are a promising technique to support adolescents with a chronic condition in managing their symptoms and ultimately enhance their quality of life. To test the effects of an MBI on emotional distress and quality of life and delineate the underlying mechanisms, the You.Mind! study uses a randomised staggered within-subjects design. 30 adolescents with a chronic condition (taking drop-out into account) will be randomised to a baseline phase of 14 to 28 days followed by an MBI, consisting of 4 online group sessions and online support spread over 8 weeks. Outcomes will be assessed by short, repeated measurements throughout the baseline, training, and follow-up phases and by standardized questionnaires and experience sampling measures before randomisation, at post-intervention and 3-months follow-up. Analysis will be based on general linear modelling and multilevel mixed-effects modelling. The investigators hypothesize that a MBI can help adolescents with a chronic condition to reduce their symptoms of stress, anxiety and depression, and increase their quality of life.

Detailed Description
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Once a pool of 15 participants has been enrolled, they will be randomised to one of three MBI groups, which start their training with half a week time lag. Within each group, participants will be randomised to a baseline phase of 2, 2.5, 3, 3.5 or 4 weeks, with 3-4 days between starting points of individual participants. Thus, the baseline phase will start at different time points for participants within the same group to enable them to start the intervention simultaneously while having baseline phases of varying length. Participants from different groups may begin their baseline phase at the same time while their intervention starts at a different time point. The same procedure will be repeated for the second pool of 15 participants.

Official Title
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You.Mind! | Boosting First-line Mental Health Care for Youngsters Suffering From Chronic Conditions With Mindfulness: A Randomised Staggered Within-subjects Design

Conditions
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Chronic Illness

Intervention / Treatment
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* Behavioral: Mindfulness-Based Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The adolescents suffer from a chronic condition lasting one year or more that impairs functional mobility and/or requires ongoing medical care. They should understand and speak Dutch. Written informed consent (including informed consent from a parent for those <18yrs) after having been informed on all aspects of the study. Exclusion Criteria: Evidence of a current or lifetime severe mental illness. Current treatment for a psychiatric disorder.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: The study uses a randomized staggered within-subjects design in which participants are randomized to a baseline assessment phase of 14 to 28 days duration. During the subsequent intervention phase, all participants receive an 8-week Mindfulness-Based Intervention. Participants complete daily (every 3 days during intervention and follow-up phases) experience sampling method (ESM) measurements throughout the baseline, intervention and follow-up phases. Before randomisation, directly post-intervention and at 3 months follow-up, participants complete self-report questionnaires and ESM measurements.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness-Based Intervention<br>The MBI 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 the investigator's 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-Based Intervention<br>* The MBI consists of four 2h online group sessions spread over eight weeks. In between sessions, online support will be offered to assist participants in their practice. Each session consists of guided mindfulness exercises (e.g., focus on the breath, body scan, breathing space, mindful yoga, insight meditation, walk meditation), sharing of experiences of these exercises, reflections in small groups, psycho-education (e.g., stress, depression, self-care), and review of home practices. An overview of core elements is given in Van der Gucht et al. (2017b). The MBI is supported by homework assignments and audio material. Groups will include 5 participants, yielding 6 groups in total. The MBI will be delivered by highly qualified certified trainers with more than 10 years of experience in mindfulness meditation and extensive experience working with adolescents. Trainers will attend inter- and supervision moments on a regular basis to check treatment fidelity and trainer adherence.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 same scale is used for all other visual analogue scales. | Before the baseline phase (pre-measurement), during the baseline phase, during the intervention phase, in the week after the intervention (post-measurement), during the follow-up phase, and 3 months after the intervention (follow-up measurement) | 
| Change in Pediatric Quality of Life InventoryTM (PedsQLTM 4.0; Varni, Seid & Kurtin, 2001) | The PedsQLTM is a 23-item scale designed to assess four domains of health, namely physical functioning, emotional functioning, social functioning, and school functioning in adolescents in the past month. Items are scores on a 5-point Likert scale ranging from 0 (never) to 4 (almost always). | Before the baseline phase (pre-measurement), in the week after the intervention (post-measurement) and 3 months after the intervention (follow-up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Depression Anxiety Stress Scales (DASS-21; Lovibond & Lovibond, 1995) | 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 the baseline phase (pre-measurement), in the week after the intervention (post-measurement) and 3 months after the intervention (follow-up) | 
| Change in the Leuven Anhedonia Self-report Scale (LASS; Bastin, Nelis, Raes, Vasey, & Bijttebier, 2018) | 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 the baseline phase (pre-measurement), in the week after the intervention (post-measurement) and 3 months after the intervention (follow-up) | 
| Change in the Dampening subscale of Responses to Positive Affect questionnaire (RPA; Feldman, Joormann, & Johnson, 2008) | 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 the baseline phase (pre-measurement), in the week after the intervention (post-measurement) and 3 months after the intervention (follow-up) | 
| 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 the baseline phase (pre-measurement), in the week after the intervention (post-measurement) and 3 months after the intervention (follow-up) | 
| Change in the Core Characteristics Subscale of the Perseverative Thinking Questionnaire (PTQ; Ehring et al., 2011) | 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 the baseline phase (pre-measurement), in the week after the intervention (post-measurement) and 3 months after the intervention (follow-up) | 
| Change in the Self-Compassion Scale - Short Form (SCS-SF; Raes, Pommier, Neff, & van Gucht, 2011) | 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 the baseline phase (pre-measurement), in the week after the intervention (post-measurement) and 3 months after the intervention (follow-up) | 
| Change in the Short Form of the Comprehensive Inventory of Mindfulness Experiences (CHIME-SF; Johnson, Burke, Brinkman, & Wade, 2017) | 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 the baseline phase (pre-measurement), in the week after the intervention (post-measurement) and 3 months after the intervention (follow-up) | 
| Change in adapted version of Pain Solutions Questionnaire (PaSol; de Vlieger, van den Bussche, Eccleston, & Crombez, 2006) | The 14-item adapted PaSol scale is used to measure participants' acceptance of their illness/condition on a 7-point Likert scale ranging from 1 (not at all) to 6 (very much). | Before the baseline phase (pre-measurement), in the week after the intervention (post-measurement) and 3 months after the intervention (follow-up) | 
| Change in (Non)Acceptance of Negative Emotions | A 2-item visual analogue scale assesses the acceptance and non-acceptance of negative emotions since the last beep. | Before the baseline phase (pre-measurement), during the baseline phase, during the intervention phase, in the week after the intervention (post-measurement), during the follow-up phase, and 3 months after the intervention (follow-up measurement) | 
| 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 the baseline phase (pre-measurement), during the baseline phase, during the intervention phase, in the week after the intervention (post-measurement), during the follow-up phase, and 3 months after the intervention (follow-up measurement) | 
| 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 the baseline phase (pre-measurement), during the baseline phase, during the intervention phase, in the week after the intervention (post-measurement), during the follow-up phase, and 3 months after the intervention (follow-up measurement) | 
| 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 the baseline phase (pre-measurement), during the baseline phase, during the intervention phase, in the week after the intervention (post-measurement), during the follow-up phase, and 3 months after the intervention (follow-up measurement) | 
| 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 the baseline phase (pre-measurement), during the baseline phase, during the intervention phase, in the week after the intervention (post-measurement), during the follow-up phase, and 3 months after the intervention (follow-up measurement) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Emotional Distress, Quality of Life