Clinical trial NCT04359563: You.Mind! | Boosting First-line Mental Health Care for Youngsters Suffering From Chronic Conditions With Mindfulness
Official title: You.Mind! | Boosting First-line Mental Health Care for Youngsters Suffering From Chronic Conditions With Mindfulness: A Randomised Staggered Within-subjects Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Illness
Keywords: Emotional Distress
Quality of Life
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Fondation Huoshen
First posted: 2020-04-24
Enrollment: 22
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Emotional Distress
timeFrame: 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)
measure: Change in Pediatric Quality of Life InventoryTM (PedsQLTM 4.0; Varni, Seid & Kurtin, 2001)
timeFrame: Before the baseline phase (pre-measurement), in the week after the intervention (post-measurement) and 3 months after the intervention (follow-up)
Secondary outcomes:
measure: Change in the Depression Anxiety Stress Scales (DASS-21; Lovibond & Lovibond, 1995)
timeFrame: Before the baseline phase (pre-measurement), in the week after the intervention (post-measurement) and 3 months after the intervention (follow-up)
measure: Change in the Leuven Anhedonia Self-report Scale (LASS; Bastin, Nelis, Raes, Vasey, & Bijttebier, 2018)
timeFrame: Before the baseline phase (pre-measurement), in the week after the intervention (post-measurement) and 3 months after the intervention (follow-up)
measure: Change in the Dampening subscale of Responses to Positive Affect questionnaire (RPA; Feldman, Joormann, & Johnson, 2008)
timeFrame: Before the baseline phase (pre-measurement), in the week after the intervention (post-measurement) and 3 months after the intervention (follow-up)
measure: Change in the Non-Acceptance and Suppression of Negative Emotions Scale (NASNES)
timeFrame: Before the baseline phase (pre-measurement), in the week after the intervention (post-measurement) and 3 months after the intervention (follow-up)
measure: Change in the Core Characteristics Subscale of the Perseverative Thinking Questionnaire (PTQ; Ehring et al., 2011)
timeFrame: Before the baseline phase (pre-measurement), in the week after the intervention (post-measurement) and 3 months after the intervention (follow-up)
measure: Change in the Self-Compassion Scale - Short Form (SCS-SF; Raes, Pommier, Neff, & van Gucht, 2011)
timeFrame: Before the baseline phase (pre-measurement), in the week after the intervention (post-measurement) and 3 months after the intervention (follow-up)
measure: Change in the Short Form of the Comprehensive Inventory of Mindfulness Experiences (CHIME-SF; Johnson, Burke, Brinkman, & Wade, 2017)
timeFrame: Before the baseline phase (pre-measurement), in the week after the intervention (post-measurement) and 3 months after the intervention (follow-up)
measure: Change in adapted version of Pain Solutions Questionnaire (PaSol; de Vlieger, van den Bussche, Eccleston, & Crombez, 2006)
timeFrame: Before the baseline phase (pre-measurement), in the week after the intervention (post-measurement) and 3 months after the intervention (follow-up)
measure: Change in (Non)Acceptance of Negative Emotions
timeFrame: 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)
measure: Change in Anhedonia
timeFrame: 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)
measure: Change in Dampening
timeFrame: 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)
measure: Change in Repetitive Negative Thinking (RNT) - worry
timeFrame: 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)
measure: Change in Self-compassion
timeFrame: 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)
Other outcomes:
measure: Harms and Unpleasant Experiences Survey (HUES)
timeFrame: In the week after the intervention (post-measurement)
measure: Positive and negative aspects of mindfulness
timeFrame: 3 months after the intervention (follow-up)
Locations:
city: Leuven
country: Belgium
facility: KU Leuven
state: Vlaams-Brabant
Study officials:
affiliation: KU Leuven
name: Katleen Van der Gucht, PhD
role: PRINCIPAL_INVESTIGATOR
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