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

Not Applicable

Completed

• Conditions: Chronic Illness
• Interventions: Behavioral: Mindfulness-Based Intervention

• Registration Number: NCT04359563
• Lead Sponsor: KU Leuven

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.

Study Timeline

• Study First Submitted: 2020-04-21
• Study First Submitted QC: 2020-04-22
• Study First Posted: 2020-04-24
• Study Start: 2020-07-02
• Primary Completion: 2022-02-09
• Study Completion: 2022-02-09
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-18
• Last Update Posted: 2023-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mindfulness-Based Intervention	Mindfulness-Based Intervention	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.

Primary Outcome Measures

Name	Time	Method
Change in Pediatric Quality of Life InventoryTM (PedsQLTM 4.0; Varni, Seid & Kurtin, 2001)	Before the baseline phase (pre-measurement), in the week after the intervention (post-measurement) and 3 months after the intervention (follow-up)	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).
Change in Emotional Distress	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)	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.

Secondary Outcome Measures

Name	Time	Method
Change in the Leuven Anhedonia Self-report Scale (LASS; Bastin, Nelis, Raes, Vasey, & Bijttebier, 2018)	Before the baseline phase (pre-measurement), in the week after the intervention (post-measurement) and 3 months after the intervention (follow-up)	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).
Change in the Non-Acceptance and Suppression of Negative Emotions Scale (NASNES)	Before the baseline phase (pre-measurement), in the week after the intervention (post-measurement) and 3 months after the intervention (follow-up)	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).
Change in the Short Form of the Comprehensive Inventory of Mindfulness Experiences (CHIME-SF; Johnson, Burke, Brinkman, & Wade, 2017)	Before the baseline phase (pre-measurement), in the week after the intervention (post-measurement) and 3 months after the intervention (follow-up)	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).
Change in adapted version of Pain Solutions Questionnaire (PaSol; de Vlieger, van den Bussche, Eccleston, & Crombez, 2006)	Before the baseline phase (pre-measurement), in the week after the intervention (post-measurement) and 3 months after the intervention (follow-up)	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).
Change in the Depression Anxiety Stress Scales (DASS-21; Lovibond & Lovibond, 1995)	Before the baseline phase (pre-measurement), in the week after the intervention (post-measurement) and 3 months after the intervention (follow-up)	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).
Change in Anhedonia	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)	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 the Core Characteristics Subscale of the Perseverative Thinking Questionnaire (PTQ; Ehring et al., 2011)	Before the baseline phase (pre-measurement), in the week after the intervention (post-measurement) and 3 months after the intervention (follow-up)	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).
Change in Self-compassion	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)	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.
Change in Dampening	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)	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 the Dampening subscale of Responses to Positive Affect questionnaire (RPA; Feldman, Joormann, & Johnson, 2008)	Before the baseline phase (pre-measurement), in the week after the intervention (post-measurement) and 3 months after the intervention (follow-up)	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).
Change in the Self-Compassion Scale - Short Form (SCS-SF; Raes, Pommier, Neff, & van Gucht, 2011)	Before the baseline phase (pre-measurement), in the week after the intervention (post-measurement) and 3 months after the intervention (follow-up)	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).
Change in (Non)Acceptance of Negative Emotions	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)	A 2-item visual analogue scale assesses the acceptance and non-acceptance of negative emotions since the last beep.
Change in Repetitive Negative Thinking (RNT) - worry	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)	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.

Trial Locations

Locations (1)

KU Leuven; 🇧🇪 Leuven, Vlaams-Brabant, Belgium