Chronic IllnessNCT04359563

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

A study testing Mindfulness-Based Intervention in people with Chronic Illness, run by KU Leuven at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 14 to 19 yearsHealthy volunteers can take part
Conditions the study is for: Chronic Illness
What is being tested?: Mindfulness-Based Intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 1 siteBelgium
Study dates: 2 Jul 2020to 9 Feb 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 to 19 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

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.

Who cannot join

Evidence of a current or lifetime severe mental illness.
Current treatment for a psychiatric disorder.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

KU Leuven
Leuven, Vlaams-Brabant, 3000

Other trials in Belgium

About this study

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

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.

Read the 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.

Conditions: Chronic Illness
Being tested: Mindfulness-Based Intervention
Keywords: Emotional Distress, Quality of Life
Medical subject headings: Chronic Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mindfulness-Based InterventionBehavioural
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.

Study groups in NCT04359563
Study group	Role	What they receive
Mindfulness-Based Intervention	Experimental	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. Receives: Behavioral: Mindfulness-Based Intervention

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 same scale is used for all other visual analogue scales.
Measured: 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).
Measured: Before the baseline phase (pre-measurement), in the week after the intervention (post-measurement) and 3 months after the intervention (follow-up)

Secondary outcomes (13)

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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Jul 20209 Feb 2022

First posted24 Apr 2020
Study start2 Jul 2020
Primary completion9 Feb 2022
Study completion9 Feb 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (23)Papers the sponsor has linked to this study.
Other trials for Chronic IllnessStudies of the same condition, open and under way.
More trials run by KU LeuvenThe sponsor's other registered studies.
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: Supportive care
Allocation: Not applicable
Intervention model: Single group
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)
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04359563
Sponsor's protocol ID: S63485
Status last verified: Apr 2023
First submitted: 21 Apr 2020
Last updated: 19 Apr 2023
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 upon reasonable request. To gain access, contact the authors at merle.kock@kuleuven.be (ORCID ID 0000-0001-9429-6321). The study protocol, statistical analysis plan and statistical code will be uploaded on clinicaltrials.gov.

Publications

Barlow JH, Ellard DR. The psychosocial well-being of children with chronic disease, their parents and siblings: an overview of the research evidence base. Child Care Health Dev. 2006 Jan;32(1):19-31. doi: 10.1111/j.1365-2214.2006.00591.x.
PubMed 16398788
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 28391490
De Vlieger P, Van den Bussche E, Eccleston C, Crombez G. Finding a solution to the problem of pain: conceptual formulation and the development of the Pain Solutions Questionnaire (PaSol). Pain. 2006 Aug;123(3):285-293. doi: 10.1016/j.pain.2006.03.005. Epub 2006 May 3.
PubMed 16675113
Ehring 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 21315886
Feldman GC, Joormann J, Johnson SL. Responses to Positive Affect: A Self-Report Measure of Rumination and Dampening. Cognit Ther Res. 2008 Aug 1;32(4):507-525. doi: 10.1007/s10608-006-9083-0.
PubMed 20360998
Johnson C, Burke C, Brinkman S, Wade T. Development and validation of a multifactor mindfulness scale in youth: The Comprehensive Inventory of Mindfulness Experiences-Adolescents (CHIME-A). Psychol Assess. 2017 Mar;29(3):264-281. doi: 10.1037/pas0000342. Epub 2016 Jun 2.
PubMed 27254018
Kabat-Zinn J. Full catastrophe living: How to cope with stress, pain and illness using mindful meditation. New York: Delacorte. 1990.
Lovibond SH, Lovibond PF. Manual for the depression anxiety stress scales. Psychology Foundation of Australia. 1996.
Pinquart M, Shen Y. Depressive symptoms in children and adolescents with chronic physical illness: an updated meta-analysis. J Pediatr Psychol. 2011 May;36(4):375-84. doi: 10.1093/jpepsy/jsq104. Epub 2010 Nov 18.
PubMed 21088072
Raes F, Pommier E, Neff KD, Van Gucht D. Construction and factorial validation of a short form of the Self-Compassion Scale. Clin Psychol Psychother. 2011 May-Jun;18(3):250-5. doi: 10.1002/cpp.702. Epub 2010 Jun 8.
PubMed 21584907
Santos T, de Matos MG, Simoes C, Leal I, do Ceu Machado M. (Health-related) quality of life and psychosocial factors in adolescents with chronic disease: a systematic literature review. Int J Adolesc Med Health. 2017 Nov 23;31(4). doi: 10.1515/ijamh-2017-0037.
PubMed 29168956
Segal ZV, Williams JMG. Mindfulness-Based Cognitive Therapy for Depression: A New Approach to Preventing Relapse (2nd ed.). New York: Guilford Publications Inc. 2012.
Van der Gucht K, Takano K, Kuppens P, Raes F. Potential Moderators of the Effects of a School-Based Mindfulness Program on Symptoms of Depression in Adolescents. Mindfulness. 2017; 8(3): 797-806. https://doi.org/10.1007/s12671-016-0658-x
Van der Gucht K, Takano K, Labarque V, Vandenabeele K, Nolf N, Kuylen S, Cosyns V, Van Broeck N, Kuppens P, Raes F. A Mindfulness-Based Intervention for Adolescents and Young Adults After Cancer Treatment: Effects on Quality of Life, Emotional Distress, and Cognitive Vulnerability. J Adolesc Young Adult Oncol. 2017 Jun;6(2):307-317. doi: 10.1089/jayao.2016.0070. Epub 2016 Dec 21.
PubMed 28002681
Varni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care. 2001 Aug;39(8):800-12. doi: 10.1097/00005650-200108000-00006.
PubMed 11468499

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: You.Mind! | Boosting First-line Mental Health Care for Youngsters Suffering From Chronic Conditions With Mindfulness: A Randomised Staggered Within-subjects Design
ClinicalTrials.gov ID: NCT04359563
Acronym / sponsor ID: S63485
Conditions: Chronic Illness
Keywords: Emotional Distress, Quality of Life
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: KU LeuvenUniversity, hospital or other
Collaborators: Fondation Huoshen
Study start: 2 Jul 2020 (actual)
Primary completion: 9 Feb 2022 (actual)
Study completion: 9 Feb 2022 (actual)
First posted: 24 Apr 2020 (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.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
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.

Arm	Type	Receives
Mindfulness-Based Intervention	Experimental	Behavioral: Mindfulness-Based InterventionThe 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.

Who may qualify

Ages: 14 to 19 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (2 listed)

Evidence of a current or lifetime severe mental illness.
Current treatment for a psychiatric disorder.

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-Based InterventionThe 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.	Behavioural	Mindfulness-Based Intervention

Primary outcome

Change in Emotional Distress
Time frame: 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.
Change in Pediatric Quality of Life InventoryTM (PedsQLTM 4.0; Varni, Seid & Kurtin, 2001)
Time frame: 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).

13 secondary outcomes

Change in the Depression Anxiety Stress Scales (DASS-21; Lovibond & Lovibond, 1995)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)

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 19 Apr 2023.
Background: PubMed 16398788Barlow JH, Ellard DR. The psychosocial well-being of children with chronic disease, their parents and siblings: an overview of the research evidence base. Child Care Health Dev. 2006 Jan;32(1):19-31. doi: 10.1111/j.1365-2214.2006.00591.x.
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 16675113De Vlieger P, Van den Bussche E, Eccleston C, Crombez G. Finding a solution to the problem of pain: conceptual formulation and the development of the Pain Solutions Questionnaire (PaSol). Pain. 2006 Aug;123(3):285-293. doi: 10.1016/j.pain.2006.03.005. Epub 2006 May 3.
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 20360998Feldman GC, Joormann J, Johnson SL. Responses to Positive Affect: A Self-Report Measure of Rumination and Dampening. Cognit Ther Res. 2008 Aug 1;32(4):507-525. doi: 10.1007/s10608-006-9083-0.
Background: PubMed 27254018Johnson C, Burke C, Brinkman S, Wade T. Development and validation of a multifactor mindfulness scale in youth: The Comprehensive Inventory of Mindfulness Experiences-Adolescents (CHIME-A). Psychol Assess. 2017 Mar;29(3):264-281. doi: 10.1037/pas0000342. Epub 2016 Jun 2.
BackgroundKabat-Zinn J. Full catastrophe living: How to cope with stress, pain and illness using mindful meditation. New York: Delacorte. 1990.
BackgroundLovibond SH, Lovibond PF. Manual for the depression anxiety stress scales. Psychology Foundation of Australia. 1996.
Background: PubMed 21088072Pinquart M, Shen Y. Depressive symptoms in children and adolescents with chronic physical illness: an updated meta-analysis. J Pediatr Psychol. 2011 May;36(4):375-84. doi: 10.1093/jpepsy/jsq104. Epub 2010 Nov 18.
Background: PubMed 21584907Raes F, Pommier E, Neff KD, Van Gucht D. Construction and factorial validation of a short form of the Self-Compassion Scale. Clin Psychol Psychother. 2011 May-Jun;18(3):250-5. doi: 10.1002/cpp.702. Epub 2010 Jun 8.
Background: PubMed 29168956Santos T, de Matos MG, Simoes C, Leal I, do Ceu Machado M. (Health-related) quality of life and psychosocial factors in adolescents with chronic disease: a systematic literature review. Int J Adolesc Med Health. 2017 Nov 23;31(4). doi: 10.1515/ijamh-2017-0037.
BackgroundSegal ZV, Williams JMG. Mindfulness-Based Cognitive Therapy for Depression: A New Approach to Preventing Relapse (2nd ed.). New York: Guilford Publications Inc. 2012.
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 upon reasonable request. To gain access, contact the authors at merle.kock@kuleuven.be (ORCID ID 0000-0001-9429-6321). The study protocol, statistical analysis plan and statistical code will be uploaded on clinicaltrials.gov.

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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.

Katleen Van der Gucht, PhD principal investigator

KU Leuven

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness-Based Intervention in people with Chronic Illness, run by KU Leuven at 1 site 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 2 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 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 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)). The study lists 2 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 NCT04359563, which also lists 23 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 19 Apr 2023.