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

NCT04359563 | Completed

• 1 other identifier: S63485
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Illness

Keywords

Emotional Distress; Quality of Life

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (13)

• 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)

• 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)

• 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)

• 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)

• 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)

Other Outcomes (2)

• Harms and Unpleasant Experiences Survey (HUES)

  In the week after the intervention (post-measurement)

• Positive and negative aspects of mindfulness

  3 months after the intervention (follow-up)

Study Arms (1)

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.

Behavioral: Mindfulness-Based Intervention

Interventions

Mindfulness-Based Intervention BEHAVIORAL

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.

Mindfulness-Based Intervention

Eligibility Criteria

• Age: 14 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• KU Leuven: lead
• Fondation Huoshen: collaborator

Study Sites (1)

KU Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Related Publications (23)

• 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.

  PMID: 16398788 BACKGROUND

• 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.

  PMID: 28391490 BACKGROUND

• 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.

  PMID: 16675113 BACKGROUND

• 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.

  PMID: 21315886 BACKGROUND

• 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.

  PMID: 20360998 BACKGROUND

• 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.

  PMID: 27254018 BACKGROUND

• Kabat-Zinn J. Full catastrophe living: How to cope with stress, pain and illness using mindful meditation. New York: Delacorte. 1990.

  BACKGROUND

• Lovibond SH, Lovibond PF. Manual for the depression anxiety stress scales. Psychology Foundation of Australia. 1996.

  BACKGROUND

• 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.

  PMID: 21088072 BACKGROUND

• 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.

  PMID: 21584907 BACKGROUND

• 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.

  PMID: 29168956 BACKGROUND

• Segal ZV, Williams JMG. Mindfulness-Based Cognitive Therapy for Depression: A New Approach to Preventing Relapse (2nd ed.). New York: Guilford Publications Inc. 2012.

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 28002681 BACKGROUND

• 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.

  PMID: 11468499 BACKGROUND

• Abujaradeh H, Safadi R, Sereika SM, Kahle CT, Cohen SM. Mindfulness-Based Interventions Among Adolescents With Chronic Diseases in Clinical Settings: A Systematic Review. J Pediatr Health Care. 2018 Sep-Oct;32(5):455-472. doi: 10.1016/j.pedhc.2018.04.001. Epub 2018 Jun 22.

  PMID: 29941236 BACKGROUND

• Ahola Kohut S, Stinson J, Davies-Chalmers C, Ruskin D, van Wyk M. Mindfulness-Based Interventions in Clinical Samples of Adolescents with Chronic Illness: A Systematic Review. J Altern Complement Med. 2017 Aug;23(8):581-589. doi: 10.1089/acm.2016.0316. Epub 2017 Mar 29.

  PMID: 28355082 BACKGROUND

• Blanck P, Perleth S, Heidenreich T, Kroger P, Ditzen B, Bents H, Mander J. Effects of mindfulness exercises as stand-alone intervention on symptoms of anxiety and depression: Systematic review and meta-analysis. Behav Res Ther. 2018 Mar;102:25-35. doi: 10.1016/j.brat.2017.12.002. Epub 2017 Dec 20.

  PMID: 29291584 BACKGROUND

• Xunlin NG, Lau Y, Klainin-Yobas P. The effectiveness of mindfulness-based interventions among cancer patients and survivors: a systematic review and meta-analysis. Support Care Cancer. 2020 Apr;28(4):1563-1578. doi: 10.1007/s00520-019-05219-9. Epub 2019 Dec 13.

  PMID: 31834518 BACKGROUND

• Greeson JM, Chin GR. Mindfulness and physical disease: a concise review. Curr Opin Psychol. 2019 Aug;28:204-210. doi: 10.1016/j.copsyc.2018.12.014. Epub 2018 Dec 27.

  PMID: 30785067 BACKGROUND

• Greeson JM, Zarrin H, Smoski MJ, Brantley JG, Lynch TR, Webber DM, Hall MH, Suarez EC, Wolever RQ. Mindfulness Meditation Targets Transdiagnostic Symptoms Implicated in Stress-Related Disorders: Understanding Relationships between Changes in Mindfulness, Sleep Quality, and Physical Symptoms. Evid Based Complement Alternat Med. 2018 May 13;2018:4505191. doi: 10.1155/2018/4505191. eCollection 2018.

  PMID: 29861769 BACKGROUND

• Hofmann SG, Gomez AF. Mindfulness-Based Interventions for Anxiety and Depression. Psychiatr Clin North Am. 2017 Dec;40(4):739-749. doi: 10.1016/j.psc.2017.08.008. Epub 2017 Sep 18.

  PMID: 29080597 BACKGROUND

• Kock M, Van Hoecke E, Raes F, Van der Gucht K. Study protocol for You.Mind!: boosting first-line mental health care for YOUngsters suffering from chronic conditions with mindfulness: a randomised staggered within-subjects design. BMJ Open. 2021 Apr 9;11(4):e042648. doi: 10.1136/bmjopen-2020-042648.

  PMID: 33837097 DERIVED

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Katleen Van der Gucht, PhD

  KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 21, 2020
• First Posted: April 24, 2020
• Study Start: July 2, 2020
• Primary Completion: February 9, 2022
• Study Completion: February 9, 2022
• Last Updated: April 19, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: The coded, pseudonomized dataset and supporting information (see above) will be available beginning from 3 months and ending 5 years after publication of the research results.
• Access Criteria: Coded, pseudonomized data can be shared with regulatory authorities, ethical committees, other parties that collaborate with the research team and will be shared, as mentioned above, upon reasonable request. Other researchers will only have access to the coded, pseudonomized data, and only if they agree with the confidentiality rules agreed upon within this study.

Locations

BE (1)