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

NCT04359563 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2023-04-19

No results posted yet for this study

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

Interventions

BEHAVIORAL

Mindfulness-Based Intervention

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.

Sponsors & Collaborators

  • Fondation Huoshen

    collaborator UNKNOWN

  • KU Leuven

    lead OTHER

Principal Investigators

  • Katleen Van der Gucht, PhD · KU Leuven

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-02
Primary Completion
2022-02-09
Completion
2022-02-09

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04359563 on ClinicalTrials.gov