You.Mind! | Boosting First-line Mental Health Care for Youngsters Suffering From Chronic Conditions With Mindfulness
Condition: Chronic Illness
MeSH terms: Chronic Disease
Study type: Interventional

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.
    

Intervention name(s): Mindfulness-Based Intervention
Intervention type(s): Behavioral
Intervention description(s): 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.
Intervention model: Single Group Assignment
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.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Emotional Distress; Quality of Life