Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT04359563
Study type Interventional
Source KU Leuven
Contact
Status Completed
Phase N/A
Start date July 2, 2020
Completion date February 9, 2022

See also
  Status Clinical Trial Phase
Terminated NCT03048565 - A Trial of an Online Mindfulness Based Programme for Informal Caregivers of People With Chronic Illnesses N/A
Recruiting NCT05785494 - Web-based Support for Family Caregivers of Patients With Advanced Cancer N/A
Completed NCT03601884 - Effectiveness of OHP in Improving Self-efficacy in Patients With Diabetes Mellitus N/A
Recruiting NCT03170167 - Communitas: A Program for Teens Living With Chronic Illness and Their Families
Completed NCT01955005 - Use of the My HealtheVet for Health Information Sharing N/A
Completed NCT01107119 - Integrated Care Pathways in a Community Setting N/A
Completed NCT00194584 - Childhood Chronic Illness: An Educational Program for Parents of Children With On-Going Health Care Needs N/A
Completed NCT03434626 - Advance Care Planning & Goals of Care Randomized Controlled Trial in Primary Care N/A
Recruiting NCT05437978 - "Sport on Prescription" in Primary Care for Patients With Long-term Illnesses N/A
Completed NCT03067207 - In-Person vs e-Health Mindfulness-Based Intervention for Adolescents With Chronic Illness N/A
Completed NCT02277327 - Trial to Reduce Hospitalizations in Children With Medical Complexity Phase 2
Recruiting NCT01480765 - Preventing Pain After Heart Surgery Phase 4
Completed NCT01834456 - Comprehensive Care of Children With Medical Complexity N/A
Completed NCT00773942 - Design & Evaluation of a Medication Therapy Management Program to Improve Patient Safety in Medicare Beneficiaries N/A
Terminated NCT00399373 - Structuring the Integration of Care Management Services For Medicaid Enrollees Recipients With Chronic Illness, Substance Abuse Problems and Possible Psychiatric Disorders N/A
Completed NCT02925897 - Enhancing Self-care in the Housebound N/A
Completed NCT01321853 - Home Care Medication Management Program for the Frail Elderly Phase 1
Completed NCT03295097 - Characteristics and Clinical Implications of a Clinical Decision Support System N/A
Suspended NCT04978610 - Virtual ACT for Adolescent Stress N/A
Completed NCT01797068 - Patient Navigation for Medicaid Frequent ED Users N/A