Chronic Illness Clinical Trial
Official title:
A Randomized-Control Trial of an In-Person vs e-Health Mindfulness-Based Intervention for Adolescents With Chronic Illness
Verified date | May 2018 |
Source | The Hospital for Sick Children |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will seek to compare the effect of a mindfulness meditation program for adolescents with chronic illness delivered either in person or via an online platform. The 8-week program will combine meditation practices, breathing exercises and group discussions. Participants will be recruited from different general and specialized clinics at the Hospital for Sick Children and will be allocated to either an in-person or the online group through a random process (like tossing a coin). The study will aim to recruit 60 participants ages 13-18. Each participant will provide data through research questionnaires, recorded interviews and saliva samples.
Status | Completed |
Enrollment | 18 |
Est. completion date | June 15, 2017 |
Est. primary completion date | June 1, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 13 Years to 18 Years |
Eligibility |
Inclusion Criteria: - Diagnosis of chronic illness - Fluent in English - Followed by a care provider at the Hospital for SickKids - Able to consent to the study - Able to attend in-person mindfulness meditation sessions at Sickkids (for the experimental arm only) Exclusion Criteria: - Active and unaddressed suicidal ideation - Developmental disability preventing participation in the mindfulness program |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
The Hospital for Sick Children | Mind and Life Institute, Hadley, Massachusetts, University of Toronto |
Chadi N, McMahon A, Vadnais M, Malboeuf-Hurtubise C, Djemli A, Dobkin PL, Lacroix J, Luu TM, Haley N. Mindfulness-based Intervention for Female Adolescents with Chronic Pain: A Pilot Randomized Trial. J Can Acad Child Adolesc Psychiatry. 2016 Fall;25(3):159-168. Epub 2016 Nov 1. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mindfulness Skills Acquisition | Acquisition of mindfulness skills as measured by the MAAS-A questionnaire a 14-item Likert-type scale that has been validated in adolescents. | Up to 6 months | |
Secondary | Anxiety and depression score | Anxiety and depression scores as measured by the DASS-21 questionnaire, a Likert-type scale that has been validated in adolescents | Up to 6 months | |
Secondary | Self-Esteem | Self-esteem scores as measured by the Rosemberg Self-Esteem Scale a validated Likert-type scale that has been validated in adolescents. | Up to 6 months | |
Secondary | Salivary cortisol levels | Salivary cortisol levels measured at 8am, 12pm, pre and post meditation at weeks 1 and 8 of the intervention. Sampled by Salivette devices (cotton swabs) and analyzed by enzyme immune-assay | Up to 6 months | |
Secondary | Perception of Illness | Perception of illness score (coping with chronic health condition) as measured by the Perceptions of Illness questionnaires a validated Likert-type scale. | Up to 6 months | |
Secondary | Mindfulness home-practice | Compilation of personal mindfulness meditation practice through self-reported log books filled at the beginning of each session of the 8-week mindfulness meditation program. | Up to 6 months | |
Secondary | Appreciation of the mindfulness intervention | Semi-structured interviews conducted by research assistant with participants having completed the 8-week mindfulness meditation program. Interviews will compare appreciation between in-person and e-Health groups | Up to 6 months |
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