Clinical trial NCT03067207: In-Person vs e-Health Mindfulness-Based Intervention for Adolescents With Chronic Illness
Official title: A Randomized-Control Trial of an In-Person vs e-Health Mindfulness-Based Intervention for Adolescents With Chronic Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Illness
Mental Health Impairment
Keywords: mindfulness meditation
Adolescent
eHealth
randomized trial
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Mind and Life Institute, Hadley, Massachusetts
name: University of Toronto
First posted: 2017-03-01
Enrollment: 18
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: The study will be conducted as a longitudinal randomized non-inferiority trial comparing two arms: an experimental arm and feasibility arm. Participants living close enough to commit to in-person sessions will be entered in the experimental arm of the study. The feasibility arm, which will only take place if the targeted number of study participants (60) is not reached for the experimental arm, will be offered to participants who are not able to commit to the in-person mode of delivery. It will consist of two groups, one early e-health group and one wait-list e-Health group. At the end of the recruitment period, once participants have been placed in the experimental and feasibility arms, two separate randomizations will take place. The first randomization (experimental arm) will serve to assign participants to one of the four experimental groups and the second randomization (feasibility arm) will assign participants to one of the two feasibility groups.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: The study will be conducted as a longitudinal randomized controlled trial comparing in-person and eHealth delivery of a mindfulness meditation intervention for adolescents with chronic illness. There will be two arms. An experimental and a feasibility arm. In the experimental arm, 4 groups of 10-15 participants will be formed: two in-person groups (early and late) and two eHealth groups (early and late). The early groups will receive the intervention at the beginning of the study period and the late groups will be wait-list controlled group that will receive the intervention at the middle of the study period. At the end of the recruitment period or when the target number of participants is met (60), whichever comes first, all teens meeting the inclusion criteria will be randomly allocated to one of the four randomized groups. Teens who are not meeting the final inclusion criteria (able to attend mindfulness sessions at Sickkids) will be offered a spot in the feasibility arm of the study until the maximum total number of study participants is reached (60). These participants will be placed in eHealth groups (either early or late) through a separate randomization process.

Data collection will take place at baseline (during the intake meeting), immediately before and following the mindfulness intervention as well as at the end of the 6-month study period. Participants in the experimental arm will provide data through research questionnaires, salivary cortisol analysis as well as individual semi-structured interviews with a research assistant. Salivary samples will be provided from home for participants in the eHealth groups. Participants in the feasibility arm will only provide information through research questionnaires.

Eligibility criteria: 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

Primary outcomes:
measure: Mindfulness Skills Acquisition
timeFrame: Up to 6 months
Secondary outcomes:
measure: Anxiety and depression score
timeFrame: Up to 6 months
measure: Self-Esteem
timeFrame: Up to 6 months
measure: Salivary cortisol levels
timeFrame: Up to 6 months
measure: Perception of Illness
timeFrame: Up to 6 months
measure: Mindfulness home-practice
timeFrame: Up to 6 months
measure: Appreciation of the mindfulness intervention
timeFrame: Up to 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Hospital for Sickkids
name: Miriam Kaufman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Chadi N, Kaufman M, Weisbaum E, Malboeuf-Hurtubise C, Kohut SA, Viner C, Locke J, Vo DX. In-Person Versus eHealth Mindfulness-Based Intervention for Adolescents With Chronic Illness: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2017 Nov 27;6(11):e241. doi: 10.2196/resprot.7700.