In-Person vs e-Health Mindfulness-Based Intervention for Adolescents With Chronic Illness

A Randomized-Control Trial of an In-Person vs e-Health Mindfulness-Based Intervention for Adolescents With Chronic Illness

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.

Study Overview

• Status: Completed
• Conditions: Mental Health Impairment; Chronic Illness
• Intervention / Treatment: Behavioral: MARS-A

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; The experimental arm will consist of four groups with a target of 15 participants each: one early intervention group, one wait-list in-person group, one early e-Health group and one wait-list e-health group. All participants will receive the mindfulness intervention, MARS-A, either in-person or via e-health by the end of the 6-month study period. Participants in the in-person groups will meet at in hospital at a designated teen-friendly room containing chairs and yoga mats. Participants in the e-health groups will be encouraged to find a quiet room in their home and will be required to have access to the Internet, a desktop/laptop computer equipped with a webcam or a tablet/smartphone with webcam function.	Behavioral: MARS-A; The intervention will consist of the 8-week mindfulness meditation program designed for adolescents with chronic health conditions.MARS-A is based on two established mindfulness-based interventions for adults: MBSR and MBCT. The content of the program will be the same for in-person and e-health groups: all participants will receive eight 90-minute weekly evening sessions led by two trained and experienced mindfulness providers. Sessions will include short meditation practices, breathing exercises, guided discussion, mindful movements and inquiry, adapted to the context of chronic illness. Every session will start with a brief review of home practice and will close with a discussion of the home practice for the following week.; Other Names: Mindful Awareness and Resiliency Skills for Adolescents
Other: Feasibility; 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. The intervention delivered, MARS-A, will be identical as the intervention delivered to e-health groups in the experimental arm.	Behavioral: MARS-A; The intervention will consist of the 8-week mindfulness meditation program designed for adolescents with chronic health conditions.MARS-A is based on two established mindfulness-based interventions for adults: MBSR and MBCT. The content of the program will be the same for in-person and e-health groups: all participants will receive eight 90-minute weekly evening sessions led by two trained and experienced mindfulness providers. Sessions will include short meditation practices, breathing exercises, guided discussion, mindful movements and inquiry, adapted to the context of chronic illness. Every session will start with a brief review of home practice and will close with a discussion of the home practice for the following week.; Other Names: Mindful Awareness and Resiliency Skills for Adolescents

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Collaborators: University of Toronto; Mind and Life Institute, Hadley, Massachusetts
• Investigators: Principal Investigator: Miriam Kaufman, MD, Hospital for SickKids

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2016
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 15, 2017

Study Registration Dates

• First Submitted: February 15, 2017
• First Submitted That Met QC Criteria: February 23, 2017
• First Posted (Actual): March 1, 2017

Study Record Updates

• Last Update Posted (Actual): May 15, 2018
• Last Update Submitted That Met QC Criteria: May 14, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Adolescent; randomized trial; eHealth; mindfulness meditation
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease
• Other Study ID Numbers: REB1000053600

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No