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

NCT03067207 | Completed

• 1 other identifier: REB1000053600
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Illness; Mental Health Impairment

Keywords

mindfulness meditation; Adolescent; eHealth; randomized trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Anxiety and depression score

  Up to 6 months

• Self-Esteem

  Up to 6 months

• Salivary cortisol levels

  Up to 6 months

• Perception of Illness

  Up to 6 months

• Mindfulness home-practice

  Up to 6 months

Study Arms (2)

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

Feasibility

OTHER

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

Interventions

MARS-A BEHAVIORAL

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.

Also known as: Mindful Awareness and Resiliency Skills for Adolescents

Experimental; Feasibility

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• Active and unaddressed suicidal ideation
• Developmental disability preventing participation in the mindfulness program

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Mind and Life Institute, Hadley, Massachusetts: collaborator
• University of Toronto: collaborator

Related Publications (2)

• 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.

  PMID: 27924146 BACKGROUND

• 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.

  PMID: 29180345 DERIVED

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Miriam Kaufman, MD

  Hospital for Sickkids

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: This study will be a single-blinded study (investigators only). Participants will be coded using Arabic numerals. A research assistant will receive all questionnaires and cortisol samples. Mindfulness facilitators will be unaware of participant identification numbers. Participants will be assigned to one of four groups (experimental arm) or to one of two groups (feasibility arm) following a computer-generated randomization list (permuted block design, using blocks of two or four). The allocation sequence will be generated by a statistician not otherwise involved in the project and passed on to a research assistant after patient identification data has been collected (ensuring that the investigators are kept blind to the allocation of each participant). Allocation sequence will be password-protected and only accessible by the statistician and research assistant.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Head, Adolescent Medicine

Model Details: 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.

Study Record Dates

• First Submitted: February 15, 2017
• First Posted: March 1, 2017
• Study Start: November 4, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 15, 2017
• Last Updated: May 15, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share