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Completed

NCT Number: NCT03067207

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.

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Key information

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Mindful Awareness and Resiliency Skills for Adolescents

Primary outcomes

  1. Mindfulness Skills Acquisition

    Time frame: Up to 6 months

    Acquisition of mindfulness skills as measured by the MAAS-A questionnaire a 14-item Likert-type scale that has been validated in adolescents.

Secondary outcomes

  1. Anxiety and depression score

    Time frame: Up to 6 months

    Anxiety and depression scores as measured by the DASS-21 questionnaire, a Likert-type scale that has been validated in adolescents

  2. Self-Esteem

    Time frame: Up to 6 months

    Self-esteem scores as measured by the Rosemberg Self-Esteem Scale a validated Likert-type scale that has been validated in adolescents.

  3. Salivary cortisol levels

    Time frame: Up to 6 months

    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

  4. Perception of Illness

    Time frame: Up to 6 months

    Perception of illness score (coping with chronic health condition) as measured by the Perceptions of Illness questionnaires a validated Likert-type scale.

  5. Mindfulness home-practice

    Time frame: Up to 6 months

    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.

  6. Appreciation of the mindfulness intervention

    Time frame: Up to 6 months

    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

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

  • Mind and Life Institute, Hadley, Massachusetts
  • University of Toronto

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 1, 2017
Registry last updated
May 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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