Chronic IllnessNCT03067207
In-Person vs e-Health Mindfulness-Based Intervention for Adolescents With Chronic Illness
A study testing MARS-A in people with Chronic Illness and Mental Health Impairment, run by The Hospital for Sick Children.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Chronic Illness, Mental Health Impairment
- What is being tested?
- MARS-A
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 4 Nov 2016to 15 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- Active and unaddressed suicidal ideation
- Developmental disability preventing participation in the mindfulness program
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Illness, Mental Health Impairment
- Being tested
- MARS-A
- Keywords
- mindfulness meditation, Adolescent, eHealth, randomized trial
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MARS-ABehavioural
Also called Mindful Awareness and Resiliency Skills for Adolescents
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: MARS-A |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 6 months
Secondary outcomes (6)
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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2017
- Study start4 Nov 2016
- Primary completion1 Jun 2017
- Study completion15 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic IllnessStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Mind and Life Institute, Hadley, Massachusetts, University of Toronto
- Responsible party
- Principal investigator, Miriam Kaufman, The Hospital for Sick Children
- Investigators
- Miriam Kaufman, MD, Principal investigator, Hospital for Sickkids
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03067207
- Sponsor's protocol ID
- REB1000053600
- Status last verified
- May 2018
- First submitted
- 15 Feb 2017
- Last updated
- 15 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 27924146Chadi 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.
PubMed 29180345
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized-Control Trial of an In-Person vs e-Health Mindfulness-Based Intervention for Adolescents With Chronic Illness
- ClinicalTrials.gov ID
- NCT03067207
- Acronym / sponsor ID
- REB1000053600
- Conditions
- Chronic Illness, Mental Health Impairment
- Keywords
- mindfulness meditation, Adolescent, eHealth, randomized trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Mind and Life Institute, Hadley, Massachusetts, University of Toronto
- Study start
- 4 Nov 2016 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 15 Jun 2017 (actual)
- First posted
- 1 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: MARS-AThe 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. |
| Feasibility | Other | Behavioral: MARS-AThe 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. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (2 listed)
- Active and unaddressed suicidal ideation
- Developmental disability preventing participation in the mindfulness program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MARS-AAlso: Mindful Awareness and Resiliency Skills for AdolescentsThe 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. | Behavioural | Experimental, Feasibility |
Primary outcome
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.
6 secondary outcomes
Anxiety and depression score
Time frame: Up to 6 months
Self-Esteem
Time frame: Up to 6 months
Salivary cortisol levels
Time frame: Up to 6 months
Perception of Illness
Time frame: Up to 6 months
Mindfulness home-practice
Time frame: Up to 6 months
Appreciation of the mindfulness intervention
Time frame: Up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2018.
- Background: PubMed 27924146Chadi 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.
- Derived from this study: PubMed 29180345Chadi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miriam Kaufman, MD principal investigator
Hospital for Sickkids
Questions about this trial
What is this clinical trial studying?
A study testing MARS-A in people with Chronic Illness and Mental Health Impairment, run by The Hospital for Sick Children.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mindfulness Skills Acquisition (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03067207, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2018.