The impact of technology supported mindfulness training on attention and emotion
| ISRCTN | ISRCTN43629398 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43629398 |
| Protocol serial number | 32099 |
| Sponsor | Ontario Centres for Excellence (OCE) |
| Funder | Ontario Centre for Excellence Voucher for Innovation Program |
- Submission date
- 15/06/2016
- Registration date
- 16/06/2016
- Last edited
- 01/12/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Mindfulness refers to a mental state achieved by becoming aware of the present moment, while recognizing one’s thoughts, feelings and bodily sensations. Mindfulness training (MT) programs are becoming more common in the treatment of a range of mental health conditions, as well as improving attention and lowering stress. Research support for MT is currently mainly based on weekly instructor-led group sessions. It is unknown whether patients may benefit from technology-supported MT (tsMT), in which meditation is delivered individually, without the need for a facilitator, travel to a training site, or the presence of a supportive group environment. The aim of this study is to find out whether tsMT could help improve attention and feelings of wellbeing more effectively than algebra training.
Who can participate?
Healthy adults with good eyesight who are fluent in English.
What does the study involve?
After learning about the study and agreeing to take part, participants are first asked to complete some questionnaires to measure their mood and sense of well-being, and also to perform a task that involved naming colour words that were sometimes presented in a different colour (Stroop test), in order to measure attention. Participants are then randomly assigned to one or two groups. Those in the first group practice meditation using a brain feedback headband (which provides sounds that reflect the brain’s state, such as beach waves and wind) and iPad for 10 minutes a day for six weeks. Those in the second group practice algebra on an online training program for 10 minutes every day for six weeks. After each practice session, participants fill out a brief survey to confirm their practice and rate their experience. Participants are required to practice on at least 75% of these days to stay in the study. At the end of the 6 weeks, participants return to the study centre and repeat questionnaires and colour naming task.
What are the possible benefits and risks of participating?
There are no known benefits of participating, although there is a possibility that taking part in the mindfulness training could promote a greater sense of wellbeing. There are no risks involved with participating in this study.
Where is the study run from?
Baycrest Health Sciences Centre (Canada)
When is the study starting and how long is it expected to run for?
March 2014 to December 2015
Who is funding the study?
Ontario Centre for Excellence Voucher for Innovation Program (Canada)
Who is the main contact?
Professor Norman Farb
norman.farb@utoronto.ca
Contact information
Public
University of Toronto Mississauga
3359 Mississauga Road
Dept of Psychology - Deerfield
Mississauga
L5L 1C6
Canada
 ORCID ID |
0000-0002-8407-2938 |
|---|---|
| Phone | +1 905 828 3859 |
| norman.farb@utoronto.ca |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Attentional and Affective Consequences of technology supported Mindfulness Training |
| Study acronym | AACtsMT |
| Study objectives | Technology-supported mindfulness training will produce greater improvements to attention and subjective well-being than an active control training condition. |
| Ethics approval(s) | 1. Clinical Ethics Committee Baycrest Health Sciences Centre, 21/11/2014, ref: 12-54 2. University of Toronto Research Ethics Committee, 24/04/2015, ref: 31579 |
| Health condition(s) or problem(s) studied | General affective health |
| Intervention | Following initial telephone screening interviews, participants sre invited to attend assessment sessions at the Rotman Research Institute at Baycrest Health Centre in Toronto, Canada, a Health Centre fully affiliated with the University of Toronto. Participants complete a short battery of attention and executive control tasks, and self-report measures of well-being. Participants are blind to experimental condition while completing the baseline assessment battery, before being informed of their group assignment to the mindfulness training or active control conditions. Randomization is carried out using a random number generator in the MATLAB computing environment, which randomly assigns sub-blocks of 4 participants to ensure even recruitment throughout the study, i.e. within each sub-block, 2 participants are assigned to the mindfulness training group and 2 are assigned to the control group. Randomization is performed by the study PI and communicated to the research assistants upon participant booking without any direct contact between the PI and participants. Mindfulness Training: To deliver the technology supported MT intervention, Interaxon Inc.’s Muse is employed, a wireless EEG headset and accompanying mobile device software application. Participants are provided with a Muse headset, iPod with the pre-installed Calm App, charging cables and headphones. Participants are taught to set up the Muse headset and associated software application, which delivers a guided-meditation application focusing attention on the breath, a core introductory meditation practice in mindfulness training. The application provides step-by-step instructions on operating the headset and guides participants through MT sessions. Users begin a mediation session by clicking on an icon and are lead through the exercise by a voice recording. The Muse headset collects data and transmits the information to the application that provides real-time auditory feedback during the meditation session. In a virtual beach environment, the auditory feedback consists of beach waves and wind sounds that reflect the brain’s state, allowing the trainee to gauge their performance in attaining a meditative state. A calm score is calculated at the end of the session, which reports the length of time the brain was calm during the session. Active Control Training: Participants are enrolled in a free, online, high school level algebra class (Khan Academy), in which they are presented with a mixture of brief lectures and math problems. Daily training consists of completing 10 minutes of course material. The program allows participants to learn concepts through feedback/hints, and watching videos demonstrating how to solve similar problems. At the end of learning each concept, participants receive a score of correct responses and are awarded a mastery level to move on to the next concept. The daily training lasts for 6 weeks (42 days). Participants are required to complete at least 32/42 (75%) sessions over the six weeks of training. A successful training session consists of completing either a 10-minute meditation session with the Muse or completing 10 minutes of algebra practice problems on Khan Academy. Following the 6 week training period, participants attend a post-intervention assessment. There is no subsequent follow-up period. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
1. Affective symptom severity is measured using the Public Health Questionnaire (PHQ-SADS) at baseline and 6 weeks |
| Key secondary outcome measure(s) |
1. Dispositional mindfulness is measured using the Freiburg Mindfulness Inventory (FMI) at baseline and 6 weeks |
| Completion date | 15/12/2015 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 40 |
| Key inclusion criteria | 1. Fluency in English 2. Normal or corrected to normal vision 3. Aged 18 and over |
| Key exclusion criteria | 1. Presence of any neuropsychological or psychiatric condition that may influence the functioning of the nervous system 2. History of head injury 3. Prior meditation experience |
| Date of first enrolment | 05/01/2015 |
| Date of final enrolment | 01/05/2015 |
Locations
Countries of recruitment
- Canada
Study participating centre
Toronto
M6A 2E1
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in repository |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 29/11/2016 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
01/12/2016: Publication reference added.
