The impact of technology supported mindfulness training on attention and emotion

ISRCTN ISRCTN43629398
DOI https://doi.org/10.1186/ISRCTN43629398
Secondary identifying numbers 32099
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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

Prof Norman Farb
Public

University of Toronto Mississauga
3359 Mississauga Road
Dept of Psychology - Deerfield
Mississauga
L5L 1C6
Canada

ORCiD logoORCID ID 0000-0002-8407-2938
Phone +1 905 828 3859
Email norman.farb@utoronto.ca

Study information

Study designSingle-centre randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Community
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet.
Scientific titleAttentional and Affective Consequences of technology supported Mindfulness Training
Study acronymAACtsMT
Study objectivesTechnology-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) studiedGeneral affective health
InterventionFollowing 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 typeBehavioural
Primary outcome measure1. Affective symptom severity is measured using the Public Health Questionnaire (PHQ-SADS) at baseline and 6 weeks
2. Attention is measured using reaction time on a behavioural Stroop Task at baseline and 6 weeks
Secondary outcome measures1. Dispositional mindfulness is measured using the Freiburg Mindfulness Inventory (FMI) at baseline and 6 weeks
2. Current emotional state is measured using the Positive and Negative Affective Schedule (PANAS) at baseline and 6 weeks
3. Well-being (physical, psychological, social, and environmental) is measured using the brief version of the World Health Organization Quality of Life scale (WHOQOL-BREF) at baseline and 6 weeks
4. Personality trait impact on intervention responsiveness is measured using the Big Five Inventory (BFI) personality checklist at baseline and 6 weeks
Overall study start date01/03/2014
Completion date15/12/2015

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants40
Key inclusion criteria1. Fluency in English
2. Normal or corrected to normal vision
3. Aged 18 and over
Key exclusion criteria1. 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 enrolment05/01/2015
Date of final enrolment01/05/2015

Locations

Countries of recruitment

  • Canada

Study participating centre

Baycrest Health Sciences Centre
3560 Bathurst Street
Toronto
M6A 2E1
Canada

Sponsor information

Ontario Centres for Excellence (OCE)
Government

156 Front Street West
Suite 200
Toronto
M5J 2L6
Canada

Phone +1 416 861 1092
Email Martin.Lord@oce-ontario.org
Website http://www.oce-ontario.org/
ROR logo "ROR" https://ror.org/01t8nk565

Funders

Funder type

Government

Ontario Centre for Excellence Voucher for Innovation Program

No information available

Results and Publications

Intention to publish date31/12/2016
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryStored in repository
Publication and dissemination planPlanned submission to peer reviewed, open source journal.
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 29/11/2016 Yes No

Editorial Notes

01/12/2016: Publication reference added.