Are the short-term benefits of two brief mindfulness interventions sustained?

ISRCTN	ISRCTN14659858
DOI	https://doi.org/10.1186/ISRCTN14659858
Secondary identifying numbers	Mind-01

Submission date: 15/03/2018
Registration date: 27/03/2018
Last edited: 26/03/2018

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

Record updated in last year

Plain English summary of protocol

100 healthy volunteers were randomly allocated to receive a 2 week online mindfulness intervention, consisting of daily 10 minute practice of either insight meditation or loving kindness meditation. All participants completed measures of anxiety, depression, stress and mindfulness stress before starting the intervention, immediately after the intervention and again at 1 month follow up. Whilst both interventions were effective in reducing anxiety, depression and stress and increasing mindfulness skills immediately post intervention, sustained effects were only evident for anxiety. Future research might usefully examine whether these effects continue over a longer follow up period.

Background and study aims
We do not yet know whether the short term benefits of brief mindfulness practice is sustained, and whether there are any differences according to type of mindfulness practice undertaken. This study examines whether two different types of mindfulness interventions - using Insight and Loving Kindness meditations - result in sustained reductions in anxiety, depression and stress, and increases in mindfulness skills, in a nonclinical sample.

Who can participate?
Healthy adults, aged 18-65, with no previous or current mental health diagnoses.

What does the study involve?
Study participants were randomly allocated to receive a 2-week brief online mindfulness intervention, consisting of daily 10-minute practice of either Insight or Loving Kindness meditation.

What are the possible benefits or risks of taking part?
Possible benefits include learning to practice mindfulness, and reductions in anxiety, depression and stress both immediately after the 2-week intervention and at 1 month after the intervention. There are no known risks of taking part.

Where is the study run from?
The study is run from Royal Holloway, University of London.

When is the study starting and how long is it expected to run for?
The trial overall started on 01/01/2016, and recruitment for the trial started on 21/05/2016. Recruitment finished in March 2017.

How long will the trial be recruiting participants for?
The trial will be recruiting participants for approximately 10 months. Royal Holloway, University of London is funding the study.

Who is the main contact?
Dr Lyn Ellett, Lyn.Ellett@rhul.ac.uk.

Contact information

Dr Lyn Ellett
Scientific

Department of Psychology
Royal Holloway, University of London
Egham
Surrey
TW20 0EX
United Kingdom

Phone	01784 414049
Email	Lyn.Ellett@rhul.ac.uk

Study information

Study design	Single-centre researcher-blinded randomised trial.
Primary study design	Interventional
Secondary study design	Randomised parallel trial
Study setting(s)	Community
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet.
Scientific title	Are the short-term benefits of two brief mindfulness interventions sustained? A randomised controlled trial.
Study objectives	Two brief online mindfulness interventions - involving insight meditation and loving kindness meditation - will result in sustained reductions in anxiety, depression and stress.
Ethics approval(s)	Royal Holloway, University of London Ethics Committee, 20/05/2016, REC project ID: 99
Health condition(s) or problem(s) studied	Anxiety, depression and stress
Intervention	Participants were randomly allocated to a 2-week online mindfulness intervention consisting of daily 10-minute practice of either Insight Meditation (n=50) or Loving Kindness Meditation (n=50).
Intervention type	Behavioural
Primary outcome measure	Anxiety, depression and stress were assessed using the Depression, Anxiety & Stress Scales questionnaire at baseline, post-intervention and at 1-month follow-up.
Secondary outcome measures	Mindfulness was assessed using the Five Facet Mindfulness Questionnaire at baseline, post-intervention and at 1-month follow-up.
Overall study start date	01/01/2016
Completion date	01/07/2017

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	Both
Target number of participants	100
Key inclusion criteria	1. Aged 18-65 years
Key exclusion criteria	1. Previous or current mental illness diagnosis
Date of first enrolment	21/05/2016
Date of final enrolment	28/02/2017

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Royal Holloway, University of London

Egham Hill, Egham
Surrey
TW20 0EX
United Kingdom

Sponsor information

Royal Holloway, University of London
University/education

Egham Hill
Egham
Surrey
TW20 0EX
England
United Kingdom

Phone	01784 414049
Email	Lyn.Ellett@rhul.ac.uk
"ROR"	https://ror.org/04g2vpn86

Funders

Funder type

Not defined

Royal Holloway, University of London

No information available

Results and Publications

Intention to publish date	31/01/2019
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Planned publication in a high-impact peer reviewed journal.
IPD sharing plan	The datasets generated during the current study are available upon request from Dr Lyn Ellett (Lyn.Ellett@rhul.ac.uk).