Condition category
Mental and Behavioural Disorders
Date applied
15/03/2018
Date assigned
27/03/2018
Last edited
26/03/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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.

Trial website

Contact information

Type

Scientific

Primary contact

Dr Lyn Ellett

ORCID ID

Contact details

Department of Psychology
Royal Holloway
University of London
Egham
Surrey
TW20 0EX
United Kingdom
01784 414049
Lyn.Ellett@rhul.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Mind-01

Study information

Scientific title

Are the short-term benefits of two brief mindfulness interventions sustained? A randomised controlled trial.

Acronym

Study hypothesis

Two brief online mindfulness interventions - involving insight meditation and loving kindness meditation - will result in sustained reductions in anxiety, depression and stress.

Ethics approval

Royal Holloway, University of London Ethics Committee, 20/05/2016, REC project ID: 99

Study design

Single-centre researcher-blinded randomised trial.

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Community

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/01/2016

Overall trial end date

01/07/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18-65 years

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Previous or current mental illness diagnosis

Recruitment start date

21/05/2016

Recruitment end date

28/02/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

Royal Holloway, University of London

Sponsor details

Egham Hill
Egham
Surrey
TW20 0EX
United Kingdom
01784 414049
Lyn.Ellett@rhul.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Not defined

Funder name

Royal Holloway, University of London

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing statement
The datasets generated during the current study are available upon request from Dr Lyn Ellett (Lyn.Ellett@rhul.ac.uk).

Intention to publish date

31/01/2019

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes