- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04099758
A Study of the Effects of a One-session Mindfulness of the Breath Meditation Practice on State Hope and State Gratitude in the General Population
August 21, 2020 updated by: Canterbury Christ Church University
One-session Mindfulness of the Breath Meditation Practice: A Randomized Controlled Study of the Effects on State Hope and State Gratitude
This study aims to examine whether a brief mindfulness of the breath meditation practice is more helpful than listening to an audio recording in relation to improving hope and gratitude in the general population.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This one-session online study will randomise members of the general public to either 1) a mindfulness of the breath meditation practice lasting 10 minutes or 2) an audio-recording control of the same length.
State measures of mindfulness, hope and gratitude will be taken immediately before (baseline) and after the intervention/control.
In addition, the study will also measure trait mindfulness at baseline.The primary hypothesis is that engaging in a brief mindfulness practice will result in beneficial changes in state hope compared to control.
Other hypotheses are that: engaging in a brief mindfulness practice will result in beneficial changes in state gratitude compared to control; that the effect of mindfulness practice on state hope will be statistically mediated by change in state mindfulness; that the effect of mindfulness practice on state gratitude will be statistically mediated by change in state mindfulness; and that baseline trait mindfulness will statistically moderate the effect of mindfulness practice on change in state mindfulness in the above mentioned mediation models (i.e. that moderated mediation will be observed).
Study Type
Interventional
Enrollment (Actual)
580
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kent
-
Tunbridge Wells, Kent, United Kingdom, TN1 2YG
- Canterbury Christ Church University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Members of the general public.
- Adequate understanding of spoken and written English.
- Internet access.
Exclusion Criteria:
-Currently experiencing very severe problems with their mental health.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mindfulness of the breath meditation
10 minute mindfulness of the breath meditation practice delivered online via audio-recording.
|
A 10-minute mindfulness of the breath meditation practice
|
|
Placebo Comparator: Audio-recording control
10 minute non-fiction audio-recording delivered online
|
10 minute non-fiction audio-recording delivered online
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline to post-intervention on the State Hope Scale (SHS).
Time Frame: Baseline (0 minutes), post-intervention (10 minutes).
|
The SHS is a 6-item self-report measure of state hope.
The total score on SHS ranges from 8 to 48 , with higher score indicating greater state hope.
|
Baseline (0 minutes), post-intervention (10 minutes).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline to post-intervention on the Gratitude Adjective Checklist (GAC).
Time Frame: Baseline (0 minutes), post-intervention (10 minutes).
|
The GAC is a 3-item self-report measure of state gratitude.
The total score on GAC ranges from 3 to 15, with higher score indicating greater state gratitude.
|
Baseline (0 minutes), post-intervention (10 minutes).
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline to post-intervention on the Toronto Mindfulness Scale (TMS).
Time Frame: Baseline (0 minutes), post-intervention (10 minutes).
|
The TMS is a 13-item self-report measure of state mindfulness that produces scores for curiosity and decentering.
The curiosity score ranges from 0 to 24, the decentering score from 0 to 28, and the total score from 0 to 52, with higher scores indicating greater curiosity, decentering and overall state mindfulness respectively.
|
Baseline (0 minutes), post-intervention (10 minutes).
|
|
Five Factor Mindfulness Questionnaire -15 item version (FFMQ-15)
Time Frame: Baseline (0 minutes)
|
The FFMQ-15 is a 15-item measure of trait mindfulness.
It will be administered at baseline only.
The total score on the FFMQ-15 ranges from 15 to 75, with higher score indicating greater trait mindfulness.
(Note that the observe subscale will be excluded from the calculation of the total score, as recommended in https://doi.org/10.1002/jclp.21865 and http://dx.doi.org/10.1037/pas0000263
producing a total score between 12 and 60).
|
Baseline (0 minutes)
|
|
Bespoke manipulation check questionnaire.
Time Frame: Post-intervention (10 minutes)
|
Participants rate the extent to which they paid attention during the intervention and followed the guidance on 0 - 10 scales, with higher scores indicating greater compliance.
|
Post-intervention (10 minutes)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: James Cane, PhD, Canterbury Christ Church University
- Principal Investigator: Sarah Strohmaier, BA, MSc, Canterbury Christ Church University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 28, 2019
Primary Completion (Actual)
July 16, 2020
Study Completion (Actual)
July 16, 2020
Study Registration Dates
First Submitted
September 20, 2019
First Submitted That Met QC Criteria
September 20, 2019
First Posted (Actual)
September 23, 2019
Study Record Updates
Last Update Posted (Actual)
August 24, 2020
Last Update Submitted That Met QC Criteria
August 21, 2020
Last Verified
September 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- S_Strohmaier_22_07_2019
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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