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

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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