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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04099758
Other study ID # S_Strohmaier_22_07_2019
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 28, 2019
Est. completion date July 16, 2020

Study information

Verified date September 2019
Source Canterbury Christ Church University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 580
Est. completion date July 16, 2020
Est. primary completion date July 16, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Mindfulness of the breath meditation
A 10-minute mindfulness of the breath meditation practice
Audio-recording control
10 minute non-fiction audio-recording delivered online

Locations

Country Name City State
United Kingdom Canterbury Christ Church University Tunbridge Wells Kent

Sponsors (1)

Lead Sponsor Collaborator
Canterbury Christ Church University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other Change from baseline to post-intervention on the Toronto Mindfulness Scale (TMS). 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).
Other Five Factor Mindfulness Questionnaire -15 item version (FFMQ-15) 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)
Other Bespoke manipulation check questionnaire. 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)
Primary Change from baseline to post-intervention on the State Hope Scale (SHS). 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 Change from baseline to post-intervention on the Gratitude Adjective Checklist (GAC). 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).
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