HealthyNCT04099758
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
A study testing Mindfulness of the breath meditation in people with Healthy, run by Canterbury Christ Church University at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Mindfulness of the breath meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 580 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Oct 2019to 16 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Members of the general public.
- Adequate understanding of spoken and written English.
- Internet access.
Who cannot join
- -Currently experiencing very severe problems with their mental health.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Canterbury Christ Church University
Royal Tunbridge Wells, Kent, TN1 2YG
About this study
Official title: 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.
Read the 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).
- Conditions
- Healthy
- Being tested
- Mindfulness of the breath meditation, Audio-recording control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness of the breath meditationBehavioural
A 10-minute mindfulness of the breath meditation practice
Audio-recording controlBehavioural
10 minute non-fiction audio-recording delivered online
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness of the breath meditation | Experimental | 10 minute mindfulness of the breath meditation practice delivered online via audio-recording. Receives: Behavioral: Mindfulness of the breath meditation |
| Audio-recording control | Placebo comparator | 10 minute non-fiction audio-recording delivered online Receives: Behavioral: Audio-recording control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (0 minutes), post-intervention (10 minutes).
Secondary outcomes (1)
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.
Measured: Baseline (0 minutes), post-intervention (10 minutes).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start28 Oct 2019
- Primary completion16 Jul 2020
- Study completion16 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled study.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 580 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canterbury Christ Church University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah Strohmaier, BA, MSc, Principal investigator, Canterbury Christ Church UniversityFergal Jones, PhD, PsychD, Study director, Canterbury Christ Church UniversityJames Cane, PhD, Study director, Canterbury Christ Church University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04099758
- Sponsor's protocol ID
- S_Strohmaier_22_07_2019
- Status last verified
- Sep 2019
- First submitted
- 20 Sep 2019
- Last updated
- 24 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-session Mindfulness of the Breath Meditation Practice: A Randomized Controlled Study of the Effects on State Hope and State Gratitude
- ClinicalTrials.gov ID
- NCT04099758
- Acronym / sponsor ID
- S_Strohmaier_22_07_2019
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 580 participants (actual)
- Lead sponsor
- Canterbury Christ Church UniversityUniversity, hospital or other
- Study start
- 28 Oct 2019 (actual)
- Primary completion
- 16 Jul 2020 (actual)
- Study completion
- 16 Jul 2020 (actual)
- First posted
- 23 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled study.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness of the breath meditation | Experimental | Behavioral: Mindfulness of the breath meditation10 minute mindfulness of the breath meditation practice delivered online via audio-recording. |
| Audio-recording control | Placebo comparator | Behavioral: Audio-recording control10 minute non-fiction audio-recording delivered online |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Members of the general public.
- Adequate understanding of spoken and written English.
- Internet access.
Key exclusion criteria (1 listed)
- -Currently experiencing very severe problems with their mental health.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness of the breath meditationA 10-minute mindfulness of the breath meditation practice | Behavioural | Mindfulness of the breath meditation |
| Audio-recording control10 minute non-fiction audio-recording delivered online | Behavioural | Audio-recording control |
Primary outcome
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.
1 secondary outcome
Change from baseline to post-intervention on the Gratitude Adjective Checklist (GAC).
Time frame: Baseline (0 minutes), post-intervention (10 minutes).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2020.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Strohmaier, BA, MSc principal investigator
Canterbury Christ Church University
Fergal Jones, PhD, PsychD study director
Canterbury Christ Church University
James Cane, PhD study director
Canterbury Christ Church University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness of the breath meditation in people with Healthy, run by Canterbury Christ Church University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to post-intervention on the State Hope Scale (SHS). (time frame: Baseline (0 minutes), post-intervention (10 minutes).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2020.