MindfulnessNCT03797599
Study Examining the Effects of Mindfulness and Similar Audio-guided Exercises.
A study testing 20 minutes of mindfulness practice, 5 minutes of mindfulness practice and 5 minute audio book in people with Mindfulness and Healthy Population, run by Canterbury Christ Church University at 1 site in United Kingdom.
Trial summary
This study aims to examine whether greater length of mindfulness practice results in more beneficial outcomes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mindfulness, Healthy Population
- What is being tested?
- 20 minutes of mindfulness practice, 5 minutes of mindfulness practice and 5 minute audio book
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Mar 2019to 5 Dec 2019
- 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, especially university students or staff.
- Adequate understanding of spoken and written English
Who cannot join
- Currently experiencing significant difficulties with their mental wellbeing.
- Currently have a personal mindfulness practice.
- Currently participating in a mindfulness-based intervention.
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: The Effects of Length of Mindfulness Practice on Mindfulness, Depression, Anxiety and Stress: A Randomised Controlled Experiment
This study aims to examine whether greater length of mindfulness practice results in more beneficial outcomes.
Read the detailed description
This study will randomise participants to one of three groups: (1) four sessions of medium length mindfulness practice (lasting 20 mins) and 5 mins of an audio book; (2) four sessions of brief mindfulness practice (lasting 5 mins) and 20 mins of an audio book; and (3) a control group who just receive 4 sessions of audio book (lasting 25 mins). In the mindfulness arms, in each session, the participants will receive the audio book prior to the mindfulness practice. Mindfulness levels, and depression, anxiety and stress will be measured by self-report at baseline, session by session, and at post-intervention.
- Conditions
- Mindfulness, Healthy Population
- Being tested
- 20 minutes of mindfulness practice, 5 minutes of mindfulness practice, 5 minute audio book, 20 minute audio book, 25 minute audio book
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20 minutes of mindfulness practiceBehavioural
A 20 minute audio guided mindfulness of breathing practice per session, for four sessions.
5 minutes of mindfulness practiceBehavioural
A 5 minute audio guided mindfulness of breathing practice per session, for four sessions.
5 minute audio bookOther
5 minutes from an audio book by Bill Bryson ('A Short History of Nearly Everything') per session, for four sessions.
20 minute audio bookOther
20 minutes from an audio book by Bill Bryson ('A Short History of Nearly Everything'), per session, for four sessions.
25 minute audio bookOther
25 minutes from an audio book by Bill Bryson ('A Short History of Nearly Everything'), per session, for four sessions.
| Study group | Role | What they receive |
|---|---|---|
| 20 minutes of mindfulness practice | Experimental | Two sessions a week for two weeks of: 5 minutes listening to audio book excerpts followed by 20 minutes of audio guided mindfulness practice. Participants will be asked not to engage in formal mindfulness practice outside of these sessions during the study. Receives: Behavioral: 20 minutes of mindfulness practice; Other: 5 minute audio book |
| 5 minutes of mindfulness practice | Active comparator | Two sessions a week for two weeks of: 20 minutes listening to audio book excerpts followed by 5 minutes of audio guided mindfulness practice. Participants will be asked not to engage in formal mindfulness practice outside of these sessions during the study. Receives: Behavioral: 5 minutes of mindfulness practice; Other: 20 minute audio book |
| Audio book control | Placebo comparator | Two sessions a week for two weeks of: 25 minutes listening to audio book excerpts (with non mindfulness practice). Participants will be asked not to engage in formal mindfulness practice during the study. Receives: Other: 25 minute audio book |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline at post-intervention (week 3) on the Five Factor Mindfulness Questionnaire -15 item version (FFMQ-15)
The Five Factor Mindfulness Questionnaire -15 item version is a self-report measure of mindfulness, producing a total score between 15 and 75, with higher scores indicating greater levels of 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).
Measured: Post-intervention (3 weeks after baseline).
Secondary outcomes (1)
Change from baseline at post-intervention (week 3) on the Depression, Anxiety and Stress Scale - 21 item version (DASS-21).
The Depression, Anxiety and Stress Scale - 21 is a self-report measure of depression, anxiety and stress, producing a total score between 0 and 63, with higher scores indicating greater symptomatology.
Measured: Post-intervention (3 weeks after baseline).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2019
- Study start28 Mar 2019
- Primary completion5 Dec 2019
- Study completion5 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MindfulnessStudies 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
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canterbury Christ Church University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fergal Jones, PhD, PsychD, Study director, Canterbury Christ Church UniversityJames Cane, PhD, Study director, Canterbury Christ Church UniversitySarah Strohmaier, MSc, Principal investigator, Canterbury Christ Church University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03797599
- Sponsor's protocol ID
- S_Strohmaier_29-11-18
- Status last verified
- Sep 2019
- First submitted
- 7 Jan 2019
- Last updated
- 11 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Length of Mindfulness Practice on Mindfulness, Depression, Anxiety and Stress: A Randomised Controlled Experiment
- ClinicalTrials.gov ID
- NCT03797599
- Acronym / sponsor ID
- S_Strohmaier_29-11-18
- Conditions
- Mindfulness, Healthy Population
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Canterbury Christ Church UniversityUniversity, hospital or other
- Study start
- 28 Mar 2019 (actual)
- Primary completion
- 5 Dec 2019 (actual)
- Study completion
- 5 Dec 2019 (actual)
- First posted
- 9 Jan 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 greater length of mindfulness practice results in more beneficial outcomes.
Detailed description
This study will randomise participants to one of three groups: (1) four sessions of medium length mindfulness practice (lasting 20 mins) and 5 mins of an audio book; (2) four sessions of brief mindfulness practice (lasting 5 mins) and 20 mins of an audio book; and (3) a control group who just receive 4 sessions of audio book (lasting 25 mins). In the mindfulness arms, in each session, the participants will receive the audio book prior to the mindfulness practice. Mindfulness levels, and depression, anxiety and stress will be measured by self-report at baseline, session by session, and at post-intervention.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 20 minutes of mindfulness practice | Experimental | Behavioral: 20 minutes of mindfulness practice, Other: 5 minute audio bookTwo sessions a week for two weeks of: 5 minutes listening to audio book excerpts followed by 20 minutes of audio guided mindfulness practice. Participants will be asked not to engage in formal mindfulness practice outside of these sessions during the study. |
| 5 minutes of mindfulness practice | Active comparator | Behavioral: 5 minutes of mindfulness practice, Other: 20 minute audio bookTwo sessions a week for two weeks of: 20 minutes listening to audio book excerpts followed by 5 minutes of audio guided mindfulness practice. Participants will be asked not to engage in formal mindfulness practice outside of these sessions during the study. |
| Audio book control | Placebo comparator | Other: 25 minute audio bookTwo sessions a week for two weeks of: 25 minutes listening to audio book excerpts (with non mindfulness practice). Participants will be asked not to engage in formal mindfulness practice during the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Members of the general public, especially university students or staff.
- Adequate understanding of spoken and written English
Key exclusion criteria (3 listed)
- Currently experiencing significant difficulties with their mental wellbeing.
- Currently have a personal mindfulness practice.
- Currently participating in a mindfulness-based intervention.
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 |
|---|---|---|
| 20 minutes of mindfulness practiceA 20 minute audio guided mindfulness of breathing practice per session, for four sessions. | Behavioural | 20 minutes of mindfulness practice |
| 5 minutes of mindfulness practiceA 5 minute audio guided mindfulness of breathing practice per session, for four sessions. | Behavioural | 5 minutes of mindfulness practice |
| 5 minute audio book5 minutes from an audio book by Bill Bryson ('A Short History of Nearly Everything') per session, for four sessions. | Other | 20 minutes of mindfulness practice |
| 20 minute audio book20 minutes from an audio book by Bill Bryson ('A Short History of Nearly Everything'), per session, for four sessions. | Other | 5 minutes of mindfulness practice |
| 25 minute audio book25 minutes from an audio book by Bill Bryson ('A Short History of Nearly Everything'), per session, for four sessions. | Other | Audio book control |
Primary outcome
Change from baseline at post-intervention (week 3) on the Five Factor Mindfulness Questionnaire -15 item version (FFMQ-15)
Time frame: Post-intervention (3 weeks after baseline).
The Five Factor Mindfulness Questionnaire -15 item version is a self-report measure of mindfulness, producing a total score between 15 and 75, with higher scores indicating greater levels of 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).
1 secondary outcome
Change from baseline at post-intervention (week 3) on the Depression, Anxiety and Stress Scale - 21 item version (DASS-21).
Time frame: Post-intervention (3 weeks after baseline).
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 11 Dec 2019.
- Individual participant dataSharing planned: Undecided
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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.
Fergal Jones, PhD, PsychD study director
Canterbury Christ Church University
James Cane, PhD study director
Canterbury Christ Church University
Sarah Strohmaier, MSc principal investigator
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 20 minutes of mindfulness practice, 5 minutes of mindfulness practice and 5 minute audio book in people with Mindfulness and Healthy Population, 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 2 inclusion and 3 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 11 Dec 2019. 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 at post-intervention (week 3) on the Five Factor Mindfulness Questionnaire -15 item version (FFMQ-15) (time frame: Post-intervention (3 weeks after baseline).). 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 11 Dec 2019.