Study Examining the Effects of Mindfulness and Similar Audio-guided Exercises.

Mindfulness Clinical Trial

Official title:

The Effects of Length of Mindfulness Practice on Mindfulness, Depression, Anxiety and Stress: A Randomised Controlled Experiment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03797599
• Other study ID #: S_Strohmaier_29-11-18
• Status: Completed
• Phase: N/A
• Start date: March 28, 2019
• Est. completion date: December 5, 2019

Study information

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

Clinical Trial Summary

This study aims to examine whether greater length of mindfulness practice results in more beneficial outcomes.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: December 5, 2019
• Est. primary completion date: December 5, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Members of the general public, especially university students or staff.

• Adequate understanding of spoken and written English

Exclusion Criteria:

• Currently experiencing significant difficulties with their mental wellbeing.

• Currently have a personal mindfulness practice.

• Currently participating in a mindfulness-based intervention.

Related Conditions & MeSH terms

• Healthy Population
• Mindfulness

Intervention

Behavioral:
• 20 minutes of mindfulness practice
A 20 minute audio guided mindfulness of breathing practice per session, for four sessions.
• 5 minutes of mindfulness practice
A 5 minute audio guided mindfulness of breathing practice per session, for four sessions.

Other:
• 5 minute audio book
5 minutes from an audio book by Bill Bryson ('A Short History of Nearly Everything') per session, for four sessions.
• 20 minute audio book
20 minutes from an audio book by Bill Bryson ('A Short History of Nearly Everything'), per session, for four sessions.
• 25 minute audio book
25 minutes from an audio book by Bill Bryson ('A Short History of Nearly Everything'), per session, for four sessions.

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	Sessional Five Factor Mindfulness Questionnaire -15 item version (FFMQ-15) scores.	The FFMQ-15 (described above) will be administered at the start of the first session (baseline), immediately after sessions 2 (week 1), 3 (week 2) and 4 (week 2), and at post-intervention (week 3), to examine patterns in changes in mindfulness over the course of the study.	Baseline, session 2 (week 1), session 3 and 4 (week 2), and post-intervention (week 3).
Other	Sessional Depression, Anxiety and Stress Scale - 21 item version (DASS-21) scores	The DASS-21 (described above) will be administered at the start of the first session (baseline), immediately after sessions 2 (week 1), 3 (week 2) and 4 (week 2), and at post-intervention (week 3), to to examine patterns in changes over the course of the study.	Baseline, session 2 (week 1), session 3 and 4 (week 2), and post-intervention (week 3).
Other	Session 1 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.	Session 1 (week 1).
Other	Session 2 Toronto Mindfulness Scale (TMS).	As described above.	Session 2 (week 1).
Other	Session 3 Toronto Mindfulness Scale (TMS).	As described above.	Session 3 (week 2).
Other	Session 4 Toronto Mindfulness Scale (TMS).	As described above.	Session 4 (week 2).
Primary	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).	Post-intervention (3 weeks after baseline).
Secondary	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.	Post-intervention (3 weeks after baseline).