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

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.

Study Overview

• Status: Completed
• Conditions: Mindfulness; Healthy Population
• Intervention / Treatment: Behavioral: 20 minutes of mindfulness practice; Other: 5 minute audio book; Behavioral: 5 minutes of mindfulness practice; Other: 20 minute audio book; Other: 25 minute audio book

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 Type: Interventional
• Enrollment (Actual): 71
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Kent
    • Tunbridge Wells, Kent, United Kingdom, TN1 2YG
      • Canterbury Christ Church University

Participation Criteria

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, 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 20 minutes of mindfulness practice; 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.	Behavioral: 20 minutes of mindfulness practice; A 20 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.
Active Comparator: 5 minutes of mindfulness practice; 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.	Behavioral: 5 minutes of mindfulness practice; A 5 minute audio guided mindfulness of breathing practice per session, for four sessions.; Other: 20 minute audio book; 20 minutes from an audio book by Bill Bryson ('A Short History of Nearly Everything'), per session, for four sessions.
Placebo Comparator: Audio book control; 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.	Other: 25 minute audio book; 25 minutes from an audio book by Bill Bryson ('A Short History of Nearly Everything'), per session, for four sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).
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).
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).
Session 2 Toronto Mindfulness Scale (TMS).	As described above.	Session 2 (week 1).
Session 3 Toronto Mindfulness Scale (TMS).	As described above.	Session 3 (week 2).
Session 4 Toronto Mindfulness Scale (TMS).	As described above.	Session 4 (week 2).

Collaborators and Investigators

• Sponsor: Canterbury Christ Church University
• Investigators: Study Director: James Cane, PhD, Canterbury Christ Church University; Principal Investigator: Sarah Strohmaier, MSc, Canterbury Christ Church University

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2019
• Primary Completion (Actual): December 5, 2019
• Study Completion (Actual): December 5, 2019

Study Registration Dates

• First Submitted: January 7, 2019
• First Submitted That Met QC Criteria: January 7, 2019
• First Posted (Actual): January 9, 2019

Study Record Updates

• Last Update Posted (Actual): December 11, 2019
• Last Update Submitted That Met QC Criteria: December 9, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: S_Strohmaier_29-11-18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No