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

• ClinicalTrials.gov Identifier: NCT03797599
• Recruitment Status: Completed
• First Posted: January 9, 2019
• Last Update Posted: December 11, 2019
• Sponsor: Canterbury Christ Church University
• Information provided by (Responsible Party): Canterbury Christ Church University

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Mindfulness; Healthy Population	Behavioral: 20 minutes of mindfulness practice; Behavioral: 5 minutes of mindfulness practice; Other: 5 minute audio book; Other: 20 minute audio book; Other: 25 minute audio book	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 71 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Masking Description: Participants will be masked to the extent that they will not be told which group they have been allocated to nor the exact nature of the the three groups. However, they will be aware of the exercises they are asked to undertake.
• Primary Purpose: Basic Science
• Official Title: The Effects of Length of Mindfulness Practice on Mindfulness, Depression, Anxiety and Stress: A Randomised Controlled Experiment
• Actual Study Start Date: March 28, 2019
• Actual Primary Completion Date: December 5, 2019
• Actual Study Completion Date: December 5, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. 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).

Secondary Outcome Measures :

1. 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). ]
   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.

Other Outcome Measures:

1. Sessional Five Factor Mindfulness Questionnaire -15 item version (FFMQ-15) scores. [ Time Frame: Baseline, session 2 (week 1), session 3 and 4 (week 2), and post-intervention (week 3). ]
   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.
2. Sessional Depression, Anxiety and Stress Scale - 21 item version (DASS-21) scores [ Time Frame: Baseline, session 2 (week 1), session 3 and 4 (week 2), and post-intervention (week 3). ]
   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.
3. Session 1 Toronto Mindfulness Scale (TMS). [ Time Frame: Session 1 (week 1). ]
   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.
4. Session 2 Toronto Mindfulness Scale (TMS). [ Time Frame: Session 2 (week 1). ]
   As described above.
5. Session 3 Toronto Mindfulness Scale (TMS). [ Time Frame: Session 3 (week 2). ]
   As described above.
6. Session 4 Toronto Mindfulness Scale (TMS). [ Time Frame: Session 4 (week 2). ]
   As described above.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

United Kingdom

Canterbury Christ Church University

Tunbridge Wells, Kent, United Kingdom, TN1 2YG

Sponsors and Collaborators

Canterbury Christ Church University

Investigators

• Study Director: Fergal Jones, PhD, PsychD; Canterbury Christ Church University
• Study Director: James Cane, PhD; Canterbury Christ Church University
• Principal Investigator: Sarah Strohmaier, MSc; Canterbury Christ Church University

More Information

• Responsible Party: Canterbury Christ Church University
• ClinicalTrials.gov Identifier: NCT03797599
• Other Study ID Numbers: S_Strohmaier_29-11-18
• First Posted: January 9, 2019
• Last Update Posted: December 11, 2019
• Last Verified: September 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No