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

NCT03797599 | Completed

• 1 other identifier: S_Strohmaier_29-11-18
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Mindfulness; Healthy Population

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change from baseline at post-intervention (week 3) on the Depression, Anxiety and Stress Scale - 21 item version (DASS-21).

  Post-intervention (3 weeks after baseline).

Other Outcomes (6)

• Sessional Five Factor Mindfulness Questionnaire -15 item version (FFMQ-15) scores.

  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

  Baseline, session 2 (week 1), session 3 and 4 (week 2), and post-intervention (week 3).

• Session 1 Toronto Mindfulness Scale (TMS).

  Session 1 (week 1).

Study Arms (3)

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.

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.

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.

Other: 25 minute audio book

Interventions

20 minutes of mindfulness practice BEHAVIORAL

A 20 minute audio guided mindfulness of breathing practice per session, for four sessions.

20 minutes of mindfulness practice

5 minutes of mindfulness practice BEHAVIORAL

A 5 minute audio guided mindfulness of breathing practice per session, for four sessions.

5 minutes of mindfulness practice

5 minute audio book OTHER

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

20 minutes of mindfulness practice

20 minute audio book OTHER

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

5 minutes of mindfulness practice

25 minute audio book OTHER

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

Audio book control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Members of the general public, especially university students or staff.
• Adequate understanding of spoken and written English

You may not qualify if:

• Currently experiencing significant difficulties with their mental wellbeing.
• Currently have a personal mindfulness practice.
• Currently participating in a mindfulness-based intervention.

Sponsors & Collaborators

• Canterbury Christ Church University: lead

Study Sites (1)

Canterbury Christ Church University

Royal Tunbridge Wells, Kent, TN1 2YG, United Kingdom

Location

Study Officials

• Fergal Jones, PhD, PsychD

  Canterbury Christ Church University

  STUDY DIRECTOR

• James Cane, PhD

  Canterbury Christ Church University

  STUDY DIRECTOR

• Sarah Strohmaier, MSc

  Canterbury Christ Church University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2019
• First Posted: January 9, 2019
• Study Start: March 28, 2019
• Primary Completion: December 5, 2019
• Study Completion: December 5, 2019
• Last Updated: December 11, 2019

Record last verified: 2019-09

Locations

GB (1)