NCT04099758

Brief Summary

This study aims to examine whether a brief mindfulness of the breath meditation practice is more helpful than listening to an audio recording in relation to improving hope and gratitude in the general population.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
580

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 23, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

October 28, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 16, 2020

Completed
Last Updated

August 24, 2020

Status Verified

September 1, 2019

Enrollment Period

9 months

First QC Date

September 20, 2019

Last Update Submit

August 21, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change from baseline to post-intervention on the State Hope Scale (SHS).

    The SHS is a 6-item self-report measure of state hope. The total score on SHS ranges from 8 to 48 , with higher score indicating greater state hope.

    Baseline (0 minutes), post-intervention (10 minutes).

Secondary Outcomes (1)

  • Change from baseline to post-intervention on the Gratitude Adjective Checklist (GAC).

    Baseline (0 minutes), post-intervention (10 minutes).

Other Outcomes (3)

  • Change from baseline to post-intervention on the Toronto Mindfulness Scale (TMS).

    Baseline (0 minutes), post-intervention (10 minutes).

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

    Baseline (0 minutes)

  • Bespoke manipulation check questionnaire.

    Post-intervention (10 minutes)

Study Arms (2)

Mindfulness of the breath meditation

EXPERIMENTAL

10 minute mindfulness of the breath meditation practice delivered online via audio-recording.

Behavioral: Mindfulness of the breath meditation

Audio-recording control

PLACEBO COMPARATOR

10 minute non-fiction audio-recording delivered online

Behavioral: Audio-recording control

Interventions

A 10-minute mindfulness of the breath meditation practice

Mindfulness of the breath meditation

10 minute non-fiction audio-recording delivered online

Audio-recording control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Members of the general public.
  • Adequate understanding of spoken and written English.
  • Internet access.

You may not qualify if:

  • Currently experiencing very severe problems with their mental health.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Canterbury Christ Church University

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

Location

Study Officials

  • Sarah Strohmaier, BA, MSc

    Canterbury Christ Church University

    PRINCIPAL INVESTIGATOR
  • Fergal Jones, PhD, PsychD

    Canterbury Christ Church University

    STUDY DIRECTOR
  • James Cane, PhD

    Canterbury Christ Church University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Participants will be randomised and complete the study, including outcome measures, through an automated online programme, without involvement of the researcher.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Randomized controlled study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2019

First Posted

September 23, 2019

Study Start

October 28, 2019

Primary Completion

July 16, 2020

Study Completion

July 16, 2020

Last Updated

August 24, 2020

Record last verified: 2019-09

Locations