NCT03072810

Brief Summary

This study aims to increase the well-being of individuals with chronic pain through a 4-week online positive mindfulness programme. Each module, lasting 4 days, will include a daily meditation and focus on a different aspect of positive psychology. This is a quantitative study. The independent variable is participation in the programme. The dependent variables are: wellbeing, mindfulness, pain severity, pain catastrophising and health quality of life. There will be one experimental group who participate in the programme as soon as they are recruited. There will be one control group who are put on a 'wait-list' to complete the programme after an 8 week wait. Pre and post measures will be taken. Participants are being recruited through NHS clinics in London and Oxford, including the Pain Management Centre at Oxford University Hospitals (Churchill site) and INPUT at St Thomas's Hospital (which are participant identification centres). Participants who hear about the study via other means including online or through word of mouth are also being accepted.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2017

Completed
9 days until next milestone

Study Start

First participant enrolled

March 1, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 7, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

December 7, 2018

Status Verified

December 1, 2018

Enrollment Period

1.7 years

First QC Date

February 20, 2017

Last Update Submit

December 6, 2018

Conditions

Pain, Chronic

Keywords

Positive psychologyWellbeingChronic painMindfulness

Outcome Measures

Primary Outcomes (2)

  • Change in mindfulness (using Freiburg Mindfulness Inventory)

    This 14 item scale measures mindfulness and will be used to check whether the intervention increases mindfulness.

    Baseline, 4 weeks, 8 weeks

  • Change in wellbeing (using PERMA profiler)

    Developed by Butler and Kern (2015). The scale measures the five aspects of the PERMA theory of wellbeing (Seligman, 2011).

    Baseline, 4 weeks, 8 weeks

Secondary Outcomes (3)

  • Change in pain catastrophizing (using Pain Catastrophizing Scale)

    Baseline, 4 weeks, 8 weeks

  • Change in subjective pain levels (using Symptom severity and widespread pain index)

    Baseline, 4 weeks, 8 weeks

  • Change in health quality of life (using EQ-5D-5L)

    Baseline, 4 weeks, 8 weeks

Study Arms (2)

Positive mindfulness program

EXPERIMENTAL

Participants will receive a 4 week online positive mindfulness program as described in previous sections.

Behavioral: Positive mindfulness program

Waitlist control

OTHER

Participants will receive the same intervention as the intervention arm (positive mindfulness program) but will be required to wait 4 weeks before commencing.

Behavioral: Positive mindfulness program

Interventions

Positive mindfulness programBEHAVIORAL

4 week program consisting of 8 modules. Each module comprises an introduction video (approx. 10 minutes), a daily meditation (approx. 10 minutes) and a daily activity.

Positive mindfulness programWaitlist control

Eligibility Criteria

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

You may qualify if:

  • Is experiencing chronic pain that has lasted for at least 3 months at time of entry to study
  • Has access to the internet daily

You may not qualify if:

  • Currently receiving another form of psychological intervention
  • Post Traumatic Stress Disorder
  • Eating disorders
  • Substance abuse (inc prescription drugs)
  • Subjected to torture or abuse Suspected factitious illness or dissociative symptoms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Canterbury Christ Church University

Royal Tunbridge Wells, Kent, TN3 0TF, United Kingdom

Location

Churchill Hospital

Oxford, Oxfordshire, OX3 7LE, United Kingdom

Location

INPUT, St Thomas's Hospital

London, SE1 7EH, United Kingdom

Location

Related Publications (7)

  • Walach, H., Buchheld, N., Buttenmüller, V., Kleinknecht, N., & Schmidt, S. (2006). Measuring mindfulness-the Freiburg mindfulness inventory (FMI). Personality and Individual Differences, 40(8), 1543-1555.

    BACKGROUND

  • Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.

    PMID: 21479777BACKGROUND

  • Hauser W, Jung E, Erbsloh-Moller B, Gesmann M, Kuhn-Becker H, Petermann F, Langhorst J, Weiss T, Winkelmann A, Wolfe F. Validation of the Fibromyalgia Survey Questionnaire within a cross-sectional survey. PLoS One. 2012;7(5):e37504. doi: 10.1371/journal.pone.0037504. Epub 2012 May 25.

    PMID: 22662163BACKGROUND

  • Butler, J. and Kern, M. (2015, September 25). The PERMA Profiler. Retrieved from http://www.peggykern.org/uploads/5/6/6/7/56678211/the_perma-profiler_092515.pdf

    BACKGROUND

  • Sullivan, M. J., Bishop, S. R., & Pivik, J. (1995). The pain catastrophizing scale: development and validation. Psychological assessment, 7(4), 524.

    BACKGROUND

  • Ivtzan, I. (2015). Positive Mindfulness Program (Chronic Pain). Retrieved from http://www.awarenessisfreedom.com/courses/positive-mindfulness-program-chronic-pain/

    BACKGROUND

  • Ivtzan, I. (2015). Integrating Mindfulness in Positive Psychology: A Randomised Controlled Trial of an 8-week Positive Mindfulness Programme (PMP). Manuscript submitted for publication.

    BACKGROUND

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Tony Lavender, Professor

    Canterbury Christ Church University

    STUDY DIRECTOR

  • Itai Ivtzan, Dr

    University of East London

    PRINCIPAL INVESTIGATOR

  • Abi Davison Jenkins, DClinPsy

    Canterbury Christ Church University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Participants will be aware that they are partaking in the programme and the researcher will see which arm each participant is in. However, participants will be allocated an anonymous code that will be used for storing and analysing outcome data.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomised wait-list control study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2017

First Posted

March 7, 2017

Study Start

March 1, 2017

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

December 7, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

GB(3)