Positive Mindfulness Program and Wellbeing in Chronic Pain
NCT ID: NCT03072810
Last Updated: 2018-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
73 participants
INTERVENTIONAL
2017-03-01
2018-11-01
Brief Summary
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Detailed Description
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The clinical guidance for treating individuals with chronic pain recommends reducing stress and improving sleep and supporting patients to gain a greater sense of control over their illness. Mindfulness has been shown to be effective in supporting patients with chronic pain to achieve these outcomes.
This study is the first of its kind to combine aspects of positive psychology and mindfulness to create an online programme specifically designed to enhance well-being. Previous participants who have undertaken the Positive Mindfulness Programme have experienced reduced depression and stress and an increase in well-being.
Participants will be recruited through the Pain Management Centre at Oxford University Hospitals (Churchill site) and INPUT at St Thomas's Hospital. Patients with chronic pain will be asked by their clinician if they would like to participate in the study. Clinicians will then pass on (with consent) the contact details of interested potential participants to the researcher. Patients can alternatively choose to get in touch with the researcher directly themselves. Participants will undertake the online programme independently in any location they choose to access the programme.
All participants will be sent an introductory email with a link to an online survey platform where they will be asked to complete 5 pre-validated questionnaires. Within this invitation email, the structure of the programme and daily commitment will be described. The researcher's contact details will be provided should potential participants have any questions regarding the 4-week programme. Participants will be asked to sign an online consent form as part of the initial completion of the outcome measures, before they commence the programme. Participants will logon to the online platform by creating a personalised, anonymous username and password.
Once the participants have completed the baseline outcome measures, the experimental group will be sent a link to the Positive Mindfulness Programme online course and they will be able to begin the 4 week course. Participants will have controlled access to the website so will be unable to start earlier than their slot.
Each week participants will watch a short video providing the theoretical basis for the aspect of Positive Psychology and mindfulness they will be practicing. Each video will be between 8 - 10 minutes long. At the end of the theory video, participants are asked to access and download an audio file which provides them with their daily meditation practice for the week. The audio files containing the daily meditation lasts 12-15 minutes. At the end of each meditation, participants are invited to engage in a daily activity that has a positive psychology focus. The topics covered include: self-awareness, positive emotions, self-compassion, autonomy, self-efficacy, meaning, relations with others and engagement.
Participants are asked to practice the meditation daily. After practicing the meditation for 4 days, participants will log back into the survey site to complete the next week's material. Participants continue this same process for the duration of the 4-weeks.
Upon completion of the 4 weeks of material, participants will be given a wrap-up session that summarises each week of the programme. They will then be asked to complete the same questionnaires that were administered at the beginning of the programme, thus providing post-measures. One month after completion, participants will be contacted again to complete the same series of questions.
Throughout the programme there will be a control group. This group will be asked to complete the same measures at the same time points as the study group (immediately, at 4 weeks, at 8 weeks). However, these individuals will not participate in the weekly programme until 8 weeks has passed. Once they have waited 8 weeks they will be offered the 4 week programme.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Positive mindfulness program
Participants will receive a 4 week online positive mindfulness program as described in previous sections.
Positive mindfulness program
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.
Waitlist control
Participants will receive the same intervention as the intervention arm (positive mindfulness program) but will be required to wait 4 weeks before commencing.
Positive mindfulness program
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.
Interventions
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Positive mindfulness program
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.
Eligibility Criteria
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Inclusion Criteria
* Has access to the internet daily
Exclusion Criteria
* Post Traumatic Stress Disorder
* Eating disorders
* Substance abuse (inc prescription drugs)
* Subjected to torture or abuse Suspected factitious illness or dissociative symptoms
18 Years
ALL
No
Sponsors
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University of East London
OTHER
Canterbury Christ Church University
OTHER
Responsible Party
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Principal Investigators
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Tony Lavender, Professor
Role: STUDY_DIRECTOR
Canterbury Christ Church University
Itai Ivtzan, Dr
Role: PRINCIPAL_INVESTIGATOR
University of East London
Abi Davison Jenkins, DClinPsy
Role: PRINCIPAL_INVESTIGATOR
Canterbury Christ Church University
Locations
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Canterbury Christ Church University
Royal Tunbridge Wells, Kent, United Kingdom
Churchill Hospital
Oxford, Oxfordshire, United Kingdom
INPUT, St Thomas's Hospital
London, , United Kingdom
Countries
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References
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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.
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.
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.
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
Sullivan, M. J., Bishop, S. R., & Pivik, J. (1995). The pain catastrophizing scale: development and validation. Psychological assessment, 7(4), 524.
Ivtzan, I. (2015). Positive Mindfulness Program (Chronic Pain). Retrieved from http://www.awarenessisfreedom.com/courses/positive-mindfulness-program-chronic-pain/
Ivtzan, I. (2015). Integrating Mindfulness in Positive Psychology: A Randomised Controlled Trial of an 8-week Positive Mindfulness Programme (PMP). Manuscript submitted for publication.
Other Identifiers
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CanterburyCCU
Identifier Type: -
Identifier Source: org_study_id