Condition category
Signs and Symptoms
Date applied
27/06/2016
Date assigned
28/06/2016
Last edited
02/12/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Chronic pelvic pain (CPP) in women is where pain is felt in the pelvic region (the area below the belly button and between the hips) for at least 6 months. It is a relatively common condition, affecting around one million women in the UK every year, which is often painful and disabling, putting a great deal of strain on women’s lives and the NHS. The exact cause of CPP can vary, making it very difficult to treat. Mindfulness is a psychological treatment that works by teaching people to accept the sensations and emotions in the present moment. This can help people to accept their pain, allowing them to focus on daily activities and improve their quality of life. This type of treatment often takes place in eight-week face-to-face courses, however recently, smartphone applications have been used to deliver this type of treatment. The aim of this study is to investigate the effectiveness of a mindfulness-based smartphone app in the treatment of CPP in women, in order to find out whether a large-scale study is possible.

Who can participate?
Adult women with CPP who have access to a smartphone.

What does the study involve?
Participants are randomly allocated to one of three groups. Those in the first group receive access a smartphone app delivering mindfulness instructions for 60 days. Those in the second group receive access to a smartphone app delivering muscle relaxation instructions for 60 days, in addition to usual care. Those in the third group receive usual care alone for 60 days. At the end of the study, the amount of participants that have been recruited and the amount of those who actively took part are recorded. In addition, participants who received the mindfulness app complete a questionnaire at 60 days about how user friendly the app is, and all participants complete a range of questionnaires at the start of the study, and then after 60 days, 3 months and 6 months, to measure their mental wellbeing, quality of life and acceptance of pain.

What are the possible benefits and risks of participating?
There are not expected to be any direct benefits or risks for participants taking part in this study.

Where is the study run from?
1. Royal London Hospital (UK)
2. Whipps Cross Hospital (UK)

When is the study starting and how long is it expected to run for?
November 2015 to August 2017

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
1. Miss Sian Newton (public)
s.newton@qmul.ac.uk
2. Miss Elizabeth Ball (scientific)
Elizabeth.Ball@bartshealth.nhs.uk

Trial website

http://www.blizard.qmul.ac.uk/research-project/1368-memphis2.html

Contact information

Type

Public

Primary contact

Miss Sian Newton

ORCID ID

http://orcid.org/0000-0001-8035-0411

Contact details

Women’s Health Research Unit
Centre for Primary Care and Population Health
Blizard Institute
Barts and The London School of Medicine and Dentistry
Yvonne Carter Building
58 Turner Street
Whitechapel
London
E1 2AB
United Kingdom
+44 20 7882 5883
s.newton@qmul.ac.uk

Type

Scientific

Additional contact

Miss Elizabeth Ball

ORCID ID

http://orcid.org/0000-0001-8739-090X

Contact details

Gynaecology Department
Royal London Hospital
Whitechapel High Street
London
E1 1BB
United Kingdom
+44 7501 980269
Elizabeth.Ball@bartshealth.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT02721108

Protocol/serial number

20814

Study information

Scientific title

Mindfulness meditation using a smart-phone application for women with chronic pelvic pain (MEMPHIS)

Acronym

Study hypothesis

The overall aim is to assess the feasibility of implementing a trial using psychological approaches delivered by a mobile phone app for patients with chronic pelvic pain (CPP).

The primary objectives are:
1. To provide feasibility data for a large multicentre RCT aimed at rigorously testing psychological approaches in CPP
2. To determine whether this app can be seamlessly integrated into clinical practice, especially CPP pathways

Ethics approval

London - Camden and Kings Cross Research Ethics Committee, 01/02/2016, ref: 15/LO/1967

Study design

Randomised; Interventional; Design type: Treatment, Psychological & Behavioural

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Specialty: Reproductive health and childbirth, Primary sub-specialty: General gynaecology; UKCRC code/ Disease: Other/ Symptoms and signs involving the digestive system and abdomen

Intervention

Following provision of informed consent, patients will be randomised to one of three groups. Randomisation will be performed using a centralised internet service.

Group A - “Intervention”: Participants receive access to a smartphone app delivering mindfulness instructions for 60 days.
Group B - “Active control”: Participants receive access to a smartphone app delivering muscle relaxation instructions for 60 days, in addition to usual care.
Group C - Treatment as usual: Participants receive usual care

Clinical outcome data will be collected at 60 days, 3 months and 6 months post randomisation. App usability data will be collected at 60 days for the intervention and active control groups.

Intervention type

Other

Phase

Drug names

Primary outcome measures

1. Recruitment rate is measured at the end of follow up
2. Adherence rate is measured using data provided by Headspace during the intervention (first 60 days)
3. Usability of the app measured using a questionnaire at 60 days post randomisation

Secondary outcome measures

Secondary outcome measures as of 02/12/2016:
1. Quality of life-Physical Functioning subscale is as measured by the RAND Short form (36) Health Survey (SF-36) at baseline, 60 days, 3 months, and 6 months post-randomisation
2. Quality of life-Social Functioning subscale as measured by the RAND Short form (36) Health Survey (SF-36) at baseline, 60 days, 3 months, and 6 months post-randomisation
3. Quality of life-Pain subscale as measured by the RAND Short form (36) Health Survey (SF-36) at baseline, 60 days, 3 months, and 6 months post-randomisation
4. Quality of life-General Health subscale as measured by the RAND Short form (36) Health Survey (SF-36) at baseline, 60 days, 3 months, and 6 months post-randomisation
5. Depression is measured using the Hospital Anxiety and Depression Scale (HADS) at baseline, 60 days, 3 months, and 6 months post-randomisation
6. Anxiety is measured using the Hospital Anxiety and Depression Scale (HADS) at v60 days, 3 months, and 6 months post-randomisation
7. Pain Acceptance is measured using the Chronic Pain Acceptance Questionnaire (CPAQ-8) at baseline, 60 days, 3 months, and 6 months post-randomisation
8. Sexual health outcomes are measured using the Sexual Health Outcomes in Women Questionnaire (SHOW-Q) at baseline, 60 days, 3 months, and 6 months post-randomisation

Original secondary outcome measures:
1. Quality of life is measured using the Short form (36) Health Survey (SF-36) at baseline, 60 days, 3 months, and 6 months post-randomisation
2. Depression is measured using the Hospital Anxiety and Depression Scale (HADS) at baseline, 60 days, 3 months, and 6 months post-randomisation
3. Anxiety is measured using the Hospital Anxiety and Depression Scale (HADS) at v60 days, 3 months, and 6 months post-randomisation
4. Pain Acceptance is measured using the Chronic Pain Acceptance Questionnaire (CPAQ-8) at baseline, 60 days, 3 months, and 6 months post-randomisation
5. Sexual health outcomes are measured using the Sexual Health Outcomes in Women Questionnaire (SHOW-Q) at baseline, 60 days, 3 months, and 6 months post-randomisation

Overall trial start date

01/11/2015

Overall trial end date

31/08/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 or over
2. Women with organic and non-organic chronic pelvic pain lasting for six months or more
3. Capable of understanding the information provided, with use of an interpreter if required and being able to understand simple English as is used in the app
4. Give written informed consent
5. Access to a personal computer or smartphone

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned Sample Size: 90; UK Sample Size: 90

Participant exclusion criteria

1. Males
2. Absence of diagnosis of organic and non-organic chronic pelvic pain (CPP)
3. Diagnosis of organic and non-organic chronic pelvic pain (CPP) lasting for less than 3 months
4. Aged under 18 years
5. No access to a Personal computer or smart phone
6. Unable to speak / understand English

Added 28/10/2016:
7. Current users of the Headspace app content available to the public’

Recruitment start date

13/05/2016

Recruitment end date

20/09/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal London Hospital
Whitechapel Road
London
E1 1BB
United Kingdom

Trial participating centre

Whips Cross Hospital
Whipps Cross Road Leytonstone
London
E11 1NR
United Kingdom

Sponsor information

Organisation

Barts Health NHS Trust

Sponsor details

The Royal London Hospital
Whitechapel Road
London
E1 1BB
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

Intention to publish date

31/12/2018

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

02/12/2016: The secondary outcome measures have been updated. 28/10/2016: The overall trial end date has been updated from 31/07/2017 to 31/08/2017 and the recruitment end date has been updated from 31/10/2016 to 20/09/2016. In addition, an additional exclusion criterion has been added. 06/07/2016: Verified study status with principal investigator.