Condition category
Mental and Behavioural Disorders
Date applied
10/01/2019
Date assigned
11/01/2019
Last edited
25/03/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Women who have experienced domestic violence and abuse (DVA) often develop post-traumatic stress disorder (PTSD) which includes reliving the traumatic events through nightmares and disturbing memories, feeling isolated, irritated and guilty, having difficulties with concentration and functioning. Children whose mothers have PTSD are at risk of developing mental health problems. Unlike a one-off traumatic event, repeated DVA results in PTSD that is harder to treat. Standard treatment for PTSD is a past-focused talking therapy which teaches how to change negative thoughts and feelings into more positive ones through ‘reliving’ traumatic memories. Many survivors of DVA drop out of the standard treatment because they find such an approach too upsetting or do not feel better. In contrast, mindfulness is a present focused talking therapy which teaches how to respond to one-self with acceptance and self-compassion. It is known that mindfulness works well for depression. In collaboration with DVA survivors and mental health professionals, the researchers have adapted a standard mindfulness course for depression to fit the special treatment preferences and needs of DVA survivors with PTSD. Now they plan to test the adapted mindfulness course for PTSD in a small study. This will help them to design a bigger study which will answer the question about the effectiveness and value for money of the adapted mindfulness course.

Who can participate?
Women service users at collaborating DVA agency, aged 18 and over, with clinically important symptoms of PTSD

What does the study involve?
54 service users with PTSD are randomly allocated into two groups. Half of the women attend eight mindfulness group sessions, while the other half receive the standard talking therapy on the NHS. The two groups are compared with respect to mental health status of women and their children before the allocation and six months later. All patients are also interviewed about their treatment experiences.

What are the possible benefits and risks of participating?
Women will have a 75% chance of getting a new talking therapy. However, it is not yet known whether it is helpful. By taking part, women will be having a say in whether the new mindfulness course is acceptable and should be tested in a bigger study. Taking part in the study means that woman will have additional contacts with the study researcher over a period of six months. This may increase the risk of other people including perpetrator of DVA finding out about woman’s participation in the study which can potentially lead to escalation of abuse. However, the researchers will always do their best to contact participants in a safe way. For example, they will only phone the woman at a time when she tells us it is safe to do so. They will also arrange safe places to meet with or be contacted by the researcher and to store study documentation. Participant’s safety will always be their priority.

Where is the study run from?
University of Bristol (UK)

When is the study starting and how long is it expected to run for?
June 2018 to September 2020

Who is funding the study?
The NIHR Biomedical Research Centre at University Hospitals Bristol NHS Foundation Trust and the University of Bristol (UK)

Who is the main contact?
Dr Natalia Lewis
nat.lewis@bristol.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Natalia Lewis

ORCID ID

http://orcid.org/0000-0002-4839-6548

Contact details

Centre for Academic Primary Care
Canynge Hall
Bristol
BS8 2PS
United Kingdom
+44 (0)117 928 7246
nat.lewis@bristol.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

38155

Study information

Scientific title

A feasibility trial of a trauma-informed mindfulness intervention for survivors of domestic violence and abuse with post-traumatic stress disorder

Acronym

coMforT

Study hypothesis

A trauma-informed mindfulness intervention co-produced with stakeholders is acceptable to women survivors of domestic violence and abuse and feasible to deliver.

Ethics approval

Faculty of Health Sciences Research Ethics Committee, University of Bristol, 1 Cathedral Square, Bristol, BS1 5DD, Tel: +44 (0)117 42 84051, Email: Liam.McKervey@bristol.ac.uk, 05/02/2018, ref: 2851 & 2018 - 2038 (Id nr.: 72206)

Study design

Randomised; Both; Design type: Treatment, Complementary Therapy, Psychological & Behavioural

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Treatment

Patient information sheet

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

Condition

Post-traumatic stress disorder

Intervention

The trialists will recruit 54 women with PTSD from DVA agency and randomly allocate them into two arms. Half of the women will attend eight mindfulness group sessions, while the other half will receive the standard past-focused talking therapy. The two groups will be compared with respect to mental health status of women before the allocation and six months later. The trialists will also interview all women about their treatment and study experiences. If they find that the mindfulness course is acceptable and that the study plan could work, they will design a full size trial and apply for funding.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Primary feasibility outcomes:
Recruitment/randomisation rate is measured as a proportion of participants recruited/randomised into two arms; the denominator will be the number of participants eligible for recruitment/randomisation by the end of the randomisation period.

Secondary outcome measures

Secondary feasibility outcomes:
1. Intervention uptake is measured as a proportion of participants who took up the intervention and usual care; the denominator will be the number of participants randomised in the arm, respectively, at 6 month post-randomisation
2. Intervention retention is measured as a proportion of participants in the intervention arm who received the “minimum dose” of the intervention, four sessions of mindfulness intervention, at 6 months post-randomisation
3. Follow-up rate is measured as a proportion of participants followed up at six months post-randomisation out of those enrolled in the trial. The proportion who have been lost to follow-up will also be calculated by the trial arms, at 6 months post-randomisation
4. Participant experience is evaluated through qualitative interviews at 6 months post-randomisation

Overall trial start date

01/06/2018

Overall trial end date

30/09/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Target population: service users from third sector DVA agency:
1. Female
2. Referred or self-referred to collaborating third sector organisation for DVA advocacy
3. No physical or sexual victimization in the prior two months
4. Meeting the DSM-5 diagnostic criteria for PTSD, as measured by the clinician administered PTSD scale

The trialists will recruit women with and without children to explore the feasibility of measuring mother-reported outcomes for children. They won't identify or contact children.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned Sample Size: 54; UK Sample Size: 54

Participant exclusion criteria

Exclusion criteria for women service users are derived from exclusion criteria for a standard MBCT course:
1. Unable to provide written informed consent
2. Inability to read or write in English (because interventions will be delivered in English)
3. Current drug or alcohol dependency
4. Organic brain damage
5. Current or past psychosis
6. Persistent self-harm or suicide risk requiring management
7. Already receiving psychological therapy -physical or sexual DVA within past 2 months

Recruitment start date

14/01/2019

Recruitment end date

30/09/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Next Link
5 Queen Square
Bristol
BS1 4JQ
United Kingdom

Trial participating centre

Blackberry Hill Hospital
Avon & Wiltshire Mental Health Partnership NHS Trust
Bristol
BS16 2EW
United Kingdom

Sponsor information

Organisation

University of Bristol

Sponsor details

Research and Enterprise Development
1 Cathedral Square
Bristol
BS1 5DD
United Kingdom
+44 (0)117 428 4011
anna.brooke@bristol.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

NIHR Bristol Biomedical Research Centre; Grant Codes: BRC-1215-20011

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

1. Protocol paper: 30/03/2019
2. Main paper: 30/09/2021

IPD sharing statement
The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository. After study has concluded, the trialists will deposit the anonymised data in the University of Bristol Data Repository where it will be made available to other health care researchers. All requests for sharing will be assessed by a data access committee to check they are authentic research requests.

Intention to publish date

30/09/2021

Participant level data

Stored in repository

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

25/03/2019: The condition has been changed from "Specialty: Primary Care, Primary sub-specialty: Mental Health; Health Category: Mental Health; Disease/Condition: Neurotic, stress-related and somatoform disorders" to "Post-traumatic stress disorder" following a request from the NIHR.