Mindfulness for trauma
| ISRCTN | ISRCTN64458065 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN64458065 |
| Secondary identifying numbers | 38155 |
- Submission date
- 10/01/2019
- Registration date
- 11/01/2019
- Last edited
- 14/07/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
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 trauma-specific 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. Two- thirds (updated 22/10/2019, previously: Half) of the women attend eight mindfulness group sessions, while the other third (updated 22/10/2019, previously: 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
Contact information
Scientific
Centre for Academic Primary Care
Canynge Hall
Bristol
BS8 2PS
United Kingdom
 ORCID ID |
0000-0002-4839-6548 |
|---|---|
| Phone | +44 (0)117 928 7246 |
| nat.lewis@bristol.ac.uk |
Study information
| Study design | Randomised; Both; Design type: Treatment, Complementary Therapy, Psychological & Behavioural |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | A feasibility trial of a trauma-informed mindfulness intervention for survivors of domestic violence and abuse with post-traumatic stress disorder |
| Study acronym | coMforT |
| Study hypothesis | Current study hypothesis as of 06/09/2021: It is feasible to conduct a full-size trial of a trauma-specific mindfulness intervention for the treatment of post-traumatic stress disorder in women survivors of domestic violence and abuse? _____ Previous 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(s) | 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) |
| Condition | Post-traumatic stress disorder |
| Intervention | Current interventions as of 06/09/2021: The trialists will recruit 54 women with PTSD from DVA agency and randomly allocate them into two arms. Two thirds of the women will attend eight trauma-specific mindfulness group sessions, while the other third 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 trauma-specific mindfulness course is acceptable and that the study plan could work, they will design a full size trial and apply for funding. _____ Previous interventions as of 22/10/2019: The trialists will recruit 54 women with PTSD from DVA agency and randomly allocate them into two arms. Two thirds of the women will attend eight mindfulness group sessions, while the other third 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. _____ Previous interventions: 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 |
| 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 | Current secondary outcome measures as of 22/10/2019: 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 experiences of the study is evaluated through qualitative interviews at completion of the intervention Previous 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 study start date | 01/06/2018 |
| Overall study end date | 30/09/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | Planned Sample Size: 54; UK Sample Size: 54 |
| Total final enrolment | 20 |
| 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 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 | 07/10/2019 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Bristol
BS1 4JQ
United Kingdom
Bristol
BS16 2EW
United Kingdom
Sponsor information
University/education
Research and Enterprise Development
1 Cathedral Square
Bristol
BS1 5DD
England
United Kingdom
| Phone | +44 (0)117 428 4011 |
|---|---|
| anna.brooke@bristol.ac.uk | |
"ROR" |
https://ror.org/0524sp257 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 30/05/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | 1. Protocol paper: 30/03/2019 2. Main paper: 30/05/2022 3. At least three conference presentations. (added 06/09/2021) |
| IPD sharing plan | Current IPD sharing plan: The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository. After the study has concluded, the trialists will deposit the anonymised data in the University of Bristol Research Data Repository data.bris (https://doi.org/10.5523/bris.j4jsx8boace42hg58jcvyinlo) where it will be made available to other healthcare researchers. All requests for sharing will be assessed by a data access committee to check they are authentic research requests. The type of data stored - Qualitative research data from phase 1 includes a table with socio-demographic characteristics of interview participants (professionals and women with a history of domestic abuse), anonymized interview transcripts, and study documentation (participant information sheets, consent forms, case report forms). Research data from phase 2 includes participant information sheets, consent forms, case report forms, a quantitative trial dataset with raw data and a data dictionary and a qualitative dataset of interview transcripts. The process for requesting access - Controlled access. Access is limited to bona fide researchers only, and governed by an institution-level Data Access Committee. Guidance on accessing research data: http://www.bristol.ac.uk/staff/researchers/data/accessing-research-data/ Dates of availability - April 2018-February 2020. Whether consent from participants was required and obtained - Participants provided written informed consent. Comments on data anonymization - The produced data have a small risk of re-identification, after the use of pseudonyms and removal of direct identifiers. Any ethical or legal restrictions - Non-Commercial Government Licence for public sector information (https://www.nationalarchives.gov.uk/doc/non-commercial-government-licence/version/2/) Previous IPD sharing plan: The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository. After the 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 healthcare researchers. All requests for sharing will be assessed by a data access committee to check they are authentic research requests. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 28/02/2020 | 13/03/2020 | Yes | No |
| Results article | 03/07/2023 | 04/07/2023 | Yes | No |
Editorial Notes
14/07/2023: The individual participant data (IPD) sharing plan was changed.
04/07/2023: Publication reference added.
06/09/2021: The following changes were made to the trial record:
1. The study hypothesis was changed.
2. The interventions were changed.
3. The publication and dissemination plan was changed.
4. The intention to publish date was changed from 30/09/2021 to 30/05/2022.
03/09/2020: Total final enrolment number added.
13/03/2020: Publication reference added.
08/11/2019: The recruitment end date was changed from 27/01/2020 to 07/10/2019.
22/10/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/09/2019 to 27/01/2020.
2. The interventions were updated.
3. The plain English summary was updated to reflect these changes.
4. The secondary outcome measures were updated.
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.
