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The coMforT study of a trauma-informed mindfulness intervention for women who have experienced domestic violence and abuse: a protocol for an intervention refinement and individually randomised parallel feasibility trial

Research output: Contribution to journalArticle

Original languageEnglish
Article number33 (2020)
Number of pages14
JournalPilot and Feasibility Studies
Volume33
DOIs
DateAccepted/In press - 11 Nov 2019
DatePublished (current) - 28 Feb 2020

Abstract

Background: Domestic violence and abuse (DVA) is common and destructive to health. Post-traumatic stress disorder (PTSD) is a major mental health consequence of DVA. People who have experienced DVA have specific needs, arising from the repeated and complex nature of the trauma. The National Institute for Health and Care Excellence recommends more research on the effectiveness of psychological interventions for people who have experienced DVA. There is growing evidence that mindfulness-based interventions may help trauma symptoms.

Methods: intervention refinement and randomised controlled feasibility trial. A prototype trauma informed mindfulness-based cognitive therapy (TI-MBCT) intervention will be co-produced following qualitative interviews and consensus exercise with stakeholders. Participants in the feasibility trial will be recruited from DVA agencies in two geographical regions and randomised to receive either TI-MBCT or usual care (self-referral to the Improving Access to Psychological Therapies (IAPT) service). TI-MBCT will be delivered as a group-based eight-week programme. It will not be possible to blind the participants or the assessors to the study allocation. The following factors will inform the feasibility of progressing to a fully-powered trial: recruitment, retention, intervention fidelity, and the acceptability of the intervention and trial design to participants. We will also test the feasibility of measuring the following participant outcomes before and six months post-randomisation: PTSD, dissociative symptoms, depression, anxiety, DVA re-victimisation, self-compassion and mother-reported child health. Process evaluation and economic analysis will be embedded within the feasibility trial.

Discussion: This study will lead to the development of a TI-MBCT intervention for DVA survivors with PTSD and inform the feasibility and design of a fully powered randomised controlled trial (RCT). The full trial will aim to determine the effectiveness and cost-effectiveness of a TI-MBCT intervention in improving the clinically important symptoms of PTSD in DVA survivors.

    Research areas

  • Domestic violence and abuse (DVA), trauma, post-traumatic stress disorder (PTSD), mindfulness, mindfulness based cognitive therapy (MBCT), intervention development, feasibility trial

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    Rights statement: This is the final published version of the article (version of record). It first appeared online via Springer Nature at https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-019-0527-1. Please refer to any applicable terms of use of the publisher.

    Final published version, 881 KB, PDF document

    Licence: CC BY

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