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 randomized parallel feasibility trial

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 randomized 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 randomized 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 program. 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 6 months post-randomization: PTSD, dissociative symptoms, depression, anxiety, DVA re-victimization, 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 randomized 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.

Trauma-specific mindfulness-based cognitive therapy for women with post-traumatic stress disorder and a history of domestic abuse: intervention refinement and a randomised feasibility trial (coMforT study)

“…Of the 15 women allocated into TS-MBCT arm, 11 started the group (73%, 95% CI 44.9-92.2%) which is better than the 33% we were expecting to drop out between randomisation and the start of the mindfulness group. Considering the number of women who never started the mindfulness group, the recruitment ratio is actually 14.7% (16/109, 95% CI 8.6-22.7%) -about half of our original estimate [25].…”

“…To give an acceptable precision for estimating the proportion of eligible women consenting to participate, we aimed to screen 120 women and to recruit 36 (recruitment ratio: 30% of those eligible). Assuming a 33% drop out rate before the start of the intervention, we in ated the sample size to 54 [25]. Following recommendations on developing progression criteria for pilot studies [37], we prespeci ed progression criteria and a tra c light system for decision-making about progression to a full trial.…”

“…Green and/or amber targets met: Study Steering Group discuss problems with study management group, and progress if strategies are available to improve the intervention and trial protocol. Red targets met: consult Steering Committee and funder if progression is justi ed [25]. We reported feasibility outcomes by mapping on the progressions criteria and tra c lights.…”

“…The recruitment ratio of 18.3% (20/109 95% CI 11.6-26.9%) was lower than the target of 30% [25]. The seven women who were assessed for eligibility but not recruited had a mean age of 38.6 years, and white ethnic background.…”

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“…A traffic light system (based on that used in a protocol by Pitt et al 2020) [ 27 ] will be used to review progression criteria to a full trial. Green will indicate that it is feasible to progress to a definitive trial with only minor or no changes made to the study design and procedures, amber will indicate that modifications should be made before progressing and red will indicate that it is not feasible to progress with this design (see Table 1 ).…”