ArticlePilot and feasibility studies2020
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.
Article in Pilot and feasibility studies, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
3 citing papers in PubMed, 22 citations in OpenAlex.
- 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).Pilot and feasibility studies · 2023Article
- Feasibility and acceptability of mindful recovery opioid use care continuum (M-ROCC): A concurrent mixed methods study.Journal of substance abuse treatment · 2021Article
- A feasibility study of the physiotherapy management of urinary incontinence in athletic women: trial protocol for the POsITIve study.Pilot and feasibility studies · 2020Article
Corrections and comments
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Authors and funding
10 authors at 2 institutions in 1 country.
Funding
Abstract
backgroundDomestic 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.
methodsIntervention 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.
trial registrationISRCTN, ISRCTN64458065, Registered 11 January 2019.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.