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Mindfulness for trauma

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN64458065
Enrollment
54
Registered
2019-01-11
Start date
2019-01-14
Completion date
Unknown
Last updated
2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-traumatic stress disorder Mental and Behavioural Disorders

Interventions

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-speci

Sponsors

University of Bristol
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 28, 2026