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A pilot randomised feasibility trial of a brief mindfulness-based intervention in a mental health secondary care setting

A pilot feasibility trial of a brief mindfulness-based intervention in a mental health secondary care setting: a randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN88000243
Enrollment
40
Registered
2014-11-03
Start date
2014-12-10
Completion date
Unknown
Last updated
2015-07-06

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

Conditions

Mental health Mental and Behavioural Disorders

Interventions

1. Intervention group Participants in the intervention group will receive a brief mindfulness intervention developed by consultation with trained mindfulness clinicians in Sussex Partnership NHS Found

Sponsors

University of Sussex (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: We hope to recruit service users who: 1. Currently access a secondary care mental health service in Sussex Partnership NHS Foundation Trust 2. Have an assigned lead practitioner/ care co-ordinator 3. Have a current risk assessment 4. Meet criteria for a current axis 1 disorder as assessed by the Mini International Neuropsychiatric Interview (MINI) 5. Are at least 18 years old

Exclusion criteria

Exclusion criteria: We will exclude service users who: 1. Are not willing to work safely in a therapeutic group 2. Experience problematic substance abuse that may adversely influence the therapy group 3. There is a risk of current or recent (past month) active suicidal attempt or intent 4. Have experienced a recent (past month) serious life event/crisis which would make an MBI inappropriate at this time 5. At the point of consent, a service user will be excluded from the study if they are currently, or have plans to take part in another form of psychological therapy (in a research or a service context), or are taking part in research investigating new medicinal products.

Design outcomes

Primary

MeasureTime frame
We will examine a number of feasibility issues in this study: 1. Are there secondary care service users eligible for the brief intervention in secondary care mental health services. This outcome will be measured at the end of the recruitment period. 2. Is it possible to recruit service users to a brief mindfulness-based intervention? Recruitment will be deemed feasible if we can recruit at least 12 service users in each of the sites across a six month period. Again, this outcome will be measured at the end of the recruitment period. 3. Rates of retention of service users to a brief MBI. We will assess intervention retention throughout the delivery of the brief MBI. 4. Rates of completion of the assessment questionnaires. Rates of assessment completion will be assessed when questionnaires are completed pre-MBI, post-MBI and at the follow-up assessment. 5. Are the measures suitable? We will assess suitability based on the qualitative feedback from the interview that will take place after the MBI. 6. Are participants willing to be randomised to a treatment and wait-list arm? This will be evaluated through service user engagement during recruitment. We will also monitor drop-out in both arms of the study throughout.

Secondary

MeasureTime frame
1. In line with good practice for feasibility studies, further to the quantitative work we plan to conduct a qualitative interview with participants? after they have completed the brief mindfulness intervention. In the interview we will ask for participants? views on the intervention and the study. We will use this information to guide any changes that may be required to the MBI protocol and to the design of the study. 2. In addition to the feasibility issues previously mentioned we will conduct preliminary analysis on the data to estimate the effect size of the intervention relative to the wait-list control group. 3. Questionnaire data will be collected at the three time points during the study and we will be using the following questionnaires: 3.1. Five Factor Mindfulness Questionnaire Short Form (FFMQSF, Bohlmeijer, ten Klooster, Fledderus, Veehof & Baer, 2011) 3.2. Self- compassion Scale Short Form (SCSSF, Raes, Pommier, Neff & Van Gucht, 2011) 3.3. The Short Warwick Edinburugh Mental Wellbeing Scale (SWEMEBS, Stewart-Brown et al., 2009) 3.4. Generalised Anxiety Disorder Questionnaire (GAD7; Spitzer et al., 2006) 3.5. Patient Health Questionnaire (PHQ9; Kroenke; Spitzer & Williams, 2001)

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026