Mindfulness for Intense Emotions: A Feasibility Trial

Study Overview
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Brief Summary
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This study explores the feasibility of a mindfulness-based intervention for people with a diagnosis of borderline personality disorder.

Detailed Description
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This is an uncontrolled feasibility trial of an eight-week mindfulness-based intervention for people with a diagnosis of borderline personality disorder. A battery of measures will be administered at baseline, in a time window of six to zero weeks prior to the start of the intervention. Outcome measures will be repeated in the two weeks after the end of the eight-week intervention, along with a qualitative interview.

Official Title
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Mindfulness Approach for Adults Experiencing Borderline Personality Disorder; Supporting the Management of Intense and Fluctuating Emotions, a Feasibility Study

Conditions
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Borderline Personality Disorder

Intervention / Treatment
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* Behavioral: Mindfulness-based intervention


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Are on the caseload of a United Kingdom National Health Service Assessment and Treatment Service in the recruitment area and have had contact with that service in the past three months Have received the diagnosis of Borderline Personality Disorder from a suitably qualified health care professional, and continue to meet criteria for this diagnosis according to the SCID-II (Structured Clinical Interview for DSM Disorders Version II) at their screening assessment Have sufficient English language speaking and comprehension abilities to access group discussions and hand-out materials Have not previously engaged in a mindfulness-based intervention. As in other similar trials, a minimum dose has been operationally defined as having undertaken 50% or more of a mindfulness-based intervention delivered face-to-face by a suitably qualified health care professional Are not currently receiving, nor have plans to receive any other form of psychological therapy during the course of the study Exclusion criteria: Have psychosis Misuse alcohol or drug to a level that requiring detox Have a intellectual disability Present a high level of risk requiring inpatient management at the time of their screening assessment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness-based intervention<br> | Behavioral: Mindfulness-based intervention<br>* A version of mindfulness-based cognitive therapy that has been adapted for people with a diagnosis of borderline personality disorder. This comprises eight weekly session, each lasting ninety minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant retention in percent | The number of participants who remain in the study at the post-intervention time point divided by the number of participants who are recruited into the study at baseline, expressed as a percentage | At post-intervention (i.e. 8 weeks after the start of the intervention). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline at post-intervention in the Difficulties in the Emotion Regulation Scale (DERS) |  | Post-intervention (i.e. 8 weeks after the start of the intervention) | 
| Change from baseline at post-intervention in the Patient Health Questionnaire (PQH-9). |  | Post-intervention (i.e. 8 weeks after the start of the intervention) | 
| Change from baseline at post-intervention in the Generalized Anxiety Disorder Scale (GAD-7) |  | Post-intervention (i.e. 8 weeks after the start of the intervention) | 
| Change from baseline at post-intervention in the Five-Facet Mindfulness Questionnaire (FFMQ) |  | Post-intervention (i.e. 8 weeks after the start of the intervention) | 
| United Kingdom National Health Service Friends and Family Test (FFT). |  | Post-intervention (i.e. 8 weeks after the start of the intervention) | 
| Elliot et al.'s (2001) Change Interview. |  | Post-intervention (i.e. 8 weeks after the start of the intervention) | 
| Recruitment rate | The number of participants recruited into the study at baseline divided by the time taken to recruit these participants, measured from the date at which recruitment opened. | Baseline | 
| Qualitative feedback from participants on intervention acceptability in response to questions 6 and 7 of Elliot et al.'s (2001) Change Interview |  | Post-intervention (i.e. 8 weeks after the start of the intervention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mindfulness