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Mindfulness for Intense Emotions: A Feasibility Trial (MindIE)

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ClinicalTrials.gov Identifier: NCT02849431
Recruitment Status : Withdrawn (Unforeseen feasibility issues arose that meant the study did not seem viable in the current form.)
First Posted : July 29, 2016
Last Update Posted : August 25, 2016
Sponsor:
Collaborator:
Sussex Partnership NHS Foundation Trust
Information provided by (Responsible Party):
Canterbury Christ Church University

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

Condition or disease Intervention/treatment Phase
Borderline Personality Disorder Behavioral: Mindfulness-based intervention Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mindfulness Approach for Adults Experiencing Borderline Personality Disorder; Supporting the Management of Intense and Fluctuating Emotions, a Feasibility Study
Study Start Date : July 2016
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mindfulness-based intervention Behavioral: Mindfulness-based intervention
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.




Primary Outcome Measures :
  1. Participant retention in percent [ Time Frame: At post-intervention (i.e. 8 weeks after the start of the intervention). ]
    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


Secondary Outcome Measures :
  1. Change from baseline at post-intervention in the Difficulties in the Emotion Regulation Scale (DERS) [ Time Frame: Post-intervention (i.e. 8 weeks after the start of the intervention) ]
  2. Change from baseline at post-intervention in the Patient Health Questionnaire (PQH-9). [ Time Frame: Post-intervention (i.e. 8 weeks after the start of the intervention) ]
  3. Change from baseline at post-intervention in the Generalized Anxiety Disorder Scale (GAD-7) [ Time Frame: Post-intervention (i.e. 8 weeks after the start of the intervention) ]
  4. Change from baseline at post-intervention in the Five-Facet Mindfulness Questionnaire (FFMQ) [ Time Frame: Post-intervention (i.e. 8 weeks after the start of the intervention) ]
  5. United Kingdom National Health Service Friends and Family Test (FFT). [ Time Frame: Post-intervention (i.e. 8 weeks after the start of the intervention) ]
  6. Elliot et al.'s (2001) Change Interview. [ Time Frame: Post-intervention (i.e. 8 weeks after the start of the intervention) ]
  7. Recruitment rate [ Time Frame: Baseline ]
    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.

  8. Qualitative feedback from participants on intervention acceptability in response to questions 6 and 7 of Elliot et al.'s (2001) Change Interview [ Time Frame: Post-intervention (i.e. 8 weeks after the start of the intervention) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02849431


Locations
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United Kingdom
Sussex Partnership NHS Foundation Trust
Brighton, Sussex, United Kingdom
Sponsors and Collaborators
Canterbury Christ Church University
Sussex Partnership NHS Foundation Trust
Investigators
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Principal Investigator: Hannah Droscher Canterbury Christ Church University
Study Director: Clara Strauss Sussex Partnership NHS Foundation Trust
Study Director: Helen Startup Sussex Partnership NHS Foundation Trust
Study Director: Fergal Jones Canterbury Christ Church University

Publications:
Elliot R. (2012). Qualitative Methods for Studying Psychotherapy Change Processes. In: Thompson, A, & Harper D. (Eds.), Qualitative research methods in mental health and psychotherapy: An introduction for students and practitioners (pp. 69-81). Chichester, UK: Wiley-Blackwells

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Responsible Party: Canterbury Christ Church University
ClinicalTrials.gov Identifier: NCT02849431     History of Changes
Other Study ID Numbers: 16/EM/0100
First Posted: July 29, 2016    Key Record Dates
Last Update Posted: August 25, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Canterbury Christ Church University:
mindfulness
Additional relevant MeSH terms:
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Personality Disorders
Borderline Personality Disorder
Mental Disorders