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Mindfulness for Intense Emotions: A Feasibility Trial (MindIE)

Primary Purpose

Borderline Personality Disorder

Status
Withdrawn
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Mindfulness-based intervention
Sponsored by
Canterbury Christ Church University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Borderline Personality Disorder focused on measuring mindfulness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sussex Partnership NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mindfulness-based intervention

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from baseline at post-intervention in the Difficulties in the Emotion Regulation Scale (DERS)
Change from baseline at post-intervention in the Patient Health Questionnaire (PQH-9).
Change from baseline at post-intervention in the Generalized Anxiety Disorder Scale (GAD-7)
Change from baseline at post-intervention in the Five-Facet Mindfulness Questionnaire (FFMQ)
United Kingdom National Health Service Friends and Family Test (FFT).
Elliot et al.'s (2001) Change Interview.
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.
Qualitative feedback from participants on intervention acceptability in response to questions 6 and 7 of Elliot et al.'s (2001) Change Interview

Full Information

First Posted
July 11, 2016
Last Updated
August 24, 2016
Sponsor
Canterbury Christ Church University
Collaborators
Sussex Partnership NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02849431
Brief Title
Mindfulness for Intense Emotions: A Feasibility Trial
Acronym
MindIE
Official Title
Mindfulness Approach for Adults Experiencing Borderline Personality Disorder; Supporting the Management of Intense and Fluctuating Emotions, a Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Unforeseen feasibility issues arose that meant the study did not seem viable in the current form.
Study Start Date
July 2016 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Canterbury Christ Church University
Collaborators
Sussex Partnership NHS Foundation Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder
Keywords
mindfulness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness-based intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-based intervention
Intervention Description
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 Measure Information:
Title
Participant retention in percent
Description
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
Time Frame
At post-intervention (i.e. 8 weeks after the start of the intervention).
Secondary Outcome Measure Information:
Title
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)
Title
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)
Title
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)
Title
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)
Title
United Kingdom National Health Service Friends and Family Test (FFT).
Time Frame
Post-intervention (i.e. 8 weeks after the start of the intervention)
Title
Elliot et al.'s (2001) Change Interview.
Time Frame
Post-intervention (i.e. 8 weeks after the start of the intervention)
Title
Recruitment rate
Description
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.
Time Frame
Baseline
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hannah Droscher
Organizational Affiliation
Canterbury Christ Church University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Clara Strauss
Organizational Affiliation
Sussex Partnership NHS Foundation Trust
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Helen Startup
Organizational Affiliation
Sussex Partnership NHS Foundation Trust
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Fergal Jones
Organizational Affiliation
Canterbury Christ Church University
Official's Role
Study Director
Facility Information:
Facility Name
Sussex Partnership NHS Foundation Trust
City
Brighton
State/Province
Sussex
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
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
Results Reference
background

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Mindfulness for Intense Emotions: A Feasibility Trial

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