Mindfulness for Intense Emotions: A Feasibility Trial (MindIE)

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

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

Study Overview

• Status: Withdrawn
• Conditions: Borderline Personality Disorder
• Intervention / Treatment: Behavioral: Mindfulness-based intervention

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Sussex
    • Brighton, Sussex, United Kingdom
      • Sussex Partnership NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Canterbury Christ Church University
• Collaborators: Sussex Partnership NHS Foundation Trust
• Investigators: Study Director: Fergal Jones, Canterbury Christ Church University; 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

Publications and helpful links

General 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

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (ACTUAL): August 1, 2016
• Study Completion (ACTUAL): August 1, 2016

Study Registration Dates

• First Submitted: July 11, 2016
• First Submitted That Met QC Criteria: July 26, 2016
• First Posted (ESTIMATE): July 29, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): August 25, 2016
• Last Update Submitted That Met QC Criteria: August 24, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: mindfulness
• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Borderline Personality Disorder
• Other Study ID Numbers: 16/EM/0100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO