Mindfulness for Intense Emotions: A Feasibility Trial

Borderline Personality Disorder Clinical Trial

— MindIE  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02849431
• Other study ID #: 16/EM/0100
• Status: Withdrawn
• Phase: N/A
• First received: July 11, 2016
• Last updated: August 24, 2016
• Start date: July 2016
• Est. completion date: August 2016

Study information

• Verified date: July 2016
• Source: Canterbury Christ Church University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health ServiceUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Personality Disorders

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.

Locations

Country	Name	City	State
United Kingdom	Sussex Partnership NHS Foundation Trust	Brighton	Sussex

Sponsors (2)

Lead Sponsor	Collaborator
Canterbury Christ Church University	Sussex Partnership NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	United Kingdom National Health Service Friends and Family Test (FFT).		Post-intervention (i.e. 8 weeks after the start of the intervention)	No
Secondary	Elliot et al.'s (2001) Change Interview.		Post-intervention (i.e. 8 weeks after the start of the intervention)	No
Secondary	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	No
Secondary	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)	No