Mindfulness for Intense Emotions: A Feasibility Trial

NCT02849431 | Withdrawn

• 1 other identifier: 16/EM/0100
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Borderline Personality Disorder

Keywords

mindfulness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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)

Study Arms (1)

Mindfulness-based intervention

EXPERIMENTAL

Behavioral: Mindfulness-based intervention

Interventions

Mindfulness-based intervention BEHAVIORAL

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.

Mindfulness-based intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Canterbury Christ Church University: lead
• Sussex Partnership NHS Foundation Trust: collaborator

Study Sites (1)

Sussex Partnership NHS Foundation Trust

Brighton, Sussex, United Kingdom

Location

Related 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

  BACKGROUND

MeSH Terms

Conditions

Borderline Personality Disorder

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Study Officials

• Hannah Droscher

  Canterbury Christ Church University

  PRINCIPAL INVESTIGATOR

• Clara Strauss

  Sussex Partnership NHS Foundation Trust

  STUDY DIRECTOR

• Helen Startup

  Sussex Partnership NHS Foundation Trust

  STUDY DIRECTOR

• Fergal Jones

  Canterbury Christ Church University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2016
• First Posted: July 29, 2016
• Study Start: July 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: August 25, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)