Clinical trial NCT02849431: Mindfulness for Intense Emotions: A Feasibility Trial
Official title: Mindfulness Approach for Adults Experiencing Borderline Personality Disorder; Supporting the Management of Intense and Fluctuating Emotions, a Feasibility Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Borderline Personality Disorder
Keywords: mindfulness
Lead sponsor: Canterbury Christ Church University
Sponsor class: OTHER
Collaborators: name: Sussex Partnership NHS Foundation Trust
First posted: 2016-07-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Participant retention in percent
timeFrame: At post-intervention (i.e. 8 weeks after the start of the intervention).
Secondary outcomes:
measure: Change from baseline at post-intervention in the Difficulties in the Emotion Regulation Scale (DERS)
timeFrame: Post-intervention (i.e. 8 weeks after the start of the intervention)
measure: Change from baseline at post-intervention in the Patient Health Questionnaire (PQH-9).
timeFrame: Post-intervention (i.e. 8 weeks after the start of the intervention)
measure: Change from baseline at post-intervention in the Generalized Anxiety Disorder Scale (GAD-7)
timeFrame: Post-intervention (i.e. 8 weeks after the start of the intervention)
measure: Change from baseline at post-intervention in the Five-Facet Mindfulness Questionnaire (FFMQ)
timeFrame: Post-intervention (i.e. 8 weeks after the start of the intervention)
measure: United Kingdom National Health Service Friends and Family Test (FFT).
timeFrame: Post-intervention (i.e. 8 weeks after the start of the intervention)
measure: Elliot et al.'s (2001) Change Interview.
timeFrame: Post-intervention (i.e. 8 weeks after the start of the intervention)
measure: Recruitment rate
timeFrame: Baseline
measure: Qualitative feedback from participants on intervention acceptability in response to questions 6 and 7 of Elliot et al.'s (2001) Change Interview
timeFrame: Post-intervention (i.e. 8 weeks after the start of the intervention)
Other outcomes:
Locations:
city: Brighton
country: United Kingdom
facility: Sussex Partnership NHS Foundation Trust
state: Sussex
Study officials:
affiliation: Canterbury Christ Church University
name: Hannah Droscher
role: PRINCIPAL_INVESTIGATOR
affiliation: Sussex Partnership NHS Foundation Trust
name: Clara Strauss
role: STUDY_DIRECTOR
affiliation: Sussex Partnership NHS Foundation Trust
name: Helen Startup
role: STUDY_DIRECTOR
affiliation: Canterbury Christ Church University
name: Fergal Jones
role: STUDY_DIRECTOR
References:
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