Borderline Personality DisorderMindIENCT02849431
Mindfulness for Intense Emotions: A Feasibility Trial
A study testing Mindfulness-based intervention in people with Borderline Personality Disorder, run by Canterbury Christ Church University at 1 site in United Kingdom.
Trial summary
This study explores the feasibility of a mindfulness-based intervention for people with a diagnosis of borderline personality disorder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- Mindfulness-based intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2016to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sussex Partnership NHS Foundation Trust
Brighton, Sussex
About this study
Official title: 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.
Read the 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.
- Conditions
- Borderline Personality Disorder
- Being tested
- Mindfulness-based intervention
- Keywords
- mindfulness
- Medical subject headings
- Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-based intervention | Experimental | Not described Receives: Behavioral: Mindfulness-based intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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).
Measured: 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)
Measured: 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)
Measured: Post-intervention (i.e. 8 weeks after the start of the intervention)
United Kingdom National Health Service Friends and Family Test (FFT).
Measured: Post-intervention (i.e. 8 weeks after the start of the intervention)
Elliot et al.'s (2001) Change Interview.
Measured: 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.
Measured: Baseline
Qualitative feedback from participants on intervention acceptability in response to questions 6 and 7 of Elliot et al.'s (2001) Change Interview
Measured: Post-intervention (i.e. 8 weeks after the start of the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionAug 2016
- Study completionAug 2016
Why it stopped: Unforeseen feasibility issues arose that meant the study did not seem viable in the current form.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canterbury Christ Church University
- Sponsor type
- University, hospital or other
- Collaborators
- Sussex Partnership NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Hannah Droscher, Principal investigator, Canterbury Christ Church UniversityClara Strauss, Study director, Sussex Partnership NHS Foundation TrustHelen Startup, Study director, Sussex Partnership NHS Foundation TrustFergal Jones, Study director, Canterbury Christ Church University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02849431
- Sponsor's protocol ID
- 16/EM/0100
- Acronym
- MindIE
- Status last verified
- Jul 2016
- First submitted
- 11 Jul 2016
- Last updated
- 25 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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 at a glance
From the registry record, last updated by the sponsor on 25 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Approach for Adults Experiencing Borderline Personality Disorder; Supporting the Management of Intense and Fluctuating Emotions, a Feasibility Study
- ClinicalTrials.gov ID
- NCT02849431
- Acronym / sponsor ID
- MindIE / 16/EM/0100
- Conditions
- Borderline Personality Disorder
- Keywords
- mindfulness
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unforeseen feasibility issues arose that meant the study did not seem viable in the current form.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Canterbury Christ Church UniversityUniversity, hospital or other
- Collaborators
- Sussex Partnership NHS Foundation Trust
- Study start
- Jul 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 29 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-based intervention | Experimental | Behavioral: Mindfulness-based intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-based interventionA 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. | Behavioural | Mindfulness-based intervention |
Primary outcome
Participant retention in percent
Time frame: At post-intervention (i.e. 8 weeks after the start of the intervention).
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
8 secondary outcomes
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)
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)
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)
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)
United Kingdom National Health Service Friends and Family Test (FFT).
Time frame: Post-intervention (i.e. 8 weeks after the start of the intervention)
Elliot et al.'s (2001) Change Interview.
Time frame: Post-intervention (i.e. 8 weeks after the start of the intervention)
Recruitment rate
Time frame: Baseline
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)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2016.
- BackgroundElliot 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
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hannah Droscher principal investigator
Canterbury Christ Church University
Clara Strauss study director
Sussex Partnership NHS Foundation Trust
Helen Startup study director
Sussex Partnership NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based intervention in people with Borderline Personality Disorder, run by Canterbury Christ Church University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant retention in percent (time frame: At post-intervention (i.e. 8 weeks after the start of the intervention).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02849431, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2016.