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Emotional Instability Personality Disorder (Borderline Personality Disorder)NCT02797873

Emotional and Non-emotional Regulation in Patients With Emotional Instability and ADHD

A study testing fMRI - Stroop task, fMRI - MID task and Stop Signal Task in people with Emotional Instability Personality Disorder (Borderline Personality Disorder) and Attention Deficit Hyperactivity Disorder, run by Karolinska Institutet.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to investigate how emotional and non-emotional regulation processes differ in EIP patients (with different levels of ADHD symptoms/ADHD-comorbidity) compared to controls. Read more about this study

Who is it for?
Ages 16 to 18 years, women onlyHealthy volunteers can take part
What is being tested?
fMRI - Stroop task, fMRI - MID task and Stop Signal Task
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
Aug 2016to May 2018
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 16 to 18 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Undergone puberty
  • Right-handed
  • Monophasic contraceptives
  • Speak Swedish fluently
  • Additional inclusion criteria EIP patients:
  • ≥4/9 criteria of DSM-IV, measured by SCID-II interview

Who cannot join

  • Impaired vision > +/- 5 D or other vision problem (squinting or severe astigmatism)
  • BMI <17, BMI >35 due to possible hormonal disturbance
  • Some medical drugs: benzodiazepines, neuroleptics, mood stabilisers, central stimulants, other neuro pharmaceuticals. (SSRIs are ok)
  • Not suitable for MRI scan (metal implants or severe claustrophobia)
  • AQ-score >26
  • Alexithymia (≥52 in TAS20 questionnaire or poor score in facial recognition test (FEFA2));
Show all 16Show fewer
  • Mental retardation (IQ <70 according to Ravens SPM)
  • Reading difficulties (reading speed >2 standard deviations slower than normal population of same age
  • Established addiction problems (nicotine ok)
  • Color blindness (>10 points on Ishihara-test)
  • Psychotic disorder (according to medical history, DAWBA, medical records)
  • Anorexia nervosa that has required hospital care
  • Bipolar disorder (according to DAWBA and medical records)
  • Neurological disease (according to medical history and medical records)
  • Endocrinological disease
  • Other disease, condition or treatment that may substantially affect cognition

Trial locations and contacts

No sites are listed yet.

Predrag Petrovic contact

predrag.petrovic@ki.se

About this study

Official title: Emotional and Non-emotional Regulation in Patients With Emotional Instability Personality Disorder (EIP) and Attention Deficit Hyperactivity Disorder (ADHD) Symptoms

The purpose of this study is to investigate how emotional and non-emotional regulation processes differ in EIP patients (with different levels of ADHD symptoms/ADHD-comorbidity) compared to controls. The investigators will test these participants' abilities to regulate emotional and non-emotional processes, reward anticipation and reward receipt while they undergo functional magnetic resonance imaging (fMRI). The participants' motor inhibition capacity on a behavioral level will also be investigated.

The hypothesis is that EIP patients will present with more deficits in emotion regulation processes compared to controls, even when controlling for ADHD symptoms. It is also hypothesized that higher levels of ADHD symptoms will correlate with dysfunctional non-emotional regulation processes, on a behavioral as well as brain mechanistic level.

Read the detailed description

Background: Comorbidity of Emotional Instability Personality Disorder (EIP) and Attention Deficit Hyperactivity Disorder (ADHD) is common, and the two patient groups partially exhibit similar problems. The main hypothesis is that the two disorders are mechanistically related. The investigators believe that the mechanisms underlying the problems are linked to two parallel regulating systems in the brain. Here, prefrontal and anterior cingulate systems are in focus. The first system - including the dorsolateral prefrontal cortex (dlPFC) and the caudal anterior cingulate cortex (cACC) - regulates non-emotional (and exteroceptive) information. The other system - including the lateral orbitofrontal prefrontal cortex (lObfc) and rostral anterior cingulate cortex (rACC) - regulates emotional (and interoceptive) information. The hypothesis is that the non-emotional/exteroceptive regulatory system is more affected in ADHD, while the emotional/interoceptive regulatory system is more affected in EIP.

Aims: The aim of this study is to differentiate between dysfunctional emotional regulation processes related to emotional instability symptoms (when controlling for non-emotional ADHD-like symptoms), and dysfunctional non-emotional regulation processes related to ADHD symptoms (when controlling for emotional instability symptoms).

Procedure:

  • Participants: 30 young women from the Emotional Instability Unit at Child and Adolescent Psychiatry in Stockholm (Dialectic Behavioral Therapy unit ("DBT-teamet")), with traits of emotional instability and with varying levels of ADHD symptoms. 30 matched healthy controls.
  • Tests:

Behavioral task: Stop Signal Task: measures participant's ability to inhibit a motor response. Outcome measures are Stop Signal Reaction Time (SSRT) and Go Reaction Time (GoRT)

fMRI task 1: Stroop task. Divided into 2 sessions of 10 minutes with 2 blocks in each. There are two types of blocks: Emotional Stroop task blocks (happy or fearful faces, with the word "HAPPY" or "FEAR" written across them) and Neutral Stroop task blocks (neutral faces of men and women with the word "MAN" or "WOMAN" written across them). Every other block is Emotional and every other is Neutral (balanced order between participants) so that each participant performs two emotional blocks and two neutral blocks. The task is to decide what emotion or gender is shown in the picture and ignore the word. Responses are made using a button box and reaction time is recorded for all the trials. Blood Oxygen Level Dependent (BOLD) signal is recorded in the brain during the task. Outcome measures are reaction times for the different trial types (incongruent(I) and congruent(C), also order dependent) as well as BOLD signal during these different types of trial.

fMRI task 2: Monetary Incentive Delay task (MID). Divided into 2 session of 10 minutes. Reward task in which the participant may win money (0 Swedish kronor (SEK), 10 SEK or 50 SEK in each trial). There is an anticipation phase in each trial, a response cue during which the participant needs to press a button as fast as she can, and an outcome phase in which feedback is presented of whether the participant has won the anticipated money or not. Outcome measures are BOLD activation during the anticipation phases of different levels of reward, and BOLD activation during the receipt/outcome phase of the different levels of reward. Reaction times for the different reward levels are also recorded.

The overall step-by-step procedure for each participant:

  • Telephone screening (both participant and guardian): information about the study, MRI safety screening, check initial inclusion/exclusion criteria are met.
  • Informed consent: sent by post to all legal guardians and the participant. Returned by post to test leader.
  • The Strengths and Difficulties Questionnaire (SDQ) and socio-economic status questionnaires sent to one legal guardian and returned to test leader upon completion.
  • Visit/Day 1: Assessment with questionnaires, interviews and behavioral testing (For selection of participants: Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV (SCID)-II interview Borderline and Antisocial parts, SDQ, Adult Self-Report Scale (ASRS), Autism Spectrum Quotient (AQ), Toronto Alexithymia Scale (TAS)-20, Ravens SPM, reading test, color vision test, questionnaire with additional questions. For characterization of participants: Brown-Attention Deficit Disorder (ADD), Mood and Feelings Questionnaire (MFQ), State and Trait Anxiety Inventory-Trait (STAI-T), Barratt's Impulsivity Scale (BIS)). Frankfurter Test und Training des Erkennens von fazialem Affekt (FEFA) 2 test (face recognition) and Stop signal test (SST). Approximately 3 hours.
  • DAWBA computerized interview at home. Both participant and one legal guardian complete this.
  • Additional information from patient records gathered, to verify current and previous diagnoses.
  • Visit/Day 2: Assessments with questionnaires (STAI-S, last menstruation, sleepiness rating, motivation rating). MRI-scan: session 1: T1, Stroop session 1, Stroop session 2, T2. Break. Session 2: MID session 1, MID session 2. Break. Session 3: resting state, DTI. Assessments after scan: debriefing questionnaire, "After MID task" questionnaire. Approximately 3 hours.
Being tested
fMRI - Stroop task, fMRI - MID task, Stop Signal Task, SCID-II, SDQ
Medical subject headings
Borderline Personality Disorder, Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • fMRI - Stroop taskOther

    2 x 10 minutes Stroop task (2 x 5 minutes emotional blocks, 2 x 5 minutes non-emotional blocks, order balanced across participants) performed during fMRI scan. See Detailed Study Description.

  • fMRI - MID taskOther

    2 x 10 minutes MID task performed during fMRI scan. See Detailed Study Description.

  • Stop Signal TaskBehavioural

    Performed at a computer at first visit, 10 minutes divided into 3 blocks. See Detailed Study Description.

  • SCID-IIOther

    See Detailed Study Description.

  • SDQOther

    See Detailed Study Description.

  • ASRSOther

    See Detailed Study Description.

  • AQOther

    See Detailed Study Description.

  • TAS-20Other

    See Detailed Study Description.

  • Raven's SPMOther

    See Detailed Study Description.

  • Reading abilityOther

    See Detailed Study Description.

  • Ishihara's tests for colour deficiencyOther

    See Detailed Study Description.

  • Additional questionnaireOther

    including questions about somatic disease, current medication, BMI, smoking habits, first menstruation, last menstruation's first day, days without active oral contraceptive pill during last month, claustrophobia, vision impairment.

  • Brown-ADDOther

    See Detailed Study Description.

  • MFQOther

    See Detailed Study Description.

  • STAI-TOther

    See Detailed Study Description.

  • BISOther

    See Detailed Study Description.

  • DAWBAOther

    See Detailed Study Description.

  • STAI-SOther

    See Detailed Study Description.

  • Sleepiness ratingOther

    Acquired 6 times while in MRI-scanner. See Detailed Study Description.

  • Motivation ratingOther

    Acquired 6 times while in MRI-scanner. See Detailed Study Description.

  • FEFA2Behavioural

    Assessing ability to recognise emotional face, performed at a computer at first visit. See Detailed Study Description.

  • Structural T1 MRI scanOther

    See Detailed Study Description and Outcome Measures.

  • Structural T2 MRI scanOther

    See Detailed Study Description.

  • DTI MRI scanOther

    See Detailed Study Description and Outcome Measures.

  • Resting state MRI scanOther

    See Detailed Study Description and Outcome Measures.

Study groups in NCT02797873
Study groupRoleWhat they receive
EIPExperimentalPatients from the DBT unit suffering from symptoms of Emotional Instability (n=30), with different levels of ADHD symptoms as assessed by questionnaires Brown-ADD, ASRS and SDQ. Interventions: * fMRI - Stroop task * fMRI - MID task * Stop Signal task * Structural T1 MRI scan * Structural T2 MRI scan * DTI MRI scan * Resting state MRI scan * FEFA 2 * SCID-II * SDQ * ASRS * AQ * TAS-20 * Raven's SPM * Reading ability * Ishihara's tests for colour deficiency * Additional questionnaire * Brown-ADD * MFQ * STAI-T * BIS * DAWBA * STAI-S * Sleepiness rating x 6 * Motivation rating x 6
Receives: Other: fMRI - Stroop task; Other: fMRI - MID task; Behavioral: Stop Signal Task; Other: SCID-II; Other: SDQ; Other: ASRS; Other: AQ; Other: TAS-20; Other: Raven's SPM; Other: Reading ability; Other: Ishihara's tests for colour deficiency; Other: Additional questionnaire; Other: Brown-ADD; Other: MFQ; Other: STAI-T; Other: BIS; Other: DAWBA; Other: STAI-S; Other: Sleepiness rating; Other: Motivation rating; Behavioral: FEFA2; Other: Structural T1 MRI scan; Other: Structural T2 MRI scan; Other: DTI MRI scan; Other: Resting state MRI scan
Healthy controlsExperimentalMatched healthy controls (according to age, IQ and socio economic status) recruited from high schools in Stockholm area (n=30). Interventions: * fMRI - Stroop task * fMRI - MID task * Stop Signal task * Structural T1 MRI scan * Structural T2 MRI scan * DTI MRI scan * Resting state MRI scan * FEFA 2 * SCID-II * SDQ * ASRS * AQ * TAS-20 * Raven's SPM * Reading ability * Ishihara's tests for colour deficiency * Additional questionnaire * Brown-ADD * MFQ * STAI-T * BIS * DAWBA * STAI-S * Sleepiness rating x 6 * Motivation rating x 6
Receives: Other: fMRI - Stroop task; Other: fMRI - MID task; Behavioral: Stop Signal Task; Other: SCID-II; Other: SDQ; Other: ASRS; Other: AQ; Other: TAS-20; Other: Raven's SPM; Other: Reading ability; Other: Ishihara's tests for colour deficiency; Other: Additional questionnaire; Other: Brown-ADD; Other: MFQ; Other: STAI-T; Other: BIS; Other: DAWBA; Other: STAI-S; Other: Sleepiness rating; Other: Motivation rating; Behavioral: FEFA2; Other: Structural T1 MRI scan; Other: Structural T2 MRI scan; Other: DTI MRI scan; Other: Resting state MRI scan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. fMRI BOLD signal differences between groups - in Stroop task

    BOLD signal Neutral and Emotional blocks, and for Congruent and Incongruent trials (order dependent)

    Measured: Acquired during fMRI scan

  2. fMRI signal variations within patient group during Stroop task, depending on level of ADHD symptoms - in Stroop task

    BOLD signal Neutral and Emotional blocks, and for Congruent and Incongruent trials (order dependent)

    Measured: Acquired during fMRI scan

  3. Reaction times in Stroop task

    Measured: Acquired during fMRI scan

  4. fMRI BOLD signal differences between groups - in Monetary Incentive Delay task (MID)

    BOLD signal during anticipation phase of different levels of reward, and BOLD signal during receipt/outcome phase of different levels of reward.

    Measured: Acquired during fMRI scan

  5. fMRI BOLD signal differences within patient group during MID task, depending on level of ADHD symptoms - in MID task

    BOLD signal during anticipation phase of different levels of reward, and BOLD signal during receipt/outcome phase of different levels of reward.

    Measured: Acquired during fMRI scan

  6. Reaction times in MID task

    Measured: Acquired during fMRI scan

  7. Stop Signal reaction times (SSRT) from Stop Signal Task (SST)

    Measured: Data necessary for estimation of SSRT acquired during fMRI scan

Secondary outcomes (12)

  1. Brown-ADD score

    Measured: Acquired from questionnaire at first visit

  2. Mood and Feelings questionnaire

    dimensional measurement of depressive symptoms

    Measured: Acquired from questionnaire at first visit

  3. STAI-T score

    Measuring anxiety trait level

    Measured: Acquired from questionnaire at first visit

  4. Barratt's impulsivity scale (BIS)

    Measured: Acquired from questionnaire at first visit

  5. STAI-S score

    Measuring anxiety state level

    Measured: Baseline, acquired from questionnaire Day 2

  6. Sleepiness score

    Acquired 6 times in MRI scanner as follows: 1) Before first Stroop session. 2) Between Stroop session 1 and 2. 3) After Stroop session 2. 4) Before first MID session. 5) Between MID session 1 and 2. 6) After MID session 2.

    Measured: Acquired during MRI scan, on Day 2

  7. Motivation score

    Acquired 6 times in MRI scanner as follows: 1) Before first Stroop session. 2) Between Stroop session 1 and 2. 3) After Stroop session 2. 4) Before first MID session. 5) Between MID session 1 and 2. 6) After MID session 2.

    Measured: Acquired during MRI scan, on Day 2

  8. Structural MRI data - volume

    Measured: Acquired during MRI scan

  9. Structural MRI data - surface area

    Measured: Acquired during MRI scan

  10. Structural MRI data - thickness

    Measured: Acquired during MRI scan

  11. Functional Connectivity (FC)

    Measuring the FC value between ROIs defined in hypothesis to determine strength of connectivity between these different brain regions.

    Measured: Acquired during resting state MRI scan

  12. Fractional Anisotropy (FA) of white matter

    Measured: Acquired during Diffusion Tensor Imaging (DTI) scan

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2016 (estimated)
  2. Study startAug 2016
  3. Primary completionDec 2017 (estimated)
  4. Study completionMay 2018 (estimated)

Resources

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
Basic science
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02797873
Sponsor's protocol ID
2015/127-31/1_EI_ADHD
Status last verified
Jun 2016
First submitted
27 Apr 2016
Last updated
14 Jun 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing fMRI - Stroop task, fMRI - MID task and Stop Signal Task in people with Emotional Instability Personality Disorder (Borderline Personality Disorder) and Attention Deficit Hyperactivity Disorder, run by Karolinska Institutet.

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 6 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 14 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Predrag Petrovic (predrag.petrovic@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

fMRI BOLD signal differences between groups - in Stroop task (time frame: Acquired during fMRI scan). The study lists 7 primary outcomes in all. 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 NCT02797873.

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 14 Jun 2016.

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