Emotional and Non-emotional Regulation in Patients With Emotional Instability and ADHD
NCT ID: NCT02797873
Last Updated: 2016-06-14
Study Results
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Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2016-08-31
2018-05-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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EIP
Patients 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
fMRI - Stroop task
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 task
2 x 10 minutes MID task performed during fMRI scan. See Detailed Study Description.
Stop Signal Task
Performed at a computer at first visit, 10 minutes divided into 3 blocks. See Detailed Study Description.
SCID-II
See Detailed Study Description.
SDQ
See Detailed Study Description.
ASRS
See Detailed Study Description.
AQ
See Detailed Study Description.
TAS-20
See Detailed Study Description.
Raven's SPM
See Detailed Study Description.
Reading ability
See Detailed Study Description.
Ishihara's tests for colour deficiency
See Detailed Study Description.
Additional questionnaire
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-ADD
See Detailed Study Description.
MFQ
See Detailed Study Description.
STAI-T
See Detailed Study Description.
BIS
See Detailed Study Description.
DAWBA
See Detailed Study Description.
STAI-S
See Detailed Study Description.
Sleepiness rating
Acquired 6 times while in MRI-scanner. See Detailed Study Description.
Motivation rating
Acquired 6 times while in MRI-scanner. See Detailed Study Description.
FEFA2
Assessing ability to recognise emotional face, performed at a computer at first visit. See Detailed Study Description.
Structural T1 MRI scan
See Detailed Study Description and Outcome Measures.
Structural T2 MRI scan
See Detailed Study Description.
DTI MRI scan
See Detailed Study Description and Outcome Measures.
Resting state MRI scan
See Detailed Study Description and Outcome Measures.
Healthy controls
Matched 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
fMRI - Stroop task
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 task
2 x 10 minutes MID task performed during fMRI scan. See Detailed Study Description.
Stop Signal Task
Performed at a computer at first visit, 10 minutes divided into 3 blocks. See Detailed Study Description.
SCID-II
See Detailed Study Description.
SDQ
See Detailed Study Description.
ASRS
See Detailed Study Description.
AQ
See Detailed Study Description.
TAS-20
See Detailed Study Description.
Raven's SPM
See Detailed Study Description.
Reading ability
See Detailed Study Description.
Ishihara's tests for colour deficiency
See Detailed Study Description.
Additional questionnaire
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-ADD
See Detailed Study Description.
MFQ
See Detailed Study Description.
STAI-T
See Detailed Study Description.
BIS
See Detailed Study Description.
DAWBA
See Detailed Study Description.
STAI-S
See Detailed Study Description.
Sleepiness rating
Acquired 6 times while in MRI-scanner. See Detailed Study Description.
Motivation rating
Acquired 6 times while in MRI-scanner. See Detailed Study Description.
FEFA2
Assessing ability to recognise emotional face, performed at a computer at first visit. See Detailed Study Description.
Structural T1 MRI scan
See Detailed Study Description and Outcome Measures.
Structural T2 MRI scan
See Detailed Study Description.
DTI MRI scan
See Detailed Study Description and Outcome Measures.
Resting state MRI scan
See Detailed Study Description and Outcome Measures.
Interventions
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fMRI - Stroop task
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 task
2 x 10 minutes MID task performed during fMRI scan. See Detailed Study Description.
Stop Signal Task
Performed at a computer at first visit, 10 minutes divided into 3 blocks. See Detailed Study Description.
SCID-II
See Detailed Study Description.
SDQ
See Detailed Study Description.
ASRS
See Detailed Study Description.
AQ
See Detailed Study Description.
TAS-20
See Detailed Study Description.
Raven's SPM
See Detailed Study Description.
Reading ability
See Detailed Study Description.
Ishihara's tests for colour deficiency
See Detailed Study Description.
Additional questionnaire
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-ADD
See Detailed Study Description.
MFQ
See Detailed Study Description.
STAI-T
See Detailed Study Description.
BIS
See Detailed Study Description.
DAWBA
See Detailed Study Description.
STAI-S
See Detailed Study Description.
Sleepiness rating
Acquired 6 times while in MRI-scanner. See Detailed Study Description.
Motivation rating
Acquired 6 times while in MRI-scanner. See Detailed Study Description.
FEFA2
Assessing ability to recognise emotional face, performed at a computer at first visit. See Detailed Study Description.
Structural T1 MRI scan
See Detailed Study Description and Outcome Measures.
Structural T2 MRI scan
See Detailed Study Description.
DTI MRI scan
See Detailed Study Description and Outcome Measures.
Resting state MRI scan
See Detailed Study Description and Outcome Measures.
Eligibility Criteria
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Inclusion Criteria
* Right-handed
* Monophasic contraceptives
* Speak Swedish fluently
≥4/9 criteria of DSM-IV, measured by SCID-II interview
Exclusion Criteria
* 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));
* 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
16 Years
18 Years
FEMALE
Yes
Sponsors
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Karolinska Institutet
OTHER
Responsible Party
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Predrag Petrovic
MD, PhD, Associate Professor
Central Contacts
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Other Identifiers
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2015/127-31/1_EI_ADHD
Identifier Type: -
Identifier Source: org_study_id
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