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

NCT02797873 | Unknown

• 1 other identifier: 2015/127-31/1_EI_ADHD
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Emotional Instability Personality Disorder (Borderline Personality Disorder); Attention Deficit Hyperactivity Disorder; Healthy Controls

Outcome Measures

Primary Outcomes (7)

• fMRI BOLD signal differences between groups - in Stroop task

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

  Acquired during fMRI scan

• 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)

  Acquired during fMRI scan

• Reaction times in Stroop task

  Acquired during fMRI scan

• 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.

  Acquired during fMRI scan

• 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.

  Acquired during fMRI scan

• Reaction times in MID task

  Acquired during fMRI scan

• Stop Signal reaction times (SSRT) from Stop Signal Task (SST)

  Data necessary for estimation of SSRT acquired during fMRI scan

Secondary Outcomes (12)

• Brown-ADD score

  Acquired from questionnaire at first visit

• Mood and Feelings questionnaire

  Acquired from questionnaire at first visit

• STAI-T score

  Acquired from questionnaire at first visit

• Barratt's impulsivity scale (BIS)

  Acquired from questionnaire at first visit

• STAI-S score

  Baseline, acquired from questionnaire Day 2

Study Arms (2)

EIP

EXPERIMENTAL

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

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 controls

EXPERIMENTAL

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

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

Interventions

fMRI - Stroop task OTHER

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.

EIP; Healthy controls

fMRI - MID task OTHER

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

EIP; Healthy controls

Stop Signal Task BEHAVIORAL

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

EIP; Healthy controls

SCID-II OTHER

See Detailed Study Description.

EIP; Healthy controls

SDQ OTHER

See Detailed Study Description.

EIP; Healthy controls

ASRS OTHER

See Detailed Study Description.

EIP; Healthy controls

AQ OTHER

See Detailed Study Description.

EIP; Healthy controls

TAS-20 OTHER

See Detailed Study Description.

EIP; Healthy controls

Raven's SPM OTHER

See Detailed Study Description.

EIP; Healthy controls

Reading ability OTHER

See Detailed Study Description.

EIP; Healthy controls

Ishihara's tests for colour deficiency OTHER

See Detailed Study Description.

EIP; Healthy controls

Additional questionnaire OTHER

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.

EIP; Healthy controls

Brown-ADD OTHER

See Detailed Study Description.

EIP; Healthy controls

MFQ OTHER

See Detailed Study Description.

EIP; Healthy controls

STAI-T OTHER

See Detailed Study Description.

EIP; Healthy controls

BIS OTHER

See Detailed Study Description.

EIP; Healthy controls

DAWBA OTHER

See Detailed Study Description.

EIP; Healthy controls

STAI-S OTHER

See Detailed Study Description.

EIP; Healthy controls

Sleepiness rating OTHER

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

EIP; Healthy controls

Motivation rating OTHER

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

EIP; Healthy controls

FEFA2 BEHAVIORAL

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

EIP; Healthy controls

Structural T1 MRI scan OTHER

See Detailed Study Description and Outcome Measures.

EIP; Healthy controls

Structural T2 MRI scan OTHER

See Detailed Study Description.

EIP; Healthy controls

DTI MRI scan OTHER

See Detailed Study Description and Outcome Measures.

EIP; Healthy controls

Resting state MRI scan OTHER

See Detailed Study Description and Outcome Measures.

EIP; Healthy controls

Eligibility Criteria

• Age: 16 Years - 18 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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));
• 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

Sponsors & Collaborators

• Karolinska Institutet: lead

MeSH Terms

Conditions

Borderline Personality Disorder; Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders

Central Study Contacts

Predrag Petrovic

CONTACT

predrag.petrovic@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Associate Professor

Study Record Dates

• First Submitted: April 27, 2016
• First Posted: June 14, 2016
• Study Start: August 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: May 1, 2018
• Last Updated: June 14, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will share