Personality Pathology and Cerebral Processing in Eating Disorders
EAT_FMRI
1 other identifier
observational
110
1 country
1
Brief Summary
The proposed study will investigate whether, on the basis of personality traits and personality disorders as well as specific cerebral activation patterns shows differences in adolescent female with anorexia nervosa (AN), bulimia nervosa (BN) and a healthy control group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2015
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 9, 2016
CompletedFirst Posted
Study publicly available on registry
December 2, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2018
CompletedMarch 30, 2018
March 1, 2018
3.8 years
November 9, 2016
March 28, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Neural correlates (fMRI): Differences on cerebral activation patterns in the AN and BN groups from those in the control group
Cerebral activation patterns ((activation of prefrontal, parahippocampal, cinculate, and insular cortex, posterior cingulate cortex ) in the AN and BN groups will differ from those in the control group
At the begin of therapy (T1, week 1) and at the end of therapy (T2) (approx. 2 months)
Secondary Outcomes (2)
Personality pathology: Identification of specific personality profiles (dimensional personality traits and personality disorders) using a structured clinical interview and questionnaire
(T1) Week 1
Relationship between personality pathology (using structured clinical interview and questionnaire) and neural correlates in ED (fMRI)
At the begin of therapy (T1, week 1) and at the end of therapy (T2) (approx. 2 months)
Study Arms (3)
Anorexia Nervosa Group
n=50 female patients with Anorexia Nervosa (AN) who fulfill the criteria for DSM-IV, BMI z-scores will be used for age and sex specific cut-off points that are extrapolated from the adult BMI cut-off \<17.5 Interventions:EDI-2, EAT, SCID-I, SCID-II, LoPF, HAWIK-IV, fMRI
Bulimia Nervosa Group
n=30 female patients with Bulimia Nervosa (BN) who have BMI z-scores from the adult range \<17.5-25.0 (this reflects the lower prevalence rates of BN compared to AN) Interventions:EDI-2, EAT, SCID-I, SCID-II, LoPF, HAWIK-IV, fMRI
Healthy Control Group
n=30 healthy females who have BMI z-scores from the adult range from 19.0-25.0 and who do not fulfill diagnostic criteria for any psychiatric disorder.Interventions:EDI-2, EAT, SCID-I, SCID-II, LoPF, HAWIK-IV, fMRI
Interventions
The structured clinical interview for DSM-IV Axis I Disorder (SCID-I, German translation, see Wittchen, Zaudig \& Fydrich, 1997) is a semi-structured interview to diagnose AN and BM. It allows a detailed assessment of ED symptoms across different settings and time periods necessary to make an accurate diagnosis.
The Eating Attitudes Test (EAT) is a standardized questionnaire of symptoms and concerns related to ED (Garner \& Garfield, 1979, German translation by Steinhausen). The questionnaire consists of 40 items on a six-point Likert scale, providing information
The Eating Disorder Inventory 2 (Paul \& Thiel, 2004) is a self-report questionnaire on psychological features generally associated with AN and BN.The instrument consists of 91 items on a six-point Likert scale. The 11 scales are drive for thinness, bulimia, body dissatisfaction, ineffectiveness, perfectionism, interpersonal distrust, interoceptive awareness, maturity fears, asceticism (provisional), impulse regulation (provisional) and social insecurity (provisional). It was designed as a diagnostic aid; its psychometrics have been tested, with studies demonstrating satisfactory internal consistency reliability coefficients (between .44 and .93), test-retest reliability of .79 to .95 (after one week) and above .80 (after three weeks), and content, convergent and discriminant validity.
The SCID-II interview (German, see Wittchen, Zaudig \& Fydrich, 1997) is a widely used and researched instrument to assess DSM-IV-TR personality disorders.The interview covers all ten DSM-IV personality disorders (antisocial, avoidant, borderline, dependent, histrionic, narcissistic, obsessive-compulsive, paranoid, schizoid and schizotypal), PD not otherwise specified, and appendix categories (depressive PD and passive-aggressive PD) and is used to make personality disorder diagnoses either dimensionally or categorically (present-absent). Furthermore, it allows the investigation of patterns of PD that co-occur with other mental disorders as well as the analysis of the underlying structure of personality pathology.
In order to specifically focus on certain personality traits, we use the LoPF as an additional measure. It is a well-validated and reliable self-report questionnaire to measure healthy and pathological personality functioning in adolescents. It is based on the DSM-5 Section III Alternative Model for Personality disorders and covers core impairments in adolescents' personality functioning: identity, self-direction (self-related personality functioning), intimacy/ attachment and empathy/ social-related personality functioning (Sevecke \& Krischer, 2011).
The Wechsler Intelligence Scale for Children (HAWIK-IV, Petermann \& Petermann, 2008) will be used assess intelligence. For adolescents older than 16.11 years, we will use the German version of the Wechsler Adult Intelligence Scale (HAWIE-IV).Results from test-retest reliability demonstrate that the mean retest scores for all subtests are higher than the mean test scores from first administration, with effect sizes ranging from .08 (comprehension) to .60 (picture completion). The test has demonstrated an acceptable relationship to other measures of achievement, memory, adaptive behavior, emotional intelligence and giftedness in children and adolescents (Canivez, 2014). For the non-clinical adolescent sample, we will use two subtests of the HAWIK.
To measure food-related brain activation, event-related fMRI will be used, with phases of high-caloric images alternating with phases of low-caloric images and images of fixation cross (not related to food images). A total of 18 blocks will be performed - see figure below. The duration of each phase will be 30 seconds. In a second run, the patients and control subjects will drink chocolate milk and water, alternating every 30 seconds, through a long silicon tube. This procedure was successfully tested in a previous fMRI study with adult AN patients (Gizewski et al. 2010, Vocks et al. 2011) and has now been adopted in preliminary measurements for young AN patients.
Eligibility Criteria
The study will include 50 female patients with AN, 30 female patients with BN and 30 healthy females
You may qualify if:
- The study will include 50 female patients with AN, 30 female patients with BN and 30 healthy females
You may not qualify if:
- Age \>18 years or \<14 years
- Extremely underweight patients requiring pediatric treatment for medical stability and improvement of cognitive functioning prior to psychiatric inpatient treatment Overweight and obese patients with BMI z-scores extrapolated from the adult BMI cut-off \> 25.0
- Acute or chronic somatic or functional diseases (i.e. strokes, tumors, heart conditions)
- A history of head trauma or fainting
- Left-handedness (determined by a standardized questionnaire)
- Evidence of structural brain abnormality on the structural MRI scan (conducted on the first day of the study)
- Pregnancy (assessed with urine pregnancy test)
- Allergy to chocolate
- Schizophrenia and other psychotic disorders
- Shrapnel or other electronic/metal implants in the body (i.e. pacemakers, surgical devices etc.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department for Child and Adolescent Psychiatry
Innsbruck, Tyrol, 6020, Austria
Related Publications (1)
Dabkowska-Mika A, Steiger R, Gander M, Haid-Stecher N, Fuchs M, Sevecke K, Gizewski ER. Evaluation of visual food stimuli paradigms on healthy adolescents for future use in fMRI studies in anorexia nervosa. J Eat Disord. 2023 Mar 6;11(1):35. doi: 10.1186/s40337-023-00761-8.
PMID: 36879292DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kathrin Seveke, Univ-Prof.Dr
Head of department of Child and Adolescent Psychiatry
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Univ.-Prof. Dr. med.
Study Record Dates
First Submitted
November 9, 2016
First Posted
December 2, 2016
Study Start
January 1, 2015
Primary Completion
November 1, 2018
Study Completion
November 1, 2018
Last Updated
March 30, 2018
Record last verified: 2018-03