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Study Protocol Summary

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(Burgmer et al., 2005), (Saunders, 1999) and after (de novo) surgery (Saunders, 2003),(Hsu, Betancourt, & Sullivan, 1996).

While a part of the literature show that eating habits can improve, mostly in the short-term post-surgical period, some authors have proven the tendency of eating disorders to persist, or relapse, after bariatric intervention; the same studies found an association between post-surgical ED symptoms and a worse outcome both in terms of a lesser and brief early weight loss and higher rates of subsequent weight gain ((Hsu, Sullivan, & Benotti, 1997), (Kalarchian et al., 2002)).

Saunders & colleagues found DSM-IV BED prevalence rates of 30% among RYGB candidates, not considering binge-type partial syndromes (EDNOS); the authors point out the need to explore and widen the range of assessed eating disorder syndromes in order to develop much needed interventions, both in preparation and in follow-up to surgery.(Saunders, 2001). Ten years later, Wadden, Falcounbridge and Sarwer reported estimates ranging from 5% to 50%, pointing out a tendency of self-report instruments to overstimate BED criteria, while clinical interviews led to prevalence estimates from 5% to 25% (Wadden et al., 2011)

MATERIALS AND METHODS

Study Protocol Summary

Study subjects have been recruited among patients hospitalised in UO Medicina Generale 3, consecutively sent to OU Psichiatria 2 for Psychiatric Evaluation

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Age between 18 and 80 years

Ability to read and understand Italian language Provisional indication to Bariatric Surgery Ability to provide informed written consent

Willingness to participate to a regular visit schedule Ability to comprehend study goals and procedures.

Exclusion criteria were psychiatric exclusion criteria for Bariatric Surgery (alcohol or substance dependence, severe psychotic symptoms) and inability to provide written informed consent.

Enrolled patients have been evaluated according to DSM-IV-TR diagnostic criteria through a psychiatric interview by two investigators. Diagnosis were thus confirmed by M.I.N.I. 5.0 and the Boston Interview for Gastric Bypass module for BED diagnosis.

During the psychiatric interview relevant behavioural habits, such as substance consumption (Tobacco, caffeine and subclinical alcohol use) were checked with the patient.

Body weight and obesity grade index (BMI) was registered at time of hospitalization. Medical comorbid conditions were checked and listed as provisional until completion of pre-surgical diagnostic protocol. Demographic and antropometric data have been registered, along with psychiatric history variables, (presence of past and ongoing treatment, family comorbidity).

PSYCHOMETRIC INSTRUMENTS

M.I.N.I. 5,0,1:

The Mini-International-Neuropsychiatric-Interview is a short structured diagnostic interview, developed byu a joint group across UA and Europe as a tool for DSM-IV and ICD-10 psychiatric

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diagnosis. With the benefit of a very short administration time (around 15 minutes), while keeping a good measure of accuracy, it was designed to address the needs of multicenter RCT, epidemiology studies and outcome tracking in clinical-only settings. It has been validated in relation to DSM-III-R SCID-P, CIDI and an expert professional panel. The 5.0.1 version allows the interviewer to diagnose sixteen DSM-IV disorders:

axis-II Anti-social personality disorder, included on account of construct lifetime stability and consistency versus all other personality disorders, and in acknowledgement of clinical and prognostic implication

Axis-I Major depressive Episode , Manic and Hypomanic Episode, Panic Disorder, Subthreshold Panic Attacks , Psychotic Syndromes, (past and current), Agoraphobia with and without PD, Social Phobia, Obsessive-Compulsive Disorder, Post-Traumatic Stress Disorder, Alcohol and Substance use disorder, Nervous Anorexia, Nervous Bulimia Dysthymia and Generalised Anxiety Disorder4 (Current Only, see below)(Sheehan et al., 1998).

M.I.N.I. focuses primarily on current symptoms (with the exception of course descriptors for mood and panic disorders); little or no consideration is paid to functional impairment, relation to somatic and substance use comorbidities.

PAS-SR – Lifetime

As other Spectrum Models, The Panic-agoraphobic Spectrum comprises “symptoms, traits and behaviours” belonging to fully-expressed Panic Disorder and to sub-threshold presentations. The symptoms considered in this model are DSM criterion, associated features, behavioural traits and

4 Both Dysthymia and GAD are considered hierarchically excluded in the presence of current EDM or any anxiety disorder, respectively.

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interpersonal styles frequently observed in patients without a PD diagnosis. Early onset of these traits can contribute to shape mental functions and personality profiles, and modulate course of illness of both other psychiatric and somatic comorbidities (Cassano et al., 1999; Shear et al., 2001). This instrument was at first developed with eight theoretical domains, and a total score with a threshold value of 35. A subsequent factor analysis allowed the extraction of 10 factors (Rucci, Miniati, Oppo, MULA, & Calugi, 2009):

1.Panic Symptoms 2.Agoraphobia 3.Claustrophobia 4.Separation Anxiety 5.Fear of Losing Control

6.Drug Sensitivity and Phobiua 7.Medical Reassurance

8.Rescue Object 9.Loss of Sensitivity 10.Family Reassurance

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MOODS-SR-Lifetime}

The Mood spectrum model allows for “a unitary and continuous approach” that can be relied upon to refine both diagnosis and treatment. The assessment of components of both mood polarities, encompassing symptoms, traits and broader lifestyles, allows to characterise the affective dysregulations at the core of mood disturbances (Dell'Osso et al., 2002; Fagiolini et al., 1999). Similarly to the PAS-SR scale, factor analysis were subsequently carried out, with the identification of depressive spectrum factors and bipolar spectrum factors:

depressive mood, psychomotor retardation, suicidality, drug/illness related depression, psychotic spectrum features, neurovegetative symptoms

psychomotor activation, creativity, mixed instability, sociability/extraversion, spirituality/ mysticism/psychoticism, mixed irritability, inflated self-esteem, euphoria, wastefulness/recklessness (Cassano et al., 2009){Cassano:2009dy

SCI-ABS-SR:

SCI-ABS-SR is a self-report questionnaire developed by the Spectrum Project Study Group and validated in 1997 for internal consistency and ability to detect patients versus healthy controls. Coherently with the spectrum model it was designed upon, SCI-Abs has proven to allow to detect both full-blown and subthreshold aspects of eating disorders. It is composed of boolean items and allows to obtain indexes structured in nine domains and 12 subdomains (see table). Moreover concurrent validity was demonstrated between the SCI-ABS and existing, commonly used validated instruments such as EAT and EDI(Mauri et al., 2000).

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In a work by Ramacciotti, SCI-ABS obese people with and without BED have been studied in terms of shared psychopathological features, framed within the model of eating disorders spectrum. The results point to a role of cognitive indexes (in detail: dichotomous reasoning and weight-shape concerns influencing self-esteem) as lifetime markers of BED comorbidity. The authors stressed the need to assess eating disorder comorbidity in obesity by following a dimensional psychopathological approach, rather than recurring to diagnostic categories(Ramacciotti et al., 2008).

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Domain 7 is an index of abnormal eating patterns: Item 89 has been employed as an index of lifetime presence of grazing behaviour5 (see chapter on Eating Disorders Comorbidity).

1.Attitude and beliefs 2.Weight history

3.Self-esteem and satisfaction 4.Phobias

4.1. Body dissatisfaction 4.2. Weight gain phobia 4.3. Secondary social phobia 4.4. Visceral perceptions 5.Avoidant and compulsive behaviours

6.Weight maintenance

6.1. Dietary habits 6.2. Physical activity 6.3. Purging behaviour 7.Eating discontrol

8.Associated features and consequences 8.1. Impulse discontrol 8.2. Personality

8.3. Physical consequences 9.Interference and level of insight

9.1. Impairment

The Structured Clinical Interview for the Anorexic-Bulimic Spectrum - Domains

5 Have you ever had extended periods of time when you ate...continuously throughout the

day, so that you ingested an amount of food that was definitely larger than most people usually eat?

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BOSTON INTERVIEW for Gastric Bypass-original version:

The Boston Interview for Gastric Bypass is a semi-structured interview developed by Sogg & colleagues for pre-surgical evaluation of Gastric Bypass candidates. The results are organised in seven evaluation areas:

In this study we employed data from the eating behaviours section in order to better assess BED symptoms.

The Boston Interview for Gastric Bypass - Evaluation Areas (Study-Selected areas in bold)

1. Weight, diet and nutrition history. 2. C u r r e n t e a t i n g b e h a v i o r s .

attitude and beliefs

3. Medical history

4. Self-esteem and satisfaction

5. U n d e r s t a n d i n g o f s u rg i c a l procedures, risks, and post-surgical regimen.

6. Motivation and expectations of surgical outcome

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SCL-90:

Self-Report Symptom Inventory-Revised - SCL-90-R), is a self-rating scale validated for asedsment of general psichiatric symptoms.

It comprises 90 items che composing 9 indexes, modeled after 9 dimensional domains encompassing a broad symptomatological variety, commonly observed in outpatient settings.

The time frame considered is the last week at time of administration.

Items are rated on a likert range from 0 (not at all) to 4 (a lot) and are thus scored in 9 index relating to domain clusters (Somatisation, Obsessive-compulsive, Interpersonal Sensitivity,Depression, Anxiety, Anger-Hostility, Phobic Anxiety, Paranoid Ideation, Psychoticism).

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1.Somatisation

Reflecting distress deriving from bodily sensations, this domain is scored by items included among diagnostic criteria for many DSM-IV anxiety disorders. High scores in this domain are prevalent so-called “functional” syndromes, but are also relevant as expression of distress from an actual somatic comorbidity

2.Obsessive-Compulsive

This domains detects typical OCD symptoms.

3.Interpersonal Sensitivity:

items in this domains represent a focus on inadequacy and inferiority in relation to significant others.

4.Depression and Anxiety

Scored upon most of depressive and anxiety syndromes

5.Anger-Hostility

thoughts, feelings and behaviours related to states of anger, irritability.

6.Phobic Anxiety

this is mainly scored by agoraphobic symptoms

7.Paranoid Thought

Thought disturbances as suspiciousness, distrust, grandiosity, self-referential thought, fear being controlled and paranoid delusions

8.Psychoticism

T h i s c o n s t r u c t r a n g e s f o r m m i l d interpersonal retirement to alienation and clear-cut psychotic syndromes.

Seven more items add only to the general score , expressed by three global indexes : General Symptomatic Index (GSI), Positive Symptoms tTl (PST) and Positive Symptoms Distress Index (PSDI)

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Barratt Impulsiveness Scale - BIS 11

The Barratt Impulsiveness Scale is a self-administered questionnaire designed to assess a personality and behavioral construct of impulsiveness. This instrument, now at the eleventh revision, is the most widely cited for assessment of impulsiveness and has been used for 50 years(Stanford, Mathias, & Dougherty, 2009).

The current version of the Barratt Impulsiveness Scale (Patton, Stanford, & Barratt, 1995) is composed of 30 items describing common impulsive or non-impulsive (for reverse scored items) behaviors and lifestyle-related preferences.

Items are scored on a 4-point likert scale from Rarely/Never (1) to Almost Always/Always (4). The perspective proposed by Dr. Barratt and researchers from the International Society for Research on Impulsivity is that of a multi-faceted construct, and this multi-dimensionality is reflected in the BIS-11 factor structure. The authors recommend that at least the second order factors be reported to account for their individual contribution to the relationship being tested.

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The Barratt Impulsiveness Scale - 11 - Factor Structure

2nd Order Factors 1st Order Factors

Attentional Attention Cognitive Instability Motor Motor Perseverance Nonplanning Self-Control Cognitive Complexity

Riferimenti

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