Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05861661 |
| Other study ID # |
0051-20-ZIV |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 12, 2020 |
| Est. completion date |
July 12, 2021 |
Study information
| Verified date |
July 2020 |
| Source |
Ziv Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
The current research has two goals: first to validate the Hebrew version of a new measurement
for assessing mentalization failures. The second goal is to examine the connection between
attachment, emotional regulation strategies, mentalization, and specific mentalization
failures - As they manifested in anorexia nervosa (AN) compared with non-patient controls.
The study includes computer tasks, questionnaires and two short tasks administrated by the
examiner.
Description:
Study goals:
1. To validate the Hebrew version of the Movie for the Assessment of Social Cognition
(MASC) which asses mentalization ability and mentalization failures (Dziobek et al.,
2006). This version of the MASC was recently designed by the study group in Haifa
University. The validation of this version of the MASC will be done by comparing
patients with AN to non-patients.
2. To examine the connection between attachment styles, emotional regulation strategies,
mentalization, and specific mentalization failures.
Study Hypotheses:
1. In respect to the first goal of the study, we hypothesize that a. a significant
correlation between the MASC and other tools examining different aspects of
mentalization (RME, CAM, TAS and RFQ) will be fond; b. different patterns of
mentalization will be found between the clinical group and the control group on the
MASC. More specifically, patients with AN will show more hypo-mentalization tendencies
on the MASC then the control group.
2. regarding the second goal of the study, we hypothesize that the connection between
attachment and mentalization failures will be mediated via emotional regulation
strategies. More specifically, we anticipate that the connection between avoidant
attachment and hypo-mentalization will be mediated via emotional isolation strategy and
the connection between anxious attachment and hyper-mentalization will be mediated via
emotional flood.
Method:
Participants This study will include 120 participants at the ages of 16-26. The participants
will be assigned into two groups. The AN group will include 60 women diagnosed according to
the DSM-5 (APA, 2013) as suffering from AN and are currently hospitalized. The control group
will include 60 women participants, which will be screened and excluded if found to be
suffering from any type ED, have a psychiatric background or any chronic disease. The control
group will be recruited threw Haifa university. The control group session will take place in
Haifa university.
Measures
Measures of mentalization
The Movie for Assessment of Social Cognition (MASC) (Dziobek et al., 2006) - Hebrew version.
This task was designed to serve as a refined, easily-administered, ecologically-valid measure
of ToM and ToM errors. It was originally shown to discriminate between adults with Asperger
syndrome and healthy controls, and has since been used in studies researching ToM,
mentalization and mentalization deficits in different psychopathology's, including AN and
SAD. It was also translated to Spanish and Norwegian, and was found to be valid in these
languages (Lahera et al., 2014, Fretland et al. 2015). The task consists of a film depicting
four young adults getting together for dinner. The film stops at various points to pose
questions regarding the thoughts, intentions and feelings of the characters. Overall, the
task includes 45 multiple-choice questions; each question has one correct answer and three
distractors, which can be characterized as reflecting exceeding ToM/hypermentalization,
insufficient ToM/hypomentalization and concrete answers which involve no ToM. We will use the
Hebrew version of the task, which was translated and dubbed for the purpose of the current
research project.
Reading the Mind in the Eyes (RME)- Revised Version (Baron-Cohen et al., 2001). This task was
designed to assess the ability to recognize basic and complex emotions and ToM. It has also
been found to be valid when translated into other languages (Hallerbäck et al., 2009, Prevost
et al., 2014). In the current study we will use the Hebrew version translated by Milo. During
the task, participants are presented with 52 photographs of eyes exhibiting basic emotions
(happy, sad, afraid, surprised, disgusted, angry) (Ekman & Friesen, 1976) as well as complex
emotions (interested, worried, confident, fantasizing, preoccupied, friendly and suspicious)
(Baron-Cohen et al., 1997). Each picture is presented twice, and participants are asked to
make a forced choice between four words naming the emotion, with only one correct answer.
The Cambridge Mindreading (CAM) Face-Voice Battery - (Golan et al., 2006). This battery
examines complex emotion and mental-state recognition in both visual and auditory format. In
the current study we will use only the visual task, which is comprised of silent clips of
adult actors, both male and female, of different ethnicities, expressing emotions facially.
Fifty faces examine recognition of 20 different complex emotions and mental states (e.g.,
intimate, insincere). During each trial, a clip is presented and the participants are asked
which of four words best describes the emotions being displayed. There is no time limit for
answering. The battery provides an overall facial emotion recognition score (max =50) as well
as individual scores for each of the 20 emotions assessed (pass/fail, i.e., recognized above
chance or not) and an overall number of the emotions correctly recognized (max=20). The
current study will use a Hebrew version of this task which was developed by Prof. Ofer Golan,
one of the designers of the original English version, alongside Prof. Lily Rothschild-Yakar.
The Toronto Alexithymia Scale (TAS-20) - (Griffith, 1998). The TAS is a 20-item self-report
measure, which was developed for the assessment of alexithymia, yet can also be used to
measure mentalization in relation to the self (Luyten et al., 2012). The scale has 3 factors
which were confirmed in several studies (Parker, Taylor, & Bagby, 2003): (a) difficulty in
identifying feelings, (b) difficulty in describing feelings to others; and (c) externally
oriented thinking. The scale's internal consistency (α =.81(, and test-retest reliability (r
= .77) have been established (Bagby, Taylor, & Parker, 1994), and its Hebrew version showed
good internal consistency (α = 0.89; Rozenstein et al. 2011) The Reflective Functioning
Questionnaire (RFQ), (Fonagy et al, 2016). The RFQ is a relatively new instrument, developed
as a brief, easy-to-administer, self-report screening measure of mentalization. It originally
included 46 items which the participant responded to on a 6-point scale. Factor analysis
yielded two main factors, assessing Certainty (RFQ_C) and Uncertainty (RFQ_U) about the
mental states of self and others. These two factors allow distinguishing between the two the
main mentalization impairments, hyper-mentalization and hypo-mentalization, with high scores
of certainty indicating hyper-mentalization and high scores of uncertainty reflecting
hypo-mentalization; low scores on both scales indicate more genuine mentalizing. The factors
were relatively distinct, invariant across clinical and non-clinical samples, had
satisfactory internal consistency and test-retest stability, and were largely unrelated to
demographic features. The questionnaire's developers have since designed a short, 8-item
version, consisting of the highest loading items on their respective factor as seen in
exploratory and confirmatory factor analyses. We will use the short Hebrew version supplied
by the questionnaire's authors.
Measure of attachment
Experiences in Close Relationships Scale (ECR), (Brennan et al., 1998). This measure examines
patterns of attachment through a self-report questionnaire containing 36 items. The
participants are required to rate to what extent each item describes his attitude toward
close relationships, from (1) - strongly disagree, to (7) - strongly agree. 18 items relate
to an insecure/anxious attachment pattern, and another 18 items relate to an
insecure/avoidant attachment pattern. The original study reported Cronbach's alpha as .91 and
.94 for the Anxiety and Avoidance subscales, respectively, and similar results have been
found since (Vogel & Wei, 2005). Test-retest reliability has been shown to be around 0.7
(Lopez & Gormley, 2002). The Hebrew version of the questionnaire will be used in this study,
translated by Mikulincer & Florian (2000). They also validated its two-factor structure on an
Israeli sample, with high internal reliability (Cronbach's alpha .92 for anxious attachment
and .93 for avoidant attachment).
Measure of emotion regulation The Differentiation of Self Inventory (DSI), (Skowron &
Friedlander, 1998; Skowron & Schmitt, 2003). The DSI is a self-report questionnaire that
measures self-other differentiation as well as adaptive emotional regulation, which are vital
for the development of mentalizing ability. This is a self-report instrument for adults (age
≥25 years), that was modification translated to Hebrew and validated for adolescents and
young adults (Rothschild-Yakar et al., 2016). We will use the Hebrew version of Skowron and
Schmitt's (2003) revised edition comprising 46 items in four subscales (Emotional Reactivity,
I Position, Emotional Cutoff and Fusion with Others). Participants rated items on a 6-point
Likert-type response scale ranging from Not at all (1) to Very true (6). Higher scores
indicate a greater level of differentiation. The DSI showed external validity, with elevated
DSI scores predicting lower chronic anxiety and better psychological adjustment (Skowron &
Friedlander, 1998). Internal consistency reliabilities of the DSI and its subscale calculated
with Cronbach's alpha were reported as follows: DSI full scale=.88, Emotional Reactivity=.84,
I Position=.83, Emotional Cutoff=.82, and Fusion with Others=.74 (Skowron & Friedlander,
1998).
Measures of background variables, comorbidity, and estimation of intellectual ability
Personal details questionnaire. This questionnaire covers basic personal details such as age,
country of origin, formal education, past or present emotional difficulties, past or present
symptoms of EDs and the height and weight of the participants, as well as family details such
as parental marital status, socioeconomic status, and parental education.
The short Depression, Anxiety and Stress Scale (DASS)-21 - (Lovibond & Lovibond, 1995). The
DASS-21 is a 21-item self-report measure designed to assess and discriminate between symptoms
of depression, anxiety, and stress. It consists of 21 items, which participants rate on a
scale of 0 to 3 about how accurately statements regarding depression, anxiety, and stress
applied to them over the past week. The DASS-21 has demonstrated acceptable psychometric
properties in clinical and nonclinical populations, with high internal consistency for each
sub-scale ranging from α = .82 to .94 (Antony, Bieling, Cox, Enns, & Swinson, 1998; Henry &
Crawford, 2005).
The Eating Attitudes Test (EAT-26): (Garner et al, 1982). The EAT-26 will be used to measure
the presence and severity of EDs. This is a self-report questionnaire that examines the level
of pathological eating-related preoccupations and behaviours. The EAT-26 includes three main
subscales: (a) dieting, refraining from fatty food, and physical appearance; (b) bulimic
symptomatology and preoccupation with food; and (c) personal control over eating habits.
Participants rate the 26 items on a 6-point scale ranging from Never (1) to Always (6). High
reliability and validity of the EAT-26 were found across different cultures (Garfinkel &
Newman, 2001; Garner et al 1982), including in Israeli patients with EDs (Koslowsky et. al.,
1992, Niv-Nadler, 1997).
The SCOFF- questionnaire for the assessment of eating disorders (Morgan et al., 1999). The
SCOFF questionnaire is a simple 5- yes/no question tool, developed to screen for eating
disorders in the general population. For every positive answer one point is given. A total
score of two and above has been found to be 100% sensitive and 87.5% specific for the
presence of any ED.
An estimated IQ: Similarities and block design subtests (Wechsler, 2008). Similarities and
Block Design will be used as an estimate for IQ. The Similarities and Block Design subtests
will be used from the Hebrew version of WAIS IIIHeb (Wechsler, 1997) for Adults. The two
subtests were found to possess high loading on the factors to which they belong (Watkins et
al, 2006).
Study procedure All tasks will be administrated individually by a master or doctoral student
in a single two hours session. After receiving an information regarding the purpose of the
study and its procedure the participants will sign a consent form. For participants under the
age of 18, parental consent will be obtained as well. During the session the participants
will complete online self-report questionnaires (personal details questionnaire, experiences
in close relationships scale and the differentiation of self inventory) followed by the
Hebrew version of the movie for assessment of social cognition (MASC-heb). Then the
participants will complete an online self report questionnaire ( the Toronto alexithymia
scale) followed by two computer tasks (the Cambridge mindreading face-voice battery and the
reading the mind in the eyes),the Wechsler's Similarities and Block design and more online
self- report questionnaires (the short depression, anxiety and stress scale, the reflective
functioning questionnaire and the eating attitudes test 26).
To ascertain that the participants of the control group will not include participants
suffering from EDs, they will pass the SCOFF questionnaire which is a common screening tool
for Eds.
Control participants will be compensated for their participation by 80 NIS for their
participation in the study. Control group sessions will take place in Haifa university.
20 participants (10 from the AN group and 10 from the control group) will be invited to a
second half hour session, 2-6 month after the first session. The session will be
administrated by a master or doctoral student. After receiving an information regarding the
purpose of the study and its procedure the participants will sign a consent form. For
participants under the age of 18, parental consent will be obtained as well. During the
session the participant will complete the MASC-heb. Control participants will be compensated
for their participation by 40 NIS for their participation in the study.
