CBT-E vs CBT-F+Metacognitive Interpersonal Therapy for Non-underweight Adults With Eating Disorders: Study Protocol for a Pilot Randomised Controlled Trial
Phase: NA
Conditions: Eating Disorders, Maladaptive Personality Trait, Emotion Regulation, Personality, Personality Disorders, Social Interaction, Perfectionism, Self Esteem, Cognitive Dysfunction, Dysfunctional Behavior, Psychology
Sponsor: Centro Trattamento Integrato: Disturbi Alimentari e Obesita

 
 
 
 
 
 
 
 
 
 
 
 
CBT-E vs CBT F+Metacognitive Interpersonal Therapy for non-underweight 
adults with Eating Disorders: 
Study Protocol for a pilot Randomised Controlled Trial 
 
Prot. n. 0000781, 05/13/2022 
 
 

 
 
 
 
CBT-E vs CBT F+Metacognitive Interpersonal Therapy for non-underweight adults with 
Eating Disorders: 
Study Protocol for a pilot Randomised Controlled Trial 
 
Gloria Fioravanti1, Giancarlo Dimaggio3, Angus MacBeth2, Martina Nicolis1, Raffaele Popolo3 
  
1 Centro di Trattamento Integrato. Disturbi Alimentari e Obesità (CTI) di Gloria Fioravanti 
2 Department of Clinical Psychology, School of Health in Social Science, The University of Edinburgh, 
Medical School (Doorway 6), Teviot Place, EH8 9AG 
3 Centro di Terapia Metacognitiva Interpersonale, Roma 
 
 
Introduction 
Psychological intervention is an evidence-based treatment option for patients with non-anorexic 
eating disorders (ED). Cognitive Behavioral Therapy (CBT) has proven effectiveness for treating a 
broad spectrum of ED diagnoses. For instance, CBT for Bulimia Nervosa (CBT-BN) is acceptable to 
service-users with 80 to 85% completion rates and effectiveness in reducing core features of BN and 
improving comorbid psychological problems (Fairburn, 1997; Fairburn et al., 1993; Anderson, 2001; 
Murphy et al., 2010). Gains on primary outcomes are also mostly maintained at long term follow-up 
(Fairburn et al., 1995, Wilson et al., 2002).  
 
More recently, attention has been paid to transdiagnostic aspects of psychopathology, present across 
all ED diagnoses. Elements such as clinical perfectionism, low self-esteem, Intolerance of Emotions 
and underlying interpersonal Difficulties all have potential to impact on the maintenance of gains and 
are also risk factors for ED relapse if unaddressed in psychotherapy. 
  
In particular, maladaptive perfectionism is considered to be a core transdiagnostic feature of ED 
(Halmi et al., 1977; Bruch, 1973; Garner, 1986; Bauer & Anderson, 1989; Casper, 1983; Davis, 1997; 
Davis, et al., 2000) and a precipitant risk factor in the development of ED (Bastiani et al., 1995; 
McLaren et al., 2001; Ruggiero et al., 2003; Vitousek & Hollon, 1990). In addition, numerous studies 
have identified low self-esteem as a risk factor for developing EDs and a maintain factor (Button et 
al., 1997; Button et al., 1996; Canals et al., 1996; Geller et al., 2000; Ghaderi & Scott, 2001; Lilenfeld 
et al., 1998; Neumark-Sztainer & Hannan, 2000; Rastam, 1992; Wichstrom, 1995; Fairburn et al., 
1997; Fairburn et all., 1998; Fairburn et al., 1999). Patients with low self-esteem endorse a 
generalized negative self-concept, above and beyond their inability to control their eating patterns, 
body image and weight. For example, as a function of low self-esteem patients may have low 
confidence in their ability to effectively maintain changes in their eating habits (Fairburn et al., 2002).  
 
Intolerance of Emotions has been identified as a potentially transdiagnostic factor, albeit in a 
subgroup of patient with EDs (Meyer et al., 1998; Steinberg et al., 1990; Stice, 1994; Waller, 2002). 
These individuals present with difficulties in effectively coping with emotional states, both negative 
and positive. Emotion regulation is often arrived at via dysfunctional strategies such as self-harm or 
alcohol and substance misuse (Claes et al., 2001; Holderness et al., 1994; Paul et al., 2002). 
 
Finally, with regard to Interpersonal Difficulties studies have shown that a dysfunctional family 
environment is associated with a higher risk of continuing with restrictive eating behaviors, 
particularly in younger patients, intensifying a need for a perceived sense of “control”. Examples are 
dysfunctional food-related activities such as controlling food intake and calories, as a response to a 
perceived hostile interpersonal environment (Fairburn et al., 1999). Bulimia nervosa has also been 
associated with interpersonal sensitivity in social interactions, further associated with self-criticism 
and lowered mood (Steiger et al., 1999). In general, poor interpersonal functioning has also been 

 
 
identified as a predictor of poorer treatment response (Agras et al., 2000a; Steiger, Leung, & 
Thibaudeau, 1993). 
Given the importance of transdiagnostic elements, an enhanced form of CBT was developed, adding 
a therapeutic focus on these maintenance factors (CBT-E; Fairburn, 2008) to CBT-focused (CBT-f, 
Fairburn et al, 2003) which originally included psycho-education, nutritional re-education and overall 
clinical management for ED. 
 
CBT-E has demonstrated acceptability and effectiveness for all forms of EDs (Cooper & Fairburn, 
2011; Fairborn et al., 2003) including anorexia nervosa (Dalle Grave et al., 2013a; Dalle Grave et al., 
2013b; Dalle Grave et al., 2014; Fairburn et al., 2013; Zipfel et al. 2014), bulimia nervosa (Poulsen 
et al., 2014; Wonderlich et al., 2014), and intransdiagnostic samples (Fairburn et al. 2009) both in 
adults (Fairburn et al, 2009; Fairburn et al, 2013) and in younger patients (Dalle Grave et al, 2013). 
In a direct comparison with interpersonal psychotherapy for adults (IPT), CBT-E was found to be 
more effective (Fairburn et al, 2015) in patients with EDs.  
 
However, there remain challenges with implementing CBT-E (Fairburn et al. 2014; Le Grange et al., 
2020; Frostad et al., 2018; 2021). First, dropout rates remain significant, affecting at least ¼ of 
patients, even in high quality trials (Linardon, et al., 2018).  
 
Second, remission rates are also a cause for concern. For instance, Poulsen and colleagues (2014) 
reported that in a sample of patients with BN, after 5 months, only CBT-E 36% of patients remitted, 
although this was favorable compared to psychoanalytic psychotherapy (23.5% remitted; (Poulsen et 
al., 2014). Other studies suggest that approximately 37% of patients who received CBT-E were 
remitted at post-treatment, which increased to 50% at 4-month follow-up (Wonderlich et al., 2014). 
Another study highlighted that 55% of CBT-E treatment completers met criteria for remission at post-
treatment (Allen et al., 2012). 
 
Third, CBT-E in transdiagnostic samples appears to result in moderate to large decreases in binge 
eating behavior and small to moderate decreases in purging behaviors. For instance, for patients with 
BN, CBT-E resulted in cessation of bingeing and purging for 22.5% (Wonderlich et al., 2014), 42% 
(Poulsen et al., 2014), and 44% to 40% (for CBT- f and CBT-E, respectively, using completer data; 
Thompson-Brenner et al., 2016) of patients at post treatment. Rates were generally well maintained 
up to 19-month follow-up.  
 
Finally, most studies have focused on eating behavior as the main outcome, while other elements 
such as social & interpersonal functioning and other comorbid symptom disorders have been less 
frequently investigated. Those outcomes have important implications for both relapse prevention and 
functional recovery, as many patients who have registered improved eating-related outcomes through 
treatment may still experience difficulties in quality of life and interpersonal relationships.   
 
Linked to this, several transdiagnostic elements that may contribute to ED psychopathology are 
potentially underspecified in CBT-E. One transdiagnostic element is poor metacognition (Semerari 
et al., 2003), denoting the capacity to make sense of mental states and use mentalistic knowledge to 
deal with suffering and interpersonal problems and the second are maladaptive interpersonal schemas 
about self and others. Recent evidence suggests metacognitive difficulties are present in ED. For 
instance, Aloi and colleagues (2020; 2021) reported poor awareness of emotions and poor emotion 
regulation in patients with binge eating disorder. Further, Monteleone et al. (2020) reported 
difficulties in overall mentalizing capacities as well as impaired empathy in ED diagnosed patients, 
and that these were also correlated with ED symptoms. A further element of metacognition, reduced 
awareness of one’s own affects (commonly known as alexithymia), with meta-analytic evidence 
(Westwood et al., 2017) that reduced capacity to identify own emotions and communicate them to 
others is present in all ED types. Overall, evidence supports the proposition that poor capacity to 

 
 
recognize and reflect upon the mental states of the self and of the others is impaired across ED 
populations and this is in turn connected with poor emotion regulation and eating disorder symptoms. 
Therefore, interventions that increase metacognitive capacity may in turn lead to reductions in ED 
symptoms.  
There are also significant associations between cognition, maladaptive patterns and dysfunctional 
eating behavior (Fairburn, 2008). In this regard, patients with EDs demonstrate negative individual 
patterns relating to the self, the world and others, alongside as autobiographical memories based 
characterized by paternal emotional inhibition and social isolation (Basile et al., 2020). From a 
therapeutic perspective, restructuring these interpersonal schemas is required to reduce ED severity 
and to improve therapeutic alliance (Gilbert & Leahy, 2009). For instance, Maher et al’s (2022) 
review of 29 studies suggests that individuals with an ED diagnosis or high level of ED 
symptomology reported higher scores across all early maladaptive schemas (EMS) subscales. In 
particular, Unrelenting Standards were pervasive across all ED diagnoses. Insufficient Self-control 
was associated with binge eating and purging behaviors. Social Isolation, Social Undesirability and 
Emotional Inhibition were also common across ED diagnoses (Maher et al., 2022). It has also been 
suggested that there is a mediating relationship between EMS, and multidimensional perfectionism, 
specifically in relation to body image concern in EDs (Boone et al., 2012). Finally, experiences of 
childhood trauma have also been associated with more severe ED symptoms, further linked to 
“disconnection and rejection” (Meneguzzo et al., 2021). 
 
Given the current status of CBT-E, and the potential for targeting transdiagnostic factors such as 
metacognition and interpersonal schemas as mechanisms of change in ED, we propose that 
Metacognitive Interpersonal Therapy (MIT; Dimaggio et al., 2007; 2015; 2020) is a candidate 
intervention to enhance treatment adherence and improve outcomes, particularly for those who have 
either struggled to engage with or not responded to CBT-E.  
 
MIT (Dimaggio et al., 2007; 2015; 2020) is focused on a fine-grained understanding of personality 
pathology, incorporating consideration of metacognitive difficulties and maladaptive interpersonal 
schemas. Therefore, it could be combined with CBT-F to form a comprehensive approach to targeting 
ED pathology, both at the level of eating behavior and personality. MIT is an empirically supported 
intervention, with evidence for its effectiveness for personality disorders and other complex mental 
health conditions, across multiple settings and geographies (Dimaggio et al., 2017; Gordon-King et 
al., 2018; Inchausti et al., 2018; 2020; Popolo et al., 2018; 2019; 2021; Pasetto et al. 2021, Simonsen 
et al., 2022). 
 
Method/Design  
2.1 Aims and hypotheses  
The study is a pilot randomized controlled trial that aims to evaluate the feasibility and effectiveness 
of weekly MIT in addiction to CBT-F in a group of adults diagnosed with ED.  Specifically, we will 
investigate in a sample of non-underweight adults presenting with ED whether once compared to 
CBT-E, a treatment combining MIT and CBT-F is a) feasible, b) well-tolerated and c) potentially 
effective on eating disorders symptoms and other outcomes. The study is defined according to the 
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement and 
guidelines (Chan et al., 2013). 
 
2.2 Study design  
A parallel-group randomized controlled trial design will be used in order to compare CBT-E (n = 10) 
condition to combined MIT/CBT-F (n = 10). Patients in both conditions will receive 20 weekly 
sessions of either CBT-E or MIT/CBT-F.  
 
Primary outcomes will be represented by ED and comorbid symptoms as assessed with the Eating 
Disorder Examination Questionnaire (EDE-Q6) (Fairburn & Beglin, 1994), which are expected to be 

 
 
reduced after treatment. Other measures of ED and comorbid symptoms will still be considered 
primary outcomes. Secondary outcomes are anxiety, depression and global psychological symptoms.  
Lastly, exploratory outcomes will be difficulties in the emotional sphere such as understanding, 
processing, regulating or describing emotions. 
Predictors, mediators and outcome variables will be measured at baseline, after 10 sessions with the 
exclusion of SCID-5 Interview, at the end of the treatment, and in the following 3, 6, 12, 18 and 24 
months after the treatment. Two psychotherapies for each arm will be randomly selected, audio 
recorded and later analysed in order to explore the therapy process. 
 
2.3 Methods 
Patients will be assessed and treated by the Centro di Trattamento Integrato - Disturbi Alimentari e 
Obesità (CTI-Disturbi Alimentari e Obesità). Two therapists will be involved in the trial: one CBT-
trained, the other trained in both CBT-F and MIT. Both therapists will be supervised throughout the 
trial. The CBT-E arm will be supervised by a certified Associazione Disturbi Alimentari (ADA) 
supervisor, the MIT/CBT-F arm will be supervised by one of the developers of MIT, also a trainer of 
the Società Italiana di Terapia Comportamentale e Cognitiva (SITCC). A research assistant will 
manage the psychometric test administration and will liaise regularly with the clinical team. 
 
2.4 Participants  
Twenty consecutive participants will be recruited at the CTI Disturbi Alimentari e Obesità. All 
participants will be aged 18 years or over and treatment-naive. They will be screened for a main 
diagnosis of ED in the past 6 months. Inclusion and exclusion criteria are reported in Table 1. 
 
Table1 Inclusion and Exclusion Criteria 
 
Inclusion Criteria 
Exclusion Criteria 
Aged >18 years  
Acute psychotic episode, psychotic symptoms, 
Bipolar I disorder; antisocial personality disorder 
ED diagnosed in the past 6 months  
Suicidal ideation 
Seeking treatment for eating disorder 
Substance abuse 
Able to provide written, informed consent 
Previous psychological intervention for other 
eating disorders  
BMI > 18.5 
Currently involved in other ongoing treatment 
 
 
All participants meeting inclusion criteria will be informed about the trial and will decide whether 
to take part. A regular ED-focused treatment will be offered to all participants excluded from 
the trial or who decline participating. All participants will give written informed consent 
before participation.  
Drop-out rates from each arm will be reported for patients withdrawing during treatment and those 
lost to follow-up. Treatment is delivered in a private center therefore participants are paying for their 
care, however there is no financial incentive to participate in the trial. The study protocol is written 
in accordance with the European Union Standards of good clinical practice and in accordance with 
the Declaration of Helsinki. The protocol has been approved by the Ethics Committee of the 
Department of Dynamic and Clinical Psychology of “La Sapienza” University (Rome) Prot. n. 
0000781, 05/13/2022 - [UOR: SI000092 - Classif. VII/15] 
 

 
 
2.5 Measures 
Primary, secondary and exploratory outcomes of the present study will be assessed over time using 
the following psychometric measures: 
• Eating Disorder Examination Questionnaire (EDE-Q6, Fairburn & Beglin, 1994): A self 
report measure assessing eating disorders over the past 4 weeks, providing a measure of the 
range of severity of eating disorder features.  
• Eating Attitude Test (EAT-26, Garner & Garfinkel, 1979): a self-report measure for 
identifying the presence of “eating disorder risk” based on attitudes, feelings and behaviors 
related to eating.  It assesses general eating behaviour and risky behaviours. 
• Clinical Impairment Assessment Questionnaire (CIA 3.0): a self-report measure f assessing 
the severity of psychosocial impairment due to eating disorder features over the past 28 days 
(Bohn and Fairburn, 2008).  
• Binge Eating Scale (BES, Gormally et al., 1992): a self-report questionnaire of the behavioral, 
cognitive and emotional features of objective binge eating (OBE). 
• State-Trait Anxiety Inventory (STAI): a self-report measure of trait and state anxiety 
(Spielberger, Gorsuch, Lushene, Vagg, & Jacobs, 1983). 
• Beck Depression Inventory (BDI): a self-report measures of depression (Beck, et al., 1961). 
• Symptom Check List (SCL-90): a measure of psychopathology symptoms and their intensity 
at a specific point in time. 
• Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004):  a self-report scale 
measuring individual differences in the ability to identify, accept and manage emotional 
experiences. This measure help in understanding emotional dysregulation that might underlie 
the disorders. 
• Structured Clinical Interview for DSM-5 Disorders (SCID-5;  Michael B. First, Janet B.W. 
Williams) for assessing and defining DSM-5 Model for Personality Disorders.  
• Toronto Alexithymia Scale (TAS – 20; Taylor & Bagby, 1992) that assess difficulties in 
understanding, processing, or describing emotions.  
• Working Alliance Inventory-Short Revised (WAI,-SR Hatcher & Gillaspy, 2006) that 
measure the therapeutic alliance by assessessing three main aspects of the therapeutic alliance: 
agreement on the tasks of therapy, agreement on the goals of therapy and development of an 
affective bond. 
 
All the psychometric tests will be administered at baseline, after 10 sessions (with the exclusion of 
SCID-5 Interview which will be only administered…), at the end of the treatment and in the following 
3, 6, 12, 18 and 24 months after the treatment. The WAI will be administered monthly. All measures 
will be carried out by the research assistant who will be trained and weekly supervised. 
 
2.6 Randomization/treatment allocation  
Each participant will be randomized in one of the two experimental conditions by allocation 
concealment. In particular, randomized-permuted blocks will be used. The research team will be also 
blind to the randomized allocation. Group allocation will remain concealed until the end of the 
assessment stage. 
 
2.7 Procedure  
Treatment-seeking participants at the CTI Disturbi Alimentari e Obesità will first receive an 
assessment screening visit. Once evaluated for inclusion/exclusion criteria, they will be informed 
about the study.  If they wish to participate, they will be required to give written informed consent.  
 
 

 
 
 
 
Tab.1. Flow chart of the study design 
 
The researcher will ensure that the person is fully informed of the randomization process and their 
chances of receiving additional MIT sessions. Once informed and written consent has been obtained, 
baseline measures about primary and secondary outcomes will be completed. 
 
Participants will then be randomized into two experimental conditions: CBT-F+MIT (experimental 
treatment) and CBT-E (standard treatment). All participants in each experimental condition will first 
receive two initial standard sessions mainly focused on investigating the compliance to the treatment 
and on understanding the maintenance factors of the ED.  
 
2.7.1. Experimental Treatment: Participants in the CBT-F+MIT condition will receive a total of 
20 sessions over 20 weeks. Specifically, 2 sessions will be based on CBT-F as usual only. During 
these sessions participants will receive psychoeducational training on eating behaviors and an 
introduction to the protocol tools, namely the monitoring form, weight chart, transdiagnostic 
formulation and Eating Problem Check List (EPCL). 
 
These elements will be used at the beginning of the remaining 18 sessions, in order to monitor the 
regulations of eating behaviors as well eliciting narrative episodes. These materials will form the 
basis for the MIT-part of the session, in which therapists will seek to form with the patient a shared 
understanding of the psychological reasons underlying their ED symptoms and their maladaptive 
interpersonal functioning. Once a shared understanding is reached, patients and therapist will work 
to develop healthier strategies for managing negative thoughts and feelings antecedent to disordered 
eating. They will also develop new strategies for engaging in social interactions that meet their 

 
 
relational basic wishes, such as attachment, personal worth, autonomy and group belonging 
(Dimaggio et al., 2015; 2020).  
 
With MIT therapy, patients will be guided in to understand that perfectionism and the need for control 
they experience through ED are coping strategies developed within interpersonal patterns of 
interaction with significant others, where low self-esteem and emotive dysregulation play a central 
role. 
 
Overall, MIT aims to improve individuals’ capacity to make sense of their own affect and cognitions 
and become aware of being driven by maladaptive, rigid and biased schemas about self and others. 
This enables the individual to form a richer understanding of the mind of the others and use this 
knowledge to react in more adaptive ways to social difficulties or evolutionary selected wishes (such 
as being cared of, finding a satisfying place in the social hierarchy, explore the environment and be 
autonomous).  MIT also enables individuals to reflect on how these schemas may act as triggers for 
disordered eating behavior and develop more effective coping strategies in face of interpersonal 
stressors. 
 
MIT sessions will be integrated within the CBT-F protocol (Fairburn; 2003) which will provide 
psycho-educational, nutritional re-education and management for ED. In particular, CBT aims to 
inform patients about the importance of self-control, the dangers of some restrictive behaviors such 
as self-induced vomiting. Moreover, CBT provides strategies to patients in order to monitor their 
usually dysfunctional behaviors and so increasing their awareness (i.e., food diary method) while 
reducing the availability of food and encourages activities that are incompatible with overeating. 
Patients will be trained in problem solving in order to change these feelings, as well as in increasing 
their self-awareness in order to recognize irrational thoughts about their body weight and shape. 
Additionally, they will be gradually exposed to foods that they had been avoiding [20]. 
 
 
2.7.2 Standard Treatment: participants in the CBT-E condition will receive a total of 20 CBT-E 
sessions over 20 weeks. This will include the standard CBT-E protocol outlined above, without the 
additional MIT elements.  
 
CBT-E treatment will consist of four stages. In the first Stage, the treatment will be focused on 
achieving a shared understanding of the patient's eating disorder and the related maintenance factors. 
In this phase the patient will be helped to regulate and stabilize his eating habits and so to address his 
weight concerns. In the second stage, progress made is reviewed in detail. In the third stage, the 
sessions will be focused on the central processes that are maintaining the psychopathology of the 
patient's eating disorder. In particular, this involves in addressing concerns about weight and body 
shape, cognitive and caloric dietary restriction, events and emotions that affect nutrition. in phase 
three and four clinical perfection, low global self-esteem, intolerance of emotions and interpersonal 
difficulties are also addressed. 
 
Towards the end of the third stage and during the fourth stage, procedures will be also implemented 
to minimize the risk of short- and long-term relapse.  
 
Each experimental condition will include up to 10 participants. In both conditions participants will 
receive an assessment session by a researcher who is blind and independent. In both arms, review 
session will be scheduled 2 weeks after the end of therapy to evaluate progress and to address any 
remaining or emerging issues. 
 
2.7.3 Supervision and monitoring.  

 
 
Clinicians will receive weekly supervision as outlined above. Besides supervision, several sessions 
audio-recorded sessions will be analyzed by another founder of MIT to assess adherence to 
MIT/CBT-F. 
 
In each experimental condition all treatment sessions will be recorded. In order to analyze the 
therapeutic processes, sessions will be chosen at random for each of the two groups. Transcription of 
the sessions will be then analyzed in order to explore the process of change mechanisms. 
 
 
3. Statistical analysis  
As a feasibility study, analyses will be mainly focused on a descriptive method. However, in order to 
assess whether the experimental condition including MIT sessions leads to a reduction in eating 
disorder there will be also carry out an intention-to-treat and per-protocol analyses in order to 
determine treatment effects on all the outcome measures, adjusting for pre-specified baseline 
covariates. An exploratory repeated measures regression model, adjusting for baseline measures, will 
be adopted to assess the treatment effects on the outcomes and their effects over time. There will be 
also explored the sub-scales measures in order to assess whether there might be any treatment signals 
within sub-scales. Estimates of treatment differences and associated standard errors will be obtained 
from the mixed-effects models analyses.  These will be run for intention-to-treat and per protocol 
analyses. 
 
Exploratory linear multiple regressions, in which all predictors and covariates will be entered 
independently into the regression algorithm to avoid artificial inflation of estimated R2, these will be 
adopted to investigate the mediational effects of the putative underlying mechanisms of change. 
Finally, number of sessions received will be examined as a putative moderator. 
  
Upon completion of the trial additional exploratory analyses will be run, from sub-samples of good 
and poor outcomes to identify mechanisms of change.   
 
4. Discussion  
 
Patients with EDs have a number of psychotherapeutic options, particularly CBT-E, but nonresponse, 
partial response and dropout remain challenges for treatment. We proposed that adding treatment 
components focusing on poor metacognition (the capacity to make sense of mental states and use 
psychological knowledge to promote emotion regulation; Dimaggio & Lysaker, 2010; Semerari et 
al., 2003; 2014) and maladaptive interpersonal schemas would offer adjunctive therapeutic options 
to address problematic eating behaviors.  In this pilot RCT we considered these components from 
MIT as a bolt-on to a commonly used, empirically validated psychological intervention (CBT-E).  
 
We hypothesize that the CBT-F+MIT arm will result as highly tolerable in terms of session 
attendance and dropouts. We expect possible <10-15% dropouts which would be above the average 
17.51% found across evidence-based treatments (Grenon et al., 2019). Low dropout rate is a feature 
of existing MIT protocols for complex mental health problems such as personality disorders, 
psychosis, either as a solo treatment (Dimaggio et al., 2017; Gordon-King et al., 2018; Inchausti et 
al., 2018, 2020; 2022; Popolo et al., 2018; 2019; 2021; Simonsen et al., 2021) or combined with other 
treatments such as combining metacognition-based interventions with compassion focused practices 
(Cheli et al., 2022).  
The main limitations of this pilot RCT are the small sample, with only 20 patients randomized to 
either of the 2 arms, possibly limiting scope to observe treatment specific effects. That said use of 
mixed effects modelling and confidence interval derived analyses may mitigate this problem. The 
trial will be an initial test of this new treatment combination. Further studies with larger samples and 
other ED based presentations will be warranted.  
 

 
 
 
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