MICBT for Non-underweight Adults With Eating Disorders

Cognitive Dysfunction Clinical Trial

— MICBT-ED  

Official title:

CBT-E vs CBT-F+Metacognitive Interpersonal Therapy for Non-underweight Adults With Eating Disorders: Study Protocol for a Pilot Randomised Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05503745
• Other study ID #: 0000781
• Status: Recruiting
• Phase: N/A
• Start date: May 31, 2022
• Est. completion date: November 30, 2024

Study information

• Verified date: August 2022
• Source: Centro Trattamento Integrato: Disturbi Alimentari e Obesita
• Contact: Gloria Fioravanti
• Phone: +39 348 9255483
• Email: info[@]gloriafioravanti.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Eating disorders (ED) are severe but treatable conditions, but there are large margin for improvements in terms of efficacy and adherence. There is room to explore new treatment options who are either more capable to retain patients in therapy, more effective. Alternative their efficacy may match the ones of current available treatments but offer new options to ones that did not respond to available therapies. Here the investigators explored if a combination of CBT-focused plus Metacognitive Interpersonal Therapy (MIT) is an empirically supported therapy for personality disorders and could be a new viable treatment option for non-underweight ED. MIT targets some aspects of ED such as poor awareness of mental states and maladaptive interpersonal schemas that are not included in the transdiagnostic model underlying the most investigated empirically supported treatment for ED that is CBT-E. It is reasonable therefore that targeting these aspects of psychopathology can be a path to treatment adherence and effectiveness

Description:

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, the investigators 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 investigators expect that the experimental group CBT-F+MIT would be able to have high treatment adherence and retention on the ground of previous studies of MIT for personality disorders. They will also expect good outcomes in the primary outcome. Given the small sample this is just a pilot study so any conclusions about other outcomes will be considered preliminary. Results will provide new evidence that may lead to consider CBT-F+MIT a treatment option for ED deserving investigations in larger trials.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: November 30, 2024
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• ED diagnosed in the past 6 months

• Seeking treatment for eating disorder

• Able to provide written, informed consent

• BMI > 18.5

Exclusion Criteria:

• Acute psychotic episode, psychotic symptoms, Bipolar I disorder; antisocial personality disorder

• Suicidal ideation

• Substance abuse

• Previous psychological intervention for other eating disorders

• Currently involved in other ongoing treatment

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Disease
• Eating Disorders
• Emotion Regulation
• Feeding and Eating Disorders
• Perfectionism
• Personality
• Personality Disorders
• Problem Behavior
• Self Esteem
• Social Interaction

Intervention

Other:
• CBT-F+MIT
The aim is to develop healthier strategies for managing negative thoughts and feelings antecedent to ED and for engaging patients in social interactions that meet their relational basic wishes. They will thus 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. 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, 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. MIT also enables individuals to reflect on how these schemas may act as triggers for ED behavior and to develop more effective coping strategies in face of interpersonal stressors.
• CBT-E
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.

Locations

Country	Name	City	State
Italy	Centro di Trattamento Integrato. Disturbi Alimentari e Obesità (CTI) di Gloria Fioravanti	Verona	VR

Sponsors (1)

Lead Sponsor	Collaborator
Centro Trattamento Integrato: Disturbi Alimentari e Obesita

Country where clinical trial is conducted

Italy, 

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Zipfel S, Wild B, Groß G, Friederich HC, Teufel M, Schellberg D, Giel KE, de Zwaan M, Dinkel A, Herpertz S, Burgmer M, Löwe B, Tagay S, von Wietersheim J, Zeeck A, Schade-Brittinger C, Schauenburg H, Herzog W; ANTOP study group. Focal psychodynamic therapy, cognitive behaviour therapy, and optimised treatment as usual in outpatients with anorexia nervosa (ANTOP study): randomised controlled trial. Lancet. 2014 Jan 11;383(9912):127-37. doi: 10.1016/S0140-6736(13)61746-8. Epub 2013 Oct 14. — View Citation

* Note: There are 98 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from baseline until after 10 sessions, at the end of the treatment and in the following 3, 6, 12, 18 and 24 months after the treatment.
Primary	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.	Change from baseline until after 10 sessions, at the end of the treatment and in the following 3, 6, 12, 18 and 24 months after the treatment.
Primary	Clinical Impairment Assessment Questionnaire (CIA 3.0; Bohn and Fairburn, 2008).	a self-report measure f assessing the severity of psychosocial impairment due to eating disorder features over the past 28 days.	Change from baseline until after 10 sessions, at the end of the treatment and in the following 3, 6, 12, 18 and 24 months after the treatment.
Primary	Binge Eating Scale (BES; Gormally et al., 1992)	a self-report questionnaire of the behavioral, cognitive and emotional features of objective binge eating (OBE).	Change from baseline until after 10 sessions, at the end of the treatment and in the following 3, 6, 12, 18 and 24 months after the treatment.
Secondary	State-Trait Anxiety Inventory (STAI; Spielberger, Gorsuch, Lushene, Vagg, & Jacobs, 1983)	A self-report measure of trait and state anxiety.	At baseline, after 10 sessions, at the end of the treatment and in the following 3, 6, 12, 18 and 24 months after the treatment.
Secondary	Beck Depression Inventory (BDI; Beck, et al., 1961)	A self-report measures of depression.	At baseline, after 10 sessions, at the end of the treatment and in the following 3, 6, 12, 18 and 24 months after the treatment.
Secondary	Symptom Check List (SCL-90)	A measure of psychopathology symptoms and their intensity at a specific point in time.	At baseline, after 10 sessions, at the end of the treatment and in the following 3, 6, 12, 18 and 24 months after the treatment.
Secondary	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.	At baseline, after 10 sessions, at the end of the treatment and in the following 3, 6, 12, 18 and 24 months after the treatment.
Secondary	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.	At baseline
Secondary	Toronto Alexithymia Scale (TAS - 20; Taylor & Bagby, 1992)	It assess difficulties in understanding, processing, or describing emotions	At baseline, after 10 sessions, at the end of the treatment and in the following 3, 6, 12, 18 and 24 months after the treatment.
Secondary	Working Alliance Inventory-Short Revised (WAI; SR Hatcher & Gillaspy, 2006)	It measure the therapeutic alliance by assessing 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.	Every 4 weeks