MICBT for Non-underweight Adults With Eating Disorders

Not Applicable

Recruiting

• Conditions: Self Esteem; Dysfunctional Behavior, Psychology; Personality Disorders; Eating Disorders; Personality; Cognitive Dysfunction; Maladaptive Personality Trait; Emotion Regulation; Social Interaction; Perfectionism

• Registration Number: NCT05503745
• Lead Sponsor: Centro Trattamento Integrato: Disturbi Alimentari e Obesita

Brief 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

Detailed 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.

Study Timeline

• Study Start: 2022-05-31
• Status Verified: 2022-08
• Study First Submitted: 2022-08-11
• Study First Submitted QC: 2022-08-12
• Last Update Submitted: 2022-08-12
• Study First Posted: 2022-08-17
• Last Update Posted: 2022-08-17
• Primary Completion: 2023-05-31
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Eating Attitude Test (EAT-26; Garner & Garfinkel, 1979)	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.	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.
Binge Eating Scale (BES; Gormally et al., 1992)	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.	a self-report questionnaire of the behavioral, cognitive and emotional features of objective binge eating (OBE).
Eating Disorder Examination Questionnaire (EDE-Q6; Fairburn & Beglin, 1994)	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.	A self report measure assessing eating disorders over the past 4 weeks, providing a measure of the range of severity of eating disorder features.
Clinical Impairment Assessment Questionnaire (CIA 3.0; Bohn and Fairburn, 2008).	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.	a self-report measure f assessing the severity of psychosocial impairment due to eating disorder features over the past 28 days.

Secondary Outcome Measures

Name	Time	Method
State-Trait Anxiety Inventory (STAI; Spielberger, Gorsuch, Lushene, Vagg, & Jacobs, 1983)	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.	A self-report measure of trait and state anxiety.
Beck Depression Inventory (BDI; Beck, et al., 1961)	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.	A self-report measures of depression.
Symptom Check List (SCL-90)	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.	A measure of psychopathology symptoms and their intensity at a specific point in time.
Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004)	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.	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.
Working Alliance Inventory-Short Revised (WAI; SR Hatcher & Gillaspy, 2006)	Every 4 weeks	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.
Toronto Alexithymia Scale (TAS - 20; Taylor & Bagby, 1992)	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.	It assess difficulties in understanding, processing, or describing emotions
Structured Clinical Interview for DSM-5 Disorders (SCID-5; Michael B. First, Janet B.W. Williams)	At baseline	For assessing and defining DSM-5 Model for Personality Disorders.

Trial Locations

Locations (1)

Centro di Trattamento Integrato. Disturbi Alimentari e Obesità (CTI) di Gloria Fioravanti; 🇮🇹 Verona, VR, Italy