MICBT for Non-underweight Adults With Eating Disorders (MICBT-ED)

August 12, 2022 updated by: GLORIA FIORAVANTI, 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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • VR
      • Verona, VR, Italy, 37100
        • Recruiting
        • Centro di Trattamento Integrato. Disturbi Alimentari e Obesità (CTI) di Gloria Fioravanti
        • Contact:
        • Sub-Investigator:
          • Giancarlo Dimaggio
        • Sub-Investigator:
          • Angus MacBeth
        • Sub-Investigator:
          • Martina Nicolis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CBT-E
Participants in the CBT-E condition will receive a total of 20 CBT-E sessions over 20 weeks. CBT-E treatment will consist of four stages. 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.
Other: 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.
Experimental: CBT-F+MIT

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. MIT sessions will be integrated within the CBT-F protocol which will provide psycho-educational, nutritional re-education and management for ED.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eating Disorder Examination Questionnaire (EDE-Q6; Fairburn & Beglin, 1994)
Time Frame: 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.
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.
Eating Attitude Test (EAT-26; Garner & Garfinkel, 1979)
Time Frame: 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.
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.
Clinical Impairment Assessment Questionnaire (CIA 3.0; Bohn and Fairburn, 2008).
Time Frame: 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.
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.
Binge Eating Scale (BES; Gormally et al., 1992)
Time Frame: 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).
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
State-Trait Anxiety Inventory (STAI; Spielberger, Gorsuch, Lushene, Vagg, & Jacobs, 1983)
Time Frame: 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.
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.
Beck Depression Inventory (BDI; Beck, et al., 1961)
Time Frame: 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.
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.
Symptom Check List (SCL-90)
Time Frame: 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.
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.
Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004)
Time Frame: 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.
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.
Structured Clinical Interview for DSM-5 Disorders (SCID-5; Michael B. First, Janet B.W. Williams)
Time Frame: At baseline
For assessing and defining DSM-5 Model for Personality Disorders.
At baseline
Toronto Alexithymia Scale (TAS - 20; Taylor & Bagby, 1992)
Time Frame: 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
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.
Working Alliance Inventory-Short Revised (WAI; SR Hatcher & Gillaspy, 2006)
Time Frame: 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.
Every 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro Trattamento Integrato: Disturbi Alimentari e Obesita

Investigators

  • Principal Investigator: Gloria Fioravanti, Centro di Trattamento Integrato. Disturbi Alimentari e Obesità (CTI) di Gloria Fioravanti
  • Study Director: Raffaele Popolo, Centro di Terapia Metacognitiva Interpersonale, Roma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 31, 2022

Primary Completion (Anticipated)

May 31, 2023

Study Completion (Anticipated)

November 30, 2024

Study Registration Dates

First Submitted

August 11, 2022

First Submitted That Met QC Criteria

August 12, 2022

First Posted (Actual)

August 17, 2022

Study Record Updates

Last Update Posted (Actual)

August 17, 2022

Last Update Submitted That Met QC Criteria

August 12, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0000781

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Outcomes, age, gender

IPD Sharing Time Frame

10 years

IPD Sharing Access Criteria

Someone who has a request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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