Clinical trial NCT05503745: MICBT for Non-underweight Adults With Eating Disorders
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Eating Disorders
Maladaptive Personality Trait
Emotion Regulation
Personality
Personality Disorders
Social Interaction
Perfectionism
Self Esteem
Cognitive Dysfunction
Dysfunctional Behavior, Psychology
Lead sponsor: Centro Trattamento Integrato: Disturbi Alimentari e Obesita
Sponsor class: OTHER
First posted: 2022-08-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 CBT-F+MIT. Repeated follow-up will be collected up to 24 months. The study is run in an private outpatient clinic specialized in eating disorder treatment. We will evaluate acceptability in terms of session attendance and number of completers and preliminary outcomes.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Eating Disorder Examination Questionnaire (EDE-Q6; Fairburn & Beglin, 1994)
timeFrame: 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.
measure: Eating Attitude Test (EAT-26; Garner & Garfinkel, 1979)
timeFrame: 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.
measure: Clinical Impairment Assessment Questionnaire (CIA 3.0; Bohn and Fairburn, 2008).
timeFrame: 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.
measure: Binge Eating Scale (BES; Gormally et al., 1992)
timeFrame: 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 outcomes:
measure: State-Trait Anxiety Inventory (STAI; Spielberger, Gorsuch, Lushene, Vagg, & Jacobs, 1983)
timeFrame: 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.
measure: Beck Depression Inventory (BDI; Beck, et al., 1961)
timeFrame: 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.
measure: Symptom Check List (SCL-90)
timeFrame: 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.
measure: Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004)
timeFrame: 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.
measure: Structured Clinical Interview for DSM-5 Disorders (SCID-5; Michael B. First, Janet B.W. Williams)
timeFrame: At baseline
measure: Toronto Alexithymia Scale (TAS - 20; Taylor & Bagby, 1992)
timeFrame: 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.
measure: Working Alliance Inventory-Short Revised (WAI; SR Hatcher & Gillaspy, 2006)
timeFrame: Every 4 weeks
Other outcomes:
Locations:
city: Verona
country: Italy
facility: Centro di Trattamento Integrato. Disturbi Alimentari e Obesità (CTI) di Gloria Fioravanti
state: VR
Study officials:
affiliation: Centro di Trattamento Integrato. Disturbi Alimentari e Obesità (CTI) di Gloria Fioravanti
name: Gloria Fioravanti
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro di Terapia Metacognitiva Interpersonale, Roma
name: Raffaele Popolo
role: STUDY_DIRECTOR
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