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

Centro Trattamento Integrato: Disturbi Alimentari e Obesita

Status: Enrolling

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

Treatments: Other: CBT-F+MIT; Other: CBT-E

Study type: Interventional

Funder types: Other

Identifiers

NCT05503745

0000781

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

CBT-E

Active Comparator group

Description:

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.

Treatment:

Other: CBT-E

CBT-F+MIT

Experimental group

Description:

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.

Treatment:

Other: CBT-F+MIT