Trials / Unknown

UnknownNCT05503745

MICBT for Non-underweight Adults With Eating Disorders

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

Status: Unknown
Phase: N/A
Study type: Interventional
Enrollment: 20 (estimated)

Sponsor: Centro Trattamento Integrato: Disturbi Alimentari e Obesita · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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.

Conditions

Interventions

Type	Name	Description
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.
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.

Timeline

Start date: 2022-05-31
Primary completion: 2023-05-31
Completion: 2024-11-30
First posted: 2022-08-17
Last updated: 2022-08-17

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT05503745. Inclusion in this directory is not an endorsement.