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Eating DisordersMICBT-EDNCT05503745

MICBT for Non-underweight Adults With Eating Disorders

A study testing CBT-F+MIT and CBT-E in people with Eating Disorders and Maladaptive Personality Trait, run by Centro Trattamento Integrato: Disturbi Alimentari e Obesita at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CBT-F+MIT and CBT-E
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteItaly
Study dates
31 May 2022to 30 Nov 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ED diagnosed in the past 6 months
  • Seeking treatment for eating disorder
  • Able to provide written, informed consent
  • BMI > 18.5

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Italy1 site

  • Centro di Trattamento Integrato. Disturbi Alimentari e Obesità (CTI) di Gloria Fioravanti

    Verona, VR, 37100

Other trials in Italy

About this study

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

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

Read the 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.

Being tested
CBT-F+MIT, CBT-E
Medical subject headings
Feeding and Eating Disorders, Emotional Regulation, Personality Disorders, Cognitive Dysfunction, Problem Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CBT-F+MITOther

    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.

  • CBT-EOther

    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.

Study groups in NCT05503745
Study groupRoleWhat they receive
CBT-EActive comparatorParticipants 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.
Receives: Other: CBT-E
CBT-F+MITExperimentalParticipants 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.
Receives: Other: CBT-F+MIT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Eating Disorder Examination Questionnaire (EDE-Q6; Fairburn & Beglin, 1994)

    A self report measure assessing eating disorders over the past 4 weeks, providing a measure of the range of severity of eating disorder features.

    Measured: Baseline; mid-treatment (assessed up to 20 weeks); end of treatment (assessed up to 60 weeks); 3, 6, 12, 18, and 24 months after end of treatment (assessed up to 156 weeks from baseline)

  2. Eating Attitude Test (EAT-26; Garner & Garfinkel, 1979)

    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.

    Measured: Baseline; mid-treatment (assessed up to 20 weeks); end of treatment (assessed up to 60 weeks); 3, 6, 12, 18, and 24 months after end of treatment (assessed up to 156 weeks from baseline)

  3. Clinical Impairment Assessment Questionnaire (CIA 3.0; Bohn and Fairburn, 2008).

    a self-report measure f assessing the severity of psychosocial impairment due to eating disorder features over the past 28 days.

    Measured: Baseline; mid-treatment (assessed up to 20 weeks); end of treatment (assessed up to 60 weeks); 3, 6, 12, 18, and 24 months after end of treatment (assessed up to 156 weeks from baseline)

  4. Binge Eating Scale (BES; Gormally et al., 1992)

    a self-report questionnaire of the behavioral, cognitive and emotional features of objective binge eating (OBE).

    Measured: Baseline; mid-treatment (assessed up to 20 weeks); end of treatment (assessed up to 60 weeks); 3, 6, 12, 18, and 24 months after end of treatment (assessed up to 156 weeks from baseline)

Secondary outcomes (7)

  1. State-Trait Anxiety Inventory (STAI; Spielberger, Gorsuch, Lushene, Vagg, & Jacobs, 1983)

    A self-report measure of trait and state anxiety.

    Measured: Baseline; mid-treatment (assessed up to 20 weeks); end of treatment (assessed up to 60 weeks); 3, 6, 12, 18, and 24 months after end of treatment (assessed up to 156 weeks from baseline)

  2. Beck Depression Inventory (BDI; Beck, et al., 1961)

    A self-report measures of depression.

    Measured: Baseline; mid-treatment (assessed up to 20 weeks); end of treatment (assessed up to 60 weeks); 3, 6, 12, 18, and 24 months after end of treatment (assessed up to 156 weeks from baseline)

  3. Symptom Check List (SCL-90)

    A measure of psychopathology symptoms and their intensity at a specific point in time.

    Measured: Baseline; mid-treatment (assessed up to 20 weeks); end of treatment (assessed up to 60 weeks); 3, 6, 12, 18, and 24 months after end of treatment (assessed up to 156 weeks from baseline)

  4. Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004)

    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.

    Measured: Baseline; mid-treatment (assessed up to 20 weeks); end of treatment (assessed up to 60 weeks); 3, 6, 12, 18, and 24 months after end of treatment (assessed up to 156 weeks from baseline)

  5. Structured Clinical Interview for DSM-5 Disorders (SCID-5; Michael B. First, Janet B.W. Williams)

    For assessing and defining DSM-5 Model for Personality Disorders.

    Measured: At baseline

  6. Toronto Alexithymia Scale (TAS - 20; Taylor & Bagby, 1992)

    It assess difficulties in understanding, processing, or describing emotions

    Measured: Baseline; mid-treatment (assessed up to 20 weeks); end of treatment (assessed up to 60 weeks); 3, 6, 12, 18, and 24 months after end of treatment (assessed up to 156 weeks from baseline)

  7. Working Alliance Inventory-Short Revised (WAI; SR Hatcher & Gillaspy, 2006)

    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.

    Measured: Every 4 weeks during treatment (up to approximately 6 months, until end of treatment).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2022
  2. Study start31 May 2022
  3. Primary completion31 May 2023
  4. Study completion30 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05503745
Sponsor's protocol ID
0000781
Acronym
MICBT-ED
Status last verified
Jan 2026
First submitted
11 Aug 2022
Last updated
18 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Outcomes, age, gender

Publications

  • Fairburn CG, Norman PA, Welch SL, O'Connor ME, Doll HA, Peveler RC. A prospective study of outcome in bulimia nervosa and the long-term effects of three psychological treatments. Arch Gen Psychiatry. 1995 Apr;52(4):304-12. doi: 10.1001/archpsyc.1995.03950160054010.

    PubMed 7702447

  • Fairburn, CG. Interpersonal psychotherapy for bulimia nervosa. 1997

  • Halmi KA, Goldberg SC, Cunningham S. Perceptual distortion of body image in adolescent girls: distortion of body image in adolescence. Psychol Med. 1977 May;7(2):253-7. doi: 10.1017/s0033291700029330.

    PubMed 877188

  • Bruch, H. (1973). Psychiatric aspects of obesity. Psychiatric Annals, 3(7), 6-9.

  • Bauer, B. G., & Anderson, W. P. (1989). Bulimic beliefs: Food for thought. Journal of Counseling & Development, 67(7), 416-419.

  • Casper, R. C. (1983). On the emergence of bulimia nervosa as a syndrome a historical view. International Journal of Eating Disorders, 2(3), 3-16.

  • Davis C. Normal and neurotic perfectionism in eating disorders: an interactive model. Int J Eat Disord. 1997 Dec;22(4):421-6. doi: 10.1002/(sici)1098-108x(199712)22:43.0.co;2-o.

    PubMed 9356890

  • Bastiani AM, Rao R, Weltzin T, Kaye WH. Perfectionism in anorexia nervosa. Int J Eat Disord. 1995 Mar;17(2):147-52. doi: 10.1002/1098-108x(199503)17:23.0.co;2-x.

    PubMed 7757095

  • Ruggiero GM, Levi D, Ciuna A, Sassaroli S. Stress situation reveals an association between perfectionism and drive for thinness. Int J Eat Disord. 2003 Sep;34(2):220-6. doi: 10.1002/eat.10191.

    PubMed 12898558

  • Vitousek, K. B., & Hollon, S. D. (1990). The investigation of schematic content and processing in eating disorders. Cognitive therapy and research, 14(2), 191-214.

  • Button EJ, Loan P, Davies J, Sonuga-Barke EJ. Self-esteem, eating problems, and psychological well-being in a cohort of schoolgirls aged 15-16: a questionnaire and interview study. Int J Eat Disord. 1997 Jan;21(1):39-47. doi: 10.1002/(sici)1098-108x(199701)21:13.0.co;2-4.

    PubMed 8986516

  • Button EJ, Sonuga-Barke EJ, Davies J, Thompson M. A prospective study of self-esteem in the prediction of eating problems in adolescent schoolgirls: questionnaire findings. Br J Clin Psychol. 1996 May;35(2):193-203. doi: 10.1111/j.2044-8260.1996.tb01176.x.

    PubMed 8773797

  • Canals J, Carbajo G, Fernandez J, Marti-Henneberg C, Domenech E. Biopsychopathologic risk profile of adolescents with eating disorder symptoms. Adolescence. 1996 Summer;31(122):443-50.

    PubMed 8726902

  • Geller J, Srikameswaran S, Cockell SJ, Zaitsoff SL. Assessment of shape- and weight-based self-esteem in adolescents. Int J Eat Disord. 2000 Nov;28(3):339-45. doi: 10.1002/1098-108x(200011)28:33.0.co;2-r.

    PubMed 10942921

  • Ghaderi A, Scott B. Prevalence, incidence and prospective risk factors for eating disorders. Acta Psychiatr Scand. 2001 Aug;104(2):122-30. doi: 10.1034/j.1600-0447.2001.00298.x.

    PubMed 11473506

Questions about this trial

What is this clinical trial studying?

A study testing CBT-F+MIT and CBT-E in people with Eating Disorders and Maladaptive Personality Trait, run by Centro Trattamento Integrato: Disturbi Alimentari e Obesita at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Eating Disorder Examination Questionnaire (EDE-Q6; Fairburn & Beglin, 1994) (time frame: Baseline; mid-treatment (assessed up to 20 weeks); end of treatment (assessed up to 60 weeks); 3, 6, 12, 18, and 24 months after end of treatment (assessed up to 156 weeks from baseline)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05503745, which also lists 99 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.

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