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A randomized controlled trial of enhanced cognitive behavioral therapy (CBT-E) and treatment as usual (TAU) for anorexia nervosa.

A multi-center, randomized, parallel-group study to compare the efficacy of enhanced cognitive behavioral therapy (CBT-E) with treatment as usual (TAU) for anorexia nervosa - CBT-E for AN in Japan: CAN-J

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000048847
Enrollment
56
Registered
2022-09-12
Start date
2023-01-11
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

anorexia nervosa

Interventions

CBT-E is a treatment for ED patients, irrespective of ED diagnosis. With patients who are underweight, CBT-E has three phases. In the first phase, the emphasis is on increasing patients&#39
motivation to change and helping them recognize their current maladaptive thinking and behaviors and the processes maintaining them. Then patients are encouraged to gain weight, while initiating and m
16: 40 sessions, 16.5 =&lt
BMI &lt
17.5: 30 sessions, 17.5 =&lt
18.5: 25 sessions) to allow for enough time to gain weight. The treatment will be terminated at the time when participants meet the criteria for remission at the end of 20 sessions (approximately at
Treatment Guidelines for Eating Disorders&quot
(Japan Society for Eating Disorders. Treatment guidelines for eating disorders. Tokyo: Igaku-shoin (in Japanese)
2012.). Sessions in TAU use a variety of modules such as psychoeducational intervention, nutritional guidance, self-monitoring of eating, excluding any module used in structured psychotherapies. The

Sponsors

The University of Tokyo
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Those who meet the diagnostic criteria of DSM-5 for anorexia nervosa. Those who are 16 years old or older when they consent to participate in this study. Those whose BMI are equal to or over 14.0 and below 18.5. (14.0 =< BMI < 18.5) Those living in Japan and being literate in Japanese Those who understand the study concepts and give written informed consent.

Exclusion criteria

Exclusion criteria: Those who are receiving or have received any type of structured psychotherapies : CBT- E, Family therapy, MANTRA, SSCM, Interpersonal Therapy (IPT). Those who have Axis-I or Axis-II psychiatric disorders : schizophrenia, bipolar disorder, substance use disorder, or somatic disease that impedes the treatment of CBT-E. Those prescribed antipsychotic medication except for antidepressant, anxiolytic or hypnotics. Those with intellectual disability. Those who are at imminent risk of suicide. Those who are pregnant or might become pregnant. Those who have difficulty in attending scheduled therapy sessions. Those who are not considered eligible to participate in the study by research directors.

Design outcomes

Primary

MeasureTime frame
Body mass index (kg/m2) at 40 weeks after treatment was initiated.

Secondary

MeasureTime frame
Japanese version of Eating Disorder Examination-Questionnaire (EDE-Q-J) . Japanese version of Clinical Impairment Assessment questionnaire (CIA)

Countries

Japan

Contacts

Public ContactNobuhiro Nohara

The University of Tokyo Hospital Psychosomatic Medicine

nobuhironohara@icloud.com03-5800-9764

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026