UMIN-CTR Clinical Trial

Public title

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

Acronym

CBT-E for AN in Japan: CAN-J

Scientific Title

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

Scientific Title:Acronym

CBT-E for AN in Japan: CAN-J

Region

Japan

Condition

anorexia nervosa

Classification by specialty

Psychosomatic Internal Medicine

Psychiatry

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The aim of this study is to compare the efficacy of CBT-E in patients with AN with treatment-as-usual (TAU) in an RCT. It was hypothesized that CBT-E would be superior to TAU at least in terms of weight gain especially in Japan as most patients with AN are likely to have lower BMI than 17.5 kg/m2.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase III

Primary outcomes

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

Key secondary outcomes

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

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

YES

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

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' 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 maintaining self-monitoring, which is one of the crucial factors of CBT-E, regular eating with snacks, and addressing their eating disorder psychopathologies. In the final phase, the focus is on helping patients maintain the changes that they have achieved and developing strategies in advance for risky situations inducing setbacks.
Patients assigned to CBT-E arm are offered 25-40 about 50 minutes sessions for 40 weeks. The number of sessions varies according to the patients initial BMI. (BMI < 16: 40 sessions, 16.5 =< BMI < 17.5: 30 sessions, 17.5 =< BMI < 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 20 weeks after commencement of the treatment).

Interventions/Control_2

Patients assigned to treatment as usual (TAU) control group receive the supportive psychotherapies with treatment modules described in the "Treatment Guidelines for Eating Disorders" (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 total number and frequency of sessions provided for patients and when to use treatment modules are not specifically determined to be approximately congruent with the treatments provided in usual outpatient settings.
Patients assigned to this group have at least one session every two weeks. Each session lasts 15-30 minutes, in which patient's weight, eating pathology and psychiatric comorbidity are assessed. The treatment will be terminated at the time when participants meet the criteria for remission at the end of 20 sessions (approximately at 20 weeks after commencement of the treatment).

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

16

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key 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.

Key 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.

Target sample size

56

Name of lead principal investigator

1st name	Kazuhiro
Middle name
Last name	Yoshiuchi

Organization

The University of Tokyo Hospital

Division name

Psychosomatic Medicine

Zip code

113-8655

Address

Hongo 7-3-1, Bunkyo-ku, Tokyo

TEL

03-5800-9764

Email

kyoshiuchi@gmail.com

Name of contact person

1st name	Nobuhiro
Middle name
Last name	Nohara

Organization

The University of Tokyo Hospital

Division name

Psychosomatic Medicine

Zip code

113-8655

Address

Hongo 7-3-1, Bunkyo-ku, Tokyo

TEL

03-5800-9764

Homepage URL

Email

nobuhironohara@icloud.com

Institute

The University of Tokyo

Institute

Department

Personal name

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

The University of Tokyo, Clinical Research Review Board

Address

Hongo 7-3-1, Bunkyo-ku, Tokyo

Tel

03-5841-0818

Email

ethics@m.u-tokyo.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

東京大学医学部附属病院（心療内科）、国立国際医療研究センター国府台病院（千葉県）、九州大学病院（福岡県）

Date of disclosure of the study information

2022

Year

09

Month

12

Day

URL releasing protocol

https://bpsmedicine.biomedcentral.com/articles/10.1186/s13030-023-00277-2

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Open public recruiting

Date of protocol fixation

2022

Year

02

Month

03

Day

Date of IRB

2022

Year

12

Month

22

Day

Anticipated trial start date

2023

Year

01

Month

11

Day

Last follow-up date

2028

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2022

Year

09

Month

04

Day

Last modified on

2024

Year

06

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055657