UMIN-CTR Clinical Trial

Public title

A randomized controlled trial of Family based ERP Program (FERP) for obsessive compulsive disorder

Acronym

FERP Study

Scientific Title

A randomized controlled trial of Family based ERP Program (FERP) for obsessive compulsive disorder

Scientific Title:Acronym

FERP Study

Region

Japan

Condition

Obsessive Compulsive Disorder

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To examine the efficacy of Family based ERP Program as an adjunct to usual care for obsessive compulsive disorder compared with usual care alone

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Yale-Brown Obsessive Compulsive Scale(Y-BOCS) score at the time of end of intervention period

Key secondary outcomes

1.Family Accommodation Scale for Obsessive Compulsive Disorder: FAS
2.OCD Family Functioning Scale: OFF
3.Beck Depression Inventory: BDI
4.Sheehan Disability Scale: SDS
5.Kessler Psychological Distress Scale-6: K6
6.Euro QOL: EQ5D
7.Patient Global Impression-severity scale: PGI-S / Patient Global Impression-improvement scale: PGI-I

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Family based ERP Program in addition to treatment as usual

Interventions/Control_2

treatment as usual

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

18

years-old

<=

Age-upper limit

65

years-old

>

Gender

Male and Female

Key inclusion criteria

(OCD patient)
1. Subjects with primary diagnosis of obsessive compulsive disorder by DSM-IV.
2. Subjects with Y-BOCS>=8
3. Aged 20 years or older, and younger than 65 years at screening.
4. Subjects who give consent with not to change current pharmacotherapy except for symptom improvement.
5. Subjects who have the possibility of going to the hospital more than 12 times during the study period.
6. Subjects who give full consent in the participation of the study.

(Patient's family)
1. Subjects with whom the patient lives at one hour daily.
2. Subjects with whom the patient has identified as the family member who is most involved the OCD.
3. Subjects who have the possibility of going to the hospital 8 times during the study period.
4. Subjects who give full consent in the participation of the study.

Key exclusion criteria

1. No alcohol or substance use disorder in 6 months prior to the screening.
2. No other primary DIM-IV Axis I Disorders at screening.
3. No serious suicidal ideation at screening.
4. No treatment of individual CBT for OCD.
5. No major cognitive deficits at screening.
6. No severe or unstable medical co-morbidities at screening.
7. Other relevant reason decided by the FERP principal investigator.

Target sample size

36

Name of lead principal investigator

1st name
Middle name
Last name	Masaru Horikoshi, PhD

Organization

National Center of Neurology and Psychiatry

Division name

National Center for Cognitive Behavior Therapy and Research

Zip code

Address

Ogawahigashi-cho 4-1-1, Kodaira-shi, Tokyo 187-8551, Japan

TEL

042-341-2711

Email

mhorikoshi@ncnp.go.jp

Name of contact person

1st name
Middle name
Last name	Yuki Kobayashi

Organization

National Center of Neurology and Psychiatry

Division name

National Center for Cognitive Behavior Therapy and Research

Zip code

Address

Ogawahigashi-cho 4-1-1, Kodaira-shi, Tokyo 187-8551, Japan

TEL

042-341-2711

Homepage URL

Email

ykobayashi@ncnp.go.jp

Institute

FERP study group, National Center of Cognitive Behavior Therapy and Research, National Center of Neurology and Psychiatry

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

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

国立研究開発法国立精神・神経医療研究センター（東京都）

Date of disclosure of the study information

2016

Year

04

Month

11

Day

URL releasing protocol

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

Completed

Date of protocol fixation

2015

Year

12

Month

17

Day

Date of IRB

2015

Year

07

Month

07

Day

Anticipated trial start date

2016

Year

04

Month

15

Day

Last follow-up date

2019

Year

03

Month

14

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

04

Month

03

Day

Last modified on

2020

Year

03

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025095