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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000021763
Receipt No. R000025095
Scientific Title A randomized controlled trial of Family based ERP Program (FERP) for obsessive compulsive disorder
Date of disclosure of the study information 2016/04/11
Last modified on 2018/06/20

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Basic information
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
Condition Obsessive Compulsive Disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
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

Base
Study type Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
Last 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

Public contact
1st 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

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

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
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)

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 11 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
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

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2015 Year 12 Month 17 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 04 Month 03 Day
Last modified on
2018 Year 06 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025095

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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