Unique ID issued by UMIN | UMIN000021763 |
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Receipt number | 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 | 2020/03/07 21:17:52 |
A randomized controlled trial of Family based ERP Program (FERP) for obsessive compulsive disorder
FERP Study
A randomized controlled trial of Family based ERP Program (FERP) for obsessive compulsive disorder
FERP Study
Japan |
Obsessive Compulsive Disorder
Psychiatry |
Others
NO
To examine the efficacy of Family based ERP Program as an adjunct to usual care for obsessive compulsive disorder compared with usual care alone
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
Yale-Brown Obsessive Compulsive Scale(Y-BOCS) score at the time of end of intervention period
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
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Active
YES
YES
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Maneuver |
Family based ERP Program in addition to treatment as usual
treatment as usual
18 | years-old | <= |
65 | years-old | > |
Male and Female
(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.
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.
36
1st name | |
Middle name | |
Last name | Masaru Horikoshi, PhD |
National Center of Neurology and Psychiatry
National Center for Cognitive Behavior Therapy and Research
Ogawahigashi-cho 4-1-1, Kodaira-shi, Tokyo 187-8551, Japan
042-341-2711
mhorikoshi@ncnp.go.jp
1st name | |
Middle name | |
Last name | Yuki Kobayashi |
National Center of Neurology and Psychiatry
National Center for Cognitive Behavior Therapy and Research
Ogawahigashi-cho 4-1-1, Kodaira-shi, Tokyo 187-8551, Japan
042-341-2711
ykobayashi@ncnp.go.jp
FERP study group, National Center of Cognitive Behavior Therapy and Research, National Center of Neurology and Psychiatry
Ministry of Health, Labour and Welfare
Japanese Governmental office
Japan
NO
国立研究開発法国立精神・神経医療研究センター(東京都)
2016 | Year | 04 | Month | 11 | Day |
Unpublished
Completed
2015 | Year | 12 | Month | 17 | Day |
2015 | Year | 07 | Month | 07 | Day |
2016 | Year | 04 | Month | 15 | Day |
2019 | Year | 03 | Month | 14 | Day |
2016 | Year | 04 | Month | 03 | Day |
2020 | Year | 03 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025095
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