UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038215 |
|---|---|
| Receipt number | R000043560 |
| Scientific Title | Effectiveness of Family Inclusive Treatment program for OCD adolescents : Before-after trial |
| Date of disclosure of the study information | 2019/10/07 |
| Last modified on | 2022/10/11 12:24:43 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effectiveness of Family Inclusive Treatment program for OCD adolescents : Before-after trial
Acronym
Effectiveness of Family Inclusive Treatment program for OCD adolescents : Before-after trial
Scientific Title
Effectiveness of Family Inclusive Treatment program for OCD adolescents : Before-after trial
Scientific Title:Acronym
Effectiveness of Family Inclusive Treatment program for OCD adolescents : Before-after trial
Region
| Japan |
Condition
Condition
Obsessive Compulsive Disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assess the effectiveness and safety of Family Inclusive Treatment program for OCD adolescents (FIT-O).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
CY-BOCS;Child Yale Brown Obsessive Compulsive Scale at the time of end of intervention period
Key secondary outcomes
1.FAS;Family Accommodation Scale
2.OFF;OCD Family Functioning Scale
3.CGI-S;Impairment
4.CGI-S;Improvement
5.CBCL;Child Behavior Checklist, YSR;Youth Self-Report
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Family Inclusive treatment program in addition to treatment as usual
Interventions/Control_2
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
| 12 | years-old | <= |
Age-upper limit
| 17 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
OCD patient
1.Subjects with primary diagnosis of obsessive compulsive disorder by DSM-5.
2.Those who have 16 or more CY-BOCS
3.Aged 12 years or older, and younger than 17 years at screening.
4.Subjects who give consent with not to change current pharmacotherapy.
5.Subjects who give full consent in the participation of the study.
Patient's family
1. One family member living with the patient for at least one year at the time of screening. The family members are primarily responsible for childcare or are most involved in patient OCD.
2. 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 Disorders in 6 months prior to the screening.
3.No serious suicidal ideation at screening.
4.Patients with IQ less than 70
5.Persons who have adjusted their drugs for 12 weeks before screening
6.Patients who are difficult to visit 14 times after screening
7.Patients whose family members are difficult to participate in all five family program sessions during CBT
8.Those who have received CBT for structured obsessive-compulsive disorder by the time of screening
9.Those who have severe cognitive impairment that makes it difficult to perform CBT at the time of screening
10.Those who have a serious or unstable physical disease that is life-threatening in clinical diagnosis at the time of screening
11.Those who are deemed inappropriate by the research supervisor
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Tetsu |
| Middle name | |
| Last name | Hirosawa |
Organization
Kanazawa University
Division name
Department of Psychiatry and Neurobiology
Zip code
920-8641
Address
13-1 Takara machi, Kanazawa City, Ishikawa Prefecture
TEL
076-265-2304
cbt_fit@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Kontani |
Organization
Kanazawa University
Division name
Department of Psychiatry and Neurobiology
Zip code
920-8641
Address
13-1 Takara machi, Kanazawa City, Ishikawa Prefecture
TEL
076-265-2304
Homepage URL
cbt_fit@yahoo.co.jp
Sponsor or person
Institute
Kanazawa University
Department of Psychiatry and Neurobiology
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Young Scientists
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kanazawa University
Address
13-1 Takara machi, Kanazawa City, Ishikawa Prefecture
Tel
076-265-2304
cbt_fit@yahoo.co.jp
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
綾瀬メンタルクリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 10 | Month | 07 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000043560
Publication of results
Unpublished
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000043560
Number of participants that the trial has enrolled
2
Results
In the first case, CY-BOCS score was 23 before participating in this program. At the end of the program, CY-BOCS decreased to 14. Three months after completing the program, the CY-BOCS score was 12.The family rating scale for obsessive-compulsive symptoms (FAS,OFF) also improved after participating in the program.
In the second case, a coronavirus pandemic occurred while participating in this program. Therefore, this participant had increased anxiety. We judged this case to be difficult to evaluate.
Results date posted
| 2022 | Year | 10 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Case 1: 16 years old, male
Case 1: 18 years old, female
Participant flow
After announcing the study outline by the research medical institution, the study participants wished to participate.The principal investigator obtained consent for study participation from them and they underwent a treatment program. They underwent a final evaluation three months after the end of the study and finished participating.
Adverse events
No adverse events
Outcome measures
1.Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)
2. Family Accomodation Scale (FAS)
3. OCD Family Functioning Scale (OFF)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2021 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Two out of twelve expected attendees has completed participation.
Management information
Registered date
| 2019 | Year | 10 | Month | 06 | Day |
Last modified on
| 2022 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043560
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
