UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056021 |
|---|---|
| Receipt number | R000064022 |
| Scientific Title | Unguided movie- and mobile therapy for patients with obsessive-compulsive disorder: randomized controlled trial |
| Date of disclosure of the study information | 2024/11/01 |
| Last modified on | 2025/02/03 10:03:56 |
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Basic information
Public title
Unguided movie- and mobile therapy for patients with obsessive-compulsive disorder: randomized controlled trial
Acronym
Unguided movie- and mobile therapy for patients with obsessive-compulsive disorder: randomized controlled trial
Scientific Title
Unguided movie- and mobile therapy for patients with obsessive-compulsive disorder: randomized controlled trial
Scientific Title:Acronym
Unguided movie- and mobile therapy for patients with obsessive-compulsive disorder: randomized controlled trial
Region
| Japan |
Condition
Condition
obsessive-compulsive disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and tolerability of a video-based mobile application for obsessive-compulsive disorder
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary outcome for effectiveness will be the comparison of the Yale-Brown Obsessive Compulsive Scale between the intervention and control groups using a linear mixed model for repeated measures (MMRM) to test the difference in score changes between the two groups from baseline to weeks 4 and 8.
As a measure of tolerability, participants in the intervention group who complete 80% or more of the sessions by the 8-week point will be defined as treatment completers, and the proportion of completers will be calculated. Participants who complete less than 50% of the sessions by the 8-week point will be defined as dropouts. In the waitlist control group, participants will be asked at the 8-week point whether they received any psychotherapy during the period; those who did will be considered dropouts from the waitlist control group.
Key secondary outcomes
Obsessive-Compulsive Inventory-Revised, Patient Health Questionnaire,The 5-level EQ-5D version (at 8 weeks, between groups)
Scale To Assess Therapeutic Relationship (desctiptive, intervention arm)
free form for impressions and areas for improvement.
Response defined as a 30% reduction in the Y-BOCS score, and remission defined as a Y-BOCS score of 14 or less.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
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
| Device,equipment |
Interventions/Control_1
The intervention group will receive a mobile device-based intervention using an application grounded in CBT. The treatment period will be 8 weeks, during which 21 sessions will be conducted.
Interventions/Control_2
Participants not allocated to the intervention group will be assigned to a waitlist control group for 8 weeks. During this period, they will receive usual care, but will not undergo any psychotherapy that includes ERP.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The study will include outpatients aged 18 years or older diagnosed with OCD, who regularly use mobile devices in their daily lives. The diagnosis will be based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. Concomitant therapies, including pharmacotherapy, will be allowed.
Key exclusion criteria
Patients who require imminent hospitalization, pose a risk of suicide or self-harm, have intellectual disabilities, have comorbid schizophrenia, or have previously undergone behavioral therapy or cognitive-behavioral therapy (CBT) will be excluded.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Hissei |
| Middle name | |
| Last name | Imai |
Organization
Ohashi psychiatric cilinic
Division name
Department of psychiatry
Zip code
665-0034
Address
2F, 10-17, 2 chome, Obayashi, Takaraduka-city, Hyogo
TEL
0797-76-4610
ihits@hotmail.com
Public contact
Name of contact person
| 1st name | Hissei |
| Middle name | |
| Last name | Imai |
Organization
Ohashi psychiatric cilinic
Division name
Department of psychiatry
Zip code
665-0034
Address
2F, 10-17, 2 chome, Obayashi, Takaraduka-city, Hyogo
TEL
0797-76-4610
Homepage URL
ihits@hotmail.com
Sponsor or person
Institute
Ohashi psychiatric clinic
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japanese association of neuro-psychiatric clinics
Address
38-2-7F, 1 chome, Yoyogi, Shibuya-ku, Tokyo
Tel
03-3320-1423
NA
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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 01 | 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
| 2024 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 07 | Day |
Last follow-up date
| 2028 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 11 | Month | 01 | Day |
Last modified on
| 2025 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064022
