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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000023580
Receipt No. R000027126
Scientific Title Gamified Acceptance & Commitment Therapy for Benzodiazepine Discontinuation: Randomised controlled trial
Date of disclosure of the study information 2016/09/15
Last modified on 2017/02/26

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Basic information
Public title Gamified Acceptance & Commitment Therapy for Benzodiazepine Discontinuation: Randomised controlled trial
Acronym Gamified ACT for Benzodiazepine Discontinuation: RCT
Scientific Title Gamified Acceptance & Commitment Therapy for Benzodiazepine Discontinuation: Randomised controlled trial
Scientific Title:Acronym Gamified ACT for Benzodiazepine Discontinuation: RCT
Region
Japan

Condition
Condition Benzodiazepine Discontinuation
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is developing gamified web-based program of acceptance and commitment therapy for Benzodiazepine discontinuation and to confirm efficacy of this program.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The success rate of benzodiazepine discontinuation during the 11th and 12th week after beginning of the program
Key secondary outcomes Benzodiazepine reduction rate,Recovery Assessment Scale(RAS),Depression Anxiety Stress Scale(DASS),Severity of Dependence syndrome(SDS),Euro Qol 5 Dimension(EQ5-D),Cognitive Fusion Questionnaire(CFQ),Personal Values Questionnaire II (PVQ-II)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
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 Intervention: Gamified acceptance & commitment therapy for benzodiazepine discontinuation
Period: 5 weeks
Interventions/Control_2 Intervention: Psychoeducation program
Period: 5 weeks
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
20 years-old <=
Age-upper limit
50 years-old >=
Gender Male and Female
Key inclusion criteria Regular use: 5 times a week and over
Required use: 4 times a week and less
Use for infomnia: Before sleeping

2.Being prescrived benzodiazepine regulary 12 weeks and over.
3.Being prescribed benzodiazepine once a day and over.(Excluded only for required use or use for insomnia)
4.Willing to stop using benzodiazepine and treating physician determine eligibility to stop benzodiazepine.
5.Being able to access the program and having an Email address for daily use.
6. Having no plan to be hospitalized more than 1 week for any reason.
7.Having no plan to transfer to a different hospital within 4 months.
8.Being able to respond to assessments via telephone.
9.Being able to understand and sign a written informed consent.
Key exclusion criteria 1.Being regulary prescribed 3 types of benzodiazepine and over. (excluded required use or use for insomnia)
2.Actively satisfied diagnostic cliteria with Mini-International Neuropsychiatric Interview.
3.Being regularly prescribed antipsychotic or mood stabilizer (lithium, valproate, carbamazepine and lamotrigine)
4.Imminent risk of suicide as judged by the treating physician.
5.Currently participating in another clinical intervention study.
6. Family members living with the researchers of the present study.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sei Ogawa
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Psychiatry
Zip code
Address 460-8601 Nagoyashi Mizuhoku Mizuhotyou Azanakawasumi 1
TEL 052-851-5511
Email tshtk.ii@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Toshitaka ii
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Psychiatry,
Zip code
Address 460-8601 Nagoyashi Mizuhoku Mizuhotyou Azanakawasumi 1
TEL 052-851-5511
Homepage URL
Email tshtk.ii@gmail.com

Sponsor
Institute Nagoya City University Graduate School of Medical Sciences
Institute
Department

Funding Source
Organization Japan Science and Technology Agency
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
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

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 15 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 Preinitiation
Date of protocol fixation
2016 Year 09 Month 15 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 01 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 08 Month 10 Day
Last modified on
2017 Year 02 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027126

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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