UMIN-CTR Clinical Trial

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

Benzodiazepine Discontinuation

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO

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

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)

Study type

Interventional

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

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

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

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

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

Institute

Nagoya City University Graduate School of Medical Sciences

Institute

Department

Personal name

Organization

Japan Science and Technology Agency

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

09

Month

15

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2016

Year

08

Month

10

Day

Last modified on

2017

Year

02

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027126