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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000042186
Receipt No. R000048154
Scientific Title Evaluation of cognitive behavioral therapy for drug use disorders in Indonesia
Date of disclosure of the study information 2020/10/21
Last modified on 2021/02/15

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Basic information
Public title Evaluation of cognitive behavioral therapy for drug use disorders in Indonesia
Acronym Indo-DARPP evaluation
Scientific Title Evaluation of cognitive behavioral therapy for drug use disorders in Indonesia
Scientific Title:Acronym Indo-DARPP evaluation
Region
Asia(except Japan)

Condition
Condition Substance use disorders
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to investigate the effectiveness of video-conference delivered Indonesia Drug Relapse Prevention Program (Indo-DARRP) on the reduction of substance consumption and other health indicators, compared to treatment as usual at outpatient, via randomized controlled trial in Indonesia.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Percentage of days of being abstinent from the primarily used drug during the past 30 days assessed by weekly-basis interviews and validated by urinalysis
Key secondary outcomes 1. Addiction severity assessed by the Addiction Severity Index (ASI)
2. Health-related quality of life assessed by the EuroQol-5D (EQ-5D-5L)
3. Motivation to change assessed by the Action subscale of the University of Rhode Island Change Assessment (URICA)
4. Coping strategies assessed by the Brief Coping Orientations to Problems Experienced (The Brief COPE)
5. Psychiatric symptoms assessed by the Symptom Checklist 90-R (SCL-90-R)
6. Cognitive function assessed by the Rey Auditory Verbal Learning Test (RAVLT)
7. Retention in treatment defined as at least 75 percent of the planned number of therapeutic contacts during the past 3 months
8. Treatment satisfaction assessed by the Client Satisfaction Questionnaire-3 (CSQ-3)
9. Group cohesion assessed by the Group Therapy Experience Scale (GTES)

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 NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Participants allocated to the intervention group will receive, besides treatment as usual, a group-based outpatient online Indo-DARPP session every week for 3 months (12 sessions in total), which will be facilitated by a trained provider and co-facilitated by a peer counsellor. Each session will be delivered by Zoom video call and last about 120 minutes. Sessions will be offered in a mutual-aid group setting (5 participants).
Interventions/Control_2 Participants allocated to the control group will receive treatment as usual which varies depending on sites (e.g. symptomatic pharmacotherapy, opioid substitution, group peer counselling).
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
65 years-old >=
Gender Male and Female
Key inclusion criteria To be eligible to participate, patients must: 1) aged between 18 and 65 years old; 2) are diagnosed as having drug or alcohol use disorder based on DSM-5; 3) have used primarily used substance for at least one day in the past one year; 4) have access to electronic devices (i.e. smartphone, mobile tablet, personal computer) with internet connection; and 5) are proficient in Indonesian.
Key exclusion criteria 1) having comorbidity of severe psychotic or physical disorder which hinder them from providing informed consent or participating in group therapy, and 2) using residential care.
Target sample size 160

Research contact person
Name of lead principal investigator
1st name Chika
Middle name
Last name Yamada
Organization Kyoto University
Division name Center for Southeast Asian Studies
Zip code 606-8501
Address 46 Yoshidashimoadachicho, Sakyo Ward, Kyoto, JAPAN
TEL 81-70-1780-1503
Email chika128@cseas.kyoto-u.ac.jp

Public contact
Name of contact person
1st name Chika
Middle name
Last name Yamada
Organization Kyoto University
Division name Center for Southeast Asian Studies
Zip code 606-8501
Address 46 Yoshidashimoadachicho, Sakyo Ward, Kyoto, JAPAN
TEL 81-70-1780-1503
Homepage URL
Email chika128@cseas.kyoto-u.ac.jp

Sponsor
Institute Psychiatric Department, University of Indonesia
Institute
Department

Funding Source
Organization JSPS KAKENHI Grant Number JP 19K24256
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Kyoto University
Name of secondary funder(s) the Japan-ASEAN Platform for Transdisciplinary Studies project of the Center for Southeast Asian Studies, Kyoto University

IRB Contact (For public release)
Organization Ethics Committee of Graduate School and Faculty of Medicine, Kyoto University
Address Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel 075-753-4680
Email ethcom@kuhp.kyoto-u.ac.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 Cipto Mangunkusumo Hospital (Jakarta), Aceh Mental Hospital (Aceh), Duren Sawit Regional Hospital (Jakarta), Karisma Foundation (Jakarta), Kapeta Foundation (Banten), Kios Atma Jaya (Jakarta), Puskesmas Jatinegara (jakarta), Puskesmas Gambir (Jakarta)

Other administrative information
Date of disclosure of the study information
2020 Year 10 Month 21 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 The full protocol and datasets of the planned study will be available from the corresponding author on reasonable request.
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2020 Year 10 Month 01 Day
Date of IRB
2020 Year 10 Month 21 Day
Anticipated trial start date
2021 Year 01 Month 01 Day
Last follow-up date
2021 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 10 Month 21 Day
Last modified on
2021 Year 02 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048154

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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