UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042186 |
|---|---|
| Receipt number | 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 18:27:18 |
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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
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
chika128@cseas.kyoto-u.ac.jp
Sponsor or person
Institute
Psychiatric Department, University of Indonesia
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048154
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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