Implementation and Effectiveness of Multidiscipline-Integrated Addiction Treatment Model
Primary Purpose
Amphetamine-Related Disorders
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
cognitive-behavior group therapy
Individual supportive psychotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Amphetamine-Related Disorders focused on measuring Methamphetamine, Cognitive behavior group therapy
Eligibility Criteria
Inclusion Criteria:
- Aged 20-65
- Current methamphetamine use disorder by DSM-5, moderate and above
- Willing and able to provide informed consents
Exclusion Criteria:
- Severe physical or psychiatric conditions requiring emergent treatment
- Currently involved in judicial or criminal conditions
- Plan to go abroad or relocate in the next 6 months
Sites / Locations
- Taipei City HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Cognitive-behavior group therapy group
Arm Description
Outcomes
Primary Outcome Measures
Urine amphetamine test During Intervention
This test looks for amphetamine in urine once a week for 16 weeks.
Urine amphetamine test,Follow-Up
This test looks for amphetamine in urine once a month for 3 months.
Secondary Outcome Measures
The World Health Organization Quality of Life -BREF (WHOQOL-BREF) During Intervention
The content of the questionnaire is divided into four domains. The converted scores of each participant's answers are as low as 4 points and as high as 20 points in each category,a higher score means better quality of life.
The World Health Organization Quality of Life -BREF (WHOQOL-BREF),Follow-Up
The content of the questionnaire is divided into four domains. The converted scores of each participant's answers are as low as 4 points and as high as 20 points in each category,a higher score means better quality of life.
Full Information
NCT ID
NCT04203654
First Posted
December 12, 2019
Last Updated
March 30, 2020
Sponsor
National Health Research Institutes, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT04203654
Brief Title
Implementation and Effectiveness of Multidiscipline-Integrated Addiction Treatment Model
Official Title
Implementation and Effectiveness of Multidiscipline-Integrated Addiction Treatment Model
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 24, 2020 (Actual)
Primary Completion Date
July 2, 2020 (Anticipated)
Study Completion Date
December 15, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Health Research Institutes, Taiwan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Management of substance use disorders in clinical settings is challenging. Approaches with integrated bio-psycho-social interventions, along with the engagement of families and self-help groups are strongly recommended. The Matrix intensive outpatient program has been developed in UCLA to help the psychostimulant misusers in the Southern California in 1980's. With integration of the existing evidence of addiction researches and empirically supported cognitive-behavior treatment techniques, the Matrix model developed manuals to address knowledge and skills needed for drug users in their early recovery and relapse prevention. The treatment was delivered in a 16-week intensive structured group sessions. There was also a 12-week educational sessions for the in-treatment individuals and their families. A substantial body of evidence has demonstrated the successful experience of the Matrix treatment model in management a broad spectrum of addictive disorders in many countries.
The objectives of the pilot project are to set up a multi-center collaborative clinical network with implementation of an integrated addiction treatment program modified from the UCLA Matrix model. Via the establishment of standardized subject recruitment criteria, treatment and outcome assessment procedures, the study aims to assess the adherence of participating clinical organizations to the study protocol, the acceptance of participating MA misusers for the integrated treatment program as well as the outcomes and their determinants for the treatment models.
Detailed Description
Methamphetamine (MA) use disorder is a serious legal and health problem worldwide. Reports from Ministry of Justice in Taiwan revealed that the MA-related crimes has tremendously increased over the past decade. The arrested users of scheduled II drugs, MA mainly, has surged from 34,886 in 2014 to 54,190 in 2016 in Taiwan. It is critical to tackle the emerging problems in Taiwan.
Management of MA use disorder in clinical settings is challenging. Approaches with integrated bio-psycho-social interventions, along with the engagement of families and self-help groups are strongly recommended. The Matrix intensive outpatient program has been developed in UCLA to help the psychostimulant misusers in the Southern California in 1980's.With integration of the existing evidence of addiction researches and empirically supported cognitive-behavior treatment techniques, the Matrix model developed manuals to address knowledge and skills needed for drug users in their early recovery and relapse prevention. The treatment was delivered in a 16-week intensive structured group sessions. There was also a 12-week educational sessions for the in-treatment individuals and their families. A substantial body of evidence has demonstrated the successful experience of the Matrix treatment model in management a broad spectrum of addictive disorders in many countries.
The objectives of the pilot project are to set up a multi-center collaborative clinical network with implementation of an integrated addiction treatment program modified from the UCLA Matrix model. Via the establishment of standardized subject recruitment criteria, treatment and outcome assessment procedures, the study aims to assess the adherence of participating clinical organizations to the study protocol, the acceptance of participating MA misusers for the integrated treatment program as well as the outcomes and their determinants for the treatment models.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amphetamine-Related Disorders
Keywords
Methamphetamine, Cognitive behavior group therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cognitive-behavior group therapy group
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
cognitive-behavior group therapy
Intervention Description
cognitive-behavior group therapy Frequency: thrice a week Treatment duration: 16 week
Intervention Type
Behavioral
Intervention Name(s)
Individual supportive psychotherapy
Intervention Description
Individual supportive psychotherapy 3 sessions during the 16-week treatment period
Primary Outcome Measure Information:
Title
Urine amphetamine test During Intervention
Description
This test looks for amphetamine in urine once a week for 16 weeks.
Time Frame
16 weeks
Title
Urine amphetamine test,Follow-Up
Description
This test looks for amphetamine in urine once a month for 3 months.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
The World Health Organization Quality of Life -BREF (WHOQOL-BREF) During Intervention
Description
The content of the questionnaire is divided into four domains. The converted scores of each participant's answers are as low as 4 points and as high as 20 points in each category,a higher score means better quality of life.
Time Frame
16 weeks
Title
The World Health Organization Quality of Life -BREF (WHOQOL-BREF),Follow-Up
Description
The content of the questionnaire is divided into four domains. The converted scores of each participant's answers are as low as 4 points and as high as 20 points in each category,a higher score means better quality of life.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged 20-65
Current methamphetamine use disorder by DSM-5, moderate and above
Willing and able to provide informed consents
Exclusion Criteria:
Severe physical or psychiatric conditions requiring emergent treatment
Currently involved in judicial or criminal conditions
Plan to go abroad or relocate in the next 6 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sheng-Chang Wang, Doctor
Phone
+886-37-206-166
Ext
36703
Email
scwang69@gmail.com
Facility Information:
Facility Name
Taipei City Hospital
City
Taipei
ZIP/Postal Code
10341
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sheng-Chang Wang
12. IPD Sharing Statement
Learn more about this trial
Implementation and Effectiveness of Multidiscipline-Integrated Addiction Treatment Model
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