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The Follow-up Study for the Patients of Illicit Substance Use Disorder

Primary Purpose

Substance Use Disorders, Illicit Drug Use

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
motivational enhancement interview
the individual psychotherapy
the group psychotherapy
the family therapy
Sponsored by
Kaohsiung Kai-Suan Psychiatric Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Use Disorders

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with illicit substance use disorder diagnosed by DSM-5

Exclusion Criteria:

The age of the patient is below 20 years old or above 65 years old, the patients cannot cooperate with the tools of investigation

Sites / Locations

  • Kaohsiung Municipal Kai-Syuan Psychiatric HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

the motivational enhancement interview

the individual psychotherapy

the group psychotherapy

the family therapy

Arm Description

The motivational enhancement interview is a counseling approach developed in part by clinical psychologists William R. Miller and Stephen Rollnick. It is a directive, client-centered counseling style for eliciting behavior change by helping clients to explore and resolve ambivalence.

The individual psychotherapy is the use of psychological methods, particularly when based on regular personal interaction with adults, to help a person change behavior and overcome problems in desired ways. Psychotherapy aims to improve an individual's well-being and mental health, to resolve or mitigate troublesome behaviors, beliefs, compulsions, thoughts, or emotions, and to improve relationships and social skills.

The group psychotherapy is a form of psychotherapy in which one or more therapists treat a small group of clients together as a group. The term can legitimately refer to any form of psychotherapy when delivered in a group format, including Art therapy, cognitive behavioural therapy or interpersonal therapy, but it is usually applied to psychodynamic group therapy where the group context and group process is explicitly utilised as a mechanism of change by developing, exploring and examining interpersonal relationships within the group.

The family therapy is is a branch of psychotherapy that works with families and couples in intimate relationships to nurture change and development. It tends to view change in terms of the systems of interaction between family members.

Outcomes

Primary Outcome Measures

The severity of substance use used by the Severity of Dependence Scale
The value is from 0 to 15, and higher scores mean a worse outcome.
The World Health Organization Quality of Life instrument (WHOQOL-BREF Taiwan version)
The instrument has four dimension and higher scores mean a better outcome.
Becker Depression Scale
The value is from 0 to 63, and higher scores mean a worse outcome.
Becker Anxiety Scale
The value is from 0 to 63, and higher scores mean a worse outcome.

Secondary Outcome Measures

Full Information

First Posted
May 19, 2020
Last Updated
June 8, 2020
Sponsor
Kaohsiung Kai-Suan Psychiatric Hospital
Collaborators
Kaohsiung Medical University, Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04426565
Brief Title
The Follow-up Study for the Patients of Illicit Substance Use Disorder
Official Title
The 9-month Follow-up Study for the Patients of Illicit Substance Use Disorder After Receiving the Different Psychosocial Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
December 30, 2021 (Anticipated)
Study Completion Date
September 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaohsiung Kai-Suan Psychiatric Hospital
Collaborators
Kaohsiung Medical University, Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The patients will be diagnosed according to DSM-5, the severity of individual substance use disorder will be assessed, and the plan of treatment will be provided. The treatment will be determined by the diagnosis and severity of addiction, the mood or psychiatric comorbidities, the hyperactivity or attention deficit, alcohol addiction, and etc. The motivational enhancement interview, the individual psychotherapy, the group psychotherapy, the family therapy will be provided by our team members. In order to evaluate the efficacy of the different therapy, we will evaluate the psychological and social status of the patients and follow up every 3 months. The efficacy of different treatment will be evaluated according to our study instruments.
Detailed Description
The patients will be diagnosed according to DSM-5, the severity of individual addiction will be assessed, and the plan of treatment will be provided. The treatment will be determined by the diagnosis and severity of addiction, the mood or psychiatric comorbidities, the hyperactivity or attention deficit, alcohol addiction, and etc. The motivational enhancement interview, the individual psychotherapy, the group psychotherapy, the family therapy will be provided by our team members. In order to evaluate the efficacy of the different therapy, we will evaluate the psychological and social status of the patients and follow up every 3 months. The patients will be received the basic physiological assessment, the chest X-ray, electrocardiogram, liver and renal function, hematology test, urine screening for addictive substances, screening for blood infectious diseases (including hepatitis B, C and HIV infection) will be included. Besides, the Drug Abuse Screen Test (DAST), the Severity of Dependence Scale (SDS), the Reliability of Readiness to Change Questionnaire, the Opiate Treatment Index (OTI), drug Avoidance Self-Efficacy Scale (DASES), the Family APGAR score, The brief version of the World Health Organization Quality of Life instrument (WHOQOL-BREF Taiwan version), Chinese health questionnaire (CHQ), parental bonding instrument (PBI), Toronto Alexithymia Scale (TAS), Brief Symptom Rating Scale (BSRS-5), Chinese version of Adult ADHD Self-Report Scale (ASRS-V1. 1), Becker Depression Scale (BDI) and Becker Anxiety Scale (BAI) will be evaluated every 3 months after receiving our treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders, Illicit Drug Use

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The motivational enhancement interview, the individual psychotherapy, the group psychotherapy, the family therapy will be provided by our team members.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
the motivational enhancement interview
Arm Type
Other
Arm Description
The motivational enhancement interview is a counseling approach developed in part by clinical psychologists William R. Miller and Stephen Rollnick. It is a directive, client-centered counseling style for eliciting behavior change by helping clients to explore and resolve ambivalence.
Arm Title
the individual psychotherapy
Arm Type
Other
Arm Description
The individual psychotherapy is the use of psychological methods, particularly when based on regular personal interaction with adults, to help a person change behavior and overcome problems in desired ways. Psychotherapy aims to improve an individual's well-being and mental health, to resolve or mitigate troublesome behaviors, beliefs, compulsions, thoughts, or emotions, and to improve relationships and social skills.
Arm Title
the group psychotherapy
Arm Type
Other
Arm Description
The group psychotherapy is a form of psychotherapy in which one or more therapists treat a small group of clients together as a group. The term can legitimately refer to any form of psychotherapy when delivered in a group format, including Art therapy, cognitive behavioural therapy or interpersonal therapy, but it is usually applied to psychodynamic group therapy where the group context and group process is explicitly utilised as a mechanism of change by developing, exploring and examining interpersonal relationships within the group.
Arm Title
the family therapy
Arm Type
Other
Arm Description
The family therapy is is a branch of psychotherapy that works with families and couples in intimate relationships to nurture change and development. It tends to view change in terms of the systems of interaction between family members.
Intervention Type
Behavioral
Intervention Name(s)
motivational enhancement interview
Intervention Description
Motivational interviewing is supported by over 200 randomized controlled trials across a range of target populations and behaviors including substance abuse, health-promotion behaviors, medical adherence, and mental health issues.
Intervention Type
Behavioral
Intervention Name(s)
the individual psychotherapy
Intervention Description
It has been demonstrated to be an effective treatment for depression and has been modified to treat other psychiatric disorders such as substance use disorders and eating disorders. It is incumbent upon the therapist in the treatment to quickly establish a therapeutic alliance with positive countertransference of warmth, empathy, affective attunement and positive regard for encouraging a positive transferential relationship, from which the patient is able to seek help from the therapist despite resistance.
Intervention Type
Behavioral
Intervention Name(s)
the group psychotherapy
Intervention Description
Group psychotherapy is a key component of milieu therapy in a therapeutic community. The total environment or milieu is regarded as the medium of therapy, all interactions and activities regarded as potentially therapeutic and are subject to exploration and interpretation, and are explored in daily or weekly community meetings. A form of group therapy has been reported to be effective in psychotic adolescents and recovering addicts.
Intervention Type
Behavioral
Intervention Name(s)
the family therapy
Intervention Description
According to a 2004 French government study conducted by French Institute of Health and Medical Research, family and couples therapy was the second most effective therapy after Cognitive behavioral therapy. The study used meta-analysis of over a hundred secondary studies to find some level of effectiveness that was either "proven" or "presumed" to exist. Of the treatments studied, family therapy was presumed or proven effective at treating schizophrenia, bipolar disorder, anorexia and substance dependence.
Primary Outcome Measure Information:
Title
The severity of substance use used by the Severity of Dependence Scale
Description
The value is from 0 to 15, and higher scores mean a worse outcome.
Time Frame
9 months
Title
The World Health Organization Quality of Life instrument (WHOQOL-BREF Taiwan version)
Description
The instrument has four dimension and higher scores mean a better outcome.
Time Frame
9 months
Title
Becker Depression Scale
Description
The value is from 0 to 63, and higher scores mean a worse outcome.
Time Frame
9 months
Title
Becker Anxiety Scale
Description
The value is from 0 to 63, and higher scores mean a worse outcome.
Time Frame
9 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: Patients with illicit substance use disorder diagnosed by DSM-5 Exclusion Criteria: The age of the patient is below 20 years old or above 65 years old, the patients cannot cooperate with the tools of investigation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hung-Chi Wu, M.S.
Phone
+886-7-7513171
Ext
2390
Email
wuhcmail@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wei-Tsung Kao, Ph.D.
Phone
+886-7-7513171
Ext
2373
Email
030854@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Huang-Chih Chou, Ph.D.
Organizational Affiliation
Kaohsiung Municipal Psychiatric Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaohsiung Municipal Kai-Syuan Psychiatric Hospital
City
Kaohsiung
ZIP/Postal Code
886
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hung-Chi Wu, M.D., M.S.
Phone
+886-7-751-3171
Ext
2390
Email
wuhcmail@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Follow-up Study for the Patients of Illicit Substance Use Disorder

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