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

The 9-month Follow-up Study for the Patients of Illicit Substance Use Disorder After Receiving the Different Psychosocial Intervention

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.

Study Overview

• Status: Unknown
• Conditions: Substance Use Disorders; Illicit Drug Use
• Intervention / Treatment: Behavioral: the individual psychotherapy; Behavioral: the group psychotherapy; Behavioral: the family therapy; Behavioral: motivational enhancement interview

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.

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hung-Chi Wu, M.S.; Phone Number: 2390 +886-7-7513171; Email: wuhcmail@gmail.com
• Study Contact Backup: Name: Wei-Tsung Kao, Ph.D.; Phone Number: 2373 +886-7-7513171; Email: 030854@gmail.com

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 886
    • Recruiting
    • Kaohsiung Municipal Kai-Syuan Psychiatric Hospital
    • Contact: Hung-Chi Wu, M.D., M.S.; Phone Number: 2390 +886-7-751-3171; Email: wuhcmail@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: the motivational enhancement interview; 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.	Behavioral: the individual psychotherapy; 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.; Behavioral: the group psychotherapy; 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.; Behavioral: the family therapy; 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.
Other: the individual psychotherapy; 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.	Behavioral: the group psychotherapy; 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.; Behavioral: the family therapy; 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.; Behavioral: motivational enhancement interview; 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.
Other: the group psychotherapy; 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.	Behavioral: the individual psychotherapy; 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.; Behavioral: the family therapy; 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.; Behavioral: motivational enhancement interview; 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.
Other: the family therapy; 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.	Behavioral: the individual psychotherapy; 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.; Behavioral: the group psychotherapy; 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.; Behavioral: motivational enhancement interview; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	9 months
The World Health Organization Quality of Life instrument (WHOQOL-BREF Taiwan version)	The instrument has four dimension and higher scores mean a better outcome.	9 months
Becker Depression Scale	The value is from 0 to 63, and higher scores mean a worse outcome.	9 months
Becker Anxiety Scale	The value is from 0 to 63, and higher scores mean a worse outcome.	9 months

Collaborators and Investigators

• Sponsor: Kaohsiung Kai-Suan Psychiatric Hospital
• Collaborators: Chang Gung Memorial Hospital; Kaohsiung Medical University
• Investigators: Principal Investigator: Frank Huang-Chih Chou, Ph.D., Kaohsiung Municipal Psychiatric Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Anticipated): December 30, 2021
• Study Completion (Anticipated): September 30, 2022

Study Registration Dates

• First Submitted: May 19, 2020
• First Submitted That Met QC Criteria: June 8, 2020
• First Posted (Actual): June 11, 2020

Study Record Updates

• Last Update Posted (Actual): June 11, 2020
• Last Update Submitted That Met QC Criteria: June 8, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: KSPH-2019-23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No