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

Substance Use Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04426565
• Other study ID #: KSPH-2019-23
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: September 30, 2022

Study information

• Verified date: June 2020
• Source: Kaohsiung Kai-Suan Psychiatric Hospital
• Contact: Hung-Chi Wu, M.S.
• Phone: +886-7-7513171
• Email: wuhcmail[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: September 30, 2022
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Illicit Drug Use
• Substance Use Disorders
• Substance-Related Disorders

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Taiwan	Kaohsiung Municipal Kai-Syuan Psychiatric Hospital	Kaohsiung

Sponsors (3)

Lead Sponsor	Collaborator
Kaohsiung Kai-Suan Psychiatric Hospital	Chang Gung Memorial Hospital, Kaohsiung Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Becker Depression Scale	The value is from 0 to 63, and higher scores mean a worse outcome.	9 months
Primary	Becker Anxiety Scale	The value is from 0 to 63, and higher scores mean a worse outcome.	9 months