<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04426565</url>
  </required_header>
  <id_info>
    <org_study_id>KSPH-2019-23</org_study_id>
    <nct_id>NCT04426565</nct_id>
  </id_info>
  <brief_title>The Follow-up Study for the Patients of Illicit Substance Use Disorder</brief_title>
  <official_title>The 9-month Follow-up Study for the Patients of Illicit Substance Use Disorder After Receiving the Different Psychosocial Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kaohsiung Kai-Suan Psychiatric Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kaohsiung Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Kaohsiung Kai-Suan Psychiatric Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The patients will be diagnosed according to DSM-5, the severity of individual substance use&#xD;
      disorder will be assessed, and the plan of treatment will be provided. The treatment will be&#xD;
      determined by the diagnosis and severity of addiction, the mood or psychiatric comorbidities,&#xD;
      the hyperactivity or attention deficit, alcohol addiction, and etc. The motivational&#xD;
      enhancement interview, the individual psychotherapy, the group psychotherapy, the family&#xD;
      therapy will be provided by our team members. In order to evaluate the efficacy of the&#xD;
      different therapy, we will evaluate the psychological and social status of the patients and&#xD;
      follow up every 3 months. The efficacy of different treatment will be evaluated according to&#xD;
      our study instruments.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The patients will be diagnosed according to DSM-5, the severity of individual addiction will&#xD;
      be assessed, and the plan of treatment will be provided. The treatment will be determined by&#xD;
      the diagnosis and severity of addiction, the mood or psychiatric comorbidities, the&#xD;
      hyperactivity or attention deficit, alcohol addiction, and etc. The motivational enhancement&#xD;
      interview, the individual psychotherapy, the group psychotherapy, the family therapy will be&#xD;
      provided by our team members. In order to evaluate the efficacy of the different therapy, we&#xD;
      will evaluate the psychological and social status of the patients and follow up every 3&#xD;
      months.&#xD;
&#xD;
      The patients will be received the basic physiological assessment, the chest X-ray,&#xD;
      electrocardiogram, liver and renal function, hematology test, urine screening for addictive&#xD;
      substances, screening for blood infectious diseases (including hepatitis B, C and HIV&#xD;
      infection) will be included.&#xD;
&#xD;
      Besides, the Drug Abuse Screen Test (DAST), the Severity of Dependence Scale (SDS), the&#xD;
      Reliability of Readiness to Change Questionnaire, the Opiate Treatment Index (OTI), drug&#xD;
      Avoidance Self-Efficacy Scale (DASES), the Family APGAR score, The brief version of the World&#xD;
      Health Organization Quality of Life instrument (WHOQOL-BREF Taiwan version), Chinese health&#xD;
      questionnaire (CHQ), parental bonding instrument (PBI), Toronto Alexithymia Scale (TAS),&#xD;
      Brief Symptom Rating Scale (BSRS-5), Chinese version of Adult ADHD Self-Report Scale&#xD;
      (ASRS-V1. 1), Becker Depression Scale (BDI) and Becker Anxiety Scale (BAI) will be evaluated&#xD;
      every 3 months after receiving our treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 1, 2020</start_date>
  <completion_date type="Anticipated">September 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>The motivational enhancement interview, the individual psychotherapy, the group psychotherapy, the family therapy will be provided by our team members.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The severity of substance use used by the Severity of Dependence Scale</measure>
    <time_frame>9 months</time_frame>
    <description>The value is from 0 to 15, and higher scores mean a worse outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The World Health Organization Quality of Life instrument (WHOQOL-BREF Taiwan version)</measure>
    <time_frame>9 months</time_frame>
    <description>The instrument has four dimension and higher scores mean a better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Becker Depression Scale</measure>
    <time_frame>9 months</time_frame>
    <description>The value is from 0 to 63, and higher scores mean a worse outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Becker Anxiety Scale</measure>
    <time_frame>9 months</time_frame>
    <description>The value is from 0 to 63, and higher scores mean a worse outcome.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Substance Use Disorders</condition>
  <condition>Illicit Drug Use</condition>
  <arm_group>
    <arm_group_label>the motivational enhancement interview</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>the individual psychotherapy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>the group psychotherapy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>the family therapy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>motivational enhancement interview</intervention_name>
    <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.</description>
    <arm_group_label>the family therapy</arm_group_label>
    <arm_group_label>the group psychotherapy</arm_group_label>
    <arm_group_label>the individual psychotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>the individual psychotherapy</intervention_name>
    <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.</description>
    <arm_group_label>the family therapy</arm_group_label>
    <arm_group_label>the group psychotherapy</arm_group_label>
    <arm_group_label>the motivational enhancement interview</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>the group psychotherapy</intervention_name>
    <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.</description>
    <arm_group_label>the family therapy</arm_group_label>
    <arm_group_label>the individual psychotherapy</arm_group_label>
    <arm_group_label>the motivational enhancement interview</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>the family therapy</intervention_name>
    <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 &quot;proven&quot; or &quot;presumed&quot; to exist. Of the treatments studied, family therapy was presumed or proven effective at treating schizophrenia, bipolar disorder, anorexia and substance dependence.</description>
    <arm_group_label>the group psychotherapy</arm_group_label>
    <arm_group_label>the individual psychotherapy</arm_group_label>
    <arm_group_label>the motivational enhancement interview</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients with illicit substance use disorder diagnosed by DSM-5&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        The age of the patient is below 20 years old or above 65 years old, the patients cannot&#xD;
        cooperate with the tools of investigation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Frank Huang-Chih Chou, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kaohsiung Municipal Psychiatric Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hung-Chi Wu, M.S.</last_name>
    <phone>+886-7-7513171</phone>
    <phone_ext>2390</phone_ext>
    <email>wuhcmail@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Wei-Tsung Kao, Ph.D.</last_name>
    <phone>+886-7-7513171</phone>
    <phone_ext>2373</phone_ext>
    <email>030854@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Kaohsiung Municipal Kai-Syuan Psychiatric Hospital</name>
      <address>
        <city>Kaohsiung</city>
        <zip>886</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hung-Chi Wu, M.D., M.S.</last_name>
      <phone>+886-7-751-3171</phone>
      <phone_ext>2390</phone_ext>
      <email>wuhcmail@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 8, 2020</last_update_submitted>
  <last_update_submitted_qc>June 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance-Related Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04426565
org study id: KSPH-2019-23
nct id: NCT04426565
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: The motivational enhancement interview, the individual psychotherapy, the group psychotherapy, the family therapy will be provided by our team members.
primary purpose: Treatment
masking: None (Open Label)
measure: The severity of substance use used by the Severity of Dependence Scale
time frame: 9 months
description: The value is from 0 to 15, and higher scores mean a worse outcome.
measure: The World Health Organization Quality of Life instrument (WHOQOL-BREF Taiwan version)
time frame: 9 months
description: The instrument has four dimension and higher scores mean a better outcome.
measure: Becker Depression Scale
time frame: 9 months
description: The value is from 0 to 63, and higher scores mean a worse outcome.
measure: Becker Anxiety Scale
time frame: 9 months
description: The value is from 0 to 63, and higher scores mean a worse outcome.
arm group label: the motivational enhancement interview
arm group type: Other
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 group label: the individual psychotherapy
arm group type: Other
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 group label: the group psychotherapy
arm group type: Other
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 group label: the family therapy
arm group type: Other
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: motivational enhancement interview
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.
arm group label: the family therapy
arm group label: the group psychotherapy
arm group label: the individual psychotherapy
intervention type: Behavioral
intervention name: the individual psychotherapy
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.
arm group label: the family therapy
arm group label: the group psychotherapy
arm group label: the motivational enhancement interview
intervention type: Behavioral
intervention name: the group psychotherapy
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.
arm group label: the family therapy
arm group label: the individual psychotherapy
arm group label: the motivational enhancement interview
intervention type: Behavioral
intervention name: the family therapy
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.
arm group label: the group psychotherapy
arm group label: the individual psychotherapy
arm group label: the motivational enhancement interview
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
last name: Frank Huang-Chih Chou, Ph.D.
role: Principal Investigator
affiliation: Kaohsiung Municipal Psychiatric Hospital
last name: Hung-Chi Wu, M.S.
phone: +886-7-7513171
phone ext: 2390
email: wuhcmail@gmail.com
last name: Wei-Tsung Kao, Ph.D.
phone: +886-7-7513171
phone ext: 2373
email: 030854@gmail.com
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Sponsor
mesh term: Substance-Related Disorders
sharing ipd: No