Substance Use DisordersNCT04426565
The Follow-up Study for the Patients of Illicit Substance Use Disorder
A study testing motivational enhancement interview, the individual psychotherapy and the group psychotherapy in people with Substance Use Disorders and Illicit Drug Use, run by Kaohsiung Kai-Suan Psychiatric Hospital at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Substance Use Disorders, Illicit Drug Use
- What is being tested?
- motivational enhancement interview, the individual psychotherapy and the group psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 May 2020to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with illicit substance use disorder diagnosed by DSM-5
Who cannot join
- The age of the patient is below 20 years old or above 65 years old, the patients cannot cooperate with the tools of investigation
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Municipal Kai-Syuan Psychiatric Hospital
Kaohsiung City, 886
Hung-Chi Wu, M.D., M.S., +886-7-751-3171 ext. 2390, wuhcmail@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Substance Use Disorders, Illicit Drug Use
- Being tested
- motivational enhancement interview, the individual psychotherapy, the group psychotherapy, the family therapy
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
motivational enhancement interviewBehavioural
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 psychotherapyBehavioural
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 psychotherapyBehavioural
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 therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| the motivational enhancement interview | Other | 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. Receives: Behavioral: the individual psychotherapy; Behavioral: the group psychotherapy; Behavioral: the family therapy |
| the individual psychotherapy | Other | 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. Receives: Behavioral: motivational enhancement interview; Behavioral: the group psychotherapy; Behavioral: the family therapy |
| the group psychotherapy | Other | 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. Receives: Behavioral: motivational enhancement interview; Behavioral: the individual psychotherapy; Behavioral: the family therapy |
| the family therapy | Other | 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. Receives: Behavioral: motivational enhancement interview; Behavioral: the individual psychotherapy; Behavioral: the group psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 9 months
Becker Depression Scale
The value is from 0 to 63, and higher scores mean a worse outcome.
Measured: 9 months
Becker Anxiety Scale
The value is from 0 to 63, and higher scores mean a worse outcome.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start1 May 2020
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Kai-Suan Psychiatric Hospital
- Sponsor type
- Other government
- Collaborators
- Kaohsiung Medical University, Chang Gung Memorial Hospital
- Responsible party
- Sponsor
- Investigators
- Frank Huang-Chih Chou, Ph.D., Principal investigator, Kaohsiung Municipal Psychiatric Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04426565
- Sponsor's protocol ID
- KSPH-2019-23
- Status last verified
- Jun 2020
- First submitted
- 19 May 2020
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The 9-month Follow-up Study for the Patients of Illicit Substance Use Disorder After Receiving the Different Psychosocial Intervention
- ClinicalTrials.gov ID
- NCT04426565
- Acronym / sponsor ID
- KSPH-2019-23
- Conditions
- Substance Use Disorders, Illicit Drug Use
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Kaohsiung Kai-Suan Psychiatric HospitalOther government
- Collaborators
- Kaohsiung Medical University, Chang Gung Memorial Hospital
- Study start
- 1 May 2020 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 11 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The motivational enhancement interview, the individual psychotherapy, the group psychotherapy, the family therapy will be provided by our team members.
| Arm | Type | Receives |
|---|---|---|
| the motivational enhancement interview | Other | Behavioral: the individual psychotherapy, Behavioral: the group psychotherapy, Behavioral: the family therapyThe 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 | Other | Behavioral: motivational enhancement interview, Behavioral: the group psychotherapy, Behavioral: the family therapyThe 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 | Other | Behavioral: motivational enhancement interview, Behavioral: the individual psychotherapy, Behavioral: the family therapyThe 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 | Other | Behavioral: motivational enhancement interview, Behavioral: the individual psychotherapy, Behavioral: the group psychotherapyThe 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. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with illicit substance use disorder diagnosed by DSM-5
Key exclusion criteria (1 listed)
- The age of the patient is below 20 years old or above 65 years old, the patients cannot cooperate with the tools of investigation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| motivational enhancement interviewMotivational 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. | Behavioural | the family therapy, the group psychotherapy, the individual psychotherapy |
| the individual psychotherapyIt 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. | Behavioural | the family therapy, the group psychotherapy, the motivational enhancement interview |
| the group psychotherapyGroup 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. | Behavioural | the family therapy, the individual psychotherapy, the motivational enhancement interview |
| the family therapyAccording 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. | Behavioural | the group psychotherapy, the individual psychotherapy, the motivational enhancement interview |
Primary outcome
The severity of substance use used by the Severity of Dependence Scale
Time frame: 9 months
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)
Time frame: 9 months
The instrument has four dimension and higher scores mean a better outcome.
Becker Depression Scale
Time frame: 9 months
The value is from 0 to 63, and higher scores mean a worse outcome.
Becker Anxiety Scale
Time frame: 9 months
The value is from 0 to 63, and higher scores mean a worse outcome.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Huang-Chih Chou, Ph.D. principal investigator
Kaohsiung Municipal Psychiatric Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing motivational enhancement interview, the individual psychotherapy and the group psychotherapy in people with Substance Use Disorders and Illicit Drug Use, run by Kaohsiung Kai-Suan Psychiatric Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hung-Chi Wu, M.S. (+886-7-7513171 ext. 2390, wuhcmail@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The severity of substance use used by the Severity of Dependence Scale (time frame: 9 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2020.