ClinicalTrials.gg
Status unknownNCT04426565Updated Jun 11, 2020

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

An interventional study of motivational enhancement interview and the individual psychotherapy in Substance Use Disorders and Illicit Drug Use, sponsored by Kaohsiung Kai-Suan Psychiatric Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-06-11.

Sponsored by Kaohsiung Kai-Suan Psychiatric Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
500
Allocation
Non-randomized
Ages
20 Years to 65 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Substance Use Disorders
  • Illicit Drug Use
03

In context

Substance-Related Disorders

2,238 studies on the registry are indexed under Substance-Related Disorders; 409 are open to participants now.

This study's planned enrollment of 500 is above the median of 108 across 1,840 interventional studies indexed under Substance-Related Disorders.

Browse Substance-Related Disorders studies →

Lead sponsor

Kaohsiung Kai-Suan Psychiatric Hospital is the lead sponsor of 10 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Patients with illicit substance use disorder diagnosed by

Exclusion criteria

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

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
500 participants (estimated)

Study arms

  • 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 · Behavioral: the group psychotherapy · Behavioral: the family therapy

  • 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: motivational enhancement interview · Behavioral: the group psychotherapy · Behavioral: the family therapy

  • 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: motivational enhancement interview · Behavioral: the individual psychotherapy · Behavioral: the family therapy

  • 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: motivational enhancement interview · Behavioral: the individual psychotherapy · Behavioral: the group psychotherapy

Interventions

  • Behavioralmotivational 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.

  • Behavioralthe 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.

  • Behavioralthe 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.

  • Behavioralthe 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 9 months

  2. The World Health Organization Quality of Life instrument (WHOQOL-BREF Taiwan version)

    The instrument has four dimension and higher scores mean a better outcome.

    Time frame: 9 months

  3. Becker Depression Scale

    The value is from 0 to 63, and higher scores mean a worse outcome.

    Time frame: 9 months

  4. Becker Anxiety Scale

    The value is from 0 to 63, and higher scores mean a worse outcome.

    Time frame: 9 months

07

Study locations

1 of 1 sites recruiting
  • Kaohsiung Municipal Kai-Syuan Psychiatric Hospital
    Kaohsiung, 886, Taiwan
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2020 (actual). Primary completion is estimated for Dec 2021, 19 months after the start.

Of 814 non-industry interventional studies with no phase under Substance-Related Disorders, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 53. This study's planned 19 months is below that.

Counting every sponsor, half of 854 studies reached it within 34 months; a quarter within 17 and three quarters within 53.

How these figures are worked out, and which studies are left out of them.

Registered
May 19, 2020
First posted
Jun 11, 2020
StartActual
May 1, 2020
Primary completionEst.
Dec 30, 2021
CompletionEst.
Sep 30, 2022
Last update
Jun 11, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 11, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04426565
Lead sponsor
Kaohsiung Kai-Suan Psychiatric Hospital
Collaborators
Kaohsiung Medical University, Chang Gung Memorial Hospital
Responsible party
Sponsor
First posted
Jun 11, 2020
Start date
May 1, 2020
Primary completion
Dec 30, 2021 (estimated)
Completion
Sep 30, 2022 (estimated)
Last update
Jun 11, 2020

Study contacts

Hung-Chi Wu, M.S.
Contact
wuhcmail@gmail.com
+886-7-7513171 ext. 2390
Wei-Tsung Kao, Ph.D.
Contact
030854@gmail.com
+886-7-7513171 ext. 2373
Frank Huang-Chih Chou, Ph.D.
principal investigator · Kaohsiung Municipal Psychiatric Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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