NCT04426565

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2020

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

May 19, 2020

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

June 11, 2020

Status Verified

June 1, 2020

Enrollment Period

1.7 years

First QC Date

May 19, 2020

Last Update Submit

June 8, 2020

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (4)

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.

Behavioral: the individual psychotherapyBehavioral: the group psychotherapyBehavioral: 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.

Behavioral: motivational enhancement interviewBehavioral: the group psychotherapyBehavioral: 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.

Behavioral: motivational enhancement interviewBehavioral: the individual psychotherapyBehavioral: 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.

Behavioral: motivational enhancement interviewBehavioral: the individual psychotherapyBehavioral: the group psychotherapy

Interventions

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 family therapythe group psychotherapythe 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 family therapythe group psychotherapythe motivational enhancement interview

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 therapythe individual psychotherapythe motivational enhancement interview

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.

the group psychotherapythe individual psychotherapythe motivational enhancement interview

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with illicit substance use disorder diagnosed by DSM-5

You may not qualify if:

  • The age of the patient is below 20 years old or above 65 years old, the patients cannot cooperate with the tools of investigation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Municipal Kai-Syuan Psychiatric Hospital

Kaohsiung City, 886, Taiwan

RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Frank Huang-Chih Chou, Ph.D.

    Kaohsiung Municipal Psychiatric Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hung-Chi Wu, M.S.

CONTACT

Wei-Tsung Kao, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The motivational enhancement interview, the individual psychotherapy, the group psychotherapy, the family therapy will be provided by our team members.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2020

First Posted

June 11, 2020

Study Start

May 1, 2020

Primary Completion

December 30, 2021

Study Completion

September 30, 2022

Last Updated

June 11, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations