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Long-term Follow-up Study of Substance Abuse Screening and Intervention in Multi Primary Care Centers

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ClinicalTrials.gov Identifier: NCT03452241
Recruitment Status : Not yet recruiting
First Posted : March 2, 2018
Last Update Posted : March 2, 2018
Sponsor:
Information provided by (Responsible Party):
DU, Jiang, Shanghai Mental Health Center

Brief Summary:
The purpose of this research is to improve the ability of primary medical staffs in screening and intervention for alcohol, benzodiazepines, and other illicit drug use.

Condition or disease Intervention/treatment Phase
Substance Use Other: Intervention Group Other: Control Group Not Applicable

Detailed Description:
In order to reduce the social and personal harm caused by drugs, it is urgent to strengthen the ability of the primary health institutions in screening and intervention the addictive substances use. Firstly, the investigators will invite 10 primary medical staffs and 10 experts in addition to revise the manual of Alcohol, Smoking, and Substance Use Involvement Screening Test (ASSIST) and Brief Intervention (BI). Then, the investigators will recruit related medical staffs in five provinces to participate the training of ASSIST and BI. Secondly, the researcher will investigate the effects of BI technology in reducing the use of addictive substances, improve the addiction related knowledge of patients through randomized controlled study. Finally, the investigators will collect the research information, revise the manual, and promote the training.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Long-term Follow-up Study of Substance Abuse Screening and Intervention in Multi Primary Care Centers
Estimated Study Start Date : March 2018
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : March 2020

Arm Intervention/treatment
Experimental: Intervention Group
The medical staffs who received the training will use the manual of brief intervention to deliver it and other materials about the harm of substance use.
Other: Intervention Group
The medical staffs who received the training will use the manual of brief intervention to deliver BI and other materials about the harm of substance use.BI refers to a standard 15-30 minute intervention that includes a series of standard models that stimulate knowledge, motivation and behavior that reduce substance abuse.the harm of substance use is a dedicated paper publicity handbook, written by the SHMC, detailing the hazards of substance abuse.

Control Group
The participants only receive the materials about the harm of substance use
Other: Control Group
The participants only receive the materials about the harm of substance use.the harm of substance use is a dedicated paper publicity handbook, written by the SHMC, detailing the hazards of substance abuse.




Primary Outcome Measures :
  1. Change from baseline in risk behaviors at 3,6,9 and 12 month [ Time Frame: baseline, 3,6,9 and 12 month ]
    Risk Behaviors will be measured by ASSIST questionnaire.


Secondary Outcome Measures :
  1. Knowledge related to Substance Use measured by Knowledge related to Addiction questionnaire [ Time Frame: 3,6,9 and 12 month ]
    Knowledge related to substance use will be measured by Knowledge related to Addiction questionnaire

  2. Motivation measured by Pre-treatment Readiness Scale [ Time Frame: baseline, 3,6,9 and 12 month ]
    PRSS is a 5-point scale and the highest score at any stage represents the patient at this stage.

  3. Depression measured by Self-Rating Depression Scale (SDS) [ Time Frame: 3,6,9 and 12 month ]
    SDS contains 20 items and the standard total score is 53, 53-62: mild to mild depression; 63-72: moderate to severe;> 72: severe depression

  4. Anxiety measured by Self-Rating Anxiety Scale (SAS). [ Time Frame: 3,6,9 and 12 month ]
    SDS contains 20 items. According to the Chinese norm results, the standard points of the cut-off value is 50 points, of which 50-59 is divided into mild anxiety, 60-69 is divided into moderate anxiety, 70 points for severe anxiety

  5. Self-esteem measured by Self-esteem questionnaire [ Time Frame: 3,6,9 and 12 month ]
    the change of self-esteem will be measured by Self-esteem questionnaire.

  6. Positive and Negative Affect measured by Positive and Negative Affect Scale (PANAS) [ Time Frame: 3,6,9 and 12 month ]
    It contains 20 entries. A high positive emotional score indicates an individual's energy, concentration, and emotional well-being while a low score indicates indifference. Negative emotional high points that the individual subjective feeling puzzled, painful emotional state, while the score is low that calm.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • aged 18-60 years;
  • the patient to the community medical institutions;
  • ASSIST score is in 12-27, in a moderate risk;
  • voluntary to participate;
  • to agree to complete baseline interviews and follow-up studies

Exclusion Criteria:

  • unable to complete the questionnaire;
  • serious physical illness, action inconvenience.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03452241


Contacts
Contact: Jiang Du, M.D 18017311220 dujiangdou@163.com

Sponsors and Collaborators
Shanghai Mental Health Center
Investigators
Principal Investigator: Jiang Du, M.D Study Principal Investigator Shanghai Mental Health Center

Responsible Party: DU, Jiang, Principal Investigator, Shanghai Mental Health Center
ClinicalTrials.gov Identifier: NCT03452241     History of Changes
Other Study ID Numbers: JDu-004
First Posted: March 2, 2018    Key Record Dates
Last Update Posted: March 2, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by DU, Jiang, Shanghai Mental Health Center:
Screening, Brief Intervention, and Referral to Treatment
Substance Use

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders