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

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.

Study Overview

• Status: Completed
• Conditions: Substance Use
• Intervention / Treatment: Other: Intervention Group; Other: Control Group

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
• Enrollment (Actual): 480
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Henan, China
    • Henan Provincical Peoples Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• aged 18-75 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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.
Other: 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.
Experimental: Intervention Group 1; The medical staffs who received the training will use the manual of brief intervention twice 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in risk behaviors at 1 and 3 month	Risk Behaviors will be measured by ASSIST questionnaire.	baseline, 1 and 3 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knowledge related to Substance Use measured by Knowledge related to Addiction questionnaire	Knowledge related to substance use will be measured by Knowledge related to Addiction questionnaire	baseline, 1 and 3 month
Motivation measured by Pre-treatment Readiness Scale	PRSS is a 5-point scale and the highest score at any stage represents the patient at this stage.	baseline, 1 and 3 month
Depression measured by Self-Rating Depression Scale (SDS)	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	baseline, 1 and 3 month
Anxiety measured by Self-Rating Anxiety Scale (SAS).	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	baseline, 1 and 3 month
Self-esteem measured by Self-esteem questionnaire	the change of self-esteem will be measured by Self-esteem questionnaire.	baseline, 1 and 3 month
Positive and Negative Affect measured by Positive and Negative Affect Scale (PANAS)	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.	baseline, 1 and 3 month

Collaborators and Investigators

• Sponsor: Shanghai Mental Health Center
• Investigators: Principal Investigator: Jiang Du, M.D, Study Principal Investigator Shanghai Mental Health Center

Publications and helpful links

General Publications

• Fu R, Yuan C, Sun W, Wang W, Zhang L, Zhai J, Guan Q, Wu X, Long J, Zhao M, Du J. Effectiveness of E-SBIRT intervention in community healthcare institution in China: study proposal for a randomised controlled trial. Gen Psychiatr. 2021 Sep 24;34(5):e100486. doi: 10.1136/gpsych-2021-100486. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2018
• Primary Completion (Actual): July 10, 2018
• Study Completion (Actual): March 10, 2020

Study Registration Dates

• First Submitted: January 19, 2018
• First Submitted That Met QC Criteria: February 28, 2018
• First Posted (Actual): March 2, 2018

Study Record Updates

• Last Update Posted (Actual): March 23, 2020
• Last Update Submitted That Met QC Criteria: March 19, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Substance Use; Screening, Brief Intervention, and Referral to Treatment
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: JDu-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No