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

Primary Purpose

Substance Use

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Intervention Group
Control Group
Sponsored by
Shanghai Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Substance Use focused on measuring Screening, Brief Intervention, and Referral to Treatment, Substance Use

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Henan Provincical Peoples Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Other

Experimental

Arm Label

Intervention Group

Control Group

Intervention Group 1

Arm Description

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.

The participants only receive the materials about the harm of substance use

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.

Outcomes

Primary Outcome Measures

Change from baseline in risk behaviors at 1 and 3 month
Risk Behaviors will be measured by ASSIST questionnaire.

Secondary Outcome Measures

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
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.
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
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
Self-esteem measured by Self-esteem questionnaire
the change of self-esteem will be measured by Self-esteem questionnaire.
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.

Full Information

First Posted
January 19, 2018
Last Updated
March 19, 2020
Sponsor
Shanghai Mental Health Center
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1. Study Identification

Unique Protocol Identification Number
NCT03452241
Brief Title
Long-term Follow-up Study of Substance Abuse Screening and Intervention in Multi Primary Care Centers
Official Title
Long-term Follow-up Study of Substance Abuse Screening and Intervention in Multi Primary Care Centers
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
April 14, 2018 (Actual)
Primary Completion Date
July 10, 2018 (Actual)
Study Completion Date
March 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Mental Health Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use
Keywords
Screening, Brief Intervention, and Referral to Treatment, Substance Use

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
480 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Other
Arm Description
The participants only receive the materials about the harm of substance use
Arm Title
Intervention Group 1
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Intervention Group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control Group
Intervention Description
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 Measure Information:
Title
Change from baseline in risk behaviors at 1 and 3 month
Description
Risk Behaviors will be measured by ASSIST questionnaire.
Time Frame
baseline, 1 and 3 month
Secondary Outcome Measure Information:
Title
Knowledge related to Substance Use measured by Knowledge related to Addiction questionnaire
Description
Knowledge related to substance use will be measured by Knowledge related to Addiction questionnaire
Time Frame
baseline, 1 and 3 month
Title
Motivation measured by Pre-treatment Readiness Scale
Description
PRSS is a 5-point scale and the highest score at any stage represents the patient at this stage.
Time Frame
baseline, 1 and 3 month
Title
Depression measured by Self-Rating Depression Scale (SDS)
Description
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
Time Frame
baseline, 1 and 3 month
Title
Anxiety measured by Self-Rating Anxiety Scale (SAS).
Description
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
Time Frame
baseline, 1 and 3 month
Title
Self-esteem measured by Self-esteem questionnaire
Description
the change of self-esteem will be measured by Self-esteem questionnaire.
Time Frame
baseline, 1 and 3 month
Title
Positive and Negative Affect measured by Positive and Negative Affect Scale (PANAS)
Description
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.
Time Frame
baseline, 1 and 3 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiang Du, M.D
Organizational Affiliation
Study Principal Investigator Shanghai Mental Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henan Provincical Peoples Hospital
City
Henan
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34651102
Citation
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.
Results Reference
derived

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

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