Substance UseNCT03452241
Long-term Follow-up Study of Substance Abuse Screening and Intervention in Multi Primary Care Centers
A study testing Intervention Group in people with Substance Use, run by Shanghai Mental Health Center at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Substance Use
- What is being tested?
- Intervention Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- 14 Apr 2018to 10 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- unable to complete the questionnaire;
- serious physical illness, action inconvenience.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Substance Use
- Being tested
- Intervention Group, Control Group
- Keywords
- Screening, Brief Intervention, and Referral to Treatment, Substance Use
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention GroupOther
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 GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Other: Intervention Group |
| Control Group | Other | The participants only receive the materials about the harm of substance use Receives: Other: Control Group |
| Intervention Group 1 | Experimental | 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. Receives: Other: Intervention Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in risk behaviors at 1 and 3 month
Risk Behaviors will be measured by ASSIST questionnaire.
Measured: baseline, 1 and 3 month
Secondary outcomes (6)
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
Measured: 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.
Measured: 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
Measured: 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
Measured: baseline, 1 and 3 month
Self-esteem measured by Self-esteem questionnaire
the change of self-esteem will be measured by Self-esteem questionnaire.
Measured: 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.
Measured: baseline, 1 and 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2018
- Study start14 Apr 2018
- Primary completion10 Jul 2018
- Study completion10 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance UseStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DU, Jiang, Shanghai Mental Health Center
- Investigators
- Jiang Du, M.D, Principal investigator, Study Principal Investigator Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03452241
- Sponsor's protocol ID
- JDu-004
- Status last verified
- Mar 2020
- First submitted
- 19 Jan 2018
- Last updated
- 23 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34651102
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up Study of Substance Abuse Screening and Intervention in Multi Primary Care Centers
- ClinicalTrials.gov ID
- NCT03452241
- Acronym / sponsor ID
- JDu-004
- Conditions
- Substance Use
- Keywords
- Screening, Brief Intervention, and Referral to Treatment, Substance Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 14 Apr 2018 (actual)
- Primary completion
- 10 Jul 2018 (actual)
- Study completion
- 10 Mar 2020 (actual)
- First posted
- 2 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Intervention GroupThe 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. |
| Control Group | Other | Other: Control GroupThe participants only receive the materials about the harm of substance use |
| Intervention Group 1 | Experimental | Other: Intervention GroupThe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- unable to complete the questionnaire;
- serious physical illness, action inconvenience.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention GroupThe 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 | Intervention Group, Intervention Group 1 |
| Control GroupThe 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. | Other | Control Group |
Primary outcome
Change from baseline in risk behaviors at 1 and 3 month
Time frame: baseline, 1 and 3 month
Risk Behaviors will be measured by ASSIST questionnaire.
6 secondary outcomes
Knowledge related to Substance Use measured by Knowledge related to Addiction questionnaire
Time frame: baseline, 1 and 3 month
Motivation measured by Pre-treatment Readiness Scale
Time frame: baseline, 1 and 3 month
Depression measured by Self-Rating Depression Scale (SDS)
Time frame: baseline, 1 and 3 month
Anxiety measured by Self-Rating Anxiety Scale (SAS).
Time frame: baseline, 1 and 3 month
Self-esteem measured by Self-esteem questionnaire
Time frame: baseline, 1 and 3 month
Positive and Negative Affect measured by Positive and Negative Affect Scale (PANAS)
Time frame: baseline, 1 and 3 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2020.
- Derived from this study: PubMed 34651102Fu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiang Du, M.D principal investigator
Study Principal Investigator Shanghai Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group in people with Substance Use, run by Shanghai Mental Health Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in risk behaviors at 1 and 3 month (time frame: baseline, 1 and 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03452241, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2020.