A randomized controlled clinical trial to study of the effectiveness of Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)-linked brief intervention according to Specific Substance Involvement Score in substance users referred to the Primary Health Care Setting
This study conducted as a controlled randomized clinical trial to evaluate the effectiveness of Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)-linked brief intervention on substance use disorders. In seven Primary Health Care Centers in Garmsar (Semnan Province) and Shahriar (Tehran Province), screening of the substance use disorders will be done using Alcohol, Smoking and Substance Involvement Screening Test (ASSIST). Seventy patients whose Specific Substance Involvement Score are 4-26 (9-26 for alcohol involvement, nicotine excluded) will enter. They are between the ages of 18 and 64 years. Sex ratio will be 2:1 (male to female). Intoxication or withdrawal syndromes are the main exclusion criteria. Individuals currently in drug treatment or they are injecting substance more than 4 times a month will be excluded, too. These individuals randomly assigned to a case group and a control one. For case group ASSIST-linked brief intervention will be done in one session. Control group are in waiting list. After three months, all participants will be interviewed and Specific Substance Involvement Score will be recorded again. Specific Substance Involvement Scores before and after intervention, within groups and between groups, will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201209051958N2
Registration date:2012-10-14, 1391/07/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-10-14, 1391/07/23
Registrant information
Name
Seyed Vahid Shariat
Name of organization / entity
Tehran Univeristy of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6650 6862
Email address
shariatv@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Office for Psychosocial Health and Addiction, Ministry of Health and Medical Education
Expected recruitment start date
2012-10-06, 1391/07/15
Expected recruitment end date
2013-01-04, 1391/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A randomized controlled clinical trial to study of the effectiveness of Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)-linked brief intervention according to Specific Substance Involvement Score in substance users referred to the Primary Health Care Setting
Public title
Brief Intervention in Substance Use Disorder
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: Between the ages of 18 and 50 years; Being Iranian; Able to communicate in Persian fluently; Willing to participate in a 3 month follow-up where they return to the treatment agency for interview; Able to be followed up three months later and give contact details of at least 2-3 other people, and of fixed address and able to provide contact details of their home; Physically well enough to participate in a 30 minute interview and intervention session; Specific Substance Involvement Score of 4-26 (for alcohol: 9-26); No more than 4 injections a month, by average, within three last months;
Exclusion criteria: Pending incarceration within the next three months; Severely cognitively impaired or have severe behavior; Tended to violent or aggressive behavior; Intoxicated or going through withdrawal from alcohol or other drugs at baseline; Currently in drug (excluding nicotine) treatment (within the last month.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mental Health Research Center
Street address
Mental Health Research Center, Tehran Psychiatric Institute, Shahid Mansouri Lane, Niayesh Street, Satarkhan Avenue,Tehran, Iran
City
Tehran
Postal code
1443813444
Approval date
2009-08-31, 1388/06/09
Ethics committee reference number
88/06/09/03
Health conditions studied
1
Description of health condition studied
Substance use disorder (abuse and dependence)
ICD-10 code
F10
ICD-10 code description
Mental and behavioural disorders due to psychoactive substance usel (harmful use and dependence syndrome)
Primary outcomes
1
Description
Specific Substance Involvement Score in ASSIST
Timepoint
month 0 & 3
Method of measurement
questionnaire
Secondary outcomes
1
Description
Client Satisfaction Questionnaire-8 (CSQ-8)
Timepoint
month 3
Method of measurement
paper & pencil questionnaire
2
Description
Total Illicit Substance Involvement in ASSIST
Timepoint
month 0 & 3
Method of measurement
paper & pencil questionnaire
Intervention groups
1
Description
One-session ASSIST-linked brief intervention (guided by World Health Organization), managed by a primary health care physician, length between 5 and 15 session
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Garmsar Health Network
Full name of responsible person
Iman Sadeghi
Street address
Garmsar Health Network. North Shaheed Rajaei Ave. Garmsar
City
Garmsar
2
Recruitment center
Name of recruitment center
Shariar Health Network
Full name of responsible person
Bahareh Fasihipour
Street address
Shariar
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Office of Psychosocial Health and Addiction, Ministry of Health
Full name of responsible person
Abbasali Nasehi
Street address
Ministry of Health and Medical Education, Hafez Street, Tehran
City
Tehran
Grant name
101034
Grant code / Reference number
30452
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Office of Psychosocial Health and Addiction, Ministry of Health
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran Psychiatric Institute
Full name of responsible person
Kaveh Alavi
Position
Psychiatrist
Other areas of specialty/work
Street address
Mental Health Research Center, Tehran Psychiatric Institute, Shahid Mansouri Lane, Niayesh Street, Satarkhan Avenue,Tehran, Iran
City
Tehran
Postal code
1445613111
Phone
+98 21 6650 6862
Fax
+98 21 6650 6862
Email
kavehalavi@yahoo.com
Web page address
www.tehranpi.org
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mental Health Research Center
Full name of responsible person
Seyyed Vahid Shariat
Position
Psychiatrist
Other areas of specialty/work
Street address
Mental Health Research Center, Tehran Psychiatric Institute, Shahid Mansouri Lane, Niayesh Street, Satarkhan Avenue,Tehran, Iran
City
Tehran
Postal code
1445613111
Phone
+98 21 6650 6862
Fax
+98 21 6650 6862
Email
vshariat@tums.ac.ir
Web page address
www.tehranpi.org
Person responsible for updating data
Contact
Name of organization / entity
Mental Health Research Center
Full name of responsible person
Kaveh Alavi
Position
Psychiatrist
Other areas of specialty/work
Street address
Mental Health Research Center, Tehran Psychiatric Institute, Shahid Mansouri Lane, Niayesh Street, Satarkhan Avenue,Tehran, Iran
City
Tehran
Postal code
1445613111
Phone
+98 21 6650 6862
Fax
+98 21 6650 6862
Email
kavehalavi@yahoo.com
Web page address
www.tehranpi.org
Sharing plan
Deidentified Individual Participant Data Set (IPD)