Effectiveness of short cognitive - behavioral therapy on opium addicts' mental health
Design
Randomized Controlled Trial with parallel groups
Settings and conduct
This study is a randomized clinical trial conducted in Ahvaz drop in center. The study population is addicts referring to this center, which according to previous studies and using Morgan table, sample size of 36 person has been calculated. They will divided into 2 equal groups of 18 person as intervention and control groups using random number table. Both groups will be on Methadone maintenance therapy. GHQ 28 questionnaire will be completed by both groups.The intervention group will receive 4 session of 90 minutes cognitive-behavioral therapy in accordance to the Ministry of Health's Cognitive-Behavioral Therapy Protocol and drop-in centers Action Plan.Finally, using the GHQ 28 questionnaire, mental health status in the areas of depression, anxiety, somatization and social performance will be compared in each group.
Participants/Inclusion and exclusion criteria
Addiction to opium
Intervention groups
This Study consist of 2 groups including intervention and control groups. Both groups are on Methadone maintenance therapy. While the intervention group will receive four 90 minutes cognitive behavioral therapy sessions, but the control group will not.
Main outcome variables
Mental health status; Depression; Anxiety; Somatization; Social performance based on GHQ 28 questionnaire score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190929044917N1
Registration date:2020-01-13, 1398/10/23
Registration timing:prospective
Last update:2020-01-13, 1398/10/23
Update count:0
Registration date
2020-01-13, 1398/10/23
Registrant information
Name
Seyed Mohammad Amin Alavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3338 9541
Email address
alavi.sma@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2020-02-04, 1398/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of short cognitive - behavioral therapy on addicts' mental health in comparison to control group
Public title
Effectiveness of short cognitive - behavioral therapy on addicts' mental health
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Addiction to opium
Exclusion criteria:
No exclusion criteria
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization, individual, using table of random numbers, assign by third party for allocation concealment
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Golestan Educational, Research and Medical Center
Street address
Research Ethics Committee, Golestan Hospital, Golestan Blvd., Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Approval date
2019-12-30, 1398/10/09
Ethics committee reference number
IR.AJUMS.HGOLESTAN.REC.1398.025
Health conditions studied
1
Description of health condition studied
Mental health in opioid addiction
ICD-10 code
F11.1
ICD-10 code description
Opioid abuse
Primary outcomes
1
Description
General Health Score
Timepoint
Before intervention and 2 weeks after intervention(after 4 session of cognitive behavioral therapy)
Method of measurement
GHQ-28 Questionnaire
2
Description
Depression Score
Timepoint
Before intervention and 2 weeks after intervention(after 4 session of cognitive behavioral therapy)
Method of measurement
GHQ-28 Questionnaire
3
Description
Anxiety Score
Timepoint
Before intervention and 2 weeks after intervention(after 4 session of cognitive behavioral therapy)
Method of measurement
GHQ-28 Questionnaire
4
Description
Somatization Score
Timepoint
Before intervention and 2 weeks after intervention(after 4 session of cognitive behavioral therapy)
Method of measurement
GHQ-28 Questionnaire
5
Description
Social Performance Score
Timepoint
Before intervention and 2 weeks after intervention(after 4 session of cognitive behavioral therapy)
Method of measurement
GHQ-28 Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: short cognitive behavioral therapy accordance to the Ministry of Health's Cognitive-Behavioral Therapy Protocol and drop-in centers Action Plan for 90 minutes in 4 sessions during 2 weeks
Category
Behavior
2
Description
Control group: without any intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Drop-in Center
Full name of responsible person
Ashraf Falahi
Street address
No. 96, 7th St. , Asiye Abad
City
Ahvaz
Province
Khouzestan
Postal code
6174664933
Phone
+98 61 3333 9194
Email
yavarannoor.ngo@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badavi
Street address
Ground Floor, Chancellor of Research and Technology Development, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd., Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3336 2414
Fax
+98 61 3336 1544
Email
itc@ajums.ac.ir
Web page address
http://vchresearch.ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Reza Davasaz Irani
Position
Head of Mental health, Social and Addiction Unit
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Chancellor of Health, Ahvaz Jundishapur University of Medical Sciences, Dr. Fatemi St. , Amaniyeh