Protocol summary

Study aim
Determining the effect of cognitive behavioral therapy of anger management on its dimensions and rumination in substance addicts under treatment
Design
This study is a randomized controlled trial with control group, with parallel groups. Samples are randomly and continuously selected from eligible individuals in two centers in Abadan and will be allocated to intervention and control groups by random blocking method with blocks of size 4 and a random numbers table through Random Allocation Software
Settings and conduct
This non-blind study is performed on 80 people who refer to the Rahaei and Arvand addiction treatment centers in Abadan city.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age over 18 years; ability to comply with study requirements including participation in group meetings and homework. Non-inclusion criteria: participation in anger management courses and cognitive-behavioral therapy and similar courses at the same time as the study, substance use Drugs and alcoholic beverages are at least two weeks before the start of treatment and during treatment sessions and have psychiatric disorders diagnosed by a doctor.
Intervention groups
Intervention group:The samples are placed in groups of 8to10 people and they will receive group therapy for Reilly and shopshire’s anger management(2002) in 12 60-90 minute sessions,two sessions per week at the same center, through lectures,question and answer,and group discussions.The control group will receive center routine treatments.
Main outcome variables
score of anger; score of anger rumination

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220223054113N1
Registration date: 2022-04-04, 1401/01/15
Registration timing: registered_while_recruiting

Last update: 2022-04-04, 1401/01/15
Update count: 0
Registration date
2022-04-04, 1401/01/15
Registrant information
Name
samaneh naeimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 903 033 5848
Email address
samanehnaeimi1377@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-12, 1400/12/21
Expected recruitment end date
2022-05-20, 1401/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of cognitive-behavioral therapy for anger management on its dimensions and rumination in drug addicts under treatment
Public title
The effect of anger management therapy on the dimensions and rumination of anger in addicted patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years Ability to match with study requirementsIncluding Participate in group meetings And do the homeworks
Exclusion criteria:
participating in other anger management courses and cognitive-behavioral therapy and similar courses at the same time as the study use any substances, drugs or alcoholic drinks for at least two weeks before starting treatment and during treatment sessions psychiatric disorders diagnosed by a Psychiatrist.
Age
From 18 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
From the four active addiction treatment centers in Abadan, two centers are selected by lottery. From eligible people of these centers, 80 samples are selected continuously and then by random blocking method with quadruple blocks and using a table of random numbers in Random Allocation Software will be allocated in two groups of intervention (40 people) and control (40 people). Blocking and allocation sequencing will be done by the person outside the research for 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
School of Nursing and Midwifery and School of Rehabilitation, Tehran University of Medical Sciences
Street address
Headquarters of the Ministry of Health, Treatment and Medical Education, 13th floor, Block A, between South Falamak and Zarafshan, Shahrak-e-Ghods (Gharb)
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2022-03-06, 1400/12/15
Ethics committee reference number
IR.TUMS.FNM.REC.1400.214

Health conditions studied

1

Description of health condition studied
Addiction
ICD-10 code
F19
ICD-10 code description
Other psychoactive substance related disorders

Primary outcomes

1

Description
Anger score in Spielberger's State Trait Anger Expression Inventory 2 (STAXI-2) questionnaire
Timepoint
Before the intervention, immediately after the intervention, 6 weeks after the intervention
Method of measurement
Spielberger's State Trait Anger Expression Inventory 2 (STAXI-2) questionnaire

Secondary outcomes

1

Description
Anger rumination score in the Sukhodolsky et al. (2001) questionnaire
Timepoint
Before the intervention, immediately after the intervention, 6 weeks after the intervention
Method of measurement
Sukhodolsky et al. (2001) questionnaire of anger rumination

Intervention groups

1

Description
Intervention group: The samples of the intervention group are in groups of 8 to 10 people and they will receive group therapy for Reilly and shopshire’s anger management(2002) in twelve sixty to ninety-minute sessions, two sessions per week
Category
Behavior

2

Description
Control group: Receive routine treatments at the treatment center
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Rahaei outpatient addiction treatment center
Full name of responsible person
Dr Seyed Shahrokh Salehpoor
Street address
Velayat 10; Ahmad abad
City
Abadan
Province
Khouzestan
Postal code
4462110631
Phone
+98 901 680 2797
Email
drsh.salehpoor@gmail.com

2

Recruitment center
Name of recruitment center
Arvand outpatient addiction treatment center
Full name of responsible person
Dr Amirhossein Shooshtarian
Street address
Next to the Taleghani hospital; Ghadamgahe-e-Emam Reza
City
Abadan
Province
Khouzestan
Postal code
6153505028
Phone
+98 916 502 5678
Email
shooshtarianamirhosein@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mehrnaz Geranmaye
Street address
Faculty of Nursing and Midwifery, University of Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6693 7120
Email
fnm-researchdeputy@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Samaneh Naeimi
Position
Master of Psychiatric Nursing student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Dr. Mirkhani St. (Eastern Nusrat), Tohid Square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 903 033 5848
Email
samanehnaeimi1377@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Samaneh Naeimi
Position
Master student of psychiatric nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Dr. Mirkhani St. (Eastern Nusrat), Tohid Square
City
tehran
Province
Tehran
Postal code
1419733171
Phone
+98 903 033 5848
Email
samanehnaeimi1377@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Samaneh Naeimi
Position
Master student of psychiatric nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Dr. Mirkhani St. (Eastern Nusrat), Tohid Square
City
tehran
Province
Tehran
Postal code
1419733171
Phone
+98 903 033 5848
Email
samanehnaeimi1377@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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