Protocol summary

Study aim
Comparing the effectiveness of cognitive therapy group and spiritual therapy on reducing cravings, preventing relapse, improving quality of life, general performance and lifestyle in addicts.
Design
clinical trial, with a control group, with a parallel group, unblinded, randomized, SPSS statistical software and will be analyzed with the help of inferential statistics and multiple covariance analysis, the sample size is 50 people
Settings and conduct
The clinical trial is conducted in the environment of the drug addiction camp on a sample and control group with a volume of 50 people and as a group treatment in two sessions per week and in a period of 1 month.
Participants/Inclusion and exclusion criteria
Addicted people / Exclusion criteria include age less than 18 or more than 60 years, lack of literacy, history of systemic disorders, history of suicide attempts, use of psychoactive drugs, narcotics, and alcohol in the past month. The entry criteria include a history of drug use and the age range of 18 to 60 years, and male persons, and having literacy and no history of systemic disorders and no history of suicide.
Intervention groups
The statistical population of the present study consists of a group of all addicted men hospitalized in Rozbeh Hospital and a group of camp addicts in Tehran. Using a random method, a sample of 50 people will be selected from among these men, who will be assigned to two experimental (25 people) and control (25 people) groups. The way to select the sample is that the audience is randomly selected from Rozbeh Hospital and Camp
Main outcome variables
Investigating the effectiveness of treatments in reducing the craving for drugs It examines the effectiveness of treatments in preventing relapse Investigating the effectiveness of treatments on lifestyle Investigating the effectiveness of treatments on quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230323057767N1
Registration date: 2023-05-07, 1402/02/17
Registration timing: registered_while_recruiting

Last update: 2023-05-07, 1402/02/17
Update count: 0
Registration date
2023-05-07, 1402/02/17
Registrant information
Name
Ghazal Panahi saeb
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7757 5817
Email address
ghazalpanahi1824@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-05, 1402/02/15
Expected recruitment end date
2023-05-22, 1402/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Effectiveness of Cognitive Group Therapy and Spiritual Therapy on Reducing Cravings, Relapse Prevention, Life Quality Improvement, Overall Function and Lifestyle of Addicts.
Public title
Investigation of cognitive therapy and spiritual therapy on drug addicts
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having a minimum age of 18 years and a maximum of 60 years Drug use history Being literate in reading and writing Absence of systemic disorders No history of suicide attempts No use of psychoactive drugs, narcotics, alcohol in the last month
Exclusion criteria:
Age less than 18 or more than 60 years Lack of literacy History of systemic disorders Having a history of suicide attempts Use of psychoactive drugs, drugs, alcohol in the last month
Age
From 18 years old to 60 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random method Individual type Using statistical software Random sequence construction
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
Ethics Committee of Tehran University of Medical Sciences
Street address
Unit 3. Plate 15. Islamic Alley. Madani Street
City
tehran
Province
Tehran
Postal code
1617784311
Approval date
2023-04-19, 1402/01/30
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1402.033

Health conditions studied

1

Description of health condition studied
Substance abuse
ICD-10 code
F10.19
ICD-10 code description
Alcohol abuse with unspecified alcohol-induced disorder

Primary outcomes

1

Description
Substance abuse
Timepoint
First the research project and the end of the project
Method of measurement
With the help of the tests taken in the first stage of the treatment, such as measuring cravings

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: cognitive and behavioral therapy intervention for a group consisting of 8 to 12 people who are hospitalized in the camp is conducted in two sessions a week and lasts for 90 minutes. A shortened version of cognitive and behavioral therapy for addicts is used. To join the group, people must be the same in the type of substance consumed and the amount of hospitalization in the camp. Sessions are conducted based on cognitive and behavioral techniques, and the result is compared to another intervention group, which is spiritual therapy
Category
N/A

2

Description
Intervention group: the intervention of spiritual therapy for a group consisting of 8 to 12 people who are hospitalized in the camp is carried out in two sessions a week and lasts for 90 minutes. The shortened version of spiritual therapy is used for addicts. To join the group, people must be the same in the type of substance consumed and the amount of hospitalization in the camp. The sessions are based on spiritual therapy techniques and the result is compared to another intervention group which is cognitive and behavioral therapy
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Alder drug addiction camp
Full name of responsible person
Ghazal Panahi Saeb
Street address
Unit 3. Plate 15. Islamic Alley. Madani Street
City
Tehran
Province
Tehran
Postal code
1617784311
Phone
+98 21 7757 5817
Email
ghazalpanahi1824@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ghazal Panahi Saeb
Street address
Unit 3. Plate 15. Islamic Alley. Madani Street
City
Tehran
Province
Tehran
Postal code
1617784311
Phone
+98 939 489 1748
Email
ghazalpanahi1824@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad University, Tehran West Branch
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
Islamic Azad University
Full name of responsible person
Ghazal Panahi Saeb
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Unit 3. Plate 15. Islamic Alley. Madani Street
City
tehran
Province
Tehran
Postal code
1617784311
Phone
+98 21 7757 5817
Email
ghazalpanahi1824@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ghazal Panahi Saeb
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Unit 3. Plate 15. Islamic Alley. Madani Street
City
tehran
Province
Tehran
Postal code
1617784311
Phone
+98 21 7757 5817
Email
ghazalpanahi1824@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
غزل پناهی صائب
Position
دانشجو
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Unit 3. Plate 15. Islamic Alley. Shahid Madani St
City
tehran
Province
Tehran
Postal code
1617784311
Phone
+98 21 7757 5817
Email
ghazalpanahi1824@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
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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