Protocol summary

Study aim
Comparing the Effectiveness of Music Therapy with Cognitive Behavioral Therapy on Quality of Life, Craving and Emotion Regulation in MMT Patients
Design
A randomized controlled clinical trial with parallel groups
Settings and conduct
First, in coordination with the Tehran health care system, they are asked to refer to methadone maintenance practitioners who have at least one year of methadone maintenance treatment. Then the researcher interviews and The survey of entry and exit criteria will select 60 of them using available sampling method and will be randomly divided into three groups. Then the researcher will randomly select two groups as the experimental group and one group as the control group. Then one of the experimental groups will be trained in 8 sessions of music therapy and the other group will receive 8 sessions of cognitive behavioral therapy.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Addicts on methadone maintenance therapy, Male gender, No physical problems, No history of exposure to psychological training, Ages 18 to 40 years, No drug use; Exclusion criteria: Non-cooperation of the sample group or family at each stage of the research, Having physical and physical problems, History of psychiatric problems, Professional team athletes, Over 40 years old, Drug use
Intervention groups
For the first group of music therapy For the second group cognitive behavioral therapy In the third group, no intervention will be performed.
Main outcome variables
Quality of Life; Craving; Emotion Regulation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191030045280N1
Registration date: 2020-01-22, 1398/11/02
Registration timing: registered_while_recruiting

Last update: 2020-01-22, 1398/11/02
Update count: 0
Registration date
2020-01-22, 1398/11/02
Registrant information
Name
seyed reza eshaghi farahmand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8822 1908
Email address
rezafarahmand@hotmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-13, 1398/09/22
Expected recruitment end date
2020-03-05, 1398/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Effectiveness of Music Therapy with Cognitive Behavioral Therapy on Quality of Life Craving and Emotion Regulation in MMT Patients
Public title
Comparing the Effectiveness of Music Therapy with Cognitive Behavioral Therapy on Quality of Life Craving and Emotion Regulation in MMT Patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Addicts on methadone maintenance therapy male gender No physical problems No history of exposure to psychological training Ages 18 to 40 years No drug use
Exclusion criteria:
Non-cooperation of sample group or family at each stage of research Having physical and physical problems A history of psychiatric problems Professional team athletes
Age
From 18 years old to 40 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
The block randomization method is performed by the statistical consultant as follows: randomization is performed in three groups: music therapy, cognitive behavioral therapy, and control: First, a list of eligible individuals is provided and coded. In block randomization, the number of participants in all groups will be very close together by making blocks of sequences so that the same number of participants are assigned to study groups within each group. We first code the groups in Latin letters as follows:  A = music therapy, B = cognitive behavioral therapy, and C control group In this study with three groups A, B and C we create the following six groups and assign 1 to 6 each: ABC-ACB-BAC-BCA-CAB-CBA Then, using the random number table, we choose one of these blocks whenever the numbers 1, 2, 3, 4, 5, 6 appear, and if the other number appears, consider null and go to the next choice. . In fact, we have obtained a random sequence of numbers with a random number table that we consider the order of assignment for each number. This way the number of people in the groups will be approximately equal.
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
IR.HUMS.REC.1398.303
Street address
North Karegar Street 17 Veteran Street 24 P 64
City
TEHRAN
Province
Tehran
Postal code
1437697419
Approval date
2019-11-30, 1398/09/09
Ethics committee reference number
IR.HUMS.REC.1398.303

Health conditions studied

1

Description of health condition studied
Addiction
ICD-10 code
Z63.72
ICD-10 code description
Alcoholism and drug addiction in family

Primary outcomes

1

Description
Quality of Life
Timepoint
Measurement will be done in pre-test, post-test and follow-up three months after post-test
Method of measurement
Quality of Life Scale Ware & Sherborne (1992)

2

Description
Cognitive Emotion Regulation
Timepoint
Measurement will be done in pre-test, post-test and follow-up three months after post-test
Method of measurement
Cognitive Emotion Regulation Questionnaire Garnefski et al. (1992)

3

Description
Craving
Timepoint
Measurement will be done in pre-test, post-test and follow-up three months after post-test
Method of measurement
DDQ questionnaire Franken et al (2002)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention Group One: Music Therapy - For the first experimental group, 8 sessions of 90-minute music therapy will be taught in groups (Zadeh Mohammadi, 2010).
Category
Treatment - Other

2

Description
Second Group Intervention: Cognitive Behavioral Therapy - For the second group Cognitive Behavioral Therapy (Kathleen, 2002, translated by Poor Roodsari, 2002) will be administered in 8 sessions and each session for 90 minutes.
Category
Treatment - Other

3

Description
Control group: No Intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Addiction Clinic
Full name of responsible person
Hasan Ahadi
Street address
South Kurdistan Highway - 17th Street - Janbazan Street - 24p 61st 4th West
City
Tehran
Province
Tehran
Postal code
2246578941
Phone
+98 21 8822 1908
Email
rezafarahmand@hotmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Alireza Roosta
Street address
Islamic Azad University of Kish International Branch, Free Zone Organization Square, Sana'i Boulevard, Kish Island.
City
Kish
Province
Hormozgan
Postal code
7941775883
Phone
+98 76 4442 2720
Email
Info@Iaukishint.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
20
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
Hasan Ahadi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
South Kurdistan Highway - 17th Street - Janbazan Street - 24p 61st 4th West
City
Tehran
Province
Tehran
Postal code
2248795031
Phone
+98 21 8822 1908
Email
drhahadi5@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hasan Ahadi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
South Kurdistan Highway - 17th Street - Janbazan Street - 24p 61st 4th West
City
Tehran
Province
Tehran
Postal code
2248795031
Phone
+98 21 8822 1908
Email
drhahadi5@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hasan Ahadi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
South Kurdistan Highway - 17th Street - Janbazan Street - 24p 61st 4th West
City
Tehran
Province
Tehran
Postal code
2248795031
Phone
+98 21 8822 1908
Email
drhahadi5@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Only part of the data, such as information about the main outcome or the like, can be shared.
When the data will become available and for how long
Start of access period 6 months after printing results
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
Any type of analysis on the data delivered is permitted
From where data/document is obtainable
Seyed Reza Ishaqi Farahmand Postal address: Tehran - South Kurdistan - 17th Street - Janbazan Street - 24p 61st 4th West Email: rezafarahmand@hotmail.com Cell: 02188221908
What processes are involved for a request to access data/document
The request will be sent by email to: drhahadi5@gmail.com
Comments
Loading...