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Comparison of the effectiveness of emotion-focused therapy and schema therapy on self-efficacy, impulsivity, shame and self-blame of addicts with Methadone Maintenance Therapy.

Protocol summary

Study aim
Comparing the effectiveness of emotion-oriented treatment and schema therapy on self-efficacy, impulsivity, shame and self-blame of addicts with methadone maintenance treatment.
Design
The addicts of three clinics in Tehran region 5 are the statistical sample of the present study. And sampling will be done by multi-stage cluster random sampling method. In this way, from the list of all addiction treatment clinics in Tehran, which was prepared in cooperation with the Tehran Medical Science Center, 3 clinics will be randomly selected from the addiction treatment clinics in the 5th district of Tehran using a table of random numbers.
Settings and conduct
The location of the study was three clinics located in the 5th district of Tehran and three groups, two of which were intervention and one control, were selected by one-sided blinding method and work therapy was performed in two experimental groups.
Participants/Inclusion and exclusion criteria
Entry criteria: people whose main use of substances: heroin, opium, juice, and crack for 5 to 10 years and their only method of use is smoking will be selected.
Intervention groups
experiment 1: emotion-oriented therapy, experiment 2: schema therapy and a control and follow-up group three months. At the end of the research, the four mentioned questionnaires will be taken as a post-test
Main outcome variables
Self-efficacy, impulsivity, shame and self-blame of addicts are considered the main outcomes of this research because they are the variables that are measured, which is expected in the current research considering the background of the research, the effectiveness of the two treatments schema therapy and emotion-oriented on these four variables. show significance with the control group.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220807055632N1
Registration date: 2022-10-03, 1401/07/11
Registration timing: registered_while_recruiting

Last update: 2022-10-03, 1401/07/11
Update count: 0
Registration date
2022-10-03, 1401/07/11
Registrant information
Name
Bita Salasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4411 2064
Email address
bt.salasi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-24, 1401/07/02
Expected recruitment end date
2022-10-24, 1401/08/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of emotion-focused therapy and schema therapy on self-efficacy, impulsivity, shame and self-blame of addicts with Methadone Maintenance Therapy.
Public title
Comparison of the effectiveness of emotion-focused therapy and schema therapy of addicts with Methadone Maintenance Therapy.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Entry criteria: In the initial screening, only people whose main use of substances: heroin, opium, juice, and crack for 5 to 10 years and their only method of use is smoking will be selected. The participants in the study must have been on maintenance treatment with methadone for one year and must not have used any other substance. Other inclusion criteria include receiving a diagnosis of only using methadone maintenance treatment by the clinic doctor, free willingness to participate in treatment sessions, education level of at least first high school, exclusion criteria: suffering from other disorders (such as schizophrenia, bipolar disorder, obsessive compulsive disorder), alcohol consumption, The use of other drugs, use of antidepressants, refusal to participate in treatment sessions, as well as the medical background of the people participating in the research will be carefully examined in terms of underlying physical diseases and will be examined by the clinic doctor, and diabetic patients, heart patients, cancer patients, and liver patients And patients who are taking drugs that increase the risk of overdose with methadone will be excluded from the study.
Exclusion criteria:
Age
From 18 years old to 54 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 54
Randomization (investigator's opinion)
Randomized
Randomization description
The research population is all drug addiction treatment clinics in Tehran, which were selected by multi-stage cluster sampling method, first from the entire list of drug addiction treatment clinics using the table of random numbers in Region 5 of Tehran, and three clinics were randomly selected from the list of all clinics in Region 5. and after matching in terms of age, education, and gender, they will be randomly assigned in three groups: schema therapy, emotion-oriented therapy, and the control group. The studied sample includes 54 clients (27 women and 27 men) who receive maintenance treatment with methadone and will refer to addiction treatment clinics in 5th district of Tehran between 1401-1402. 18 people for the first test group, 18 people for the second test group and 18 people for the control group will be randomly assigned.
Blinding (investigator's opinion)
Single blinded
Blinding description
After fully explaining the objectives of the study and giving full knowledge of the absence of any risk for the participants and respect for individuals and independence in making decisions and obtaining an informed consent form, in this study, clinical samples were divided into three groups using one-way blinding method. )): that is, the samples were kept unaware of being assigned to the intervention groups 1 and 2 and the control group, that is, the sample did not know whether it was in the schema therapy or emotion-oriented or control group, but the researcher was doing the treatment and evaluation. He was fully aware of the experimental and control conditions in the three groups.
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه آزاد اسلامی واحد سمنان
Street address
Tehran - Ferdous Gharb - Northern Bahar St. - Manochehri Gharbi - Ezzati Alley - Plate 33 - Unit 4
City
semnan
Province
Semnan
Postal code
1484757981
Approval date
2022-09-26, 1401/07/04
Ethics committee reference number
IR.IAU.SEMNAN.REC.1401.036

Health conditions studied

1

Description of health condition studied
Addicts undergoing maintenance treatment with methadone
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
self-efficacy
Timepoint
6 weeks
Method of measurement
Sharr self-efficacy questionnaire

2

Description
impulsivity
Timepoint
6 weeks
Method of measurement
Barat impulsivity questionnaire

3

Description
shame
Timepoint
6 weeks
Method of measurement
guilt and shame Cohen Questionnaire

4

Description
self blame
Timepoint
6 weeks
Method of measurement
The self-criticism questionnaire of Gilbert et al

Secondary outcomes

empty

Intervention groups

1

Description
First Intervention group: Schema therapy according to the treatment protocol for 12 sessions, twice a week, on addicts with methadone maintenance treatment
Category
Treatment - Other

2

Description
Second Intervention group: Emotion-Focused Therapy according to the treatment protocol for 12 sessions, i.e. twice a week, on addicts with methadone maintenance treatment.
Category
Treatment - Other

3

Description
Control group: In the three selected groups, the first intervention: schema therapy, the second intervention: emotion-oriented therapy without intervention of the control group. The third group is the control group, which did not receive any treatment, and filled the four mentioned questionnaires in the pre-test and post-test without any intervention.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Pendar Nu addiction treatment center
Full name of responsible person
Shohreh Shahriyari
Street address
Janat Abad Central St., above Hammet highway, Touba building, 5th floor, unit 506
City
Tehran
Province
Tehran
Postal code
1475634813
Phone
+98 21 4448 8913
Email
Shohreh.shahri@gmail.com

2

Recruitment center
Name of recruitment center
Jantabad addiction treatment center
Full name of responsible person
Hossein Azari
Street address
Jenatabad Central St., above Hammet highway, Sina Building, Unit 192
City
Tehran
Province
Tehran
Postal code
1475687611
Phone
+98 21 4444 5666
Email
Azari.H@gmail.com

3

Recruitment center
Name of recruitment center
Better future addiction treatment center
Full name of responsible person
Parviz Azarm
Street address
Simon Bolivar, the beginning of Shahid Fakuri St., Sepehr Building, Unit 3
City
Tehran
Province
Tehran
Postal code
1477684955
Phone
+98 21 4482 2420
Email
Dr.Pa@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University, Semnan Branch
Full name of responsible person
Bita Salasi
Street address
Ferdous Gharb St., Nasser Hejazi St., North Bahar St., No. 33, Ezzati Alley
City
Tehran
Province
Tehran
Postal code
1484757981
Phone
+98 21 4411 2064
Email
bt.salasi@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, Semnan Branch
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Bita Salasi
Position
phd student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Ferdous Gharb St., Nasser Hijazi St., North Bahar St., West Manochehri St., Ezzati Alley, No. 33
City
Tehran
Province
Tehran
Postal code
1484757981
Phone
+98 21 4411 2064
Email
bt.salasi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University, Semnan branch
Full name of responsible person
Bita Salasi
Position
Phd Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Ferdous Gharb St., Nasser Hijazi St., North Bahar St., West Manochehri St., Ezzati Alley, No. 33, Islamic Azad University, Semnan Branch
City
Tehran
Province
Tehran
Postal code
1484757981
Phone
+98 21 4411 2064
Email
bt.salasi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University, Semnan branch
Full name of responsible person
Bita Salasi
Position
Phd Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Unit 33, Ferdous Gharb St., Nasser Hejazi St., West Manouchehri St., Ezzati Alley
City
Tehran
Province
Tehran
Postal code
1484757981
Phone
+98 21 4411 2064
Email
bt.salasi@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
Undecided - It is not yet known if there will be 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
Yes - There is a plan to make this available
Title and more details about the data/document
All the data of this study before and after the presentation of schema therapy and emotion-oriented therapy in the form of a questionnaire in the four variables of self-efficacy, impulsivity, shame and self-blame, and only the demographic information of each clinical sample, which includes age, education and gender, It is given accurately and the name and surname are recorded as a pseudonym. The informed consent form was filled by all people before the implementation of the treatment protocol.
When the data will become available and for how long
This research is my doctoral thesis that will be defended in March 1401 and the articles extracted from this research will probably be published and accessible after about 6 months.
To whom data/document is available
All researchers interested in the field of psychology, especially in the field of addiction, and other interdisciplinary researchers can use these data.
Under which criteria data/document could be used
The Excel file of the raw data collected in the research as well as the descriptive and inferential analysis is available by spss software.
From where data/document is obtainable
All data are available in the researcher's archive. Researcher's email address: bt.salasi@gmail.com Postal address: Ezzati Alley, Unit 33, Nasser Hijazi St., West Ferdous Gharb St., Manochehri West, Tehran
What processes are involved for a request to access data/document
It is enough for him to send a Gmail and present his goals for having the data in a justified manner, and it will be sent immediately after verification. 33
Comments
This research, with clear and accurate data and documentation, with the aim of finding effective psychological treatments, tries to know more effective solutions to solve the serious pathological problem of addiction.
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