Protocol summary

Study aim
Comparison of the effect of cognitive behavioral therapy with interpersonal psychotherapy on alexithymia, emotional regulation and psychological capital of male substanece abusers referred to addiction treatment centers in Kerman.
Design
Clinical trial with 2 experimental groups: interpersonal psychotherapy and cognitive behavioral therapy and a control group, Double blind, randomized using random number table and concealment (numbered, sealed and opaque envelopes) And has a volume of 75 people.
Settings and conduct
This double-blind clinical trial was performed in the field of substance abuse and in addiction treatment centers in Kerman. At first, a center (Moein center) was randomly selected. Then, 75 participants in this center were randomly selected using a random number table, and randomly and concealed (numbered, sealed and opaque envelopes) using a random number table by an individual Unaware of the objectives of the research, they were assigned into two experimental groups and a control group.
Participants/Inclusion and exclusion criteria
Admission Requirements: Being a substance abuser based on Diagnostic and Statistical Criteria for Mental Disorders Version 5, absence of severe mental disorder, having a minimum education of primary school level, and willingness to participate in research. Exclusion criteria: Absence of more than two sessions and unwillingness to continue participating in the research.
Intervention groups
Interpersonal psychotherapy training package according to the book "Interpersonal psychotherapy A quick guide for the therapist", Author: Mirna Weiss Man et al., Translator: Mehdi Dadashi et al. (2012) For the experimental group a, "Carl Cognitive Behavior Therapy Training Package" for Experimental Group b, the control group won't receive any intervention.
Main outcome variables
Alexithymia scores; Emotional regulation scores and psychological capital scores.

General information

Reason for update
Acronym
IPT and CBT
IRCT registration information
IRCT registration number: IRCT20211113053052N1
Registration date: 2021-12-27, 1400/10/06
Registration timing: retrospective

Last update: 2021-12-27, 1400/10/06
Update count: 0
Registration date
2021-12-27, 1400/10/06
Registrant information
Name
Ali Saeedi Rashk olya
Name of organization / entity
Islamic Azad University, Zarand Branch
Country
Iran (Islamic Republic of)
Phone
+98 34 3212 0723
Email address
a.manzari@iauk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-22, 1400/03/01
Expected recruitment end date
2021-08-06, 1400/05/15
Actual recruitment start date
2021-05-22, 1400/03/01
Actual recruitment end date
2021-08-16, 1400/05/25
Trial completion date
2021-08-16, 1400/05/25
Scientific title
Comparison of the effectiveness of interpersonal psychotherapy with cognitive behavioral therapy on alexithymia, emotional regulation and psychological capital of male Substance abuser
Public title
Comparison of the effectiveness of interpersonal psychotherapy with cognitive behavioral therapy on alexithymia, emotional regulation and psychological capital of male Substance abuser
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Being a substance abuser according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition criteria Absence of severe mental disorders having a minimum education of primary school level Willingness to participate in the study Age between 15 to 50 years
Exclusion criteria:
Absences of more than two sessions unwillingness to continue participating in research
Age
From 18 years old to 50 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 75
Actual sample size reached: 60
Randomization (investigator's opinion)
Randomized
Randomization description
To conduct this research, first a list of addiction treatment centers was prepared. Then, a center was selected for research using a simple random method (lottery) based on the names of the centers, by a person who was not aware of the objectives of the project. this person will randomly select 75 of the center's clients using a random number table. Again in a simple random method, using a random number table and a concealment method (numbered, sealed and opaque envelopes), this person will assign the participants into experimental and control groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants in the experimental group will not aware about the control group. They will also initially be unaware of which group they belong to. Questionnaires will be completed under the supervision of an individual unaware of the objectives of the research. The analyzer is only aware of the hypotheses, and the data will be provided to him with sufficient supervision.
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University, Kerman Branch
Street address
Islamic Azad University, Kerman Branch, Valiasr Blvd., Kerman
City
kerman
Province
Kerman
Postal code
۷۶۳۵۱۳۱۱۶۷
Approval date
2021-05-12, 1400/02/22
Ethics committee reference number
IR.IAU.KERMAN.REC.1400.012

Health conditions studied

1

Description of health condition studied
substance abusers
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Alexithymia score in Toronto alexithymia scale
Timepoint
Evaluation of alexithymia (before intervention), 42 days after intervention (post-test) .
Method of measurement
Toronto Alexithymia scale (TAS-20)

2

Description
Emotion regulation score in the cognitive emotional regulation questionnaire
Timepoint
Evaluation of emotional regulation (before intervention), 42 days after intervention (post-test).
Method of measurement
Cognitive emotional regulation questionnaire developed by Garnowski.

3

Description
Psychological capital score in the Luthans psychological capital questionnaire
Timepoint
Evaluation of Psychological capital (before intervention), 42 days after intervention (post-test).
Method of measurement
Psychological capital questionnaire 24 developed by Luthans

Secondary outcomes

empty

Intervention groups

1

Description
The intervention group a: In this study, interpersonal psychotherapy training was taught to participants in twelve sessions per 42 days.
Category
Treatment - Other

2

Description
The intervention group b: In this study, participants were taught a cognitive behavioral therapy training package in ten sessions per 35 days.
Category
Treatment - Other

3

Description
The control group: The control group did not receive any intervention.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Moein substance abuse treatment center.
Full name of responsible person
Dr. Naser Ebrahimpour
Street address
Moin Addiction Treatment Center, between 24th and 26th Alley, above Dr. Mollai Pharmacy, Shahid Mostafa Khomeini St., Kerman
City
kerman
Province
Kermanshah
Postal code
7617669845
Phone
+98 34 3323 8533
Fax
Email
nasser.ebrahimpoor@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
nasser.ebrahimpoor@gmail.com
Street address
Islamic Azad University, Zarand Branch, Sarbagh Road, University Square, Zarand city, Kerman
City
zarand
Province
Kerman
Postal code
7761146595
Phone
+98 34 2425 0856
Fax
+98 34 3345 0855
Email
Hamid.molayi@gmail.com
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
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
Ali Saeedi Rashk Olya
Position
PhD Candidate
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
3rd North dead end, No. 30, Komeil Ave., Jomhouri Blvd.
City
kerman
Province
Kerman
Postal code
7618873646
Phone
+98 34 3212 0723
Email
ali.saeedi1352@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ali Saeedi Rashk olya
Position
PhD Candidate
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
3rd North dead end, No. 30, Komeil Ave., Jomhouri Blvd.
City
Kerman
Province
Kerman
Postal code
7618873646
Phone
+98 34 3212 0723
Fax
Email
ali.saeedi1352@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ali Saeedi Rashk Olya
Position
PhD Candidate
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
3rd North dead end, No. 30, Komeil Ave., Jomhouri Blvd.
City
Kerman
Province
Kerman
Postal code
7618873646
Phone
+98 34 3212 0723
Fax
Email
ali.saeedi1352@yahoo.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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All documents of this study include: information about the main outcomes of the study, statistical analysis map, informed consent form and clinical study report, in a file entitled: "Comparison of the effectiveness of interpersonal psychotherapy with cognitive-behavioral therapy on alexithymia, emotional regulation and psychological capital in substance abusers", can be shared.
When the data will become available and for how long
The start of the access period is 6 months after the results are published.
To whom data/document is available
Researchers working in academic and scientific institutions as well as officials of addiction treatment centers can apply for the file.
Under which criteria data/document could be used
Those who receive this file can use the data and results in addiction treatment centers and conduct research.
From where data/document is obtainable
Applicants can send their application to the e-mail address: ali.saeedi1352@yahoo.com to receive the documents.
What processes are involved for a request to access data/document
Send your request to receive the research documentation file to the e-mail: ali.saeedi1352@yahoo.com. after reviewing, the requested documents and data will be sent to your e-mail within 72 hours.
Comments
Loading...