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A randomized, parallel-controlled study evaluating the efficacy of a program of group psychodrama interventions based on maladaptive schemas on reducing effects of early maladaptive schemas in adults aged 25 to 45

Protocol summary

Study aim
Evaluating the efficacy of a program of group psychodrama interventions based on schemas on reducing the effects of early maladaptive schemas
Design
A clinical trial with a parallel control group, random allocation of participants in groups and blinding in random sequence, and data analysis
Settings and conduct
This study was conducted in the workshop hall at the Haftad psychological clinic, Tehran, Iran.
Participants/Inclusion and exclusion criteria
Inclusion criteria: aged 25 to 45; Employment status: employing in knowledge-enterprise companies in Tehran; Salay more than 4.5 million tomans per month
Intervention groups
The experimental group was subjected to a program of group psychodrama interventions based on schemas in eight, four-hour sessions for two months. The interventional program used in this study was developed by the researchers of this study, after reviewing the content of the research literature, extracting related interventional programs, techniques, and worksheets of group schema therapy and psychodrama approaches, analyzing and matching the findings with culture, statistical population, and research objectives. Also, the process of assessing the content validity and apparent validity of the program has been implemented and approved. The structure of this program consists mainly of three stages: warm-up, main exercises, and ending up. Each session revolves around specific moods, schemas, and related techniques, and at the end of each session, the members of the group were given homework assignments to prepare themselves for the next session while practicing the learned in the interval between sessions. The control group did not receive any intervention during this period.
Main outcome variables
Early maladaptive schemas

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220124053814N1
Registration date: 2022-04-30, 1401/02/10
Registration timing: retrospective

Last update: 2022-04-30, 1401/02/10
Update count: 0
Registration date
2022-04-30, 1401/02/10
Registrant information
Name
Mohammadreza Jabbari
Name of organization / entity
The University of Tehran
Country
Iran (Islamic Republic of)
Phone
+98 21 2211 3325
Email address
mr.jabbari@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-06, 1400/04/15
Expected recruitment end date
2021-08-21, 1400/05/30
Actual recruitment start date
2021-07-06, 1400/04/15
Actual recruitment end date
2021-08-21, 1400/05/30
Trial completion date
empty
Scientific title
A randomized, parallel-controlled study evaluating the efficacy of a program of group psychodrama interventions based on maladaptive schemas on reducing effects of early maladaptive schemas in adults aged 25 to 45
Public title
The efficacy of a program of group psychodrama interventions based on maladaptive schemas on reducing effects of early maladaptive schemas
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age: Adults aged 25 to 45 Employment status: Employing in knowledge-enterprise companies in Tehran Salary: More than 4.5 million tomans per month (This amount has been identified as a median of income in 2020. According to the latest report from the Ministry of cooperatives labour and social Welfare (2021), the income of a three-person household in Tehran for 2020 is estimated to be approximately between 3 and 5 million tomans).
Exclusion criteria:
Psychological disorders, such as: depression or anxiety
Age
From 25 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Actual sample size reached: 70
Randomization (investigator's opinion)
Randomized
Randomization description
The participants were assigned to the experimental and control groups based on permuted block randomization, each group consisting of 35 individuals, and to avoid bias, the random allocation was performed based on the sequentially, numbered, sealed, opaque envelopes (SNOSE) method. According to this method, cards tailored to the sample size were prepared on which the control group or experimental group were written. These cards were placed in non-transparent and sealed envelopes, and participants got the cards and were placed in their groups.
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
Research Ethics Committees of Faculty of Psychology and Education
Street address
No. 107, West 2nd Aseman St., Ketab Square., Farahzadi Blvd., Sa'adat Abad "Apt. 7"
City
Tehran
Province
Tehran
Postal code
1998143719
Approval date
2021-07-05, 1400/04/14
Ethics committee reference number
IR.UT.PSYEDU.REC.1400.028

Health conditions studied

1

Description of health condition studied
Early maladaptive schemas
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Early maladaptive schemas
Timepoint
Before starting the intervention, and after finishing up the intervention
Method of measurement
In this study, the Young schema questionnaire (third version of the short form) was used. This questionnaire is a self-report tool with 90 items that can measure 18 schemas determined by Young in five domains. Each item is scored based on a six-degree Likert spectrum.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The experimental group was subjected to a program of group psychodrama interventions based on schemas in eight, four-hour sessions for two months. The interventional program used in this study was developed by the researchers of this study, after reviewing the content of the research literature, extracting related interventional programs, techniques, and worksheets of group schema therapy and psychodrama approaches, analyzing and matching the findings with culture, statistical population, and research objectives. Also, the process of assessing the content validity and apparent validity of the program has been implemented and approved. The structure of this program consists mainly of three stages: warm-up, main exercises, and ending up. Each session revolves around specific moods, schemas, and related techniques, and at the end of each session, the members of the group were given homework assignments to prepare themselves for the next session while practicing the learned in the interval between sessions.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
The workshop hall at the Haftad psychological clinic, Tehran, Iran
Full name of responsible person
Mohammadreza Jabbari
Street address
No. 107, West 2nd Aseman St., Ketab Square., Farahzadi Blvd., Sa'adat Abad "Apt. 7"
City
Tehran
Province
Tehran
Postal code
1998143719
Phone
+98 21 2211 3325
Email
mr.jabbari@ut.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Tehran
Full name of responsible person
Mohammadreza Jabbari
Street address
No. 107, West 2nd Aseman St., Ketab Square., Farahzadi Blvd., Sa'adat Abad "Apt. 7"
City
Tehran
Province
Tehran
Postal code
1998143719
Phone
+98 21 2211 3325
Email
mr.jabbari@ut.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Tehran
Proportion provided by this source
50
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
The University of Tehran
Full name of responsible person
Mohammadreza Jabbari
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No. 107, West 2nd Aseman St., Ketab Square., Farahzadi Blvd., Sa'adat Abad "Apt. 7"
City
Tehran
Province
Tehran
Postal code
1998143719
Phone
+98 21 2211 3325
Email
mr.jabbari@ut.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Tehran
Full name of responsible person
Mohammadreza Jabbari
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No. 107, West 2nd Aseman St., Ketab Square., Farahzadi Blvd., Sa'adat Abad "Apt. 7"
City
Tehran
Province
Tehran
Postal code
1998143719
Phone
+98 21 2211 3325
Email
mr.jabbari@ut.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
The University of Tehran
Full name of responsible person
Mohammadreza Jabbari
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No. 107, West 2nd Aseman St., Ketab Square., Farahzadi Blvd., Sa'adat Abad "Apt. 7"
City
Tehran
Province
Tehran
Postal code
1998143719
Phone
+98 21 2211 3325
Email
mr.jabbari@ut.ac.ir

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
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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