1. Home
  2. Approved trials
  3. » فارسی

The Effect of Short-term Psychodynamic Psychotherapy in Improvement of Intrapsychic Conflicts, Acceptance and Adjustment with Diabetes, Adherence to Treatment and Level of Glycated Hemoglobin (HBA1c): A Randomized Controlled Trial

Protocol summary

Study aim
The aim of the current research is the effectiveness of Short-term Psychodynamic Psychotherapy in Improvement of Intrapsychic Conflicts, Acceptance and Adjustment with Diabetes, Adherence to Treatment and Level of Glycated Hemoglobin (HBA1c): A Randomized Controlled Trial.
Design
This research is semi-experimental and applied, which will be conducted with a pre-test-post-test research design with experimental and control groups. According to the size of the sample group (20 people in the experimental group and 20 people in the control group), 40 people will cooperate in the present research; These people will be selected from among the members of the Iranian Diabetes Association based on targeted sampling and will complete the pre-test. Then, through random replacement, they will be placed in two experimental and control groups. The members of the experimental group will undergo 15 sessions of short-term psychodynamic therapy for about 3 to 4 months. Finally, after completing the pre-test, the data will be analyzed through SPSS-28.
Settings and conduct
Considering that the Iranian Diabetes Society is located in Tehran, the research will be conducted in Tehran
Participants/Inclusion and exclusion criteria
Inclusion criteria: Suffering from type 1 diabetes, Membership in Iranian Diabetes Society, Desire to participate in research. Exclusion criteria: Suffering from other chronic diseases, Taking psychiatric medications, Experience of participating in similar researches.
Intervention groups
The members of the experimental group will receive short-term psychodynamic therapy, and the members of the control group will not receive any intervention.
Main outcome variables
Intrapsychic Conflicts, Acceptance and Adjustment with Diabetes, Adherence to Treatment and Level of Glycated Hemoglobin (HBA1c)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240317061321N1
Registration date: 2024-05-02, 1403/02/13
Registration timing: prospective

Last update: 2024-05-02, 1403/02/13
Update count: 0
Registration date
2024-05-02, 1403/02/13
Registrant information
Name
Fatemeh Eisazadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4445 1189
Email address
f.eisazadeh74@semnan.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-14, 1403/03/25
Expected recruitment end date
2024-09-22, 1403/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Short-term Psychodynamic Psychotherapy in Improvement of Intrapsychic Conflicts, Acceptance and Adjustment with Diabetes, Adherence to Treatment and Level of Glycated Hemoglobin (HBA1c): A Randomized Controlled Trial
Public title
The Effect of Short-term Psychodynamic Psychotherapy in Improvement of Intrapsychic Conflicts, Acceptance and Adjustment with Diabetes, Adherence to Treatment and Level of Glycated Hemoglobin (HBA1c): A Randomized Controlled Trial
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Suffering from type 1 diabetes Membership in Iranian Diabetes Society Desire to participate in research
Exclusion criteria:
Suffering from other chronic diseases Taking psychiatric medications Experience of participating in similar researches
Age
From 13 years old to 19 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random sampling of the lottery type
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 semnan University of Medical Sciences and Health Services
Street address
Unit 1, No. 8, Golzar 2, Punak Square
City
Tehran
Province
Tehran
Postal code
1476777593
Approval date
2024-03-11, 1402/12/21
Ethics committee reference number
IR.SEMUMS.REC.1403.002

Health conditions studied

1

Description of health condition studied
type 1 Diabetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition

Primary outcomes

1

Description
Intrapsychic Conflicts
Timepoint
The beginning of the study (before the start of the intervention) and the end of the study (after receiving short-term psychodynamic therapy)
Method of measurement
Questionnaire of Intrapsychic conflicts (2008)

2

Description
Acceptance of diabetes
Timepoint
The beginning of the study (before the start of the intervention) and the end of the study (after receiving short-term psychodynamic therapy)
Method of measurement
The Persian version of Smith et al.'s Diabetes Acceptance Questionnaire (2022)

3

Description
Adherence to treatment
Timepoint
The beginning of the study (before the start of the intervention) and the end of the study (after receiving short-term psychodynamic therapy)
Method of measurement
Adherence to treatment questionnaire by Morisky et al. (1992)

4

Description
Adjustment with Diabetes
Timepoint
The beginning of the study (before the start of the intervention) and the end of the study (after receiving short-term psychodynamic therapy)
Method of measurement
Adjustment with Diabetes questionnaire by Ebrahimi et al. (2016)

5

Description
Level of Glycosylated Hemoglobin (HBA1c)
Timepoint
The beginning of the study (before the start of the intervention) and the end of the study (after receiving short-term psychodynamic therapy)
Method of measurement
HBA1c blood test

Secondary outcomes

empty

Intervention groups

1

Description
Receive Intensive Short-Term Dynamic Psychotherapy intervention
Category
Lifestyle

2

Description
Control group: They do not receive any intervention
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Iranian Diabetes Society
Full name of responsible person
Asadollah Rajab
Street address
No. 27, Malkuti St, Patrice Lumumba St, Sattarkhan neighborhood
City
Tehra
Province
Tehran
Postal code
1443914661
Phone
+98 21 8825 3113
Email
iraniandiabetessociety@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Semnan
Full name of responsible person
Isaac Rahimian Boogar
Street address
Department of Clinical Psychology, Faculty of Psychology and Educational Sciences, Semnan University, Darband Road, Mahdishahr, Semnan
City
semnan
Province
Semnan
Postal code
3564111556
Phone
+98 23 3153 3066
Fax
+98 23 3362 6888
Email
i_rahimian@semnan.ac.ir
Web page address
https://psy.semnan.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 Semnan
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
The University of Semnan
Full name of responsible person
Fatemeh Eisazadeh
Position
Postdoctoral Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Unit 1, No. 8, Golzar 2, Punak Square
City
Tehran
Province
Tehran
Postal code
1476777593
Phone
+98 21 4445 1189
Email
f.eisazadeh74@semnan.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Semnan
Full name of responsible person
Fatemeh Eisazadeh
Position
Postdoctoral Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Unit 1, No. 8, Golzar 2, Punak Square
City
Tehran
Province
Tehran
Postal code
1476777593
Phone
+98 21 4445 1189
Email
f.eisazadeh74@semnan.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
The University of Semnan
Full name of responsible person
Fatemeh Eisazadeh
Position
Postdoctoral Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Unit 1, No. 8, Golzar 2, Punak Square
City
Tehran
Province
Tehran
Postal code
1476777593
Phone
+98 21 4445 1189
Email
f.eisazadeh74@semnan.ac.ir

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
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
Title and more details about the data/document
All personal data of the participants including age, child of divorce or not, level of educational attainment, duration of diabetes and their weight can be shared after de-identification.
When the data will become available and for how long
Simultaneously with the publication of the results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
It is allowed to use documentation to choose research topics and create treatment protocols
From where data/document is obtainable
Dr Fatemeh Eisazadeh f.eisazadeh74@gmail.com
What processes are involved for a request to access data/document
The applicant should send an email to the main researcher through the mentioned email and while introducing himself/herself and fully explaining the purpose and process of his/her research, request to receive the documents. In this case, the documents will reach the applicant as soon as possible.
Comments
In the present study, the individual data of the participants (after de-identification), study protocol (short-term psychodynamic therapy), statistical analysis map, informed consent form and clinical study report will be published.
Loading...