Protocol summary

Study aim
Determining the effect of a positive psychotherapy-based program on perceived social support and social adjustment of patients
Design
Clinical trial with control group, one-way blind, randomized, has done on 66 patients with use of Random number table
Settings and conduct
The research environment in the present study is Farabi and Khorshid hospitals in Isfahan. by referring to psychiatric wards at certain hours of the day and attending among patients admitted to the ward. select the samples in an easy way and while explaining the research method and the desired goals, the samples are invited to participate in the study. in addition to obtaining written consent from the family for their patient to participate in the study, the patients themselves are also satisfied. Participants will complete the questionnaires in three stages.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1-The patient is interested in participating in the study and is satisfied 2- depressed diagnosis 3-The patient must be at least 18 years old 4-Be able to read, write and speak Persian 5- Do not have a patient with a mental disability 6-The patient has not participated in similar training programs 7-The patient has not experienced severe stress during the last six months Exclusion criteria: 1- The patient is reluctant to continue collaborating in the study 2-Development of any physical or mental problems or the occurrence of severe stressful events for the patient during the study 3-The patient is absent for more than two sessions in the training sessions
Intervention groups
Positive psychotherapy program will be performed in groups of eight to ten patients for the intervention group.
Main outcome variables
Independent variable :Positive Psychology Program The dependent variable: Perceived social support and social adjustment

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220409054461N1
Registration date: 2022-04-20, 1401/01/31
Registration timing: prospective

Last update: 2022-04-20, 1401/01/31
Update count: 0
Registration date
2022-04-20, 1401/01/31
Registrant information
Name
Seyed Reza Mousavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3320 0894
Email address
rmousavi3174@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-21, 1401/02/01
Expected recruitment end date
2022-06-22, 1401/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of a positive psychotherapy-based program on perceived social support and social adjustment in patients with depression
Public title
The effect of a positive psychotherapy-based program on perceived social support and social adjustment of patients with depression
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The patient is interested in participating in the study and is satisfied According to the psychiatrist, the patient is diagnosed as depressed so that he is not in the acute stage of the disease and is hospitalized in one of the wards of Khorshid or Farabi hospitals The patient must be at least 18 years old Be able to read, write and speak Persian Do not have a patient with a mental disability or diagnosed cognitive problems such as dementia according to patient records that impair the patient's learning The patient has not participated in similar training programs at the same time or before The patient has not experienced severe stress such as divorce, etc. during the last six months
Exclusion criteria:
The patient is reluctant to continue collaborating in the study Development of any physical or mental problems or the occurrence of severe stressful events for the patient during the study who are no longer able to continue to cooperate in the study The patient is absent for more than two sessions in the training sessions
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 66
Randomization (investigator's opinion)
Randomized
Randomization description
This study will be performed experimentally and randomly in two groups of test and control. For this purpose, a table of random numbers is used. In this way, the researcher will first determine that all the people to whom the odd number is assigned to be in the control group and those to whom the even number is assigned to be in the test group.He will then close his eyes and place his finger on one of the digits in the random number table. The researcher will select the required number of even and odd numbers by moving in the table of random numbers. All numbers will be placed in separate envelopes and all will be placed in a box. When the sample enters the study easily with the entry conditions, then the number one card will be returned to him and depending on whether this card has an even or odd number will be in one of two test or control groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, there will be two groups, including intervention and control groups, which will be performed among people with depressive disorder. The selection of individuals for inclusion in the study will be based on the inclusion criteria and with the written consent. The subjects will be randomly divided into two groups with equal numbers so that the participants themselves and other clinicians will not be informed of this division. It will also be explained to all participants in the study that by the end of the study, they will not have any exchange of data and data with each other or with other people. It is necessary to explain that the intervention, data collection and data entry will be done by the researcher himself.
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences,Isfahan,Iran
City
isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2022-04-03, 1401/01/14
Ethics committee reference number
IR.MUI.NUREMA.REC.1401.001

Health conditions studied

1

Description of health condition studied
perceived social support
ICD-10 code
ICD-10 code description

2

Description of health condition studied
social adjustment
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Perceived social support score on a multidimensional scale Perceived social support Zimet et al and Social adjustment score in Bell Social Adjustment Questionnaire
Timepoint
The beginning of the study (before the intervention), immediately after and one month after the educational program
Method of measurement
Multidimensional Scale of Perceived Social Support Zimet et al And Bell Social Adjustment Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Positive psychotherapy program will be performed in 6 sessions of one and a half hours in the form of groups of eight to ten patients for the intervention group and twice a week by the student and under the supervision of his supervisor in the classroom of Farabi Hospital in Isfahan. The educational content of the sessions will be based on the existing texts and the educational package of positive thinking and practical positivity of Susan Quilliam, which will be approved by 5 faculty members of the Psychiatric Nursing Department of Isfahan School of Nursing and Midwifery. Speeches, questions and answers ... will be transmitted.
Category
Treatment - Other

2

Description
Control group: In this study, a group discussion session will be held for the participants of the control group. During which they will discuss and exchange views on general topics such as mental illness and their problems
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Farabi Hospital and Khorshid Hospital
Full name of responsible person
Seyed Reza Mousavi
Street address
No. 38, 8th St, Ghazi Abad, Khorramabad, Lorestan Province
City
Khorramabad
Province
Lorestan
Postal code
6818749433
Phone
+98 66 3320 0894
Email
rmousavi3174@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Vice Chancellor for Research and Technology, Isfahan University of Medical Sciences
Street address
Vice Chancellor for Research and Technology, Isfahan University of Medical Sciences, Hezar Jerib St., Isfahan, Isfahan Province
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 7153
Email
webmaster@nm.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
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
Esfahan University of Medical Sciences
Full name of responsible person
ُSeyed Reza Mousavi
Position
Master student of psychiatric nursing
Latest degree
Bachelor
Other areas of specialty/work
psychiatric nursing
Street address
Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Hezar Jerib St., Isfahan, Isfahan Province
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
rmousavi3174@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
sima ghezelbash
Position
faculty member
Latest degree
Master
Other areas of specialty/work
psychiatric nursing
Street address
Isfahan University of Medical Sciences,Isfahan,Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
simagh1396@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Seyed Reza Mousavi
Position
Master of nursing student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 38, 8th street, Ghaziabad,Khorramabad city,Lorestan province,
City
Khorramabad
Province
Lorestan
Postal code
8174673461
Phone
+98 66 3320 0894
Fax
Email
rmousavi3174@gmail.com

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
Not applicable
Data Dictionary
Not applicable
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