Protocol summary

Study aim
Objectives: This research intends to evaluate the effect of peer support on moderate depression in type II diabetics. Peer support can link people sharing experiences to provide the practical, emotional, and ongoing support to control patients’ sustained behavior changes.
Design
Design: This study is a randomized clinical trial with pretest - posttest and control group.
Settings and conduct
Sixty-six patients were randomly divided into intervention and control groups. Then, one person with type 2 diabetes was selected as a peer. In the next stage, the test group is divided into three groups. Then, the test group sessions will be held in the form of six 60-minute support sessions for each group with the help of a peer patient in the Diabetes Clinic of Sabzevar University of Medical Sciences. The materials presented in the sessions include familiarizing patients with each other and sharing experiences about the symptoms and problems of the disease in reducing depression and expressing experiences in ways that reduce the physical problems of the disease that can lead to depression. The content and the way the program is run for all groups is the same.
Participants/Inclusion and exclusion criteria
Major entry requirements: Age 18 to 65 years old; reading and writing skills; not having a physical limitation in self-care; having active records in the diabetes clinic; having a type 2 diabetes last at least three months previously; having no problems with hearing and hearing; Written consent for participation in the research; lack of experience of acute and severe stress (such as the death of first degree relatives or the like) in the last six months; the rate of glycosylated hemoglobin was greater than 7%; fasting blood glucose greater than 140 mg; Beck's Beck Depression Inventory Score Between 19-29 (moderate depression) Major exit conditions: lack of mental illness and illnesses that prevent learning; such as (memory problems, Alzheimer's disease); the use of drugs that affect the level of consciousness and learning; have medical and paramedical education;History of the company in the same research and having severe depression or suicidal thoughts.
Intervention groups
One person with type 2 diabetes is selected as a peer. Choosing this patient based on features such as better adaptation for disease control, the ability to administer meetings, proper social relationships, lesser symptoms of illness with the approval of a clinician, having a history of at least 5 years of illness, having a diploma or higher, and having an interest in leading the group is. In the next stage, the test group is divided into three groups. Then, the faculty group sessions are held face-to-face and held for six consecutive weeks in 6 consecutive 60-minute support sessions. Before the start of the study, immediately after the sessions and Six weeks after the end of the intervention, the Beck questionnaire was completed by both groups. The control group only receives clinic routine care (such as doctor's visits and training classes, etc.).
Main outcome variables
Depression rate; Measures:Before and 45 and 90 days after the intervention began; Variable Measurement Method: Beck Depression Inventory II

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180103038209N1
Registration date: 2018-03-15, 1396/12/24
Registration timing: registered_while_recruiting

Last update: 2018-03-15, 1396/12/24
Update count: 0
Registration date
2018-03-15, 1396/12/24
Registrant information
Name
Zahra Rahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4465 5287
Email address
RahimiZ94@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-05, 1396/12/14
Expected recruitment end date
2018-07-05, 1397/04/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of peer support on depression in patients with diabetes type II
Public title
"The effect of peer support group on depression diabetes"
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Based on patient records in Sabzevar Diabetes Clinic and diagnosis of endocrinologists, and the results of a fasting blood sugar test, they will have type 2 diabetes and will take anti-diabetes medication Have literacy to read and write. There is no vision and hearing problem. Have written consent to participate in the research. The age of the patient is between 18-65 years. Experience of acute and severe stress (such as the death of first degree relatives or the like) in the last six months The patient's glycosylated hemoglobin is greater than 7%. He has been determined for at least three months before diagnosis of diabetes The fasting blood glucose of the patient is more than 140 milligrams. Beck Depression Inventory Score Between 19-29 (Moderate Depression)
Exclusion criteria:
Company history in similar research Use of drugs that affect the level of consciousness and learning Have medical and paramedical education Affected by aging diseases that prevent learning (memory problem, Alzheimer's ...) Having severe depression or suicidal thoughts Disabling physical and mental disabilities
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Randomized
Randomization description
All patients with active records in the diabetes clinic of Sabzevar University of Medical Sciences who are eligible to enter the study are selected to access the study. Based on the sample size, 64 patients were divided into two groups of intervention and control in random allocation based on four blocks
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
Ethics Committee of Sabzevar University of Medical Sciences
Street address
Towhid City, Sabzevar University of Medical Sciences
City
Sabzevar
Province
Razavi Khorasan
Postal code
613873136 9
Approval date
2017-12-07, 1396/09/16
Ethics committee reference number
IR.MEDSAB.REC.1396.82

Health conditions studied

1

Description of health condition studied
Moderate depression-Type 2 diabetes
ICD-10 code
E10,E11,E1
ICD-10 code description
Moderate depression- Diabetes mellitus

Primary outcomes

1

Description
Moderate depression
Timepoint
At the beginning of the study, 45 and 90 days after the start of the study
Method of measurement
Beck Depression Inventory-2

Secondary outcomes

empty

Intervention groups

1

Description
Interventions: After preparing peers, the participants in the intervention group in the selected center was supported by their peers in face to face meetings for 6 following weeks (6 sessions of 1 hours) whit Instructional content is defined in relation to the identification diabetes, types of diabetes, risk factors, complications, treatment and control, the role of diet, exercise, Self-monitoring of blood glucose and medications to control diabetes by group discussions, asking and answering sessions and sharing their personal experiences and success on the diabetes disease control. whereas the control group received only routine care(such as the periodical doctor visits and pedagogical classes...).
Category
N/A

2

Description
Control group: The control group received only routine care (such as the periodical doctor visits and pedagogical classes).
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Diabetes Clinic of Sabzevar University of Medical Sciences
Full name of responsible person
Rahimi Zahra
Street address
Special Clinic of Sabzevar University of MedicalTabas Sciences, Tabas Square
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4401 1579
Email
M.S@medsab.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Rahimi Zahra
Street address
Sabzevar University of Medical Sciences,Tawhid Township
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4401 8300
Email
M.S@medsab.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Rahimi Zahra
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Sabzevar University of Medical Sciences, Tawhid Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4465 5287
Email
zahra.rahimi1789@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Rahimi Zahra
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Sabzevar University of Medical Sciences, Towhid Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4465 5287
Email
RahimiZ94@medsab.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Rahimi Zahra
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Motahari 23,Motahari St, Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
96187-93945
Phone
+98 51 4465 5287
Email
zahra.rahimi1789@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
No - There is not 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
Only part of the information, such as information on the main outcome or the like, can be shared
When the data will become available and for how long
6 months after printing results
To whom data/document is available
Information will only be available to scholars working in academic and academic institutions.
Under which criteria data/document could be used
Only part of the information, such as information on the main outcome or the like, can be shared
From where data/document is obtainable
Call 989154088549 or send a message to zahra.rahimi1789@gmail.com.
What processes are involved for a request to access data/document
Access to information immediately after receiving the email and checking it.
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