The efficacy of resiliency training on reducing anxiety and depression on patients with type 2 diabetes mellitus
Design
Controlled clinical trial,24 people in two 12 people groups of intervention and control,Not blinded,Randomized with restricted randomization based on random allocation rule
Settings and conduct
The research method is quasi-experimental. This research is based on the aims and nature of the research, a semi-experimental design, and a pre-test, post-test with the control group. From both groups, Beck Anxiety Scale, Beck Depression Scale, Resilient Conor and Davidson were taken. Then the training program for 12 sessions was conducted for the experimental group and after the end of the sessions, to evaluate the effect of this intervention, the two post-test groups were run and the results of the pre-test and post-test were compared in both groups.
Participants/Inclusion and exclusion criteria
People who live in Kermanshah, who have had their diabetes for at least 3 years and have criteria for depression, will participate in the study. Older and illiterate people who will not be able to participate will not be included.
Intervention groups
The intervention group after registering the pre-test score,participate in training sessions and participate in post-test after receiving the necessary training.The control group only participates in pre-test and post-test stages and does not attend training sessions.
Main outcome variables
Anxiety and depression in patients with type 2 diabetes mellitus
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190213042706N1
Registration date:2019-04-13, 1398/01/24
Registration timing:registered_while_recruiting
Last update:2019-04-13, 1398/01/24
Update count:0
Registration date
2019-04-13, 1398/01/24
Registrant information
Name
Mohammadhossein Rashidi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3824 7932
Email address
mohammadrashidi86@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-06, 1398/01/17
Expected recruitment end date
2019-05-20, 1398/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of resiliency traning on reducing anxiety and depression on patients with type 2 diabetes mellitus
Public title
The efficacy of resiliency traning in diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All diabetics who have diabetes for more than 3 years
Resident of Kermanshah
Depressed is based on structured clinical interviews
Having Depression Based on structured Clinical Interview
Exclusion criteria:
Elderly and illiterate patients who are difficult to obtain information from
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, due to the desire to equalize the number of members of the intervention and control group,using restricted randomization based on random allocation rule.To do this, first determine a total sample size then randomly and based on even or odd of last number of visit No. assign 12 person of them to intervention group and leave 12 person to control group.In fact coupling the last digit of the visit number,putting up the patient into intervention group and odd number of them putting up the patient into control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Shahid Beheshti Blvd., Building No. 2 of the University
City
Kermanshah
Province
Kermanshah
Postal code
6714635568
Approval date
2018-12-26, 1397/10/05
Ethics committee reference number
IR.KUMS.REC.1397.787
Health conditions studied
1
Description of health condition studied
Resiliency training
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Depression Patient's score in Beck Questionnaire
Timepoint
Twelve weeks after the start of resiliency training
Method of measurement
Beck Depression Inventory
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group after registering the pre-test score,participate in training sessions and participate in post-test after receiving the necessary training. The control group only participates in pre-test and post-test stages and does not attend training sessions.
Category
Lifestyle
2
Description
Control group: The control group only participates in pre-test and post-test stages and does not attend training sessions.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes Special Clinic
Full name of responsible person
Mohammad Hossein Rashidi
Street address
Mostafa Emami Blvd., Alley 7 Bargh, No. 61
City
Kermanshah
Province
Kermanshah
Postal code
6714635568
Phone
+98 83 3824 7932
Email
mohammadrashidi86@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Assistance of Research and Technology
Street address
Mostafa Emami Blvd., Alley 7 Bargh, No. 61
City
Kermanshah
Province
Kermanshah
Postal code
6714635568
Phone
+98 83 3824 7932
Email
mohammadrashidi86@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Habib Allah Khazaei
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Bridge of Isar, Farabi Hospital
City
Kermanshah
Province
Kermanshah
Postal code
6714635568
Phone
+98 83 3824 7932
Email
hakhazaei@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Habib Allah Khazaei
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Isar Bridge, Farabi Hospital
City
Kermanshah
Province
Kermanshah
Postal code
6714712658
Phone
+98 83 3824 7932
Email
hakhazaei@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mohammad Hossein Rashidi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
General Practitioner
Street address
Mostafa Emami Blvd., Alley 7 Bargh, No. 61
City
Kermanshah
Province
Kermanshah
Postal code
6714635568
Phone
+98 83 3824 7932
Email
mohammadrashidi86@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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The total potential data of this study after unidentifiable individuals can be shared
When the data will become available and for how long
Initiate access at least 6 months after printing results
To whom data/document is available
Researchers working in university and academia
Under which criteria data/document could be used
Researchers are subject to the above requirements, which tend to work more on the subject of the study
From where data/document is obtainable
Mohammad Hossein Rashidi
Kermanshah,Mostafa Emami Blvd.7 bargh Alley,No.61
Postal Code 6714635568
00989189282125
mohammadrashidi86@gmail.com
What processes are involved for a request to access data/document