(1) The main purpose of this project was to determine the effect of life skills-based interventions on stress disorders, anxiety and depression in type 1 diabetic patients referred to the Urmia Diabetes Association in 96 (2). This study was a clinical trial study with "pretest and Post-test with control group ". (3) A final sample of 80 patients with type 1 diabetes was selected by available sampling method and assigned to two groups of intervention (n = 40) and control group (n = 40) by random allocation method. The data are The study will be compiled by demographic questionnaire and DASS-21 questionnaire. (4) Entry criteria for participants including: Type 1 diabetes mellitus, age range of 12-40 cases at the Diabetes Association, in terms of physical and mental health, ability to answer questions, have reading and writing skills, addiction to non-narcotics Not attending 6 months in the life skills workshop, according to a patient's opinion. (5) Interventions: At first, both groups undergo a pretest, and then the intervention group participates in 9 sessions of one-fifth-hour lifestyle education that is conducted in collaboration with a psychologist. The control group does not receive any intervention. Finally, the post-test will be applied to both groups after the intervention and 2 months later. The results of the two groups will be compared. (6) The main outcome variable is stress, anxiety and depression.
General information
Acronym
Life Skills Training(LST)
IRCT registration information
IRCT registration number:IRCT2017082326347N6
Registration date:2017-11-07, 1396/08/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-11-07, 1396/08/16
Registrant information
Name
Soheyla Ahangarzade Rezaei
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3223 4897
Email address
rezaei.s@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor For Research Of Urmia University Of Medical Scinces
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2017-11-21, 1396/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of life skills-based interventions on stress, anxiety and depression in patients with type 1 diabetes
Public title
The effect of life skills-based interventions on stress, anxiety and depression in patients with type 1 diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Entry criteria: Type 1 diabetes; Age range of 40-40; Case records in the Diabetes Association; Physical and mental health; Ability to answer questions; Have a reading and writing literacy; Drug addiction; Do not attend. 6 months ago at the store of life skills according to the patient's opinion
Age
From 84 years old to 59 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The randomized assignment of the groups into two groups is as follows: on the sheets of numbers 1 to 80 will be written and, after being placed in a container, will be asked from patients, each of which will be one In the end, individuals with paired numbers in the intervention group and individuals with numbers in the control group will be placed at random.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Urmia University of Medical Sciences
Street address
Central Headquarters of Urmia University of Medical Sciences,Organs Quarter,Resalat Boulevard,Urmia
Before intervention - after intervention - two months after intervention
Method of measurement
Dass-21 questionnaire
2
Description
Anxiety
Timepoint
Before intervention - after intervention - two months after intervention
Method of measurement
Dass-21 questionnaire
3
Description
Depression
Timepoint
Before intervention - after intervention - two months after intervention
Method of measurement
Dass-21 questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group was first measured by the DASS-21 questionnaire. The mean of depression, anxiety and stress was measured and then the intervention group in 9 sessions of life skills training included self-awareness, stress management, problem-solving and effective communication skills, which was conducted by a psychologist Runs, participate. Then, the mean of depression, anxiety and stress after the completion of the intervention and two months after the intervention measure and the results are compared
Category
Other
2
Description
Control group: This group does not receive any intervention. The mean of stress, anxiety and depression was compared by using the DASS-21 questionnaire in the pre-intervention, post-intervention, and 2-month intervals after intervention.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Urmia Diabetes Association
Full name of responsible person
Mr. Enari
Street address
Urmia Diabetes Association, Municipality Health Building, Corner of Vesal Street, Mehrab Ave, Facing Mosalli, Resalat Boulevard, Orumieh
City
Urmia
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor For Research Of Urmia University Of Medical Scinces
Full name of responsible person
Ms. Ghaffarzadeh
Street address
Central Headquarters of Urmia University of Medical Sciences,Organs Quarter,Resalat Boulevard,Urmia
City
Urmia
Grant name
-----
Grant code / Reference number
---------
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor For Research Of Urmia University Of Medical Scinces
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Urmia Nursing and Midwifery Faculty
Full name of responsible person
Soheila Ahangarzadeh Rezaei
Position
PHD
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Pardis Nazlou, 11 km Road sero
City
Urmia
Postal code
Phone
+98 443275496361
Fax
---
Email
nursing-college@umsu.ac.ir
Web page address
http://www.nm.umsu.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Urmia Nursing and Midwifery Faculty
Full name of responsible person
Sayedeh Farideh Hashemi
Position
Student of Master of Psychiatric Nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Pardis Nazlou, 11 km Road sero
City
Urmia
Postal code
5551338335
Phone
+98 44 3275 4961
Fax
----
Email
f.hashemi9062@gmail.com
Web page address
---
Person responsible for updating data
Contact
Name of organization / entity
Alzahra Hospital Tabriz University of Medical Sciences