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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: IRCT
Last refreshed on: 22 February 2018
Main ID:  IRCT2017082326347N6
Date of registration: 2017-11-07
Prospective Registration: No
Primary sponsor: Vice Chancellor For Research Of Urmia University Of Medical Scinces
Public title: The effect of life skills-based interventions on stress, anxiety and depression in patients with type 1 diabetes
Scientific title: The effect of life skills-based interventions on stress, anxiety and depression in patients with type 1 diabetes
Date of first enrolment: 2017-07-23
Target sample size: 80
Recruitment status: Complete
URL:  http://en.irct.ir/trial/21856
Study type:  interventional
Study design:  Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, 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.  
Phase:  N/A
Countries of recruitment
Iran (Islamic Republic of)
Contacts
Name: Soheila Ahangarzadeh Rezaei   
Address:  Faculty of Nursing and Midwifery, Pardis Nazlou, 11 km Road sero Urmia Iran (Islamic Republic of)
Telephone: +98 443275496361
Email: nursing-college@umsu.ac.ir
Affiliation:  Urmia Nursing and Midwifery Faculty
Name: Sayedeh Farideh Hashemi   
Address:  Faculty of Nursing and Midwifery, Pardis Nazlou, 11 km Road sero 5551338335 Urmia Iran (Islamic Republic of)
Telephone: +98 44 3275 4961
Email: f.hashemi9062@gmail.com
Affiliation:  Urmia Nursing and Midwifery Faculty
Key inclusion & exclusion criteria
Inclusion 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
Exclusion criteria:

Age minimum: 84 years
Age maximum: 59 years
Gender: Both
Health Condition(s) or Problem(s) studied
Diabets.
With coma,With ketoacidosis ,With renal complications,With ophthalmic complications ,With neurological complications ,With peripheral circulatory complications ,With other specified complications ,With multiple complications ,With unspecified complication
E10.0,E10.
With coma,With ketoacidosis ,With renal complications,With ophthalmic complications ,With neurological complications ,With peripheral circulatory complications ,With other specified complications ,With multiple complications ,With unspecified complication
Intervention(s)
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.
Intervention 1: 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. Intervention 2: 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.
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
Primary Outcome(s)
Depression. Timepoint: Before intervention - after intervention - two months after intervention. Method of measurement: Dass-21 questionnaire.
Anxiety. Timepoint: Before intervention - after intervention - two months after intervention. Method of measurement: Dass-21 questionnaire.
Stress. Timepoint: Before intervention - after intervention - two months after intervention. Method of measurement: Dass-21 questionnaire.
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Vice Chancellor For Research Of Urmia University Of Medical Scinces
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date:
Contact:
Ethics Committee of Urmia University of Medical Sciences
Results
Results available:
Date Posted:
Date Completed:
URL:
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