History
# Registration date Revision Id
2 2019-01-06, 1397/10/16 75621
1 2019-01-04, 1397/10/14 73780
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  • Protocol summary

    Regarding the high prevalence of type 2 diabetes, its severe complications in the community, the association of this disease with the lifestyle of the individual and the lack of medical interventions. we should used psychological interventions along with medical interventions. The aim of this study was to determine the effectiveness of Acceptance and Commitment Therapy on Self-efficacy and HbA1C in type 2 diabetic patients.
    The aim of this study was to determine the effectiveness of Acceptance and Commitment Therapy on Self-compassion, Self-efficacy, Illness perception, Self-care activities, Psychological flexibility and HbA1C in type 2 diabetic patients.
    با توجه به شیوع زیاد دیابت نوع 2، عوارض شدید آن در جامعه، ارتباط این بیماری با سبک زندگی فرد و از طرف دیگر ناکافی بودن مداخلات پزشکی باید از مداخلات روانشناختی در کنار مداخلات پزشکی استفاده شود. هدف از مطالعه بررسی تاثیر درمان مبتنی بر پذیرش و تعهد بر خودکارآمدی و HbA1C در بیماران مبتلا به دیابت نوع 2 است
    هدف از مطالعه بررسی تاثیر درمان مبتنی بر پذیرش و تعهد بر خودشفقت ورزی، خودکارآمدی، ادراک بیماری، رفتارهای خودمراقبتی، انعطاف پذیری روانشناختی و HbA1C در بیماران مبتلا به دیابت نوع 2 است
    قبل و بعد از انجام مداخله از هر دو گروه پرسشنامه و آزمایش HbA1C گرفته شده است
    قبل و بعد از انجام مداخله از هر دو گروه پرسشنامه ها و آزمایش HbA1C گرفته شده است
    Independent variable: Acceptance and Commitment Therapy Dependent variable: Self-efficacy and HbA1c
    Self-compassion, Self-efficacy, Illness perception, Self-care activities, Psychological flexibility and HbA1C
    متغیر مستقل: درمان مبتنی بر پذرش و تعهد متغییر وابسته: خودکارآمدی و HbA1c
    خودشفقت ورزی، خودکارآمدی، ادراک بیماری، رفتارهای خود -مراقبتی، انعطاف پذیری روانشناختی وHbA1C
  • General information

    Effectiveness of group Acceptance and Commitment Therapy on Self-efficacy and HbA1C in type II diabetic patients.
    Effectiveness of group Acceptance and Commitment Therapy on Self-compassion, Self-efficacy, Illness perception, Self-care activities, Psychological flexibility and HbA1C in type II diabetes
    بررسی تاثیر درمان گروهی مبتنی بر پذیرش و تعهد بر خودکارآمدی و HbA1C بیماران مبتلا به دیابت نوع دو
    بررسی تاثیر درمان گروهی مبتنی بر پذیرش و تعهد بر خودشفقت ورزی، خودکارآمدی، ادراک بیماری، رفتارهای خود -مراقبتی، انعطاف پذیری روانشناختی و هموگلوبین A1C بیماران مبتلا به دیابت نوع II
  • Primary outcomes

    #1
    empty
    Self compassion
    empty
    خود شفقت ورزی
    empty
    Before and after the intervention
    empty
    قبل از مداخله و پس از مداخله
    empty
    Self-compassion scale
    empty
    مقیاس خودشفقت ورزی
    #2
    empty
    Self- care
    empty
    خودمراقبتی
    empty
    Weekly
    empty
    هفتگی
    empty
    Diabetes Self-Care Activities questionnaire (SDSCA)
    empty
    پرسشنامه ی رفتارهای خودمراقبتی در دیابت
    #3
    empty
    Psychological flexibility
    empty
    انعطاف پذیری روانشناختی
    empty
    Before and after the intervention
    empty
    قبل از مداخله و پس از مداخله
    empty
    Acceptance and Action Diabetes questionnaire (AADQ)
    empty
    پرسشنامه ی پذیرش و عمل در دیابت
    #4
    empty
    Illness perception
    empty
    ادراک بیماری
    empty
    Before and after the intervention
    empty
    قبل از مداخله و پس از مداخله
    empty
    Brief illness perception questionnaire(B-IPQ)
    empty
    پرسشنامه ی ادراک بیماری فرم کوتاه
  • Recruitment centers

    #1
    Name of recruitment center - English: shahid beheshti hospital
    Name of recruitment center - Persian: بیمارستان شهید بهشتی
    Full name of responsible person - English: mozafari
    Full name of responsible person - Persian: مظفری
    Street address - English: Ravand Blv
    Street address - Persian: بلوار راوند
    City - English: kashan
    City - Persian: کاشان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 8715981151
    Phone: +98 31 5554 0026
    Fax:
    Email: beheshtihospital@kaums.ac.ir
    Web page address:
    Name of recruitment center - English: Shahid Beheshti hospital
    Name of recruitment center - Persian: بیمارستان شهید بهشتی
    Full name of responsible person - English: Dr.Majid Mozafari
    Full name of responsible person - Persian: دکتر مجید مظفری
    Street address - English: Kashan University of Medical Science, Qhotbe Ravandi Blv, Kashan, Esfahan
    Street address - Persian: اصفهان، کاشان، بلوار قطب راوندی، دانشگاه علوم پزشکی کاشان
    City - English: Kashan
    City - Persian: کاشان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 8715981151
    Phone: +98 31 5554 0026
    Fax:
    Email: beheshtihospital@kaums.ac.ir
    Web page address:
  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Gholamali Hamidi
    Full name of responsible person - Persian: غلام علی حمیدی
    Street address - English: kashan university of medical science, ghotbe ravandi blv, Kashan
    Street address - Persian: کاشان، بلوار قطب راوندی، دانشگاه علوم پزشکی کاشان
    City - English: kashan
    City - Persian: کاشان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 8715988141
    Phone: +98 31 5554 9111
    Fax:
    Email: f99n99@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr.Gholamali Hamidi
    Full name of responsible person - Persian: دکتر غلام علی حمیدی
    Street address - English: Kashan University of Medical Science, Qhotbe Ravandi Blv, Kashan
    Street address - Persian: کاشان، بلوار قطب راوندی، دانشگاه علوم پزشکی کاشان
    City - English: Kashan
    City - Persian: کاشان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 8715988141
    Phone: +98 31 5554 9111
    Fax:
    Email: f99n99@yahoo.com
    Web page address:

Protocol summary

Study aim
The aim of this study was to determine the effectiveness of Acceptance and Commitment Therapy on Self-compassion, Self-efficacy, Illness perception, Self-care activities, Psychological flexibility and HbA1C in type 2 diabetic patients.
Design
A clinical trial with a pretest and post test design with a control group that 60 patients with diagnosis type 2 diabetes were randomly assigned to two groups of intervention and control
Settings and conduct
Before and after the intervention,from both groups received questionnaires and HbA1C tests
Participants/Inclusion and exclusion criteria
Inclusion criteria Having an age of 40 til 55 years Diagnosis of Type II diabetes by Endocrinologist Having a degree in secondary education or higher Having Type 2 diabetes at least for one year Exit criteria Receiving another psychological treatments in a recent year and research time Failing to participate in more than two sessions of the study Need to change medication or hospitalization during the study Having diabetes complications that prevent the study
Intervention groups
Intervention group: The intervention group includes routine medicine treatment that depends on Endocrinologist diagnosis and receiving Acceptance and Commitment Therapy in eight 90- minutes sessions for two months. Control group: Control group includes routine medicine treatment that depends on Endocrinologist diagnosis without psychotherapy .
Main outcome variables
Self-compassion, Self-efficacy, Illness perception, Self-care activities, Psychological flexibility and HbA1C

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181127041774N1
Registration date: 2019-01-04, 1397/10/14
Registration timing: retrospective

Last update: 2019-01-16, 1397/10/26
Update count: 1
Registration date
2019-01-04, 1397/10/14
Registrant information
Name
Fahimeh Nasiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0021
Email address
f99n99@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-25, 1396/07/03
Expected recruitment end date
2017-11-01, 1396/08/10
Actual recruitment start date
2017-09-25, 1396/07/03
Actual recruitment end date
2017-11-01, 1396/08/10
Trial completion date
2019-02-01, 1397/11/12
Scientific title
Effectiveness of group Acceptance and Commitment Therapy on Self-compassion, Self-efficacy, Illness perception, Self-care activities, Psychological flexibility and HbA1C in type II diabetes
Public title
Effect of ACT on diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 40 to 55 years old Diagnosis of type 2 diabetes by doctor Having a degree in secondary education or higher Having Type 2 diabetes at least for one year
Exclusion criteria:
Receiving another psychological treatments in a recent year and research time Failing to participate in more than two sessions of the study Need to change medication or hospitalization during the study Having diabetes complications that prevent the study
Age
From 40 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Actual sample size reached: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomized
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 Kashan University of Medical Sciences
Street address
Qotb Ravandi Blv
City
Kashan
Province
Isfehan
Postal code
8713781147
Approval date
2017-09-06, 1396/06/15
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1396.60

Health conditions studied

1

Description of health condition studied
Type 2 diabetes mellitus
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus

Primary outcomes

1

Description
Self-efficacy
Timepoint
Before intervention, After intervention
Method of measurement
The Diabetes Management Self-efficacy Scale (DMSES)

2

Description
Hemoglobin A1c
Timepoint
Before and after the intervention
Method of measurement
Blood-test

3

Description
Self compassion
Timepoint
Before and after the intervention
Method of measurement
Self-compassion scale

4

Description
Self- care
Timepoint
Weekly
Method of measurement
Diabetes Self-Care Activities questionnaire (SDSCA)

5

Description
Psychological flexibility
Timepoint
Before and after the intervention
Method of measurement
Acceptance and Action Diabetes questionnaire (AADQ)

6

Description
Illness perception
Timepoint
Before and after the intervention
Method of measurement
Brief illness perception questionnaire(B-IPQ)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The intervention group includes routine medicine treatment that depends on Endocrinologist diagnosis and receiving Acceptance and Commitment Therapy in eight 90- minutes sessions for two months.
Category
Behavior

2

Description
Control group: control group includes routine medicine treatment that depends on Endocrinologist diagnosis without psychotherapy .
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti hospital
Full name of responsible person
Dr.Majid Mozafari
Street address
Kashan University of Medical Science, Qhotbe Ravandi Blv, Kashan, Esfahan
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0026
Email
beheshtihospital@kaums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr.Gholamali Hamidi
Street address
Kashan University of Medical Science, Qhotbe Ravandi Blv, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 9111
Email
f99n99@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Fahimeh Nasiri
Position
MSc student of clinical psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Kashan University of Medical Science, Qhotbe Ravandi Blv, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 9111
Email
f99n99@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Fahimeh Nasiri
Position
MSc student of clinical psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Kashan University of Medical Science, Qhotbe Ravandi Blv, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 9111
Email
f99n99@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Fahimeh Nasiri
Position
MSc student of clinical psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Kashan University of Medical Science, Qhotbe Ravandi Blv, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 9111
Email
f99n99@yahoo.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
All information about questionnaires and tests is available
When the data will become available and for how long
Start the access period 6 months after publishing the results
To whom data/document is available
Researchers who works in academic institutions and university
Under which criteria data/document could be used
If data is only intended to facilitate another research work, and the use of this information alone is not permissible in other articles.
From where data/document is obtainable
Fahimeh Nasiri Contact number:98 9366422655 email: f99n99@yahoo.com
What processes are involved for a request to access data/document
By e-mail with their introduction and explanation of the cause and manner of using the information, they can request information.
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