Protocol summary
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Study aim
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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.
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Design
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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
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Settings and conduct
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Before and after the intervention,from both groups received questionnaires and HbA1C tests
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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 .
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Main outcome variables
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Self-compassion, Self-efficacy, Illness perception, Self-care activities, Psychological flexibility and HbA1C
General information
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Reason for update
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Acronym
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IRCT registration information
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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
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Registration date
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2019-01-04, 1397/10/14
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2017-09-25, 1396/07/03
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Expected recruitment end date
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2017-11-01, 1396/08/10
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Actual recruitment start date
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2017-09-25, 1396/07/03
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Actual recruitment end date
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2017-11-01, 1396/08/10
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Trial completion date
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2019-02-01, 1397/11/12
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Scientific title
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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
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Public title
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Effect of ACT on diabetes
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 40 years old to 55 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
60
Actual sample size reached:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Simple randomized
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-09-06, 1396/06/15
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Ethics committee reference number
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IR.KAUMS.MEDNT.REC.1396.60
Health conditions studied
1
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Description of health condition studied
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Type 2 diabetes mellitus
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ICD-10 code
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E11
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ICD-10 code description
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Type 2 diabetes mellitus
Primary outcomes
1
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Description
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Self-efficacy
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Timepoint
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Before intervention, After intervention
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Method of measurement
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The Diabetes Management Self-efficacy Scale (DMSES)
2
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Description
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Hemoglobin A1c
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Timepoint
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Before and after the intervention
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Method of measurement
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Blood-test
3
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Description
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Self compassion
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Timepoint
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Before and after the intervention
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Method of measurement
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Self-compassion scale
4
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Description
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Self- care
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Timepoint
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Weekly
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Method of measurement
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Diabetes Self-Care Activities questionnaire (SDSCA)
5
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Description
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Psychological flexibility
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Timepoint
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Before and after the intervention
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Method of measurement
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Acceptance and Action Diabetes questionnaire (AADQ)
6
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Description
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Illness perception
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Timepoint
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Before and after the intervention
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Method of measurement
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Brief illness perception questionnaire(B-IPQ)
Intervention groups
1
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Description
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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.
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Category
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Behavior
2
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Description
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Control group: control group includes routine medicine treatment that depends on Endocrinologist diagnosis without psychotherapy .
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Kashan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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All information about questionnaires and tests is available
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When the data will become available and for how long
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Start the access period 6 months after publishing the results
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To whom data/document is available
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Researchers who works in academic institutions and university
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Under which criteria data/document could be used
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If data is only intended to facilitate another research work, and the use of this information alone is not permissible in other articles.
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From where data/document is obtainable
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Fahimeh Nasiri
Contact number:98 9366422655
email: f99n99@yahoo.com
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What processes are involved for a request to access data/document
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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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Comments
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