Determine the effectiveness of acceptance and commitment therapy on the severity of pain perception, improvement in pain acceptance, self-compassion, quality of sleep, and occupational and social function of diabetic neuropathy
Design
A randomized, clinical trial with a control group and a sample size of 24
Settings and conduct
Patients with diabetic neuropathy after diagnosis by a neurologist in Kermanshah Diabetes Centers and consideration of entry and exit criteria are included in the study and divided into control and experimental groups. Initially, a pre-test is performed from both groups, Then the test group is provided with eight therapy sessions. After the therapy is completed, the post-test is taken from the patients and eventually, a two month follow-up period is taken from the patients. The control group also receives a common psychological therapy after the end of the study. All stages of therapy are carried out at the Farabi hospital in Kermanshah.
Participants/Inclusion and exclusion criteria
Inclusion criteria: diagnosis of diabetic neuropathy is characterized by a neurologist. Patient agrees to participate in the research. Age range 35 to 65 years. Having at least the eighth grade. Exit criteria: Concurrent participation in other therapeutic plan having substance abuse and somatization disorder
Intervention groups
Experimental group: they receive 8 psychological therapy sessions. Control group: they receive only medication.
A study of effectiveness of acceptance and commitment therapy on improving psychopathological symptoms of patients with diabetic neuropathy
Public title
Effect of acceptance and commitment therapy on diabetic neuropathy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of diabetic neuropathy by a neurologist
willingness to participate in the research
Age range 35 to 65 years old
Having at least eighth school grade
Exclusion criteria:
Drug abuse
Concurrent participation in other therapeutic plan
Having any somatization disorder
Age
From 35 years old to 65 years old
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
By the simple random method, individuals are assigned to the control and test groups using a sealed envelope
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 Kermanshah University of Medical Sciences
Street address
In front of Taleghani Hospital, Naft square
City
Kermanshah
Province
Kermanshah
Postal code
56423-22222
Approval date
2019-02-16, 1397/11/27
Ethics committee reference number
IR.KUMS.REC.1397.939
Health conditions studied
1
Description of health condition studied
diabetic neuropathy
ICD-10 code
E13.40
ICD-10 code description
Other specified diabetes mellitus with diabetic neuropathy, unspecified
Primary outcomes
1
Description
Score in Acceptance Chronic Pain Questionnaire
Timepoint
At the beginning of the study, after the study (after the end of the intervention) and two months after the study
Method of measurement
Acceptance chronic pain Questionnaire
2
Description
Score in McGill Pain Revised Questionnaire
Timepoint
At the beginning of the study, after the study (after the end of the intervention) and two months after the study
Method of measurement
McGill Pain Revised Questionnaire
3
Description
Score in Self-Compassion Scale (Short Form)
Timepoint
At the beginning of the study, after the study (after the end of the intervention) and two months after the study
Method of measurement
Self-Compassion Scale
4
Description
Score in Sleep Quality Inventory
Timepoint
At the beginning of the study, after the study (after the end of the intervention) and two months after the study
Method of measurement
Sleep Quality Inventory
5
Description
Score in Occupational and Social Adjustment Scale
Timepoint
At the beginning of the study, after the study (after the end of the intervention) and two months after the study
Method of measurement
Occupational and Social Adjustment Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Individuals receive acceptance and commitment therapy in addition to anti-pain medication for eight weeks. After the treatment is completed, the post test will be taken from people under treatment and the two-month follow-up period will be done.
Category
Behavior
2
Description
Control group: Individuals receive anti-pain medication for eight weeks. After the treatment is completed, the post test will be taken from people under treatment and the two-month follow-up period will be done.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Farabi Hospital
Full name of responsible person
leila Afshar Hazarkhani
Street address
Farabi Hospital, Dolat Abad Square
City
Kermanshah
Province
Kermanshah
Postal code
49564-39936
Phone
+98 83 3822 6451
Email
taheriamir679@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
In front of Taleghani Hospital, Naft square
City
kermanshah
Province
Kermanshah
Postal code
4562388887
Phone
+98 83 3838 4180
Fax
Email
fnajafi@kums.ac.ir
Grant name
Kermanshah University of Medical Sciences
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
Amir Abbas Taheri
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Faculty of Medical, Sorkhe lize Ave, Parastar Blvd
City
Kermanshah
Province
Kermanshah
Postal code
8614733481
Phone
+98 31 5322 6077
Email
taheriamir679@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Ali Akbar Foroughi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Medical School, Kermanshah University of Medical Sciences, Parastar Blvd
City
Kermanshah
Province
Kermanshah
Postal code
671451568
Phone
+98 83 3837 4371
Email
foroughi_2002@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Amir Abbas Taheri
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Medical School, Kermanshah University of Medical Sciences, Parastar Blvd
City
kermanshah
Province
Kermanshah
Postal code
8614733491
Phone
+98 31 5322 6077
Email
taheriamir679@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available