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Investigation and comparison of two treatment protocols based on transcranial direct current stimulation (Tdcs) and treatment based on acceptance and commitment (ACT) on reducing the intensity of pain, anxiety and depression in patients with rheumatoid arthritis.

Protocol summary

Study aim
Comparison of the effect of two treatment protocols of transcranial stimulation with acceptance and commitment therapy on chronic pain, anxiety and depression.
Design
The statistical population of the study includes all male and female outpatients suffering from chronic pain of rheumatoid arthritis in Tehran city, who will be diagnosed with rheumatoid arthritis by a rheumatology specialist through referring to the rheumatology department of Shariati and Family Hospitals.
Settings and conduct
Department of Rheumatology, Family and Dr. Shariati Hospitals, Tehran
Participants/Inclusion and exclusion criteria
The criteria for entry is to have a medical record as a patient with rheumatoid arthritis, not having a mental disorder and not abusing drugs and drug addiction, the desire to Participation in research.No medical conditions in the past 6 months, cardiovascular diseases, use of illegal drugs in the past 30 days, psychotic disorder, bipolar disorder, clinically significant suicidal thoughts, previous seizures, current pregnancy, trying to conceive, current breastfeeding, disorder Active alcohol consumption, metal in the head, implanted electromedical device, brain injury with loss of consciousness longer than five minutes and previous exposure to tdcs.
Intervention groups
The current cross-sectional study and the research method in this research will be semi-experimental with the structure of three experimental groups and one control group, with pre-test - post-test and one-month follow-up. Measurements will be taken three times: at baseline, post-intervention, and 1-month follow-up.
Main outcome variables
Main variables (independent): Two treatment protocols based on transcranial direct electrical stimulation (Tdcs) and treatment based on acceptance and commitment Act) Dependent variables: anxiety, depression and chronic pain.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240629062274N1
Registration date: 2024-07-01, 1403/04/11
Registration timing: registered_while_recruiting

Last update: 2024-07-01, 1403/04/11
Update count: 0
Registration date
2024-07-01, 1403/04/11
Registrant information
Name
Maryam Sadeqpur
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7709 1533
Email address
sadeqpur931@atu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-01, 1403/04/11
Expected recruitment end date
2024-09-01, 1403/06/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation and comparison of two treatment protocols based on transcranial direct current stimulation (Tdcs) and treatment based on acceptance and commitment (ACT) on reducing the intensity of pain, anxiety and depression in patients with rheumatoid arthritis.
Public title
Investigation and comparison of two treatment protocols based on transcranial direct current stimulation (Tdcs) and treatment based on acceptance and commitment (ACT) on reducing the intensity of pain, anxiety and depression in patients with rheumatoid arthritis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The people assigned to the groups must have the entry criteria, which include: having a history of one year of treatment under the supervision of a rheumatic disease specialist and having a medical record, not having a mental disorder and not abusing drugs and drug addiction, the desire to Participation in research.
Exclusion criteria:
Exclusion criteria for participants: medical diseases in the last 6 months, cardiovascular diseases, use of illegal drugs in the last 30 days, psychotic disorder, bipolar disorder, clinically significant suicidal thoughts, previous seizures, current pregnancy, attempt to Being pregnant, current breastfeeding, active alcohol use disorder, metal in the head, implanted electromedical device, brain injury with loss of consciousness longer than five minutes, and previous exposure to tdcs.
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
N/A
Randomization description
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
Research Ethics Committees of Lorestan University of Medical Sciences
Street address
Faculty of Medicine,Khorramabad University of Medical Sciences
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Approval date
2024-06-18, 1403/03/29
Ethics committee reference number
IR.LUMS.REC.1403.127

Health conditions studied

1

Description of health condition studied
rheumatoid arthritis
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
reduction Chronic pain will be determined by the participant's score on the McGill Pain Questionnaire
Timepoint
Assessment in the pre-test - after the intervention and once a month after the intervention in the follow-up period
Method of measurement
McGill pain questionnaire and visual pain scale

2

Description
reduction depression
Timepoint
Assessment in the pre-test - after the intervention and once a month after the intervention in the follow-up period
Method of measurement
It will be measured through the person's score in the Beck depression test

3

Description
reduction anxiety
Timepoint
Assessment in the pre-test - after the intervention and once a month after the intervention in the follow-up period
Method of measurement
The score that the participant will get in the Beck anxiety test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 3 intervention groups,Two groups of transcranial direct electrical stimulation and one treatment group based on acceptance and commitment.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Family and Dr. Shariati hospitals
Full name of responsible person
Maryam Sadeqpur
Street address
Kaj St , Shariati St. Family Superspeciality Hospital, Tehran
City
Tehran
Province
Tehran
Postal code
1648778661
Phone
+98 21 7750 7512
Email
sadeqpur931@atu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
سیاوش بیرانوند
Street address
University of Medical Sciences, Shahid Moalem ,SKhorram Abad,t. Rezaei Square, Lorestan
City
خرم آباد
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3330 2030
Email
publicrelation@lums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Dissertation grant
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
Khoram-Abad University of Medical Sciences
Full name of responsible person
Firuzeh Ghazanfari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No.26, Hossein Asgary Ave.,Resalat Square, High way Soleimani, Tehran
City
Tehran
Province
Tehran
Postal code
1648778661
Phone
+98 21 7709 1533
Email
Firoozeh.ghazanfari@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Lorestan University
Full name of responsible person
Maryam Sadeqpur
Position
PhD student
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No.26, Hossein Asgary Ave.,Resalat Square, High way Soleimani, Tehran
City
Tehran
Province
Tehran
Postal code
1648778661
Phone
+98 21 7709 1533
Email
sadeqpur931@atu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Lorestan University
Full name of responsible person
Firuzeh Ghazanfari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No.26, Hossein Asgary Ave.,Resalat Square, High way Soleimani, Tehran
City
Tehran
Province
Tehran
Postal code
1648778661
Phone
+98 21 7709 1533
Email
Firoozeh.ghazanfari@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
No - There is not 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
No - There is not a plan to make this available
Title and more details about the data/document
The results of the data extracted from this research and statistical analysis will be published in general and without the names of the participants
When the data will become available and for how long
A period of 6 months is considered for data access
To whom data/document is available
Research supervisor, supervisor, consultant, statistician, and in the end, it will be included in the doctoral dissertation as a statistical statement.
Under which criteria data/document could be used
Documentary data can be used for research activities
From where data/document is obtainable
Lorestan University Library
What processes are involved for a request to access data/document
Probably physical presence in Lorestan University library or electronic request
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