The effect of Barlow's unified protocol for transdiagnostic treatment on emotional symptoms, pain catastrophizing, fear of movement and disease activity in patients with rheumatoid arthritis
Determining the effect of Barlow's unified transdiagnostic treatment on emotional symptoms, pain catastrophizing, fear of movement and disease activity in rheumatoid arthritis patients.
Design
By referring to a rheumatology specialist, people who have a diagnosis are evaluated in the initial review of the entry criteria, and those who meet the entry criteria are selected. A pre-test is taken from these people and then the study group is subjected to extradiagnostic treatment. At the end, the questionnaires are re-administered to check their effectiveness.
Settings and conduct
The study will be conducted in the personal office of specialist in rheumatology. First, from the entry conditions, a pre-test was taken and then Barlow's unified transdiagnostic treatment was started for 8 sessions of 45 minutes for the experimental group, and after the completion of the treatment, the mentioned questionnaires will be administered again to check the effect. in all stages of the control group, they continued their usual drug treatment without any changes
Participants/Inclusion and exclusion criteria
Entry requirements
1- Age range from 18 to 60 years old
2- Rheumatoid arthritis has been diagnosed
3- At least 6 months have passed since the diagnosed
4- There is no other psychological illness
5- Informed consent
6- Keeping the type and amount of drug used
7- Education level of at least fifth grade
Non-entry conditions
1- The presence of any chronic physical disease
2- drug use
3- alcohol consumption
4- Absence in more than two meetings
5- Lack of participation and homework
6- The appearance of suicidal thoughts
7- Taking antidepressants and anti-anxiety drugs
Intervention groups
The group with UT treatment along with drug treatment; control group (received common drug treatment)
Main outcome variables
Emotional symptoms,pain catastrophizing,fear of movement,disease activity
General information
Reason for update
Acronym
Rheumatoid arthritis
IRCT registration information
IRCT registration number:IRCT20231210060327N1
Registration date:2024-04-19, 1403/01/31
Registration timing:registered_while_recruiting
Last update:2024-04-19, 1403/01/31
Update count:0
Registration date
2024-04-19, 1403/01/31
Registrant information
Name
zhina zarif khalili yazdani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3865 6513
Email address
zhina.yzn@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-23, 1402/11/03
Expected recruitment end date
2024-05-23, 1403/03/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Barlow's unified protocol for transdiagnostic treatment on emotional symptoms, pain catastrophizing, fear of movement and disease activity in patients with rheumatoid arthritis
Public title
The effect of Barlow's unified protocol for transdiagnostic treatment on emotional symptoms, pain catastrophizing, fear of movement and disease activity in patients with rheumatoid arthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range from 18 to 60 years old
Rheumatoid arthritis has been diagnosed by a specialist
At least 6 months have passed since the diagnosis of the disease by a specialist
There is no other psychological illness at the same time
Informed consent to participate in the research
Keeping the type and amount of drug used constant during the research period
Education level of at least fifth grade
Exclusion criteria:
The presence of any chronic physical disease such as cancer and MS at the same time, except for rheumatoid arthritis
Drug use
Alcohol consumption
Absence in more than two meetings
Lack of participation and homework
The appearance of suicidal thoughts or the experience of the death of a loved one
Taking antidepressants and anti-anxiety drugs
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
52
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
After individuals enter the study, code is decided for each individual and their survey. In this way, instead of their identification name, a code is placed at the beginning of the form. As a result, the evaluator and analyst do not know the identity of the people, the group in which each individua is (expectation or intervention) and the stage of treatment.
Placebo
Not used
Assignment
Parallel
Other design features
By referring to a rheumatology specialist, people who qualify for the interview will be invited. In the initial review, the entry criteria are evaluated and 52 people who have the entry criteria are selected as a sample for the purpose. Then, using the simple random method and the table of random numbers, the participants are divided into two experimental and control groups, and 26 people are placed in each group. In the pre-examination stage, questionnaires are mentioned from all the companies and the level of disease activity will be evaluated by means of formulas and questionnaires. Then, the experimental group will undergo Barlow's unified protocol for transdiagnostic treatment in addition to their usual medicine treatment, and the control group will continue their usual medicine treatment. After the completion of 8 sessions of 45 minutes of the experimental group, the questionnaire will be implemented again to check the effectiveness of the treatment for each group.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Faculty of Medicine and Dentistry - Kashan University of Medical Sciences (Research Ethics Committee
Street address
Pezeshk Boulevard, Qutb Ravandi Boulevard.
City
Kashan
Province
Isfehan
Postal code
8715981151
Approval date
2024-01-09, 1402/10/19
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1402.242
Health conditions studied
1
Description of health condition studied
Rheumatoid arthritis
ICD-10 code
M06.9
ICD-10 code description
Rheumatoid arthritis, unspecified
Primary outcomes
1
Description
Emotional symptoms (stress,anxiety,depression)
Timepoint
At the beginning of the study, after the end of the intervention
Method of measurement
Questionnaire DASS-21
2
Description
Pain catastrophizing
Timepoint
At the beginning of the study, after the end of the intervention
Method of measurement
PCS questionnaire
3
Description
Fear of movement
Timepoint
At the beginning of the study, after the end of the intervention
Method of measurement
Tampa questionnaire
4
Description
Disease activity
Timepoint
At the beginning of the study, after the end of the intervention
Method of measurement
DAS-28 questionnaire
5
Description
Difficulty regulating emotions
Timepoint
At the beginning of the study, after the end of the intervention
Method of measurement
DERS questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: unified protocol for transdiagnostic treatment for 8 sessions of 45 minutes.This treatment is generally used to help people who suffer from emotional disorders, regardless of the type of emotional problem. The focus of this treatment is on emotions, because emotional experiences take over a person's life and affect a person's behavior. The treatment includes 5 main parts: emotional awareness, cognitive flexibility, prevention of emotional avoidance and modification of behaviors caused by emotions, awareness of bodily sensations.
Category
Behavior
2
Description
Control group: receiving their usual drug treatment unchanged during the study period. The control group means the same group that does not receive any treatment except for its drug treatment.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr Zamani's office
Full name of responsible person
Zhina Zarif Khalili Yazdani
Street address
Shahid Beheshti St., Serah Ziarat - Nikan Building, first floor
City
kashan
Province
Isfehan
Postal code
8713783976
Phone
+98 31 5558 2405
Email
zhina.yzn@gmail.com
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 Sciences, Pezeshk Blvd., 57 Hekmat
City
Kashan
Province
Isfehan
Postal code
8713783976
Phone
+98 31 5544 3022
Email
hamidi_gh@kaums.ac.ir
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
70
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
Zhina Zarif Khalili Yazdani
Position
Master's student in clinical psychology
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Kashan University of Medical Sciences, Pezeshk Blvd., 57 Hekmat
City
Kashan
Province
Isfehan
Postal code
8713783976
Phone
+98 933 944 0984
Email
zhina.yzn@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zahra Zanjani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Kashan University of Medical Sciences, Pezeshk Blvd., 57 Hekmat
City
Kashan
Province
Isfehan
Postal code
8713783976
Phone
+98 31 5544 3022
Email
zanjani-z@kaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zhina Zarif Khalili Yazdani
Position
Master's Degree in Clinical Psychology
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Kashan University of Medical Sciences, Pezeshk Blvd., 57 Hekmat
City
Kashan
Province
Isfehan
Postal code
8713783976
Phone
+98 31 5544 3022
Email
zhina.yzn@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
According to the principle of confidentiality, the data is with the public official and can be sent and accessed if needed.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
The presentation of the study protocol is by mentioning the source and the description of the sessions. Also, the results of the study will be presented in a group form and with the average and standard deviation report.
When the data will become available and for how long
Autumn 2024
To whom data/document is available
People who want to use the data can access the data by contacting the general manager of the trial.
Under which criteria data/document could be used
In order to conduct meta-analysis studies if a study registration certificate is presented
From where data/document is obtainable
Kashan University of Medical Sciences, Research Unit
What processes are involved for a request to access data/document
First, establishing contact with Kashan University of Medical Sciences, Faculty of Medicine, and then communicating with the researcher via email or the relevant number, and finally stating the request for data and documents.