Determining the effectiveness of cognitive-behavioral therapy on reducing waiting anxiety and death anxiety in patients with multiple sclerosis
Design
Clinical trial work with a control group with parallel groups of a simple blind randomized phase 3 on 30 patients. A simple method has been used for randomization. That is, the first is included in the intervention group, the second is included in the non-intervention group, and so on.
Settings and conduct
The current research is a semi-experimental design of pre-test-post-test type with a control group. The statistical population of the present study consisted of 100 people from all patients with multiple sclerosis in Mazandaran province who had visited the MS clinic of Bo Ali Sina Hospital in Sari city between May 1401 and Shahrivar 1401 and met the criteria for entering the study. 30 people were randomly replaced in two experimental (15 people) and control (15 people) groups.
Participants/Inclusion and exclusion criteria
The criteria for entering the research included the following. The person has multiple sclerosis. At least 18 years old. Have at least a diploma. Do not have an acute psychiatric problem that may interfere with the intervention process—consent to participate in the research.
Exclusion criteria from the research: Occurrence of intervening psychiatric illness during the research. Non-cooperation of the participant absence of more than two sessions and receiving psychological interventions at the same time
Intervention groups
The intervention group underwent 45-minute cognitive-behavioral therapy individually once a week for 8 sessions. However, no action was taken on the control group.
Main outcome variables
Waiting anxiety; death anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220506054750N1
Registration date:2024-01-29, 1402/11/09
Registration timing:retrospective
Last update:2024-01-29, 1402/11/09
Update count:0
Registration date
2024-01-29, 1402/11/09
Registrant information
Name
Ramin Raee varandi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3339 3795
Email address
ramin.raee1373@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-21, 1401/02/01
Expected recruitment end date
2022-09-21, 1401/06/30
Actual recruitment start date
2022-04-21, 1401/02/01
Actual recruitment end date
2022-09-21, 1401/06/30
Trial completion date
2022-09-23, 1401/07/01
Scientific title
The effectiveness of cognitive-behavioral therapy in reducing anticipatory anxiety and death anxiety in patients with multiple sclerosis
Public title
Cognitive-Behavioral Therapy in MS
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All MS patients referred to the MS clinic of Bo Ali Sina Hospital in Sari from May 1401 to September 1401
Exclusion criteria:
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization: To ensure that all patients had an equal chance of receiving the new treatment under study, a coin toss was used for the participants to assign lions to the treatment group and lines to the no-treatment group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Biomedical Research, Islamic Azad University, Sari Branch
Street address
km 7 of Darya Road (Farahabad), Islamic Azad University, Khazar Square Sari branch, Sari, Mazandaran
City
Sari
Province
Mazandaran
Postal code
48164-194
Approval date
2022-04-17, 1401/01/28
Ethics committee reference number
IR.IAU.SARI.REC.1401.036
Health conditions studied
1
Description of health condition studied
multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
anxiety
Timepoint
8 sessions and once a week
Method of measurement
Anticipatory Anxiety Questionnaire; Death Anxiety Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: During 8 sessions, they underwent 45-minute cognitive-behavioral therapy individually once a week
Category
Rehabilitation
2
Description
Control group: No action was taken
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
بیمارستان بوعلی سینا ساری
Full name of responsible person
Ramin Raee Verandi
Street address
Pasdaran Blvd, Sari, Mazandaran Province,
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 3348
Email
smbaghbanian@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
دکتر علی عباس زاده
Street address
km 7 of Darya Road (Farahabad), university complex of Islamic Azad University, Sari branch
City
Sari
Province
Mazandaran
Postal code
48164-194
Phone
+98 11 3303 2891
Email
mohammadbaghbanian@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
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
Mazandaran University of Medical Sciences
Full name of responsible person
Seyed Mohammad Baghbanian
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Neurology
Street address
Pasdaran Blvd, Sari
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 3348
Email
mohammadbaghbanian@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Seyed Mohammad Baghbanian
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Neurology
Street address
Pasdaran Blvd, Sari,
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 3348
Email
smbaghbanian@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
SEYED MOHAMMAD BAGHBANIAN
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Neurology
Street address
Pasdaran Blvd, Sari
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 3348
Email
mohammadbaghbanian@gmail.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
Only a part of the data, such as the information related to the main result or the like, can be shared.
When the data will become available and for how long
"The access period starts 6 months after the publication of the results
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
There are no other conditions for the use of data or documentation
From where data/document is obtainable
Sayed Mohammad Baghbanian - Bo Ali Sina Hospital, MS Clinic, Pasdaran Blvd., Sari - Tel: 00981133343348
What processes are involved for a request to access data/document
The applicant can receive the documents through the email below and after presenting the ethics code of her study.
mohammadbaghbanian@gmail.com