Comparing the effectiveness of acceptance and commitment-based therapy and compassion-focused therapy on death anxiety, fear of falling, life expectancy and demoralization symptoms in patients with multiple sclerosis
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Intervention groups
#1
Control group: It will include 15 sample people who will not receive any treatment intervention
Control Group: Includes 20 samples who will not get any therapeutic intervention
Control groupGroup: It will include 15 sample peopleIncludes 20 samples who will not receiveget any treatmenttherapeutic intervention
گروه کنترل: شامل 15 نفر نمونه خواهد بود که هیچ گونه مداخله درمانی نخواهند گرفت
گروه کنترل: شامل 20 نفر نمونه خواهد بود که هیچ گونه مداخله درمانی نخواهند گرفت
گروه کنترل: شامل 1520 نفر نمونه خواهد بود که هیچ گونه مداخله درمانی نخواهند گرفت
Recruitment centers
#1
Name of recruitment center - English: Imam Reza Tabriz Hospital
Name of recruitment center - Persian: بیمارستان امام رضا تبریز
Full name of responsible person - English: Mojtaba Mohammadzadeh
Full name of responsible person - Persian: مجتبی محمدزاده
Street address - English: Golgasht St., in front of the central organization of the University-Imam Reza Educational and Medical Center
Street address - Persian: خیابان گلگشت روبروی سازمان مرکزی دانشگاه-مرکز آموزشی و درمانی امام رضا
City - English: تبریز
City - Persian: Tabriz
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5166614756
Phone: +98 41 3334 7054
Fax: +98 41 3335 2073
Email: imamreza@tbzmed.ac.ir
Web page address: https://imamreza.tbzmed.ac.ir/
Name of recruitment center - English: Imam Reza Tabriz Hospital
Name of recruitment center - Persian: بیمارستان امام رضا تبریز
Full name of responsible person - English: Mojtaba Mohammadzadeh
Full name of responsible person - Persian: مجتبی محمدزاده
Street address - English: Golgasht St., in front of the central organization of the University-Imam Reza Educational and Medical Center
Street address - Persian: خیابان گلگشت روبروی سازمان مرکزی دانشگاه-مرکز آموزشی و درمانی امام رضا
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5166614756
Phone: +98 41 3334 7054
Fax: +98 41 3335 2073
Email: imamreza@tbzmed.ac.ir
Web page address: https://imamreza.tbzmed.ac.ir/
Name of recruitment center - English: Imam Reza Tabriz Hospital Name of recruitment center - Persian: بیمارستان امام رضا تبریز Full name of responsible person - English: Mojtaba Mohammadzadeh Full name of responsible person - Persian: مجتبی محمدزاده Street address - English: Golgasht St., in front of the central organization of the University-Imam Reza Educational and Medical Center Street address - Persian: خیابان گلگشت روبروی سازمان مرکزی دانشگاه-مرکز آموزشی و درمانی امام رضا City - English: تبریزTabriz City - Persian: Tabrizتبریز Province: East Azarbaijan Country: Iran (Islamic Republic of) Postal code: 5166614756 Phone: +98 41 3334 7054 Fax: +98 41 3335 2073 Email: imamreza@tbzmed.ac.ir Web page address: https://imamreza.tbzmed.ac.ir/
Protocol summary
Study aim
Determining the comparative effectiveness of acceptance and commitment-based therapy and compassion-focused therapy on death anxiety, fear of falling, life expectancy and demoralization symptoms in patients with multiple sclerosis.
Design
The clinical trial will include two intervention groups, ACT, CFT, and a control group, which will be purposefully sampled and assigned to the groups using a random number table.
Settings and conduct
After sampling and performing the pre-test, each group will be individually subjected to CFT and ACT intervention, and then the post-test will be performed in that case, and these measures will be performed by obtaining the necessary permits in Imam Reza Hospital, Tabriz University of Medical Sciences
Participants/Inclusion and exclusion criteria
Criteria for the diagnosis of MS by a neurologist
Being 20 to 50 years old
At least two years have passed since the illness
Consent to participate in the research and not having other acute and chronic physical and psychological diseases based on the patient's medical record
Exit criteria
Absence in two training sessions
Non-cooperation and not doing the tasks specified in the training course
Intervention groups
In this research, there will be three groups including two intervention groups with ACT and CFT treatment on MS patients and one group as a control group.
Main outcome variables
death anxiety ; fear of falling (falling); life expectancy; Depression syndrome
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231112060034N1
Registration date:2024-01-04, 1402/10/14
Registration timing:prospective
Last update:2024-01-08, 1402/10/18
Update count:1
Registration date
2024-01-04, 1402/10/14
Registrant information
Name
AmirAbolfazl Azizpour
Name of organization / entity
Tabriz Azad University
Country
Iran (Islamic Republic of)
Phone
+98 41 4423 9382
Email address
stu.a.azizpour@iaut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-05, 1402/10/15
Expected recruitment end date
2024-02-04, 1402/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of acceptance and commitment-based therapy and compassion-focused therapy on death anxiety, fear of falling, life expectancy and demoralization symptoms in patients with multiple sclerosis
Public title
Investigating the effect of acceptance and commitment-based therapy and compassion-focused therapy on multiple sclerosis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of MS disease by brain and nerve specialist and referral of medical case to MS Society
Being 20 to 50 years old
At least two years have passed since the illness
Consent to participate in the research
Not having other acute and chronic physical and psychological diseases based on the patient's medical record
Exclusion criteria:
Absence in two training sessions and non-cooperation
Not doing the tasks specified in the training course
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
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 Islamic Azad university-Tabriz Branch
Street address
Nagin Building, Golestan Street, Amir Kabir Street, Baghmisheh Town
City
Tabriz
Province
East Azarbaijan
Postal code
5155994599
Approval date
2023-08-08, 1402/05/17
Ethics committee reference number
IR.IAU.TABRIZ.REC.1402.201
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
The score that subjects will get from answering the questions of the death anxiety scale (Templer, 1970).
Timepoint
Pre-test and post-test before and after ACT, CFT intervention and after the follow-up period
Method of measurement
Templer Death Anxiety Scale
2
Description
The score that the subjects will get from the answers to the questions of the short scale of efficiency in falling the international form (Kampen et al., 2008).
Timepoint
Pre-test and post-test before and after ACT, CFT intervention and after the follow-up period
Method of measurement
Short scale of efficiency in falling - international form
3
Description
The score that the subjects will get from the answers to the questions of the depression syndrome questionnaire (Kisan et al., 2004).
Timepoint
Pre-test and post-test before and after ACT, CFT intervention and after the follow-up period
Method of measurement
Questionnaire of Kisan's low morale syndrome
4
Description
The score that subjects will get from answering the questions of Omid Snyder's questionnaire (Snyder, 1991).
Timepoint
Pre-test and post-test before and after ACT, CFT intervention and after the follow-up period
Method of measurement
Hope Snyder questionnaire
5
Description
In the current research, acceptance and commitment based therapy is the training of skills based on the acceptance and commitment therapy protocol (Hayes and Stroshall, 2005), and it will be carried out during 8 sessions of 60 minutes.
Timepoint
Pre-test and post-test before and after ACT, CFT intervention and after the follow-up period
Method of measurement
Treatment protocol based on acceptance and commitment
6
Description
In the present research, the treatment focused on compassion is the training of skills based on the program of Gilbert (2010) and will be carried out during 8 sessions of 60 minutes.
Timepoint
Pre-test and post-test before and after ACT, CFT intervention and after the follow-up period
Method of measurement
Compassion-focused therapy
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For the first experimental group, commitment-based acceptance therapy will be performed in 8 sessions of 60 minutes. The commitment-based acceptance therapy used in this research will be based on the therapeutic protocol of Hayes and Stroshall (2005).
Category
Treatment - Other
2
Description
Intervention group: For the second experimental group, treatment focused on compassion will be done in 8 sessions of 60 minutes. The therapy focused on compassion used in this study was determined based on the program of Gilbert (2010).
Category
Treatment - Other
3
Description
Control Group: Includes 20 samples who will not get any therapeutic intervention
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Tabriz Hospital
Full name of responsible person
Mojtaba Mohammadzadeh
Street address
Golgasht St., in front of the central organization of the University-Imam Reza Educational and Medical Center
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 7054
Fax
+98 41 3335 2073
Email
imamreza@tbzmed.ac.ir
Web page address
https://imamreza.tbzmed.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Rahim Vakilzadeh
Street address
astern side of Pasdaran highway, Tabriz Islamic Azad University educational complex
City
Tabriz
Province
East Azarbaijan
Postal code
5157944533
Phone
+98 41 3196 6000
Fax
+98 41 3196 6000
Email
info@iaut.ac.ir
Web page address
https://tabriz.iau.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad university
Proportion provided by this source
1
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
Islamic Azad University
Full name of responsible person
AmirAbolfazl Azizpour
Position
Psychologist
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Nagin Building, Golestan Street, Amir Kabir Street, Baghmisheh Town
City
Tabriz
Province
East Azarbaijan
Postal code
5155994599
Phone
+98 41 4423 9382
Fax
Email
stu.a.azizpour@iaut.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
AmirAbolfazl Azizpour
Position
Psychologist
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Nagin Building, Golestan Street, Amir Kabir Street, Baghmisheh Town
City
Tabriz
Province
East Azarbaijan
Postal code
5155994599
Phone
+98 41 4423 9382
Fax
Email
stu.a.azizpour@iaut.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
AmirAbolfazl Azizpour
Position
Psychologist
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Nagin Building, Golestan Street, Amir Kabir Street, Baghmisheh Town
City
Tabriz
Province
East Azarbaijan
Postal code
5155994599
Phone
+98 41 4423 9382
Fax
Email
stu.a.azizpour@iaut.ac.ir
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
Yes - There is 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
Title and more details about the data/document
There is no further information
When the data will become available and for how long
There is no further information
To whom data/document is available
There is no further information
Under which criteria data/document could be used
There is no further information
From where data/document is obtainable
There is no further information
What processes are involved for a request to access data/document