The Effectiveness of Acceptance and Commitment-Based Treatment Approach on Perceived Stress Scales and Emotional Adjustment in Patients with Multiple Sclerosis
The purpose of this study was to evaluate the effectiveness of treatment based on acceptance and commitment on perceived stress components(perceived tensin and self-efficacy) and emotional adjustment in patients with multiple sclerosis.
Design
Clinical trial with experimental and control groups, parallel groups, not-blind, non-random allocation to control and experimental groups; sample size is 40 patients
Settings and conduct
Intervention sessions were held during 8 sessions and for 2 months (one session per week) at Sina Hospital in Hamadan Province.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Multiple sclerosis according to neurologist diagnosis; willingness and conscious consent to participate in the research project; being literate; Ability to attend meetings; age range between 20 to 50 years old; The duration of the disease ranges from 2 to 5 years.
Non-inclusion criteria: severe physical problems.
Intervention groups
The research groups consisted of experimental group and control group. The experimental group received admission and commitment-based treatment interventions within two months, but the control group did not receive any intervention.
The Effectiveness of Acceptance and Commitment-Based Treatment Approach on Perceived Stress Scales and Emotional Adjustment in Patients with Multiple Sclerosis
Public title
The Effectiveness of Acceptance and Commitment-Based Treatment in Multiple Sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Multiple sclerosis is diagnosed by a neurologist
Ability to attend meetings
Being literate
Conscious desire and satisfaction to participate in research
The duration of the disease is between 2 to 5 years
Age range 20 to 50 years
Exclusion criteria:
Existence of severe physical condition
Age
From 20 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Actual sample size reached:
26
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
Ethics Committee of Bu Ali Sina University of Hamadan
Street address
Faculty of Economics and Social Sciences, Bu Ali Sina University, Chaharbagh Ahmadi Roshan
City
Hamadan
Province
Hamadan
Postal code
3869565178
Approval date
2019-10-15, 1398/07/23
Ethics committee reference number
IR.BASU.REC.1398.012
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
Perceived tension
Timepoint
Before and after Intervention
Method of measurement
Perceived stress questionnaire
2
Description
Emotional adjustment
Timepoint
Before and after Intervention
Method of measurement
emotional adjustment questionarie
3
Description
Perceived self-efficacy
Timepoint
Before and after Intervention
Method of measurement
Perceived stress questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: People in the intervention group underwent psychological treatment based on acceptance and commitment for two months. 8 weekly sessions were held over two months and lasted between 60 and 90 minutes. At acceptance and commitment-based psychological sessions, home exercises were given to patients to do during the week, followed by a group discussion and instructional intervention. The number of exercises was determined according to the course of the sessions and each time in a way that challenged the patients' thoughts.
Category
Treatment - Other
2
Description
Control group: The control group did not receive any intervention in this study.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Dr Mahyar Motaghed
Street address
Sina hospital, Mirzade Eshqi street
City
Hamadan
Province
Hamadan
Postal code
1111111111
Phone
+98 81 3827 4191
Email
sarapournaghiii@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bu-ali Sina University
Full name of responsible person
Mohamad Reza Zoghipaydar
Street address
Charbaq Khaje Rashid, Bu ali Sina University
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۴۳۳۳۹۱
Phone
+98 81 3838 1601
Email
zoghi.p@basu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Bu-ali Sina university
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
Bu ali Sina univercity
Full name of responsible person
Sara Pournaghi
Position
gratuated
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Khaleghi Alley; Ghaem Magham boulevard
City
Malayer
Province
Hamadan
Postal code
6571611316
Phone
+98 81 3838 1601
Email
sarapournaghiii@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bu Ali Sina University
Full name of responsible person
Sara Pournaghi
Position
Graduated
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Faculty of Economics and Social Sciences, Bu Ali Sina University, Charbagh Ahmadi Roshan
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 1601
Fax
Email
sarapournaghiii@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bu Ali Sina University
Full name of responsible person
Sara Pournaghi
Position
Graduated
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Faculty of Economics and Social Sciences, Bu Ali Sina University, Charbagh Ahmadi Roshan
City
Hamadan
Province
Hamadan
Postal code
6571611316
Phone
+98 81 3838 1601
Fax
Email
sarapournaghiii@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
The information of the participants is completely confidential.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not 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
Information on the questionnaires is available
When the data will become available and for how long
Start of access 2 years after publication
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
Data will be available for related researchers
From where data/document is obtainable
It will be refereed to the supervisor.
What processes are involved for a request to access data/document
The data file will be reachable receiving the request.