The purpose of this study was the effectiveness of acceptance and commitment therapy on Chronic Fatigue Syndrome and Pain Perception in people with multiple sclerosis.
Design
Treatment interventions were performed according to a model adapted from a six-point protocol for chronic Brassington pain in the form of 120-minute sessions, once a week for the experimental group, and the control group did not receive the therapeutic intervention.
Settings and conduct
MS forum in Ahvaz city
Participants/Inclusion and exclusion criteria
Entry criteria (having a history of illness for more than three years, a diagnosis of mild MS, and obtaining a minimum score of 40 in the fatigue measurement questionnaire) and exit criteria (no addiction, cancer, epilepsy, renal failure, heart disease, and major psychological problems such as psychosis)
Intervention groups
Two groups of patients with MS who received acceptance and commitment treatment were applied to one group and the other group did not receive any treatment.
Main outcome variables
Chronic Fatigue Syndrome and Pain Perception
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181124041742N1
Registration date:2019-04-28, 1398/02/08
Registration timing:retrospective
Last update:2019-04-28, 1398/02/08
Update count:0
Registration date
2019-04-28, 1398/02/08
Registrant information
Name
Leila Shameli
Name of organization / entity
Salman Farsi University of Kazeroon
Country
Iran (Islamic Republic of)
Phone
+98 71 4222 6050
Email address
dr.shameli@kazerunsfu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2018-06-15, 1397/03/25
Actual recruitment start date
2018-05-05, 1397/02/15
Actual recruitment end date
2018-06-20, 1397/03/30
Trial completion date
2018-08-21, 1397/05/30
Scientific title
The Effectiveness of Acceptance and Commitment Therapy on Chronic Fatigue Syndrome and Pain Perception in People with Multiple Sclerosis
Public title
"Effect of Acceptance and Commitment Treatment in MS Patients"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having a history of MS for more than three years
Having a diagnosis of mild grade of MS
Obtaining a minimum score of 40 in the fatigue measurement questionnaire
Exclusion criteria:
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
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
By simple random sampling based on the lottery, intervention group received a treatment course and the control group did not receive any treatment.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The intervention group received the course of treatment, but the control group did not receive any treatment during the study, and after finishing the study, the control group received a course of treatment.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee on Biomedical Research of Islamic Azad University, Kazerun Branch
Street address
5 km of Kazeroon-Bushehr road
City
Kazerun
Province
Fars
Postal code
7319846451
Approval date
2019-03-07, 1397/12/16
Ethics committee reference number
IR.IAU.KAU.REC.1397.029
Health conditions studied
1
Description of health condition studied
Multiple Sclerosis (MS)
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
Chronic Fatigue Syndrome and Pain Perception
Timepoint
summer
Method of measurement
Fatigue Severity Scale (FSS) and McGill Pain Questionnaire (MGPQ)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with multiple sclerosis that receiving an acceptance and commitment treatment course in 6 sessions of 120 minutes and once a week.
Category
Treatment - Other
2
Description
Control group: Patients with multiple sclerosis disorder did not receive any treatment interventions during the 6-week period of the study.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
MS Forum of Ahvaz city
Full name of responsible person
Dr Nastaran Majdinasab
Street address
Jondishapur University of Medical Sciences, Faculty of Rehabilitation
City
Ahvaz
Province
Khouzestan
Postal code
6136954669
Phone
+98 61 3374 3660
Email
Ms.Ahvaz.counceling@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Salman Farsi University of Kazerun
Full name of responsible person
Aboozar Khosravi
Street address
Cross Culture, University of St. Taleghani
City
Kazerun
Province
Fars
Postal code
73196-73544
Phone
+98 71 4222 6050
Email
Lshameli29@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Salman Farsi University of Kazerun
Proportion provided by this source
40
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
Salman Farsi University of Kazerun
Full name of responsible person
Leila Shameli
Position
Assistant Professor of university
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Cross Culture, University of St. Taleghani
City
Kazerun
Province
Fars
Postal code
73196-73544
Phone
+98 71 4222 6050
Email
lshameli29@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Salman Farsi university of Kazerun
Full name of responsible person
Leila Shameli
Position
Assistant Professor of university
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Cross Culture, University of St. Taleghani
City
Kazerun
Province
Fars
Postal code
73196-73544
Phone
+98 71 4222 6050
Email
lshameli29@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Salman Farsi university of Kazerun
Full name of responsible person
Leila Shameli
Position
Assistant Professor of university
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Cross Culture, University of St. Taleghani
City
Kazerun
Province
Fars
Postal code
73196-73544
Phone
+98 71 4222 6050
Email
lshameli29@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
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
The Effectiveness of Acceptance and Commitment Therapy on Chronic Fatigue Syndrome and Pain Perception in People with Multiple Sclerosis
When the data will become available and for how long
2019
To whom data/document is available
public
Under which criteria data/document could be used
scientific journal
From where data/document is obtainable
finding of scientific journal
What processes are involved for a request to access data/document