Investigate the effectiveness of quality of life therapy on well-being, illness perception and disease severity in multiple sclerosis patients
Design
Clinical trial with treatment, and control group with random assignment.
Settings and conduct
Patients from Tehran who have the characteristics required to participate in the study will be invited.Participants are randomly assigned following
block randomization in quality of life treatment and control groups. Then, questionnaires and consent form are provided to the participants. Patients participate in 10 sessions last 45 minutes. After the treatment will be completed, patients will fill the questionnaires again, and the follow-up process will be conducted three months later. The control treatment group do not received any psychological treatment, and they just fill the questionnaires.
Participants/Inclusion and exclusion criteria
Participants are 30 patients in whom the Multiple Sclerosis is initially diagnosed. Inclusion Criteria include: The patient has Multiple Sclerosis disorder based on Magnetic resonance imaging (MRI), Patient's education should be up to diploma, and exclusion criteria include: Patient has another medical diagnosis based on medical records. patient has a psychological disorder assessed by structured interview (SCID-I). Receiving psychological intervention simultaneously.
Intervention groups
Intervention group: In this study, we use the individual quality of life therapy protocol. Patients participate in ten sessions.The therapist works with the patient to select two to five areas of life, then clarify the attitudes of the area, standards of fulfillment for the area, and the relative importance placed on the area for overall happiness. Control group: patients who did not receive psychological treatment.
Main outcome variables
Quality of life, illness perception, and disease severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181221042068N2
Registration date:2019-11-23, 1398/09/02
Registration timing:registered_while_recruiting
Last update:2019-11-23, 1398/09/02
Update count:0
Registration date
2019-11-23, 1398/09/02
Registrant information
Name
Afsaneh Akhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8898 9487
Email address
akhani.a@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-23, 1398/08/01
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of quality of life therapy on well-being, illness perception and disease severity in multiple sclerosis patients
Public title
Quality of life therapy in multiple sclerosis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The patient has Multiple Sclerosis disorder based on Magnetic resonance imaging (MRI)
Patient's education should be up to diploma
Exclusion criteria:
Patients has another medical diagnosis based on medical records.
a psychological disorder assessed by structured interview (SCID-I)
Receiving psychological intervention simultaneously
Age
To 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Participants are randomly assigned following block randomization in quality of life treatment and control groups.
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 Commitee of Iran University of Medical Science
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2017-12-08, 1396/09/17
Ethics committee reference number
IR.IUMS.REC 1396.30686
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
Illness perception
Timepoint
At the beginning of the study, 70 days and Six months later
Method of measurement
The Brief Illness Perception Questionnaire
2
Description
Quality Of Life
Timepoint
At the beginning of the study, 70 days and Six months later
Method of measurement
36-Item Short Form Survey (SF-36)
3
Description
Level of Disability
Timepoint
At the beginning of the study, 70 days and Six months later
Method of measurement
Expanded Disability Status Scale (EDSS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this study, we use the individual quality of life therapy protocol. This program is as follows: Patients participate in ten sessions. The therapist works with the patient to select two to five areas of life, then clarify the attitudes or perceptions of the area, standards of fulfillment for the area, and the relative importance placed on the area for overall happiness, then Cognitive-behavioral strategies are implement within each targeted area.
Category
Lifestyle
2
Description
Control group: patients who did not receive psychological treatment.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram hospital
Full name of responsible person
Afsaneh Akhani
Street address
Hazrate Rasoole Akram Hospital, Maziar Mansoori st, Satarkhan Av, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۳۱
Phone
+98 21 6651 5001
Email
akhani.a@tak.iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Kazem Malakuti
Street address
Iran University of Medical Sciences, Shahid Hemmat
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 5503
Email
malakouti.K@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
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
Iran University of Medical Sciences
Full name of responsible person
Afsaneh Akhani
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
School of Behavioral Sciences and Mental Health Shahid Mansouri Street, Niyayesh Street, Satarkhan Avenue, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1445613111
Phone
+98 21 6655 1655
Email
akhani.a@tak.iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ahmad Ashouri
Position
associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
School of Behavioral Sciences and Mental Health Shahid Mansouri Street, Niyayesh Street, Satarkhan Avenue, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1445613111
Phone
+98 21 6655 1655
Email
ahmad.ashouri@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Afsaneh Akhani
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 1, School of Behavioral Sciences and Mental Health,Shahid Mansouri Street, Niyayesh Street, Satarkhan Avenue
City
Tehran
Province
Tehran
Postal code
1445613111
Phone
+98 21 6655 1668
Fax
Email
akhani.a@tak.iums.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
Undecided - It is not yet known if there will be a plan to make this available