Effectiveness of dialectical behavior therapy for fatigue, depression, anxiety, stress and quality of life of patients with Multiple Sclerosis
Design
The research is an experimental test (pretest, posttest, and follow up stage) with a control group. Statistical population of the research includes all patients with Multiple Sclerosis in MS center of Isfahan. 30 patients with Multiple Sclerosis were selected by using convenient sampling.They were randomly assigned to two groups: experimental group(15 individuals) and control group(15 individual)
Settings and conduct
After sampling, patients entered the study with informed consent. An individually pretest session was held in MS Association in September 2016.At this stage, patients completed Depression, Anxiety and Stress Scale (DASS-21), Quality of Life Questionnaire (MSQOL-54) and Fatigue Severity Scale (FSS). The assessments were also done in posttest stage. The course of dialectical behavior therapy in the experimental group was 8 sessions as a group and 1 session per week according to the dialectical behavioral therapy guideline of Moshaine.
Participants/Inclusion and exclusion criteria
Having MS diagnostic criteria based on McDonald's criteria
Age group (between 25 and 40 years)
Having no severe attack and recurrence of the disease
Scored above 14 in depression scale (DASS-21)
Scored above 25 in anxiety scale (DASS-21)
Scored above 19 in stress scale (DASS-21)
Ability to communicate and collaborate
Having interest in the study and participating in it with consent
Intervention groups
intervention group:Term of Dialectical Behavior Therapy was 8 sessions with one session per week in the test group.
Control group: psychological intervention was not performed in this group. Participants solely answered the questionnaires in pretest, posttest and follow up stages.
Main outcome variables
Fatigue; Depression; Anxiety; Stress; Quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210720051948N1
Registration date:2021-09-24, 1400/07/02
Registration timing:retrospective
Last update:2021-09-24, 1400/07/02
Update count:0
Registration date
2021-09-24, 1400/07/02
Registrant information
Name
Fatemeh Nazari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3233 4907
Email address
fatemehnazarik1991@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
2016-09-05, 1395/06/15
Actual recruitment end date
2016-10-06, 1395/07/15
Trial completion date
2016-12-20, 1395/09/30
Scientific title
Effectiveness of dialectical behavior therapy for fatigue, depression, anxiety, stress and quality of life of patients with Multiple Sclerosis.
Public title
Effectiveness of dialectical behavior therapy for fatigue, depression, anxiety, stress and quality of life of patients with Multiple Sclerosis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having MS diagnostic criteria based on McDonald's criteria
being at the age group of between 25 and 40 years
Having no severe attack and recurrence of the disease
Scored above 14 in depression scale (DASS-21)
Scored above 25 in anxiety scale (DASS-21)
Scored above 19 in stress scale (DASS-21)
being able to communicate and collaborate
Having interest in the study as well as inclination to participate in it
Exclusion criteria:
Age
From 25 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
30 patients with Multiple Sclerosis were selected by using convenience sampling. They were randomly assigned to two groups (in a way thet we randomly selected a number from the sample table and move to one side): One experimental group of 15 persons and another control group of also 15 persons.
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
Islamic Azad University of Isfahan(khorasgan)
Street address
Eastern Jey, Arghavaniye
City
Isfahan
Province
Isfehan
Postal code
8155139998
Approval date
2021-08-03, 1400/05/12
Ethics committee reference number
1400041423531
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
Depression, Anxiety, Stress
Timepoint
Prior to the study(before starting treatment), 60 days(right after ending the treatment) and finally 30 days later (after ending the treatment in follow-up stage)
Method of measurement
Depression, Anxiety and Stress Scale (DASS-21)
2
Description
Quality of life
Timepoint
Prior to the study(before starting treatment), 60 days(right after ending the treatment) and finally 30 days later (after ending the treatment in follow-up stage)
Method of measurement
Quality of life questionnaire (MSQOL-54)
3
Description
Fatigue
Timepoint
Prior to the study(before starting treatment), 60 days(right after ending the treatment) and finally 30 days later (after ending the treatment in follow-up stage)
Method of measurement
Fatigue Severity Scale (FSS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After pretest, term of dialectical behavior therapy was 8 sessions with one session per week in the test group (15 individuals). Follow-up assessment took place in 30 days after posttest stage.
Category
Behavior
2
Description
Control group: In this group psychological intervention was not performed. The only thing that participants did was answering the questionnaires in pretest, posttest and follow-up stage.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
M.S center of Isfahan
Full name of responsible person
Masoud Etemadifar
Street address
Bahonar
City
Isfahan
Province
Isfehan
Postal code
6719915976
Phone
+98 31 3346 2494
Email
Isfahan-socity@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Gholamreza Manshaee
Street address
Eastern Jey, Arghavaniye
City
Isfahan
Province
Isfehan
Postal code
81155139998
Phone
+98 31 3535 4001
Email
info@khuisf.ac.ir
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
10
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fatemeh Nazari
Position
Graduated
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Tohid, farshchian alley, no31
City
Isfahan
Province
Isfehan
Postal code
6717717486
Phone
0098314226425
Email
fatemehnazarik1991@gmai.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fatemeh Nazari
Position
Graduated
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Tohid , farshchian alley, no31
City
Isfahan
Province
Isfehan
Postal code
6717717486
Phone
0098314226425
Email
fatemehnazarik1991@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fatemeh Nazari
Position
Graduated
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Tohid, farshchian alley, no31
City
Isfahan
Province
Isfehan
Postal code
6717717486
Phone
0098314226425
Email
fatemehnazarik1991@gmail.com
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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available