The effectiveness of compassion focused acceptance and commitment therapy on psychological flexibility and psychological distress in patients with multiple sclerosis
The purpose of this research is evaluation of the effectiveness of compassion focused acceptance and commitment therapy on psychological flexibility and psychological distress in patients with multiple sclerosis.
Design
The design of this study will be a randomized controlled clinical trial or a pretest-posttest-follow-up design with a control group. Participants will be randomly assigned to the intervention group (n= 16) and the control group (n=16). In this non-blind study, lottery will be used for randomization.
Settings and conduct
Therapeutic sessions will be held at the Faculty of Rehabilitation, Ahvaz Jundishapur University of Medical Sciences. The experimental group and the control group will respond to the research tools in the pre-test phase. Upon completion of the intervention for the experimental group, all sample subjects (experimental group and control group) will be tested in one posttest session and participants will be re-evaluated for follow-up 2 months after posttest.
Participants/Inclusion and exclusion criteria
Inclusion criteria are: Being residence in Ahvaz, Getting a score between 0 and 5 on the Expanded Disability Status Scale, Inclination to participate in the psychological intervention sessions, The diagnosis of the disease by a neurologist.
Exclusion criteria are: Use of psychiatric and psychotropic drugs, Simultaneous participation in other psychological therapies, Three absences in treatment sessions.
Intervention groups
The experimental group will receive 10 sessions of 90 minutes of compassion-focused acceptance and commitment therapy (The ACT practitioner's guide to the science of compassion : tools for fostering psychological flexibility) twice a week. The control group does not receive any Psychological intervention. Both groups receive routine drug treatment for MS
Main outcome variables
Psychological flexibility؛ Psychological distress
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210101049903N1
Registration date:2021-11-23, 1400/09/02
Registration timing:retrospective
Last update:2021-11-23, 1400/09/02
Update count:0
Registration date
2021-11-23, 1400/09/02
Registrant information
Name
Reza Mansouri Koryani
Name of organization / entity
Shahid Chamran University of Ahvaz
Country
Iran (Islamic Republic of)
Phone
+98 84 2439 3006
Email address
rmansouri.psychology@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-04, 1398/06/13
Expected recruitment end date
2019-10-05, 1398/07/13
Actual recruitment start date
2019-09-04, 1398/06/13
Actual recruitment end date
2019-10-05, 1398/07/13
Trial completion date
2020-03-17, 1398/12/27
Scientific title
The effectiveness of compassion focused acceptance and commitment therapy on psychological flexibility and psychological distress in patients with multiple sclerosis
Public title
The effectiveness of compassion focused acceptance and commitment therapy in patients with multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being residence in Ahvaz
Being in the age range of 18 to 52
With at least a diploma degree
Getting a score between 0 and 5 on the Expanded Disability Status Scale (EDSS)
Inclination to participate in the psychological intervention sessions
The diagnosis of the disease by a neurologist
Exclusion criteria:
Use of psychiatric and psychotropic drugs
Simultaneous participation in other psychological therapies
Three absences in treatment sessions.
Age
From 18 years old to 52 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
32
Actual sample size reached:
32
Randomization (investigator's opinion)
Randomized
Randomization description
A simple randomization method was used, so that first the names of the subjects were listed and each one was assigned a number from 1 to 32, then we put the numbers in a box and started removing the numbers from the box. The first 16 issues were assigned to the experimental group and the remaining 16 issues were assigned to the control group.
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
Shahid Chamran University of Ahvaz
Street address
Golestan Boulevard, Shahid Chamran University of Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
اهواز، بلوار گلستان،
Approval date
2019-06-13, 1398/03/23
Ethics committee reference number
EE/98.24.3.58272 /scu.ac.ir
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
Psychological flexibility
Timepoint
Before the intervention, After the intervention, 2 months later(follow-up )
Method of measurement
Open and Engaged State Questionnaire(OESQ)
2
Description
Psychological Distress
Timepoint
Before the intervention, After the intervention, 2 months later(follow-up)
Method of measurement
Depression Anxiety Stress Scale (DASS-21)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: compassion focused acceptance and commitment therapy+ routine drug treatment for MS
Category
Behavior
2
Description
Control group: routine drug treatment for MS
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Khuzestan MS Society
Full name of responsible person
Nastaran Majdi Nasab
Street address
Ahvaz-Golestan Hospital-Faculty of Rehabilitation
City
Ahwaz
Province
Khouzestan
Postal code
6135733133
Phone
+98 61 3311 5713
Email
golestanhospital@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Chamran University of Ahvaz
Full name of responsible person
Soodabeh Bassak Nejad
Street address
Golestan Boulevard, Shahid Chamran University of Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
۶۱۳۵۷۸۳۱۵۱
Phone
+98 61 3333 0011
Email
Public@scu.ac.ir
Web page address
https://scu.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Chamran University of Ahvaz
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
Shahid Chamran University of Ahvaz
Full name of responsible person
Soodabeh Bassak Nejad
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Golestan Boulevard, Shahid Chamran University of Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
۶۱۳۵۷۸۳۱۵۱
Phone
+98 61 3333 0011
Email
s.bassak@scu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Chamran University of Ahvaz
Full name of responsible person
Soodabeh Bassak Nejad
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Golestan Boulevard, Shahid Chamran University of Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
۶۱۳۵۷۸۳۱۵۱
Phone
+98 61 3333 0011
Email
s.bassak@scu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Chamran University of Ahvaz
Full name of responsible person
Reza Mansouri Koryani
Position
Masters student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Golestan Boulevard, Shahid Chamran University of Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
۶۱۳۵۷۸۳۱۵۱
Phone
+98 991 041 7970
Email
rmansouri.psychology@gmail.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
All potential data can be shared after unidentified individuals
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
It will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
Any kind of analysis on the delivered data is allowed