Comparison of effectiveness of interpretation bias correction training and acceptance and commitment therapy (ACT) on cognitive-behavioral and emotional symptoms of patients with multiple sclerosis (M.S).
To compare the effectiveness of interpretation bias correction training and acceptance and commitment therapy on the cognitive-behavioral and emotional symptoms of patients with multiple sclerosis (MS).
Design
A clinical trial with a control group, using parallel groups, is conducted in a non-blinded manner on 54patients, with randomization performed using www.randomization.com.
Settings and conduct
Patients with MS who are members of the MS Association of Urmia will be randomly assigned to intervention and control groups using simple randomization, provided they meet the eligibility criteria.
Participants/Inclusion and exclusion criteria
The inclusion criteria for the study comprised a diagnosis of MS, an age range of 18 to 45years, possession of at least a high school diploma, and the necessity for identifying impairments in cognitive-behavioral and emotional symptoms assessed through interviews and tests. The exclusion criteria included concurrent treatment with other therapies, the emergence of symptoms due to substance use or bereavement, and a history of receiving similar interventions.
Intervention groups
Intervention group1: Over 4 weeks and each week 2 sessions of 90 minutes will be intervened. In the form of cognitive behavioral therapy, patients are taught to identify their negative interpretations and then be able to reconstruct them into more logical interpretations.
Intervention group2:Over 4 weeks and each week 2 sessions of 90 minutes will be intervened. The content of these sessions will include 6 main axes of the acceptance and commitment approach along with the use of related metaphors in the sessions.
Control group: In this research, no intervention is carried out for the control group and initially it is considered solely for measurement and observation.
Main outcome variables
cognitive bias; profile of psychosis; emotional information processing; M.S. self-efficacy; acceptance of illness.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241026063497N1
Registration date:2025-05-13, 1404/02/23
Registration timing:retrospective
Last update:2025-05-13, 1404/02/23
Update count:0
Registration date
2025-05-13, 1404/02/23
Registrant information
Name
saleh sadighi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 4308 0317
Email address
s.sadighi@urmia.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-12-30, 1403/10/10
Expected recruitment end date
2025-01-09, 1403/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effectiveness of interpretation bias correction training and acceptance and commitment therapy (ACT) on cognitive-behavioral and emotional symptoms of patients with multiple sclerosis (M.S).
Public title
Comparison of effectiveness of interpretation bias correction training and acceptance and commitment therapy on patients with multiple sclerosis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Must have a definitive diagnosis of multiple sclerosis.
Must be at least 18 and at most 45 years old.
Have at least a diploma.
Damage in cognitive, behavioral and emotional symptoms examined in this research should be diagnosed by interview and test.
Exclusion criteria:
Receive other concurrent treatment.
The symptoms are due to drug use and bereavement.
Have a history of receiving similar interventions.
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method was considered as simple randomization with individual random units. Subsequently, the final sample was divided into two experimental groups and one control group. The randomization process was carried out using the website www.randomization.com.
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
Research Ethical Committee of Urmia University
Street address
University of Urmia, 11 km Sero Road, Azerbaijangharbi Province - Urmia
City
urmia
Province
West Azarbaijan
Postal code
5756151818
Approval date
2024-05-18, 1403/02/29
Ethics committee reference number
IR.URMIA.REC.1403.006
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
cognitive bias
Timepoint
Before the intervention, the last intervention session and 2 months after the last intervention session
Method of measurement
Cognitive bias questionnaire of Woody, Chambless and Glass
2
Description
profile of psychosis
Timepoint
Before the intervention, the last intervention session and 2 months after the last intervention session.
Method of measurement
Depression, Anxiety, Stress Scale (DASS) Lavibond and Lavibond
3
Description
emotional information processing
Timepoint
Before the intervention, the last intervention session and 2 months after the last intervention session
Method of measurement
Emotional Information Processing Questionnaire Baker et al.'s
4
Description
M.S self-efficacy
Timepoint
Before the intervention, the last intervention session and 2 months after the last intervention session
Before the intervention, the last intervention session and 2 months after the last intervention session
Method of measurement
Disease Acceptance Scale (ALS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Training in interpretation bias modification: In the present study, while providing necessary explanations to patients and ensuring the confidentiality of their information, patients are trained over 4 weeks with 2 individual sessions of 90 minutes each per week in the form of cognitive-behavioral therapy to identify their negative interpretations and then be able to reconstruct them into more logical interpretations. The term 'interpretation bias' in this research refers to individuals' tendency to interpret ambiguous and neutral events negatively and threateningly. This bias can manifest in various areas such as social relationships, health, and job performance. During therapy sessions, various cognitive-behavioral techniques are used, such as thought recording, Socratic questioning, identifying cognitive errors (especially errors related to interpretation), providing supporting and opposing evidence, creating alternative perspectives, and behavioral exercises.
Category
Rehabilitation
2
Description
Acceptance and Commitment Therapy: In the present study, while providing the necessary explanations to the group members and ensuring the confidentiality of their information, patients are treated in a group setting and over 4 weeks, with 2 sessions per week lasting 90 minutes, under Acceptance and Commitment Therapy. The content of these sessions includes the 6 main components of the Acceptance and Commitment approach, along with the use of metaphors related to the sessions and practical exercises. During the sessions, various metaphors are used to facilitate understanding of Acceptance and Commitment approach concepts. For example, the metaphor of "quicksand" is used to show that trying to control unpleasant thoughts and feelings can lead to becoming more submerged in them, the metaphor of the "bus" is used to show that thoughts and feelings are the passengers on the bus and the individual is the driver and can choose their route, and the metaphor of "tug-of-war with a monster" is used to show that fighting unpleasant thoughts and feelings takes a lot of energy and it is better to drop the rope. During the sessions, the therapist plays the role of a facilitator and helps the members to identify their values, set committed goals, and face their unpleasant experiences with more acceptance and flexibility. The therapist also provides a safe and supportive environment so that members can share their experiences and support each other.
Category
Rehabilitation
3
Description
Control group: In this study, no intervention is performed for the control group, and it is initially considered solely for measurement and observation purposes.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Urmia MS Association
Full name of responsible person
Simin Mahmod Akhgar
Street address
46 Unit, 4th Floor, Almas Gharb Building, Keshtegar Street, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5713613948
Phone
+98 44 3224 6764
Email
anjomanmsurmia@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Urmia University
Full name of responsible person
Abbas Banj Shafiei
Street address
University of Urmia, 11 km Sarv Road, West Azerbaijan Province - Urmia
City
urmia
Province
West Azarbaijan
Postal code
5756151818
Phone
+98 44 3277 0555
Email
a.banjshafiei@urmia.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Urmia 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
Urmia University
Full name of responsible person
Saleh Sadighi
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Mir building, 55.3 Side alley, 55 Darya, Kelkaser, Amol
City
Amol
Province
Mazandaran
Postal code
4617139606
Phone
+98 11 4308 0317
Email
salehsadighi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Urmia University
Full name of responsible person
Saleh Sadighi
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Mir building, 55.3 Side alley, 55 Darya, Kelakaser, Amol
City
Amol
Province
Mazandaran
Postal code
4617139606
Phone
+98 11 4308 0317
Email
salehsadighi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Urmia University
Full name of responsible person
Saleh Sadigi
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Mir building, 55.3 Side alley, 55 Darya, Kelkaser, Amol.
City
Amol
Province
Mazandaran
Postal code
4617139606
Phone
+98 11 4308 0317
Email
salehsadighi@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
Pre-test, Post-test, Retention test
When the data will become available and for how long
6 months after the results are published
To whom data/document is available
All researchers
Under which criteria data/document could be used
Can be used for therapists in this field as well as researchers of review research, meta-analysis, etc.
From where data/document is obtainable
Saleh Sadighi
What processes are involved for a request to access data/document