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The Effectiveness of Acceptance and Commitment Therapy for Reducing Interference and improving Verbal and Visual Working Memory in Patients with Multiple Sclerosis

Protocol summary

Study aim
The present research attempted to answer the question whether acceptance and commitment therapy would affect interference, verbal and visual working memory of MS patients?
Design
Regarding its objective, the present study is an applied research, and concerning the data collection method, it is a quasi-experimental one carried out in the form of a pre-test/post-test with a control group.
Settings and conduct
The statistical population included all the MS patients referring to Ahvaz MS Society in 2018. Of those, 30 patients whose disease was classified as mild by the doctors using the Expanded Disability Status Scale (EDSS) were selected through purposive sampling and were randomly divided into the experimental and control groups, each containing 15 individuals.
Participants/Inclusion and exclusion criteria
The statistical population included all the MS patients referring to Ahvaz MS Society in 2018. Of those, 30 patients whose disease was classified as mild by the doctors using the Expanded Disability Status Scale (EDSS) were selected. The participants were selected with regard to the inclusion criteria (having a history of the disease for over 3 years and being diagnosed with mild MS) as well as the exclusion criteria (not having addiction, cancer, epilepsy, renal failure, heart disease, and major psychological problems such as psychosis) which were reviewed through a clinical interview.
Intervention groups
A group included 15 patients with MS as the experimental group, who were recieved acceptance and commitment therapy. A group included 15 patients with MS as the control group, didn't received acceptance and commitment therapy until the end of the course
Main outcome variables
Reducing Interference, Verbal Working Memory, Visual Working Memory

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200113046118N1
Registration date: 2020-02-11, 1398/11/22
Registration timing: retrospective

Last update: 2020-02-11, 1398/11/22
Update count: 0
Registration date
2020-02-11, 1398/11/22
Registrant information
Name
Maryam Davoodi
Name of organization / entity
Salman Farsi University of Kazerun
Country
Iran (Islamic Republic of)
Phone
+98 71 4225 2956
Email address
dr.s.davoodi2010562@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2018-06-20, 1397/03/30
Actual recruitment start date
2018-06-05, 1397/03/15
Actual recruitment end date
2018-06-29, 1397/04/08
Trial completion date
2018-09-03, 1397/06/12
Scientific title
The Effectiveness of Acceptance and Commitment Therapy for Reducing Interference and improving Verbal and Visual Working Memory in Patients with Multiple Sclerosis
Public title
The Effectiveness of Acceptance and Commitment Therapy for Reducing Interference and improving Verbal and Visual Working Memory in Patients with Multiple Sclerosis
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The participants were selected with regard to the inclusion having a history of the disease for over 3 years and being diagnosed with mild Ms
Exclusion criteria:
not having addiction not having cancer not having epilepsy not having renal failure not having heart disease not having major psychological problems such as psychosis
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Actual sample size reached: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization with random number table that create one- digit column in the random number table, by the size of population, and then units are randomly selected. Finally, any number smaller than or equal to the size of the population was considered as the sample of choice. Also, by using sequentially numbered opaque sealed envelopes (SNOSE). according to the order of entry of eligible participants, one of the envelopes was opened sequentially and their assigned group was identified.
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 Kazerun
Street address
5 km Kazeroon- Bushehr road
City
Kazerun
Province
Fars
Postal code
7319846451
Approval date
2020-01-11, 1398/10/21
Ethics committee reference number
IR.IAU.KAU.REC.1398.165

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
interference is the relative processing speed, which is most simply argued as the fact that faster processes can affect slower ones, but the opposite is not true.
Timepoint
The evalution of this variable was when patient only receive drug therapy and didn't receive psychological
Method of measurement
Computerized Stroop Test evaluates the capacity to attend to specific characteristics of a stimulus, ignoring characteristics irrelevant to the task. In this test, 48 matching and 48 mismatching colored words (red, blue, yellow and green) were shown to the subjects. The term matching words refers to the words whose color and name are the same, and mismatching words refer to those whose color and name are different. A total of 96 words were randomly and sequentially presented. The subjects were asked to say each word’s color, regardless of its meaning. Each stimulus was shown on the screen for two seconds, and the stimuli were presented at the intervals of 800 milliseconds. According to the researchers, the mismatching color-word task (second phase of the experiment) measured interference. The degree of interference was obtained by subtracting the number of correct mismatching words from that of correct matching ones.

Secondary outcomes

1

Description
Working memory resources include verbal and visual working memory. Visual memory plays a key role in the formation and manipulation of mental images. On the other hand, verbal memory covers the phonological loop. The verbal information provided verbally enters the phonological loop directly, immediately and automatically, and is stored phonologically for a short time
Timepoint
The evalution of this variable was when patient only receive drug therapy and didn't receive psychological
Method of measurement
Wechsler Memory Scale - Third Edition (WMS-III) has 18 subscales (11 primaries and 7 optional subscales), and 8 scores are obtained from the 11 primary subscales. In this research, only two subscales were used to measure verbal and visual working memory. Visual Memory Subscale is a visual rehabilitation test, in which the subject is asked to use his/her memory to draw the simple shapes provided to him/her for 10 seconds. The total scores of forward and reverse digit span subtest were also used to measure verbal working memory.

Intervention groups

1

Description
The intervention was acceptance and commitment therapy for Multiple sclerosis. The experimental group according to the model adapted from ACT’s six-session protocol for chronic illness in the form of 120-minute sessions once a week and the control group received no therapeutic intervention. Following the completion of the sessions, both groups were given a post-test. At the end of the sessions, post-test was performed on both groups. The main content of the intervention was psychoeducation about MS’s thoughts, emotions and behavior, avoidance, relaxation via mindfulness and cognitive restructuring (e.g. Introducing values by purpose, Cognitive Fusion, Problem-solving strategies, Establishing effective relationships to valuable life, Identify obstacles in the path of values and The practice of conscious acceptance ). The practice of each session was reviewed via whatsapp for the group between the sessions.
Category
Other

2

Description
Control group: The control group did not receive any treatment during the treatment period, but after running the post-test the control and groups received therapy in one session.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ahvaz MS Society
Full name of responsible person
Nastaran MajdiNasab
Street address
Golestan Street, Jundishapur University of Medical Sciences, Faculty of Rehabilitation
City
Ahvaz
Province
Khouzestan
Postal code
۶۱۳۶۹۵۴۶۶۹
Phone
+98 61 3374 3660
Email
Maryam.d_2014@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Salman Farsi University of Kazerun
Full name of responsible person
Leila Shameli
Street address
Ershad crossroad, Shahi Ayatallah Taleghani Avenue
City
Kazerun
Province
Fars
Postal code
7319673544
Phone
+98 71 4222 6050
Email
maryam.d_2014@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Maryam Davoodi
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
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Salman Farsi University of Kazerun
Full name of responsible person
Maryam Davoodi
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Babune Avenue, alley 6, Davoodi’s house
City
Kazerun
Province
Fars
Postal code
7315654486
Phone
+98 71 4225 2956
Email
Dr.s.davoodi2010562@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Salman Farsi University of Kazerun
Full name of responsible person
Maryam Davoodi
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Babune Avenue, alley 6, Davoodi’s house
City
Kazerun
Province
Fars
Postal code
7315654486
Phone
+98 71 4225 2956
Email
Dr.s.davoodi2010562@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Salman Farsi University of Kazerun
Full name of responsible person
Maryam Davoodi
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Babune Avenue, alley 6, Davoodi’s house
City
Kazerun
Province
Fars
Postal code
7315654486
Phone
+98 71 4225 2956
Email
Dr.s.davoodi2010562@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The data is not important for release, but the result obtained from the data is important and release
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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The study protocol, statistical analysis map and clinical report are important because release of the study want to understand the treatment process, data analysis and ultimately the results obtained and application of the results. In other words, it might be a guidance for other researchers, as well as active therapists in this field.
When the data will become available and for how long
By publishing this research in the journal, it can be available to readers for 6 months to a year.
To whom data/document is available
All relevant people, including patients with MS, psychologists, psychiatrists and others can benefit from the research
Under which criteria data/document could be used
MS Associations that communicate, specialists in the field, including neuroscientists, health psychologists, and patients can access this information. Research has some limitations that are as simple as removing the limitations to obtain more desirable and generalizable results
From where data/document is obtainable
All the information required by the applicants is fully stated in the research, applications can obtain the information by searching. If they need further information, they can contact the authors of the article by email.
What processes are involved for a request to access data/document
The applicant can receive the file by sending an email mentioned in the article. It will be available for a maximum of one week.
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