Evaluating the effectiveness of acceptance and commitment therapy with a focus on compassion and yoga exercises on self-management, difficulty in emotion regulation, pain acceptance and pain catastrophizing in multiple sclerosis patients.
Determining the equivalence of acceptance and commitment-based therapy focusing on compassion and yoga exercises on self-management, difficulty in emotion regulation, pain acceptance and pain catastrophizing in multiple sclerosis patients.
Design
A clinical trial with a control group and two other groups, a blind strain, by available sampling method, on 45 patients.
Settings and conduct
This study is conducted on MS patients, and the setting for the group receiving acceptance and commitment therapy with a focus on compassion is the MS Association and the group doing yoga exercises is a yoga club.
Participants/Inclusion and exclusion criteria
Entry conditions: definitive diagnosis based on neurological examinations and magnetic resonance imaging by a specialist doctor; not suffering from other neurological and chronic diseases at the same time; Not suffering from psychological disorders. Non-entry conditions: suffering from other neurological and chronic diseases; suffering from severe psychological disorders at the same time; Taking psychiatric and psychoactive drugs
Intervention groups
One group receives Compassion-Focused Acceptance and Commitment Therapy, which is a third-wave therapy that combines an Acceptance and Commitment Therapy approach with a Compassion-Focused Therapy approach. A group of yoga exercises that combine asana (movement), pranayama (breath control), relaxing meditation. The control group receives no treatment approach..
Main outcome variables
Self management ; Difficulty in regulating emotions; Acceptance of pain; Pain catastrophizing
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230222057491N1
Registration date:2023-03-06, 1401/12/15
Registration timing:prospective
Last update:2023-03-06, 1401/12/15
Update count:0
Registration date
2023-03-06, 1401/12/15
Registrant information
Name
Farhad Jahangiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 4250 6423
Email address
jahangirifarhad3@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-11, 1401/12/20
Expected recruitment end date
2023-03-19, 1401/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effectiveness of acceptance and commitment therapy with a focus on compassion and yoga exercises on self-management, difficulty in emotion regulation, pain acceptance and pain catastrophizing in multiple sclerosis patients.
Public title
Comparison of the effect of therapy based on acceptance and commitment with a focus on compassion and yoga exercises on MS patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis based on neurological examinations and magnetic resonance imaging by a specialist doctor
Not suffering from other neurological and chronic diseases at the same time
Absence of mild cognitive problems by short mental state test
Absence of severe psychological disorders
Membership in the Multiple Sclerosis Association
Age range from 26 to 44 years
Literacy for reading and writing
Exclusion criteria:
Suffering from other neurological and chronic diseases
Suffering from severe psychological disorders at the same time
Having cognitive problems
Taking psychiatric and psychoactive drugs
No membership in the Multiple Sclerosis Association
Age less than 26 and more than 44 years
Lack of literacy
Age
From 26 years old to 44 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Available sampling and individual randomization unit. In this study, using non -residential sampling methods available and voluntarily, citing previous research records and valid research books of 45 are selected as statistical samples. In this study we have three groups, people are randomly in each group as I explain below. Group 1 receive admission -based and commitment treatment focusing on compassion, the second group performs yoga exercises, and the third group is a control group that does not receive any treatment. 45 pieces of paper are numbered from number 1 to 45, group one from 1 to 15 and Group two are from 16 to 30 and Group 3 from number 31 to 45. Participants are unaware of what group numbers are. We urge people to draw one of the papers that are unclear, and the number that each person has to show in which group is randomly placed.
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 committee of Borujerd Islamic Azad University of Medical Science
Street address
Imam Khomeini University Complex, Nawab، 3 km Yadgar Imam Road, Nawab Square, Borujerd
City
Borujerd
Province
Lorestan
Postal code
6915136335
Approval date
2023-02-12, 1401/11/23
Ethics committee reference number
IR.IAU.B.REC.1401.053
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
Self-management is a score that the subject receives through the self-management scale of MS patients (revised) by Bishop and Frain (2011). This self-report tool is compiled in 24 items and 5 subscales. The higher the person's score, the higher the level of self-management. The range of changes in this tool is between 24 and 120.
Timepoint
At the beginning of the study, that is, before the intervention in the form of a pre-test and after the intervention in the form of a post-test and then in the follow-up
Method of measurement
The Multiple Sclerosis Self-Management Scale–Revised (MSSM-R)
2
Description
Difficulty in emotion regulation is the score that the subject receives through the difficulty of emotion regulation scale by Gratz and Roemer (2004). This self-report tool has 36 items and 6 subscales. Higher scores mean more difficulty in emotional regulation.
Timepoint
At the beginning of the study, that is, before the intervention in the form of a pre-test and after the intervention in the form of a post-test and then in the follow-up
Method of measurement
Difficulties in Emotion Regulation Scale
3
Description
Acceptance of pain is the score that the subject receives from the Chronic Pain Acceptance Questionnaire - Revised by McCracken et al. (2004). The questionnaire has 20 items and two factors of participation in activity and desire for pain have been identified in this questionnaire. To obtain a total score, we add the scores of each factor together. Higher scores indicate higher levels of acceptance.
Timepoint
At the beginning of the study, that is, before the intervention in the form of a pre-test and after the intervention in the form of a post-test and then in the follow-up.
Method of measurement
Chronic Pain Acceptance Questionnaire - Revised
4
Description
Pain catastrophizing is a score that the subject receives through the pain catastrophizing scale of Sullivan et al. (1995). This questionnaire contains 13 statements about the person's thoughts and feelings during past painful experiences, which has subscales of rumination, magnification, and helplessness. . Questions are scored on a 5-point Likert scale, and a higher total score indicates a higher level of catastrophizing thoughts and feelings.
Timepoint
At the beginning of the study, that is, before the intervention in the form of a pre-test and after the intervention in the form of a post-test and then in the follow-up.
Method of measurement
Pain Catastrophizing Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: This group includes MS patients who receive treatment based on acceptance and commitment with a focus on compassion. The sessions include one pre-session and ten treatment sessions. It lasts 72 days in total. The pre-meeting is related to getting to know the group members and each other, checking the reasons for participation and expectations, the necessity of psychotherapy, introducing the approach, stating the rules and structure of the meetings, obtaining written consent and performing the pre-test, and the next ten treatment sessions will receive therapeutic intervention. . The first session: performing awareness training (body observation exercise), establishing a therapeutic alliance (metaphor of 2 mountains), expressing control as a performance measurement problem (metaphor of sand pool), introducing emotion regulation systems and assigning homework. It takes a total of 72 days. The second session: reviewing homework, practicing mindfulness, getting to know the old and new brain, introducing the dimensions of compassion and the three competitors of kindness (metaphor of the mother cat), creating creative frustration (metaphor of pressing the work board), training to create a blameless perspective and determine Homework. Third session: 3rd: Reviewing assignments, doing a brief mindfulness practice, creating sensitivity to human suffering in the context of the present, extending conscious mind compassion to the outside world and developing sensitivity to the disturbances of the present, practicing compassionate attention, filling in the daily compassionate worksheet and reviewing experiences and assigning homework. The fourth session: reviewing assignments, practicing compassionate attention, teaching and creating compassionate disruption, applying the metaphor of the freeway of the mind, and practicing the white room in a compassionate context, and assigning homework. Fifth: Homework Review, Compassionate Mindfulness Practice, Compassionate Intention Training, Compassionate Letting Go Metaphor, Ending War Practice Rope, and Homework Assignments. Sixth: Review assignments, practice compassionate attention, provide necessary training about the observer self in a compassionate context with an emphasis on empathy and compassion as a common human sense, the metaphor of the sky and the weather, perform the 2-chair technique for the inner critic and compassionate self, and determine Homework. The seventh session is reviewing homework, practicing mindfulness, teaching and freely choosing compassionate values with an emphasis on health care and the importance of loving relationships, determining life values in a context of compassion in the nine domains (compass of life), magic wand metaphors and Mind reading machine and homework assignments. Eighth session: Reviewing assignments, practicing mindfulness, teaching committed action in line with compassionate values with an emphasis on healing human suffering, children's practice on the bus, setting 4 goals and how to deal with obstacles to action, and setting homework. Ninth session: Reviewing assignments , practicing awareness attention, cultivating a kind mind in the framework of functional contextualism, practicing kind self-imagery, practicing communicating with different aspects of oneself and setting homework. Tenth session: reviewing homework, doing awareness attention practice, reviewing and summarizing the contents, thanks and appreciation and post-test implementation.
Category
Treatment - Other
2
Description
Intervention group: This group includes people who have been definitively diagnosed with MS through neurological examinations and magnetic resonance imaging, which have been confirmed by a specialist doctor and are recorded in the MS register. The members of this group do 24 sessions of yoga exercises. The time interval of the meetings is once every three days and it lasts 72 days in total.
Category
Treatment - Other
3
Description
Control group: people in this group do not undergo any psychological treatment or yoga exercises and remain on the waiting list. After the completion of the treatment sessions, at the same time as the other groups, they will be given a pre-test, post-test and follow-up test. are compared. Also, after 60 days, the subjects will answer the questions of the questionnaires again as a follow-up step.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Borujerd MS Association
Full name of responsible person
Fatemeh Yarahmadi
Street address
MS Association ., Special Medical Center of Borujerd Islamic Azad University, Resalat St, Shahid Molla Aghaei Ave ,Shahid Torabi blvd, phase 8 , Andisheh Town, Borujerd
City
Borujerd
Province
Lorestan
Postal code
6919736587
Phone
+98 66 4231 1401
Fax
+98 66 4231 1400
Email
fa.yarahmadi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farhad Jahangiri
Street address
Library building, Imam Khomeini University Complex, Nawab،3 km Yadgar Imam Road, Nawab Square, Borujerd
City
Borujerd
Province
Lorestan
Postal code
6915136335
Phone
+98 66 4251 8023
Email
jahangirifarhad3@gmail.com
Web page address
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
100
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
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farhad Jahangiri
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 21, Shahid Ghane Alley, Takhti Street
City
Borujerd
Province
Lorestan
Postal code
6915757857
Phone
+98 66 4250 6423
Email
jahangirifarhad3@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farhad Jahangiri
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 21, Shahid Ghane Alley, Takhti Street
City
Borujerd
Province
Lorestan
Postal code
6915757857
Phone
+98 66 4250 6423
Email
jahangirifarhad3@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farhad Jahangiri
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 21, Shahid Ghane Alley, Takhti Street
City
Borujerd
Province
Lorestan
Postal code
6915757857
Phone
+98 44 4250 6423
Email
jahangirifarhad3@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
Total data
When the data will become available and for how long
A few months after the results were published
To whom data/document is available
Researchers and all those who read articles
Under which criteria data/document could be used
For scientific research
From where data/document is obtainable
For academic and scientific journals
What processes are involved for a request to access data/document