The evaluation of the effectiveness of metacognitive therapy on reducing cognitive-attention syndrome, reducing pain intensity and reducing pain catastrophizing in patients affected by fibromyalgia
Design
A random, not blinded clinical trial with a control group design of 42 patients. To make it random, the lottery method is used.
Settings and conduct
Women with fibromyalgia syndrome make up the statistical population in this study. These women will go to rheumatology and orthopedic clinics in Tehran from April 26, 2022 to June 20, 2022.
Participants/Inclusion and exclusion criteria
In this study, the statistical population is women with fibromyalgia syndrome. The inclusion criteria are based on the definitive diagnosis of fibromyalgia by a rheumatologist or orthopedist according to the criteria of the American College of Rheumatology (ACR) and also the absence of rheumatoid arthritis and inflammatory arthritis. Pregnant women, women with a history of hospitalization due to psychotic disorders, women with a history of orthopedic surgery, and patients with multiple sclerosis cannot take part.
Intervention groups
In this study, metacognitive therapy will be performed on the experimental group members individually and the control group members only will participate in the pre-test and post-test part. Treatment will be 60-minute sessions in ten weeks.
Main outcome variables
Reducing cognitive-attention syndrome, reducing pain intensity and pain catastrophizing in patients with fibromyalgia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211031052927N1
Registration date:2022-04-20, 1401/01/31
Registration timing:prospective
Last update:2022-04-20, 1401/01/31
Update count:0
Registration date
2022-04-20, 1401/01/31
Registrant information
Name
Yaser Bodaghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2301 1240
Email address
yaserbodaghi@yahoo.co.uk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-25, 1401/02/05
Expected recruitment end date
2022-05-20, 1401/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Meta-Cognitive Therapy on Cognitive-Attention Syndrome, Pain Catastrophizing and Pain Intensity in Women with Fibromyalgia
Public title
The Effectiveness of Meta-Cognitive Therapy on Cognitive-Attention Syndrome, Pain Catastrophizing and Pain Intensity in Women with Fibromyalgia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The definitive diagnosis of fibromyalgia in the patient by a rheumatologist or orthopedist based on the criteria of the American College of Rheumatology (ACR)
Exclusion criteria:
The dismissal of the existence of rheumatoid arthritis and inflammatory arthritis
Pregnant women, women with a history of hospitalization due to psychotic disorders, women with a history of orthopedic surgery, and patients with multiple sclerosis cannot take part in the research.
Age
From 20 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Patients who meet the conditions to take part in the research are randomly assigned to one of the two groups in a random order by an analyst who is not involved in the participation of the patients. The method used to conceal the diagnosis is the use of a non-transparent sealed envelope. Each random sequence is recorded on a card, and the cards are placed inside the envelopes in order. Based on the order of the entry of eligible participants in the study, one of the envelopes is opened at the beginning of the registration and the assigned group of the participant is revealed.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Participants in this study are divided into experimental and control groups. Psychological intervention is performed on the experimental group and participants in the control group participate in only pre-tests and post-tests.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Semnan University of Medical Sciences (Research Ethics Committee)
Street address
Headquarter of Semnan University of Medical Sciences and Health Services, Bassij Blvd, Semnan, Iran.
City
Semnan
Province
Semnan
Postal code
35147-99442
Approval date
2021-10-26, 1400/08/04
Ethics committee reference number
IR.SEMUMS.REC.1400.193
Health conditions studied
1
Description of health condition studied
Fibromyalgia
ICD-10 code
M79.7
ICD-10 code description
Fibromyalgia
Primary outcomes
1
Description
Cognitive-Attention Syndrome score based on a special questionnaire of Attentive Cognitive Syndrome Scale (CAS-1)
Timepoint
Before beginning the intervention and 7 days after the end of the intervention
Method of measurement
Cognitive-Attention Syndrome score will be based on score and evaluation of the special questionnaire of Attentive Cognitive Syndrome Scale (CAS-1)
2
Description
Pain intensity score in the chronic pain questionnaire of Vonkorff et al.
Timepoint
Before beginning the intervention and 7 days after finishing the intervention
Method of measurement
Pain intensity score will be based on the score obtained as a result of the Vonkorff et al (1992) chronic pain questionnaire
3
Description
Pain Catastrophizing Score Obtained from pain Catastrophizing questionnaire of Sullivan et al.
Timepoint
Before beginning the intervention and 7 days after finishing the intervention.
Method of measurement
Pain Catastrophizing score will be based on the score obtained from the Sullivan et al. (1995) Pain Catastrophizing Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In this study, metacognitive therapy will be performed on the experimental group members individually and the control group members will participate only in the pre-test and post-test trials. The metacognitive therapy protocol is 8 to 10 weekly sessions of 45-60 minutes; due to the fact that this study is based on three variables and also these patients generally suffer from a lot of pain and bad mood and high anxiety, psychological interventions will be in 10 weekly sessions of 60 minutes. The title of the techniques and activities of each treatment session will be as follows; Session 1: Generate case formulation. Socialize to model. Run suppression experiment. Introduce worry (about pain) postponement. Practice detached mindfulness (DM). Homework: DM and worry postponement. Session 2: Review homework. Continue socialization (if necessary). Begin challenging uncontrollability belief (about pain). Practice detached mindfulness (DM). Attention training technique (ATT) practice. Complete ATT summary sheet. Homework: Postponement of worry (about pain), DM, ATT. Session 3: Review homework. Continue to challenge uncontrollability belief (about pain); giving counterevidence. Explore and ban thought suppression. Explore and ban maladaptive control/avoidance behaviors. Attention training technique (ATT) practice. Homework: Postponement of worry (about pain), DM, ATT. Session 4: Review homework. Continue to challenge uncontrollability belief (about pain), (If necessary). Broaden application of worry/rumination postponement. Continue to explore and ban maladaptive control/avoidance behaviors. Attention training technique (ATT) practice. Homework: Postponement of worry (about pain) and rumination, broaden application of DM, ATT, schedule activities. Session 5: Review homework. Begin to challenge positive beliefs about worry (about pain). Review activity levels and suggest enhancements (explore and ban other unhelpful coping, e.g., excessive sleep, alcohol). Attention training technique (ATT) practice. (increase difficulty). Homework: Postponement of worry (about pain) and rumination, broaden application of DM, ATT, increased activities. Session 6: Review homework. Continue to challenge positive beliefs about worry (about pain). Challenging negative beliefs about worry (about symptoms). Continue reviewing activity levels and suggest enhancements (explore and ban other unhelpful coping, e.g., excessive sleep, alcohol). Attention training technique (ATT) practice. Homework: Postponement of worry (about pain) and rumination, ATT, maintain activities. Session 7: Review homework. Run advantages–disadvantages analysis of threat monitoring. Challenge positive beliefs about threat monitoring. Ban threat monitoring. Suggest alternatives. Attention training technique (ATT) practice. Homework: Practice awareness and abandonment of threat monitoring, ATT, increased activities. Session 8: Review homework. Continue challenging positive beliefs about threat monitoring, banning threat monitoring and suggesting alternatives (If necessary). Work on residual beliefs. Begin work on therapy blueprint. Homework: Patient writes brief summary of treatment. Continue ban on worry/rumination, threat monitoring. Session 9: Review homework. Write out new plan for dealing with intrusions and symptoms.Complete therapy blueprint. Explore and modify fears of recurrence.Homework: Practice implementing new plan. Session 10: Review homework. Reinforce new plan and illustrate with a hypothetical future example. Check for any residual beliefs. Schedule booster session. Homework: Specify continued application.
Category
Treatment - Other
2
Description
Control group: The members will participate only in pre-test and post-test
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Sefibzadeh's clinic
Full name of responsible person
Dr. Mohammad Sefibzadeh
Street address
No 6, 3rd Golzari Alley, Pounak, Tehran
City
Tehran
Province
Tehran
Postal code
3315848887
Phone
+98 21 4462 7358
Email
yaserbodaghi0393@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Isaac Rahimian Boogar
Street address
Faculty of Psychology and Educational Sciences, Semnan University, Darband, Mahdishahr, Semnan
City
Semana
Province
Semnan
Postal code
3564111556
Phone
+98 23 3362 4250
Email
psychology@semnan.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences
Proportion provided by this source
10
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
Semnan University of Medical Sciences
Full name of responsible person
Dr. Isaac Rahimian Boogar
Position
Aَ member of Faculty of Psychology and Educational Sciences, Semanan
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Faculty of Psychology and Educational Sciences, Semnan University, Darband, Mahdishahr, Semnan
City
Semnan
Province
Semnan
Postal code
3564111556
Phone
+98 23 3362 4250
Email
i_rahimian@semnan.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Isaac Rahimian Boogar
Position
A member of Faculty of Psychology and Educational Sciences, Semnan University
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Faculty of Psychology and Educational Sciences, Semnan University, Darband, Mahdishahr, Semnan
City
Semnan
Province
Semnan
Postal code
3564111556
Phone
+98 23 3362 4250
Email
i_rahimian@semnan.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Isaac Rahimian Boogar
Position
A member of Faculty of Psychology and Educational Sciences, Semnan University
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Faculty of Psychology and Educational Sciences, Semnan University, Darband, Mahdishahr, Semnan
City
Semnan
Province
Semnan
Postal code
3564111556
Phone
+98 23 3362 4250
Email
i_rahimian@semnan.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
At the end of the intervention, the data about the participants will be presented separately but without mentioning their identity details.
When the data will become available and for how long
August to September of 2022
To whom data/document is available
University lecturers, university students, researchers, psychologists, psychiatrists, orthopedists, rheumatologists
Under which criteria data/document could be used
No special condition is considered
From where data/document is obtainable
Sending an email to researcher`s email address.
What processes are involved for a request to access data/document
The request must be sent via email and will be answered within a week