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Investigating the effect of Mindfulness-based cognitive therapy (MBCT) on Kinesiophobia in the elderly with chronic osteoarthritis

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History
# Registration date Revision Id
2 2026-07-11, 1405/04/20 386138
1 2023-11-11, 1402/08/20 284850
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  • General information

    empty
    56
    2023-11-22, 1402/09/01
    2024-04-09, 1403/01/21
    2023-12-22, 1402/10/01
    2024-06-10, 1403/03/21
    empty
    2024-04-09, 1403/01/21
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    2024-06-10, 1403/03/21
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    2024-06-10, 1403/03/21
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    The study sampling and data collection dates, as well as the cognitive assessment tool for the elderly (AMT was used instead of MMSE), and the duration of the intervention sessions (from 120 minutes to 90 minutes) were updated..
    empty
    تاریخ نمونه گیری و جمع اوری داده های مطالعه و همچنین ابزار بررسی وضعیت شناختی سالمندان (به جای MMSE از AMT استفاده شد) و مدت زمان جلسات مداخله (از 120 دقیقه به 90 دقیقه) به روز شد.
    Presence of autoimmune diseases, malignancy, congenital anomalies (except lordosis and mild scoliosis), fracture or infection in the knee
    History of falling during the last month
    Using psychiatric drugs (to reduce fear of movement)
    Using non-pharmacological and complementary treatments
    Suffering from known mental illness and mental retardation (based on the contents of the electronic health record)
    Suffering from cognitive impairment (getting a score above 20 on the MMSE instrument)
    Presence of autoimmune diseases, malignancy, congenital anomalies (except lordosis and mild scoliosis), fracture or infection in the knee
    History of falling during the last month
    Using psychiatric drugs (to reduce fear of movement)
    Using non-pharmacological and complementary treatments
    Suffering from known mental illness and mental retardation (based on the contents of the electronic health record)
    Suffering from cognitive impairment (getting a score above 8 from AMT)
    ابتلا به بیماری‌های اتوایمون، بدخیمی، ناهنجاری‌های مادرزادی (به استثناء لوردوز و اسکولیوز خفیف)، شکستگی و یا عفونت در زانو
    سابقه سقوط در طول یک ماه گذشته
    استفاده از داروهای روانپزشکی ( برای کاهش ترس از حرکت)
    استفاده از درمان های غیر دارویی و مکمل
    ابتلا به بیماری روانی و عقب‌ماندگی‌ ذهنی شناخته‌شده (بر اساس مندرجات پرونده الکترونیک سلامت)
    ابتلاء به اختلال شناختی (کسب امتیاز بالای 20 از ابزار(MMSE))
    ابتلا به بیماری‌های اتوایمون، بدخیمی، ناهنجاری‌های مادرزادی (به استثناء لوردوز و اسکولیوز خفیف)، شکستگی و یا عفونت در زانو
    سابقه سقوط در طول یک ماه گذشته
    استفاده از داروهای روانپزشکی ( برای کاهش ترس از حرکت)
    استفاده از درمان های غیر دارویی و مکمل
    ابتلا به بیماری روانی و عقب‌ماندگی‌ ذهنی شناخته‌شده (بر اساس مندرجات پرونده الکترونیک سلامت)
    ابتلاء به اختلال شناختی (کسب امتیاز بالای 8 از ابزار (AMT))

  • Intervention groups

    #1
    Intervention group: The intervention group will receive 8 sessions of 120 minutes, twice a week for one month, a mindfulness based cognitive therapy program, taken from the study of Segal et al. (2018).
    Intervention group: The intervention group will receive 8 sessions of 90 minutes, twice a week for one month, a mindfulness based cognitive therapy program, taken from the study of Segal et al. (2018).
    گروه مداخله: گروه مداخله 8 جلسه 120 دقیقه ایی دوبار در هفته به مدت یک ماه، برنامه شناخت درمانی مبتنی بر ذهن‌ آگاهی ، برگرفته از مطالعه سیگال و همکاران (2018) را دریافت خواهد نمود.
    گروه مداخله: گروه مداخله 8 جلسه 90 دقیقه ایی دوبار در هفته به مدت یک ماه، برنامه شناخت درمانی مبتنی بر ذهن‌ آگاهی ، برگرفته از مطالعه سیگال و همکاران (2018) را دریافت خواهد نمود.

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: fallahifatema@gmail.com
    Full name of responsible person - Persian: فاطمه فلاحی
    Street address - English: Deputy of research and technology, Doctor's Blvd., Qutb Rawandi Blvd
    Street address - Persian: بلوار قطب راوندی، بلوار پزشک، معاونت تحقیقات و فناوری
    City - English: Kashan
    City - Persian: کاشان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 8715988141
    Phone: +98 31 5554 2999
    Fax: +98 31 5557 5057
    Email: research@kaums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr. Gholamali Hamidi
    Full name of responsible person - Persian: دکتر غلامعلی حمیدی
    Street address - English: Deputy of research and technology, Doctor's Blvd., Qutb Rawandi Blvd
    Street address - Persian: بلوار قطب راوندی، بلوار پزشک، معاونت تحقیقات و فناوری
    City - English: Kashan
    City - Persian: کاشان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 8715988141
    Phone: +98 31 5554 2999
    Fax: +98 31 5557 5057
    Email: research@kaums.ac.ir
    Web page address:

Protocol summary

Study aim
Determining the effect of cognitive therapy based on mindfulness on Kinesiophobia in the elderly with chronic osteoarthritis
Design
A single-blind trial, parallel groups, randomized using software, on 56 elderly people with chronic osteoarthritis.
Settings and conduct
56 elderly people referred to Kashan comprehensive health centers will be selected according to the inclusion criteria. The selected individuals divided into two equal groups. A group of 28 people selected to participate in mindfulness sessions that held for 8 sessions. The questions of Kinesiophobia asked and completed before the intervention. Then, 4 weeks after the end of the sessions, the questionnaire asked again by the researcher. The control group does not participate in mindfulness sessions; they only answer a series of questions at the beginning of the study, 4 and 8 weeks after that.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 60-75 years Knee osteoarthritis At least 3 months have passed since the diagnosis of arthritis. Exclusion criteria: Inability to participate in meetings Absence of at least 3 sessions Lack of access to samples in the follow-up phase Occurrence of cognitive and psychological disorders during the study Death Hospitalization during the study
Intervention groups
The intervention group receive 8 sessions of cognitive therapy program based on mindfulness. The content of the cognitive therapy sessions based on the conscious mind taken from the study of Segal et al. (2018). The control group will receive routine treatments and educational brochures.
Main outcome variables
The degree of Kinesiophobia

General information

Reason for update
The study sampling and data collection dates, as well as the cognitive assessment tool for the elderly (AMT was used instead of MMSE), and the duration of the intervention sessions (from 120 minutes to 90 minutes) were updated..
Acronym
IRCT registration information
IRCT registration number: IRCT20231105059961N1
Registration date: 2023-11-11, 1402/08/20
Registration timing: prospective

Last update: 2026-07-11, 1405/04/20
Update count: 1
Registration date
2023-11-11, 1402/08/20
Registrant information
Name
Fatemeh Fallahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5558 9392
Email address
fallahi-f@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-09, 1403/01/21
Expected recruitment end date
2024-06-10, 1403/03/21
Actual recruitment start date
2024-04-09, 1403/01/21
Actual recruitment end date
2024-06-10, 1403/03/21
Trial completion date
2024-06-10, 1403/03/21
Scientific title
Investigating the effect of Mindfulness-based cognitive therapy (MBCT) on Kinesiophobia in the elderly with chronic osteoarthritis
Public title
The effect of Mindfulness-based cognitive therapy (MBCT) on Kinesiophobia in the elderly with chronic osteoarthritis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Knee osteoarthritis (doctor's diagnosis) At least 3 months have passed since the diagnosis of arthritis. Obtaining a score higher than 18 from the fear of movement questionnaire Ability to communicate in Farsi Iranian nationality Consent to participate in the study
Exclusion criteria:
Presence of autoimmune diseases, malignancy, congenital anomalies (except lordosis and mild scoliosis), fracture or infection in the knee History of falling during the last month Using psychiatric drugs (to reduce fear of movement) Using non-pharmacological and complementary treatments Suffering from known mental illness and mental retardation (based on the contents of the electronic health record) Suffering from cognitive impairment (getting a score above 8 from AMT)
Age
From 60 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 56
Actual sample size reached: 56
Randomization (investigator's opinion)
Randomized
Randomization description
The samples will be randomly assigned to each of the two groups in the form of blocks of 4 and 6. By using www.sealedenvelope.com, 6 blocks of 4 pieces and 4 blocks of 8 pieces and a total of 10 blocks will be defined. The blocks will be divided into 4 categories based on the list taken from the mentioned site and randomly each category of blocks will be considered from one center.
Blinding (investigator's opinion)
Single blinded
Blinding description
One-way blinding process will be possible for this research. In this way, in the final analysis of the data, the statistical analyst is unaware of the test groups and they will be named A and B.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Faculty of Nursing & Midwifery, Faculty of Health & Faculty of Parame
Street address
Doctor's Blvd., Qutb Rawandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715988141
Approval date
2023-10-30, 1402/08/08
Ethics committee reference number
IR.KAUMS.NUHEPM.REC.1402.054

Health conditions studied

1

Description of health condition studied
Kinesiophobia
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Kinesiophobia Score
Timepoint
Measurement ofKinesiophobia Score before intervention, 4 and 8 weeks after intervention
Method of measurement
TSK: Tampa scale of kinesiophobia

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The intervention group will receive 8 sessions of 90 minutes, twice a week for one month, a mindfulness based cognitive therapy program, taken from the study of Segal et al. (2018).
Category
Rehabilitation

2

Description
Control group: The elderly in the control group will receive routine treatments and educational pamphlets.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Kashan Comprehensive Health Centers
Full name of responsible person
Fatemeh Fallahi
Street address
Doctor's Blvd., Qutb Rawandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5558 9392
Fax
+98 31 5558 9392
Email
fallahifatema@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Gholamali Hamidi
Street address
Deputy of research and technology, Doctor's Blvd., Qutb Rawandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 2999
Fax
+98 31 5557 5057
Email
research@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
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
Kashan University of Medical Sciences
Full name of responsible person
Fatemeh Fallahi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Doctor's Blvd., Qutb Rawandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5558 9392
Email
fallahifatema@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Fatemeh Fallahi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Doctor's Blvd., Qutb Rawandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5558 9392
Email
fallahifatema@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Fatemeh Fallahi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery​, Kashan University of Medical Sciences, Doctor Blvd., Qutb Rawandi Blvd.,
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5558 9392
Fax
+98 31 5558 9392
Email
fallahi-f@kaums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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