Protocol summary
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Study aim
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Determining the effect of cognitive therapy based on mindfulness on Kinesiophobia in the elderly with chronic osteoarthritis
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Design
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A single-blind trial, parallel groups, randomized using software, on 56 elderly people with chronic osteoarthritis.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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The degree of Kinesiophobia
General information
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Reason for update
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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..
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Acronym
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IRCT registration information
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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
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Registration date
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2023-11-11, 1402/08/20
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2024-04-09, 1403/01/21
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Expected recruitment end date
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2024-06-10, 1403/03/21
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Actual recruitment start date
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2024-04-09, 1403/01/21
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Actual recruitment end date
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2024-06-10, 1403/03/21
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Trial completion date
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2024-06-10, 1403/03/21
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Scientific title
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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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Public title
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The effect of Mindfulness-based cognitive therapy (MBCT) on Kinesiophobia in the elderly with chronic osteoarthritis
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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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)
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Age
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From 60 years old to 75 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
56
Actual sample size reached:
56
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-10-30, 1402/08/08
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Ethics committee reference number
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IR.KAUMS.NUHEPM.REC.1402.054
Health conditions studied
1
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Description of health condition studied
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Kinesiophobia
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Kinesiophobia Score
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Timepoint
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Measurement ofKinesiophobia Score before intervention, 4 and 8 weeks after intervention
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Method of measurement
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TSK: Tampa scale of kinesiophobia
Intervention groups
1
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Description
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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).
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Category
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Rehabilitation
2
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Description
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Control group: The elderly in the control group will receive routine treatments and educational pamphlets.
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Kashan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available