Protocol summary
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Study aim
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Determining the comparative effectiveness of acceptance and commitment-based therapy and compassion-focused therapy on death anxiety, fear of falling, life expectancy and demoralization symptoms in patients with multiple sclerosis.
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Design
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The clinical trial will include two intervention groups, ACT, CFT, and a control group, which will be purposefully sampled and assigned to the groups using a random number table.
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Settings and conduct
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After sampling and performing the pre-test, each group will be individually subjected to CFT and ACT intervention, and then the post-test will be performed in that case, and these measures will be performed by obtaining the necessary permits in Imam Reza Hospital, Tabriz University of Medical Sciences
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Participants/Inclusion and exclusion criteria
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Criteria for the diagnosis of MS by a neurologist
Being 20 to 50 years old
At least two years have passed since the illness
Consent to participate in the research and not having other acute and chronic physical and psychological diseases based on the patient's medical record
Exit criteria
Absence in two training sessions
Non-cooperation and not doing the tasks specified in the training course
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Intervention groups
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In this research, there will be three groups including two intervention groups with ACT and CFT treatment on MS patients and one group as a control group.
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Main outcome variables
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death anxiety ; fear of falling (falling); life expectancy; Depression syndrome
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20231112060034N1
Registration date:
2024-01-04, 1402/10/14
Registration timing:
prospective
Last update:
2024-01-08, 1402/10/18
Update count:
1
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Registration date
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2024-01-04, 1402/10/14
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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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2024-01-05, 1402/10/15
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Expected recruitment end date
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2024-02-04, 1402/11/15
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparing the effectiveness of acceptance and commitment-based therapy and compassion-focused therapy on death anxiety, fear of falling, life expectancy and demoralization symptoms in patients with multiple sclerosis
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Public title
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Investigating the effect of acceptance and commitment-based therapy and compassion-focused therapy on multiple sclerosis patients
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Diagnosis of MS disease by brain and nerve specialist and referral of medical case to MS Society
Being 20 to 50 years old
At least two years have passed since the illness
Consent to participate in the research
Not having other acute and chronic physical and psychological diseases based on the patient's medical record
Exclusion criteria:
Absence in two training sessions and non-cooperation
Not doing the tasks specified in the training course
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Age
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From 20 years old to 50 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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No information
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Not randomized
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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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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2023-08-08, 1402/05/17
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Ethics committee reference number
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IR.IAU.TABRIZ.REC.1402.201
Health conditions studied
1
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Description of health condition studied
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Multiple sclerosis
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ICD-10 code
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G35
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ICD-10 code description
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Multiple sclerosis
Primary outcomes
1
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Description
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The score that subjects will get from answering the questions of the death anxiety scale (Templer, 1970).
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Timepoint
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Pre-test and post-test before and after ACT, CFT intervention and after the follow-up period
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Method of measurement
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Templer Death Anxiety Scale
2
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Description
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The score that the subjects will get from the answers to the questions of the short scale of efficiency in falling the international form (Kampen et al., 2008).
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Timepoint
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Pre-test and post-test before and after ACT, CFT intervention and after the follow-up period
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Method of measurement
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Short scale of efficiency in falling - international form
3
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Description
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The score that the subjects will get from the answers to the questions of the depression syndrome questionnaire (Kisan et al., 2004).
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Timepoint
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Pre-test and post-test before and after ACT, CFT intervention and after the follow-up period
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Method of measurement
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Questionnaire of Kisan's low morale syndrome
4
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Description
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The score that subjects will get from answering the questions of Omid Snyder's questionnaire (Snyder, 1991).
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Timepoint
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Pre-test and post-test before and after ACT, CFT intervention and after the follow-up period
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Method of measurement
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Hope Snyder questionnaire
5
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Description
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In the current research, acceptance and commitment based therapy is the training of skills based on the acceptance and commitment therapy protocol (Hayes and Stroshall, 2005), and it will be carried out during 8 sessions of 60 minutes.
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Timepoint
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Pre-test and post-test before and after ACT, CFT intervention and after the follow-up period
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Method of measurement
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Treatment protocol based on acceptance and commitment
6
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Description
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In the present research, the treatment focused on compassion is the training of skills based on the program of Gilbert (2010) and will be carried out during 8 sessions of 60 minutes.
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Timepoint
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Pre-test and post-test before and after ACT, CFT intervention and after the follow-up period
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Method of measurement
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Compassion-focused therapy
Intervention groups
1
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Description
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Intervention group: For the first experimental group, commitment-based acceptance therapy will be performed in 8 sessions of 60 minutes. The commitment-based acceptance therapy used in this research will be based on the therapeutic protocol of Hayes and Stroshall (2005).
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Category
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Treatment - Other
2
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Description
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Intervention group: For the second experimental group, treatment focused on compassion will be done in 8 sessions of 60 minutes. The therapy focused on compassion used in this study was determined based on the program of Gilbert (2010).
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Category
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Treatment - Other
3
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Description
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Control Group: Includes 20 samples who will not get any therapeutic intervention
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Category
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Diagnosis
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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No
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Title of funding source
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Islamic Azad university
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Proportion provided by this source
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1
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Public or private sector
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Private
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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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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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There is no further information
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When the data will become available and for how long
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There is no further information
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To whom data/document is available
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There is no further information
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Under which criteria data/document could be used
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There is no further information
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From where data/document is obtainable
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There is no further information
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What processes are involved for a request to access data/document
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There is no further information
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Comments
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