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The effects of mindfulness-based cognitive therapy on promoting medication adherence among patient with epilepsy: an application of social media intervention

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History
# Registration date Revision Id
4 2021-03-23, 1400/01/03 176103
3 2020-07-11, 1399/04/21 143441
2 2020-07-03, 1399/04/13 141667
1 2020-07-03, 1399/04/13 141576
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  • Recruitment centers

    #1
    Name of recruitment center - English: Boali clinic
    Name of recruitment center - Persian: کلینیک بوعلی
    Full name of responsible person - English: Roghaye Mehrdel
    Full name of responsible person - Persian: رقیه مهردل
    Street address - English: Ferdowsi Cross.,Ferdowsi Ave
    Street address - Persian: خیابان فردوسی،بالاتر از چهارراه فردوسی
    City - English: Qazvin
    City - Persian: قزوین
    Province: Qazvin
    Country: Iran (Islamic Republic of)
    Postal code: 3419915315
    Phone: +98 28 3336 1733
    Fax:
    Email: boali.hospital@qums.ac.ir
    Web page address:
    Name of recruitment center - English: Boali clinic
    Name of recruitment center - Persian: کلینیک بوعلی
    Full name of responsible person - English: Mahdi Nikobakht
    Full name of responsible person - Persian: مهدی نیکوبخت
    Street address - English: Ferdowsi Cross.,Ferdowsi Ave
    Street address - Persian: خیابان فردوسی،بالاتر از چهارراه فردوسی
    City - English: Qazvin
    City - Persian: قزوین
    Province: Qazvin
    Country: Iran (Islamic Republic of)
    Postal code: 3419915315
    Phone: +98 28 3336 1733
    Fax:
    Email: boali.hospital@qums.ac.ir
    Web page address:
    #2
    Name of recruitment center - English: Mohammadzadeh clinic
    Name of recruitment center - Persian: کلینیک محمدزاده
    Full name of responsible person - English: Reza Gorgi
    Full name of responsible person - Persian: رضاگرجی
    Street address - English: Amirkabir12 Ave.,Pirouzi Ave.,Nokhbegan Blvd
    Street address - Persian: بلوار نخبگان،خیابان پیروزی،خیابان امیرکبیر12
    City - English: Qazvin
    City - Persian: قزوین
    Province: Qazvin
    Country: Iran (Islamic Republic of)
    Postal code: 3419915315
    Phone: +98 28 3333 6001
    Fax:
    Email: info@qums.ac.ir
    Web page address:
    Name of recruitment center - English: Mohammadzadeh clinic
    Name of recruitment center - Persian: کلینیک محمدزاده
    Full name of responsible person - English: Mahdi Nikobakht
    Full name of responsible person - Persian: مهدی نیکوبخت
    Street address - English: Amirkabir12 Ave.,Pirouzi Ave.,Nokhbegan Blvd
    Street address - Persian: بلوار نخبگان،خیابان پیروزی،خیابان امیرکبیر12
    City - English: Qazvin
    City - Persian: قزوین
    Province: Qazvin
    Country: Iran (Islamic Republic of)
    Postal code: 3419915315
    Phone: +98 28 3333 6001
    Fax:
    Email: info@qums.ac.ir
    Web page address:
    #3
    Name of recruitment center - English: Velayat clinic
    Name of recruitment center - Persian: کلینیک ولایت
    Full name of responsible person - English: Sepideh Paybast
    Full name of responsible person - Persian: سپیده پای بست
    Street address - English: Taavon Sq.,Minudar Town
    Street address - Persian: شهرک مینودر،میدان تعاون
    City - English: Qazvin
    City - Persian: قزوین
    Province: Qazvin
    Country: Iran (Islamic Republic of)
    Postal code: 3419915315
    Phone: +98 28 3379 0648
    Fax:
    Email: aakaramai@qums.ac.ir
    Web page address:
    Name of recruitment center - English: Velayat clinic
    Name of recruitment center - Persian: کلینیک ولایت
    Full name of responsible person - English: Mahdi Nikobakht
    Full name of responsible person - Persian: مهدی نیکوبخت
    Street address - English: Taavon Sq., Minudar Town
    Street address - Persian: شهرک مینودر، میدان تعاون
    City - English: Qazvin
    City - Persian: قزوین
    Province: Qazvin
    Country: Iran (Islamic Republic of)
    Postal code: 3419915315
    Phone: +98 28 3379 0648
    Fax:
    Email: aakaramai@qums.ac.ir
    Web page address:
    #4
    Name of recruitment center - English: Shahid Rajaei clinic
    Name of recruitment center - Persian: کلینیک شهید رجایی
    Full name of responsible person - English: Muslem Jaberian Hamedani
    Full name of responsible person - Persian: مسلم جابریان همدانی
    Street address - English: Padegan Cross.,Padegan Ave
    Street address - Persian: خیابان پادگان،چهارراه پادگان
    City - English: Qazvin
    City - Persian: قزوین
    Province: Qazvin
    Country: Iran (Islamic Republic of)
    Postal code: 3419915315
    Phone: +98 28 3333 5800
    Fax:
    Email: alitaremiha@yahoo.com
    Web page address:
    Name of recruitment center - English: Shahid Rajaei clinic
    Name of recruitment center - Persian: کلینیک شهید رجایی
    Full name of responsible person - English: Mahdi Nikobakht
    Full name of responsible person - Persian: مهدی نیکوبخت
    Street address - English: Padegan Cross., Padegan Ave
    Street address - Persian: خیابان پادگان، چهارراه پادگان
    City - English: Qazvin
    City - Persian: قزوین
    Province: Qazvin
    Country: Iran (Islamic Republic of)
    Postal code: 3419915315
    Phone: +98 28 3333 5800
    Fax:
    Email: alitaremiha@yahoo.com
    Web page address:

  • Person responsible for general inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Sara Fazeli Rooshande
    Full name of responsible person - Persian: سارا فاضلی روشنده
    Position - English: Master of Science student
    Position - Persian: دانشجوی کارشناسی ارشد
    Latest degree: bachelor
    Area of specialty/work: 14
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Qazvin University of Medical Sciences, Shahid Bahonar Blvd.
    Street address - Persian: بلوار شهید باهنر،دانشگاه علوم پزشکی قزوین
    City - English: Qazvin
    City - Persian: قزوین
    Province: Qazvin
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 3419915315
    Phone: +98 28 3334 4589
    Mobile: +98 919 189 7511
    Fax:
    Email: s.fazelirooshande@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Amir Pakpour
    Full name of responsible person - Persian: امیر پاکپور
    Position - English: Professor
    Position - Persian: استاد
    Latest degree: phd
    Area of specialty/work: 14
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Social Determenant of Health Research Center.,Shahid Bahonar Blvd.,Qazvin University of Medical Sciences
    Street address - Persian: بلوار شهید باهنر،دانشگاه علوم پزشکی قزوین،مرکز تحقیقات عوامل اجتماعی موثر بر سلامت (SDH)
    City - English: Qazvin
    City - Persian: قزوین
    Province: Qazvin
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 3419915315
    Phone: +98 28 3334 4589
    Mobile: +98 919 314 4371
    Fax:
    Email: apakpour@qums.ac.ir
    Web page address:

  • Person responsible for updating data


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Sara Fazeli Rooshande
    Full name of responsible person - Persian: سارا فاضلی روشنده
    Position - English: Master of Science student
    Position - Persian: دانشجوی کارشناسی ارشد
    Latest degree: bachelor
    Area of specialty/work: 14
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Qazvin University of Medical Sciences, Shahid Bahonar Blvd.
    Street address - Persian: بلوار شهید باهنر،دانشگاه علوم پزشکی قزوین
    City - English: Qazvin
    City - Persian: قزوین
    Province: Qazvin
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 3419915315
    Phone: +98 28 3334 4589
    Mobile: +98 919 189 7511
    Fax:
    Email: s.fazelirooshande@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Amir Pakpour
    Full name of responsible person - Persian: امیر پاکپور
    Position - English: Professor
    Position - Persian: استاد
    Latest degree: phd
    Area of specialty/work: 14
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Social Determenant of Health Research Center.,Shahid Bahonar Blvd.,Qazvin University of Medical Sciences
    Street address - Persian: بلوار شهید باهنر،دانشگاه علوم پزشکی قزوین،مرکز تحقیقات عوامل اجتماعی موثر بر سلامت(SDH)
    City - English: Qazvin
    City - Persian: قزوین
    Province: Qazvin
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 3419915315
    Phone: +98 28 3334 4589
    Mobile: +98 919 314 4371
    Fax:
    Email: apakpour@qums.ac.ir
    Web page address:

Protocol summary

Study aim
Determining the effectiveness of mindfulness based cognitive-behavioral therapy on promoting medication adherence among patient with epilepsy
Design
This research is a prospective cluster randomized controlled trial and It is a single blind with parallel groups.128 patients are selected from 4 neurology clinics by simple randomization method. People receive a special code and then will be randomly divided into intervention and control groups.
Settings and conduct
This study will conduct among 4 neurology clinics in Qazvin.The study sample is patients with epilepsy who are referred to neurology clinics for routine examinations by physicians.Randomization will be performed at a center level. Randomization and allocation will be performed by an independent statistician who is blinded to participants’ clinical histories.
Participants/Inclusion and exclusion criteria
Inclusion criteria: confirmed diagnosis of epilepsy in patients by a physician specializing in neurology; age of 18 years or older; prescribing antiepileptic drugs. Exclusion criteria: suffering from progressive neurological disease; diagnosis of an intellectual disability.
Intervention groups
The content of the 4 sessions of mindfulness training is sent to the participants weekly and online through social networks. The content will be an online version of the face-to-face eight-week mindfulness course in Mindfulness-Based Stress Reduction program (MBSR). Patients are provided with information about the etiology, prognosis of epilepsy, as well as antiepileptic drugs. Also the group mindfulness training sessions will lead by a licensed clinical psychologist who have 5 years of experience in teaching mindfulness meditation.
Main outcome variables
The Medication Adherence Report; Mindful Attention Awareness

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181226042140N2
Registration date: 2020-07-03, 1399/04/13
Registration timing: registered_while_recruiting

Last update: 2020-07-04, 1399/04/14
Update count: 3
Registration date
2020-07-03, 1399/04/13
Registrant information
Name
sara fazelirooshande
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 6001
Email address
s.fazelirooshande@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-20, 1399/03/31
Expected recruitment end date
2020-08-20, 1399/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of mindfulness-based cognitive therapy on promoting medication adherence among patient with epilepsy: an application of social media intervention
Public title
Investigating the intervention of mindfulness on on promoting medication adherence among patient with epilepsy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
A confirmed diagnosis of epilepsy in patients by a physician specializing in neurology An age of 18 years or older Prescribing antiepileptic drugs Being responsible for taking the medicine by oneself or an independent person
Exclusion criteria:
Suffering from progressive neurological disease Do not prescribed antiepileptic drugs Diagnosis of an intellectual disability Having a major cognitive impairment
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 128
Randomization (investigator's opinion)
Randomized
Randomization description
Regarding the stratified block ranomization in this study, it is stated that the randomization is performed in 4 neurology clinics.Two groups are selected from each of these centers, one for the intervention group and the other for the control group.32 patients are selected from each center, of which 16 are in the intervention group and 16 are in the control group.Randomization is done using software, and after the groups are identified, the code for the intervention group and control group is placed in the envelope and the envelopes are numbered.This is determined by whether the patient is in the intervention group or the control group, after he or she visits the center and receives the envelope and sees the content inside.
Blinding (investigator's opinion)
Single blinded
Blinding description
Randomization will be performed at a center level. Neurology clinics will randomly allocate (1:1) in intervention and treatment as usual groups. Randomization and allocation will be performed by an independent statistician who is blinded to participants’ clinical histories.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee in Research of the National Institute for Medical Research Development in Sciences
Street address
No.21, Besat Ave., Western Fatemi Ave.
City
Tehran
Province
Tehran
Postal code
1419693111
Approval date
2019-12-06, 1398/09/15
Ethics committee reference number
IR.NIMAD.REC.1399.008

Health conditions studied

1

Description of health condition studied
Epilepsy
ICD-10 code
G40.1
ICD-10 code description
Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with simple partial seizures

Primary outcomes

1

Description
The medication adherence score
Timepoint
Immediately after the intervention and 6 months after the intervention
Method of measurement
The Medication Adherence Report Scale(MARS)

2

Description
Mindful Attention Awareness score
Timepoint
Immediately after the intervention and 6 months after the intervention
Method of measurement
Mindful Attention Awareness Scale(MAAS)

Secondary outcomes

1

Description
Severity of a patient's seizures score
Timepoint
Immediately after the intervention and 6 months after the intervention
Method of measurement
Liverpool Seizure Severity Scale(LSSS)

2

Description
Quality of life in epilepsy score
Timepoint
Immediately after the intervention and 6 months after the intervention
Method of measurement
Health-related quality of life

3

Description
Perceived behavioral control questions
Timepoint
Immediately after the intervention and 6 months after the intervention
Method of measurement
Perceived behavioral control(PBC)

4

Description
Anxiety and depression score
Timepoint
Immediately after the intervention and 6 months after the intervention
Method of measurement
Hospital Anxiety and Depression Scale (HADS)

Intervention groups

1

Description
Intervention group: It will be the first trial targeting medication adherence through an online mindfulness intervention.Each week, the intervention group will receive an email from the primary researcher to inform them that a class has uploaded to the social media group to be completed at a time that suited them and would be accessible for one week.It will be 4 sessions of online psychoeducation in the treatment as usual group. At the sessions, the patients will give information about the aetiology, symptoms, and prognosis of epilepsy, as well as antiepileptic drug, and their possible side effects. Each patient member is also provided with information about the importance of medication adherence and the risks of discontinuing the medication. An online booklet providing information about epilepsy and possible drug treatments will be provided for the patients.Patients with epilepsy will randomly assig into two groups 1) intervention and 2) treatment as usual. All participants will complete measurements at baseline (before randomization) and post intervention and six months after completing the intervention.
Category
Behavior

2

Description
Control group: They receive their medications as usual.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Boali clinic
Full name of responsible person
Mahdi Nikobakht
Street address
Ferdowsi Cross.,Ferdowsi Ave
City
Qazvin
Province
Qazvin
Postal code
3419915315
Phone
+98 28 3336 1733
Email
boali.hospital@qums.ac.ir

2

Recruitment center
Name of recruitment center
Mohammadzadeh clinic
Full name of responsible person
Mahdi Nikobakht
Street address
Amirkabir12 Ave.,Pirouzi Ave.,Nokhbegan Blvd
City
Qazvin
Province
Qazvin
Postal code
3419915315
Phone
+98 28 3333 6001
Email
info@qums.ac.ir

3

Recruitment center
Name of recruitment center
Velayat clinic
Full name of responsible person
Mahdi Nikobakht
Street address
Taavon Sq., Minudar Town
City
Qazvin
Province
Qazvin
Postal code
3419915315
Phone
+98 28 3379 0648
Email
aakaramai@qums.ac.ir

4

Recruitment center
Name of recruitment center
Shahid Rajaei clinic
Full name of responsible person
Mahdi Nikobakht
Street address
Padegan Cross., Padegan Ave
City
Qazvin
Province
Qazvin
Postal code
3419915315
Phone
+98 28 3333 5800
Email
alitaremiha@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
National Institute for Medical Research Development
Full name of responsible person
National Institute for Medical Research Development
Street address
No.21, Besat Ave., Western Fatemi Ave
City
Tehran
Province
Tehran
Postal code
1419693111
Phone
+98 21 6693 8037
Email
NIMAD@RESEARCH.AC.IR
Grant name
Bridging Grant Call
Grant code / Reference number
987827
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
National Institute for Medical Research Development
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
Qazvin University of Medical Sciences
Full name of responsible person
Amir Pakpour
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Social Determenant of Health Research Center.,Shahid Bahonar Blvd.,Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
3419915315
Phone
+98 28 3334 4589
Email
apakpour@qums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Amir pakpour
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Social Determenant of Health Research Center.,Shahid Bahonar Blvd.,Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
3419915315
Phone
+98 28 3334 4589
Fax
+98 28 3335 0056
Email
apakpour@qums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Amir Pakpour
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Social Determenant of Health Research Center.,Shahid Bahonar Blvd.,Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
3419915315
Phone
+98 28 3334 4589
Email
apakpour@qums.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
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
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