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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General information
3
N/A
3na
empty
Complete all variables related to the study outcomes that will be measured.
Complete all variables related to the study outcomes that will be measured.
empty
تکمیل تمامی متغیرهای مربوط به پیامدهای مطالعه که اندازه گیری خواهند شد.
تکمیل تمامی متغیرهای مربوط به پیامدهای مطالعه که اندازه گیری خواهند شد.
Secondary outcomes
#1
empty
Patient's beliefs about medication
Patient's beliefs about medication
empty
عقاید بیماران در مورد مصرف دارو
عقاید بیماران در مورد مصرف دارو
empty
Immediately after the intervention and 6 months after the intervention
Immediately after the intervention and 6 months after the intervention
empty
بلافاصله پس از مداخله و ۶ ماه بعد از مداخله
بلافاصله پس از مداخله و ۶ ماه بعد از مداخله
empty
Beliefs about Medications Questionnaire (BMQ)
Beliefs about Medications Questionnaire (BMQ)
empty
پرسشنامه عقاید مربوط به درمان
پرسشنامه عقاید مربوط به درمان
#2
empty
Intention to adhere to medication
Intention to adhere to medication
empty
قصد تبعیت از مصرف دارو
قصد تبعیت از مصرف دارو
empty
Immediately after the intervention and 6 months after the intervention
Immediately after the intervention and 6 months after the intervention
empty
بلافاصله پس از مداخله و ۶ ماه بعد از مداخله
بلافاصله پس از مداخله و ۶ ماه بعد از مداخله
empty
Behavioral intention Questions
Behavioral intention Questions
empty
سوالات قصد رفتاری
سوالات قصد رفتاری
#3
empty
Self-monitoring by the patient in taking his medications
Self-monitoring by the patient in taking his medications
empty
خود نظارتی توسط بیمار در مصرف داروهایش
خود نظارتی توسط بیمار در مصرف داروهایش
empty
Immediately after the intervention and 6 months after the intervention
Immediately after the intervention and 6 months after the intervention
empty
بلافاصله پس از مداخله و ۶ ماه بعد از مداخله
بلافاصله پس از مداخله و ۶ ماه بعد از مداخله
empty
Self-monitoring questions
Self-monitoring questions
empty
سوالات مربوط به خود پایشی
سوالات مربوط به خود پایشی
#4
empty
Plan for time, place, how to take medicine
Plan for time, place, how to take medicine
empty
برنامه ریزی برای زمان،مکان،نحوه مصرف دارو
برنامه ریزی برای زمان،مکان،نحوه مصرف دارو
empty
Immediately after the intervention and 6 months after the intervention
Immediately after the intervention and 6 months after the intervention
empty
بلافاصله پس از مداخله و ۶ ماه بعد از مداخله
بلافاصله پس از مداخله و ۶ ماه بعد از مداخله
empty
Questions about Action planning
Questions about Action planning
empty
سوالات مربوط به برنامه ریزی برای عمل
سوالات مربوط به برنامه ریزی برای عمل
#5
empty
Predicting drug use barriers and creating strategies to overcome those barriers
Predicting drug use barriers and creating strategies to overcome those barriers
empty
پیش بینی موانع مصرف دارو و ایجاد راهکارهایی برای غلبه بر آن موانع
پیش بینی موانع مصرف دارو و ایجاد راهکارهایی برای غلبه بر آن موانع
empty
Immediately after the intervention and 6 months after the intervention
Immediately after the intervention and 6 months after the intervention
empty
بلافاصله پس از مداخله و ۶ ماه بعد از مداخله
بلافاصله پس از مداخله و ۶ ماه بعد از مداخله
empty
Questions about Coping planning
Questions about Coping planning
empty
سوالات درباره برنامه ریزی برای مقابله
سوالات درباره برنامه ریزی برای مقابله
#6
empty
Investigation of automatic drug use by patients with epilepsy
Investigation of automatic drug use by patients with epilepsy
empty
بررسی مصرف خودکار دارو توسط بیماران مبتلا به صرع
بررسی مصرف خودکار دارو توسط بیماران مبتلا به صرع
empty
Immediately after the intervention and 6 months after the intervention
Immediately after the intervention and 6 months after the intervention
empty
بلافاصله پس از مداخله و ۶ ماه بعد از مداخله
بلافاصله پس از مداخله و ۶ ماه بعد از مداخله
empty
Self-Report Behavioural Automaticity Index (SRBAI)
Self-Report Behavioural Automaticity Index (SRBAI)
empty
شاخص خودگزارشی خودبخودی رفتاری
شاخص خودگزارشی خودبخودی رفتاری
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
Complete all variables related to the study outcomes that will be measured.
Acronym
IRCT registration information
IRCT registration number:IRCT20181226042140N2
Registration date:2020-07-03, 1399/04/13
Registration timing:registered_while_recruiting
Last update:2020-07-17, 1399/04/27
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
N/A
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)
5
Description
Patient's beliefs about medication
Timepoint
Immediately after the intervention and 6 months after the intervention
Method of measurement
Beliefs about Medications Questionnaire (BMQ)
6
Description
Intention to adhere to medication
Timepoint
Immediately after the intervention and 6 months after the intervention
Method of measurement
Behavioral intention Questions
7
Description
Self-monitoring by the patient in taking his medications
Timepoint
Immediately after the intervention and 6 months after the intervention
Method of measurement
Self-monitoring questions
8
Description
Plan for time, place, how to take medicine
Timepoint
Immediately after the intervention and 6 months after the intervention
Method of measurement
Questions about Action planning
9
Description
Predicting drug use barriers and creating strategies to overcome those barriers
Timepoint
Immediately after the intervention and 6 months after the intervention
Method of measurement
Questions about Coping planning
10
Description
Investigation of automatic drug use by patients with epilepsy
Timepoint
Immediately after the intervention and 6 months after the intervention
Method of measurement
Self-Report Behavioural Automaticity Index (SRBAI)
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