Protocol summary
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Study aim
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Determining the effectiveness of mindfulness based cognitive-behavioral therapy on promoting medication adherence among patient with epilepsy
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Design
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This research is a prospective cluster randomized controlled trial and It is a single blind with parallel groups.256 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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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The Medication Adherence Report; Mindful Attention Awareness
General information
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Reason for update
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Complete all variables related to the study outcomes that will be measured.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20181226042140N2
Registration date:
2020-07-03, 1399/04/13
Registration timing:
registered_while_recruiting
Last update:
2021-03-23, 1400/01/03
Update count:
3
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Registration date
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2020-07-03, 1399/04/13
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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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2020-06-20, 1399/03/31
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Expected recruitment end date
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2020-08-20, 1399/05/30
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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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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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Public title
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Investigating the intervention of mindfulness on on promoting medication adherence among patient with epilepsy
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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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
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Age
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From 18 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:
256
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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. Of these 128 are in the intervention group and 128 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.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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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.
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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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2019-12-06, 1398/09/15
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Ethics committee reference number
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IR.NIMAD.REC.1399.008
Health conditions studied
1
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Description of health condition studied
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Epilepsy
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ICD-10 code
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G40.1
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ICD-10 code description
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Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with simple partial seizures
Primary outcomes
1
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Description
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The medication adherence score
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Timepoint
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Immediately after the intervention and 6 months after the intervention
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Method of measurement
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The Medication Adherence Report Scale(MARS)
2
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Description
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Mindful Attention Awareness score
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Timepoint
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Immediately after the intervention and 6 months after the intervention
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Method of measurement
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Mindful Attention Awareness Scale(MAAS)
Secondary outcomes
1
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Description
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Severity of a patient's seizures score
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Timepoint
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Immediately after the intervention and 6 months after the intervention
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Method of measurement
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Liverpool Seizure Severity Scale(LSSS)
2
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Description
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Quality of life in epilepsy score
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Timepoint
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Immediately after the intervention and 6 months after the intervention
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Method of measurement
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Health-related quality of life
3
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Description
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Perceived behavioral control questions
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Timepoint
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Immediately after the intervention and 6 months after the intervention
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Method of measurement
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Perceived behavioral control(PBC)
4
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Description
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Anxiety and depression score
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Timepoint
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Immediately after the intervention and 6 months after the intervention
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Method of measurement
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Hospital Anxiety and Depression Scale (HADS)
5
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Description
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Patient's beliefs about medication
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Timepoint
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Immediately after the intervention and 6 months after the intervention
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Method of measurement
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Beliefs about Medications Questionnaire (BMQ)
6
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Description
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Intention to adhere to medication
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Timepoint
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Immediately after the intervention and 6 months after the intervention
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Method of measurement
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Behavioral intention Questions
7
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Description
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Self-monitoring by the patient in taking his medications
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Timepoint
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Immediately after the intervention and 6 months after the intervention
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Method of measurement
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Self-monitoring questions
8
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Description
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Plan for time, place, how to take medicine
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Timepoint
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Immediately after the intervention and 6 months after the intervention
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Method of measurement
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Questions about Action planning
9
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Description
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Predicting drug use barriers and creating strategies to overcome those barriers
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Timepoint
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Immediately after the intervention and 6 months after the intervention
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Method of measurement
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Questions about Coping planning
10
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Description
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Investigation of automatic drug use by patients with epilepsy
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Timepoint
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Immediately after the intervention and 6 months after the intervention
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Method of measurement
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Self-Report Behavioural Automaticity Index (SRBAI)
Intervention groups
1
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Description
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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.
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Category
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Behavior
2
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Description
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Control group: They receive their medications as usual.
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Category
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N/A
1
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Sponsor
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Grant name
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Bridging Grant Call
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Grant code / Reference number
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987827
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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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National Institute for Medical Research Development
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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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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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Undecided - It is not yet known if there will be 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