Protocol summary
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Study aim
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Determining the Effect of 8-Week Psychological Therapy as Mindfulness on Mental Health in Patients with Hypertension
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Design
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Clinical trials with control group, with parallel groups, randomized
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Settings and conduct
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The study was conducted in 1398 in Isfahan. The target population of Hypertension referred to the Imam Ali hospital’s comprehensive health center (Isfahan).
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Hypertension with the approval of a specialist, The history of regular visits for at list past 6 months, Absence of alcohol and substance abuse, Ability to attend medical sessions, Lack of pregnancy and lactation. Exclusion criteria: Participate in training sessions outside of research project protocol, Acute psychological illness.
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Intervention groups
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A total of 80 people are randomly selected for each group and then the participants are allocated to intervention and control groups. For the intervention group, 8 sessions of 2 hours a week, once a Mindfulness education is conducted by a psychologist with a skill in this field and then they will do homework for 4 weeks, which is reported weekly in the form of a self report.
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Main outcome variables
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The amount of anxiety, depression and stress levels,
General information
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Reason for update
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Hypertension is an important cardiovascular risk factor. Recent meta-analyzes have emphasized the positive effect of mindfulness interventions on hypertension, but further studies are recommended. On the other hand, given the devastating effects of stress and depression on blood pressure, an affordable, reasonable and repeatable treatment such as mindfulness can significantly reduce this problem and its subsequent damage. On the other hand, both hypertension and mental health disorders affect the quality of life of individuals and control of these factors can have an effective role in improving the quality of life. We therefore sought to test the effect of mindfulness on blood pressure and quality of life in patients with hypertension.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190410043230N1
Registration date:
2019-06-10, 1398/03/20
Registration timing:
retrospective
Last update:
2020-01-18, 1398/10/28
Update count:
1
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Registration date
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2019-06-10, 1398/03/20
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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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2018-07-23, 1397/05/01
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Expected recruitment end date
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2018-09-23, 1397/07/01
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Actual recruitment start date
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2018-07-23, 1397/05/01
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Actual recruitment end date
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2018-09-23, 1397/07/01
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Trial completion date
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2018-12-22, 1397/10/01
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Scientific title
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The Effect of Mindfulness Meditation, when Compared to routine education on Mental Health in Patients with Hypertension
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Public title
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The Effect of Mindfulness Meditation, when Compared to routine education on Mental Health in Patients with Hypertension
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Hypertension with the approval of a specialist
The history of regular visits to the center for at list the past 6 months
Absence of alcohol and substance abuse
Failure to receive psychological treatment in the past year
Ability to attend medical sessions
Earn a minimum score of 7 from the DASS21 questionnaire before starting the study
Lack of pregnancy and lactation
Exclusion criteria:
Acute psychological illness
Having chronic illnesses, such as cancer or any other serious medical conditions
Participate in psychotherapy sessions outside the research project protocol
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Age
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From 30 years old to 59 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:
80
Actual sample size reached:
80
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization method: Randomization block
Randomization unit: Individual
Randomization layer: Not done
Randomization tool: Random sequence generation software (excel)
How to creat random sequence: Using random blocks, each block contains 4 people and assign a number from 1 to 6 to each block.
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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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2018-09-03, 1397/06/12
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Ethics committee reference number
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IR.MUI.MED.REC.1397.015
Health conditions studied
1
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Description of health condition studied
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Hypertension
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ICD-10 code
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I10
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ICD-10 code description
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Essential (primary) hypertension
Primary outcomes
1
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Description
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Anxiety, Depression and Stress
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Timepoint
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Beginning of the study and 13 weeks after the intervention
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Method of measurement
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DASS21 questionnaire
Secondary outcomes
1
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Description
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blood pressure
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Timepoint
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Beginning of the study and 13 weeks after the intervention
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Method of measurement
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In a sitting position from right arm after 15 minutes rest with a standard Mercury barometer. The mean of 2 measures (5 minutes interval) will be considered as blood pressure
2
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Description
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quality of life
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Timepoint
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Beginning of the study and 13 weeks after the intervention
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Method of measurement
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short form (SF)-36 QUESTIONNAIRE
Intervention groups
1
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Description
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Intervention group: 8 weekly 2 hours sessions of Mindfulness training is conducted by a PhD in psychology, And then they will do homework for 4 weeks which is reported weekly in the form of a self report.
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Category
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Rehabilitation
2
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Description
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Control group: There is no treatment on this group.
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Category
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Other
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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Esfahan 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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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is 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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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Whole data will be available
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When the data will become available and for how long
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Immediately after publishing manuscript
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To whom data/document is available
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To whom is in need to this data
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Under which criteria data/document could be used
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Email to Dr Anahita Babak, Email: babakanahita@yahoo.com
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From where data/document is obtainable
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Dr Anahita Babak Email: babakanahita@yahoo.com
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What processes are involved for a request to access data/document
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Send an Email to Dr Anahita Babak
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Comments
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