Comparison of the Effectiveness of Mindfulness and Body Psychotherapy on Hippocampal Modulation (Volume and Function) and Depression and Executive Function in Patients with Post-Stroke Depression
The main purpose of this study was to find if body psychotherapy and mindfulness interventions that improve the symptoms of depression can change (increase) the hippocampal volume in depressed patients after stroke.
Design
This study is a three-group clinical trial with pre-test and post-test quasi-experimental design. This study has two intervention groups and one control group. The number of patients is 30 women who are randomly divided into three groups.
Settings and conduct
The intervention center is the Anna Mehr Elderly Center. Methods: First, the purposeful sampling will be done based on the patients' scores on the Beck Depression Inventory and the NIHSS test score. It will be taken as a pretest. Patients will be randomly assigned to either intervention or control groups. After the intervention, the questionnaires and computerized tests will be completed again as well as analyzing the recorded scores and comparing the results in the pre-test and post-test stages.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
The lesion is located in the left hemisphere; they have a history of stroke only once. Non-inclusion criteria:
The patient has a history of a second or more strokes; a history of another chronic illness.
Intervention groups
Intervention group 1: The group that receives the conscious mind. This group includes ten female patients. The intervention is administered to patients during sixteen one-hour sessions, two days a week.
Intervention group 2: The second group receives physical therapy intervention. This group includes ten female patients who receive physical therapy intervention for one hour a day, three days a week.
Control group: This group consisted of ten female patients who don't receive any intervention.
Main outcome variables
Depression, executive function, function and volume of hippocamp
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190812044518N1
Registration date:2019-10-08, 1398/07/16
Registration timing:retrospective
Last update:2019-10-08, 1398/07/16
Update count:0
Registration date
2019-10-08, 1398/07/16
Registrant information
Name
Sahar sadae Nazm Bojnourdi
Name of organization / entity
Ferdowsi of University
Country
Iran (Islamic Republic of)
Phone
+98 58 3222 6225
Email address
sdoctornazmb@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-11, 1397/11/22
Expected recruitment end date
2019-02-21, 1397/12/02
Actual recruitment start date
2019-02-11, 1397/11/22
Actual recruitment end date
2019-03-10, 1397/12/19
Trial completion date
2019-07-15, 1398/04/24
Scientific title
Comparison of the Effectiveness of Mindfulness and Body Psychotherapy on Hippocampal Modulation (Volume and Function) and Depression and Executive Function in Patients with Post-Stroke Depression
Public title
Comparison of the Effectiveness of Mindfulness and Body Pysichotherapy on Hippocampus Modulation
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Lasting more than three months after a stroke
a left hemisphere lesion confirmed by a neurologist and an MRI or CT scan
A history of having stroke only for one time
ability to read and write
depression test score above ten
Exclusion criteria:
The patient has a history of a second stroke
Simultaneous use of tobacco and smoking
The patient has a history of other chronic illnesses
The patient has a history of psychological illness other than depression
Patient with aphasia and impaired consciousness
The patient has acute economic problems
Age
From 35 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Actual sample size reached:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization using statistical site
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Bojnourd University of Medical Sciences
Street address
Bojnourd University of Medical Sciences, Janbaz Blvd, Talghni street
City
Bojnourd
Province
North Khorasan
Postal code
94149-74877
Approval date
2019-08-23, 1398/06/01
Ethics committee reference number
IR.NKUMS.REC.1398.033
Health conditions studied
1
Description of health condition studied
Post-stroke depression
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Depression score in Beck Questionnaire
Timepoint
Depression test scores are measured before the intervention as pre-test and also in the first intervention group at the end of the eighth week of mindfulness intervention and in the second intervention group at the end of the twelfth week, body pcychotherapy intervention.
Method of measurement
Beck Depression Questionnaire
2
Description
National Institutes of Health(NIH) Stroke Scale Questionnaire Score
Timepoint
National Institutes of Health(NIH) Stroke Scale Questionnaire Score is measured before the intervention as pre-test and also in the first intervention group at the end of the eighth week of mindfulness intervention and in the second intervention group at the end of the twelfth week, body pcychotherapy intervention.
Method of measurement
National Institutes of Health(NIH) Stroke Scale Questionnaire
3
Description
Wechsler Digit Span measurement tool Score
Timepoint
Wechsler Digit Span measurement tool Score is measured before the intervention as pre-test and also in the first intervention group at the end of the eighth week of mindfulness intervention and in the second intervention group at the end of the twelfth week, body pcychotherapy intervention.
Method of measurement
Wechsler Digit Span measurement tool
4
Description
Course block Computer Psychological Test Score
Timepoint
Course block Computer Psychological Test Score is measured before the intervention as pre-test and also in the first intervention group at the end of the eighth week of mindfulness intervention and in the second intervention group at the end of the twelfth week, body pcychotherapy intervention.
Method of measurement
Course block Computer Psychological Test
Secondary outcomes
1
Description
Wisconsin Card Test score
Timepoint
Wisconsin Card Test score is measured before the intervention as pre-test and also in the first intervention group at the end of the eighth week of mindfulness intervention and in the second intervention group at the end of the twelfth week, body pcychotherapy intervention.
Method of measurement
Wisconsin Card Test
2
Description
London Tower Test score
Timepoint
London Tower Test score is measured before the intervention as pre-test and also in the first intervention group at the end of the eighth week of mindfulness intervention and in the second intervention group at the end of the twelfth week, body pcychotherapy intervention.
Method of measurement
London Tower Test
Intervention groups
1
Description
Intervention group 1: This intervention group receives mindfulness for sixteen one-hour sessions, two days a week. This stress reduction protocol is designed by Kabat Zain (1990). Techniques in this section include relaxation, meditation and meditation along with simple yoga exercises.
Category
Rehabilitation
2
Description
Intervention group 2: This group receives physical therapy intervention for thirty-six one hour sessions, three days a week. This protocol is based on a mix motor and psychological exercises designed by Rohrichet in 2013. Among the techniques in this section are systematic relaxation, balance exercises and rhythmic exercises with breathing and eye movement desentisation reprossesing.
Category
Rehabilitation
3
Description
Control group: Ten patients who don't receive any intervention in this group.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Wellbeing - Mehrana Elderly Center
Full name of responsible person
Dr. Azam Benny Hashim Rad
Street address
Vali Asr 2 alley., Vali Asr street., Farhangian Town
City
Bojnourd
Province
North Khorasan
Postal code
941461-4201
Phone
+98 58 3226 4707
Email
sdoctornazmb@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ferdowsi University of Mashhad
Full name of responsible person
Dr. Ali Ghanaie Chamanabad
Street address
Ferdowsi University of Mashhad, Azadi Square,
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948974
Phone
+98 51 3880 2000
Fax
Email
pr@um.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Ferdowsi University of Mashhad
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad Ferdowsi University
Full name of responsible person
Sahar Sadat Nazm Bojnourdi
Position
Postgraduate student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
18.., misagh Alley No. Mirza kochak Khan St.
City
Bojnourd
Province
North Khorasan
Postal code
9414614201
Phone
0098 58 3226225
Email
sdoctornazmb@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad Ferdowsi University
Full name of responsible person
sahar sadat nazm bojnourdi
Position
Postgraduate student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No 18, Misagh alley, Mirza Kochak Khan street
City
Bojourd
Province
North Khorasan
Postal code
9414614201
Phone
0098 58 3226225
Email
sdoctornazmb@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad Ferdowsi University
Full name of responsible person
sahar sadat nazm bojnourdi
Position
Postgraduate student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No 18, Misagh alley, Mirza Kochak Khan street
City
Bojnourd
Province
North Khorasan
Postal code
9414614201
Phone
0098 58 3226225
Email
sdoctornazmb@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Data can be shared transparently and without identification variables
When the data will become available and for how long
Start access period one year after publishing the results in a reputable journal
To whom data/document is available
Data will be available only to university researchers and university affiliates
Under which criteria data/document could be used
The data will be available only for the purpose of modeling the process and comparing the results and forecasting the scientific results...
From where data/document is obtainable
Sending e mail to responsible author for access to data
Email sdoctornazmb@gmail.com
What processes are involved for a request to access data/document
The data will be made available to the researcher one or two weeks after receiving the email from the applicant.