Determining the effect of mindfulness on resilience and Assertiveness in patient with Major Depressive Disorder
Design
A clinical trial with two test groups and a control group, one blind strain, randomized on 60 patients. A table of randomized numbers was used for randomization.
Settings and conduct
This clinical trial was conducted in Ibn Sina Psychiatric Hospital of Mashhad. 60 patients with major depressive disorder will be selected as a simple random sample and will be divided into two experimental and control groups. The experimental group (5 to 8 people) ) will undergo 8 sessions of 90 minutes (3 sessions per week) of mindfulness training. The control group will receive the usual training during hospitalization. The summary of the training sessions will include: 30 minutes of body inspection exercises, 10 minutes of stretching exercises, 20 minutes of new topics, 10 minutes of mind presence on breathing, and 20 minutes of assigned task review. The method of blinding was one-way and the participants were blinded.
Participants/Inclusion and exclusion criteria
Entry conditions: participants must have a medical diagnosis of major depression; non-entry conditions: being illiterate
Intervention groups
The experimental group (5 to 8 people) will undergo 8 sessions of 90 minutes (3 sessions per week) of mindfulness training. The control group will receive the usual training during hospitalization.
Main outcome variables
Mindfulness increases resilience and Assertiveness in patients with major depressive disorder
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230518058224N1
Registration date:2023-06-20, 1402/03/30
Registration timing:prospective
Last update:2023-06-20, 1402/03/30
Update count:0
Registration date
2023-06-20, 1402/03/30
Registrant information
Name
Ghazaleh Derakhshandeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 4220 8643
Email address
derakhshandeqazale@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-01, 1402/04/10
Expected recruitment end date
2023-09-21, 1402/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Mindfulness on Resilience and Assertiveness in Patients with Major Depressive Disorder
Public title
"Effect of Mindfulness on Resilience and Assertiveness"
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having a diagnosis of major depressive disorder based on a psychiatrist's diagnosis
Age 18 to 60 years
The patient has passed the acute phase of the disease and is in the phase of mood stabilization
Having at least reading and writing literacy
Willingness to participate in the study
Don't participate in the same training program
Exclusion criteria:
Do not attend two or more meetings
A sudden change in the patient's mood
Discharge of the patient
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random sampling of individuals who are selected by lottery.
Blinding (investigator's opinion)
Single blinded
Blinding description
The participants in the study were kept blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
No.4, Baharestan Dormitory, Medical Sciences Pardis, Bahonar Blvd., Vakil Abad Street, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Approval date
2023-05-30, 1402/03/09
Ethics committee reference number
IR.MUMS.NURSE.REC.1402.034
Health conditions studied
1
Description of health condition studied
Major Depressive Disorder
ICD-10 code
F32
ICD-10 code description
Major depressive disorder, single episode
Primary outcomes
1
Description
Resilience score of Connor and Davidson's questionnaire, boldness score of Gambrill Rich questionnaire
Timepoint
Completing the assertiveness and resilience questionnaire before starting the intervention and four weeks after the end of the intervention.
Method of measurement
Connor and Davidson's Resilience Questionnaire, Gambrill Rich's Assertiveness Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The group (5 to 8 people) will undergo 8 sessions of 90 minutes (3 sessions per week) of mindfulness training. The training sessions will include: 30 minutes of body inspection exercises, 10 minutes of stretching exercises, 20 minutes of new topics, 10 minutes of mind presence on breathing, and 20 minutes of reviewing assigned assignments.
Category
Behavior
2
Description
Control group: The control group will receive the usual training during hospitalization
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ibn Sina Hospital
Full name of responsible person
Saeed Vaghei
Street address
Ibn Sina Psychiatric Hospital, Hor Aamili Blvd., Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
919583134
Phone
+98 51 3711 2545
Email
derakhshandeqazale@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Saeed Vaghei
Street address
No.4, Baharestan Dormitory, Medical Sciences Pardis, Bahonar Blvd., Vakil Abad Street, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
nms.pr@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
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
Mashhad University of Medical Sciences
Full name of responsible person
Ghazaleh Derakhshandeh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.4, Baharestan Dormitory, Medical Sciences Pardis, Bahonar Blvd., Vakil Abad Street, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 11 4220 8643
Email
derakhshandeqazale@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ghazaleh Derakhshandeh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.4, Baharestan Dormitory, Medical Sciences Pardis, Bahonar Blvd., Vakil Abad Street, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 11 4220 8643
Email
derakhshandeqazale@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ghazaleh Derakhshandeh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.4, Baharestan Dormitory, Medical Sciences Pardis, Bahonar Blvd., Vakil Abad Street, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 11 4220 8643
Email
derakhshandeqazale@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
Yes - There is a plan to make this available
Title and more details about the data/document
Data freezes, such as primary outcome information, can be shared after de-identifying individuals.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Study data will be available to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
People who are also engaged in the industry can apply to receive them.
From where data/document is obtainable
derakhshandeqazale@gmail.com
What processes are involved for a request to access data/document
The requester of these documents or data files can access the documents or data files by referring to the registered e-mail address and by introducing full details such as the field of study and the profession and the reason for accessing the data.