A study of efficacy of mindfulness-based cognitive therapy in reducing ruminating, improving mindfulness and self-compassion in patients with treatment-resistant depression
Determine the efficiency of efficacy of Mindfulness-based cognitive therapy in Reducing Ruminating, Improving Mindfulness and Self-Compassion in Patients with Treatment-resistant depression
Design
Randomised,with a sample size of 24,a clinical trial with a control group
Settings and conduct
Farabi Hospital
Participants/Inclusion and exclusion criteria
Lack of therapeutic response to enough doses of two antidepressants for an adequate period( after 18 weeks)؛Score 19 or higher in Beck depression inventory؛Having a diagnostic criterion for major depressive disorder؛Reading 9th grade education level to complete the questionnaire
Intervention groups
Patients are randomly divided into experimental and control groups, and the treatment program will be provided to the experimental group for eight sessions, and the control group will receive only medication.
Main outcome variables
Increase self-compassion, increase consciousness and reduce stomach cramps, and reduce symptoms of depression.
General information
Reason for update
Acronym
MBCT
IRCT registration information
IRCT registration number:IRCT20180205038630N1
Registration date:2018-02-27, 1396/12/08
Registration timing:prospective
Last update:2018-02-27, 1396/12/08
Update count:0
Registration date
2018-02-27, 1396/12/08
Registrant information
Name
Ali Akbar Foroughi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3837 4371
Email address
aliakbar.foroughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2018-04-19, 1397/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A study of efficacy of mindfulness-based cognitive therapy in reducing ruminating, improving mindfulness and self-compassion in patients with treatment-resistant depression
Public title
A study of efficacy of mindfulness-based cognitive therapy in patients with treatment-resistant depression
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Lack of therapeutic response to enough doses of two antidepressants for an adequate period( after 18 weeks)
Score 19 or higher in Beck depression inventory
Having a diagnostic criterion for major depressive disorder
Reading 9th grade education level to complete the questionnaire
Having a minimum age of 18 and a maximum of 45 years
Exclusion criteria:
Having intense suicidal thoughts
Need to be Hospitalization
Failure to do homework related to treatment
Affected by seasonal depression
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
By simple random method individuals are assigned to the control and test groups using sealed envelope
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 Kermanshah University of Medical Sciences
Street address
Oil field, Facing Taleghani Hospital
City
Kermanshah
Province
Kermanshah
Postal code
56423-22222
Approval date
2018-01-17, 1396/10/27
Ethics committee reference number
IR.KUMS.REC.1396.586
Health conditions studied
1
Description of health condition studied
Resistant to depression
ICD-10 code
P91.4
ICD-10 code description
Neonatal cerebral depression
Primary outcomes
1
Description
Score in Self-Compassion Inventory (Short Form)
Timepoint
At the beginning of the study, after the study (after the end of the intervention) and two months after the study
Method of measurement
Self-Compassion Inventory
2
Description
Mindfulness Questionnaire Score
Timepoint
At the beginning of the study, after the study (after the end of the intervention) and two months after the study
Method of measurement
Southampton Mindfulness Questionnaire for Consciousness
3
Description
Score in the rumination questionnaire
Timepoint
At the beginning of the study, after the study (after the end of the intervention) and two months after the study
Method of measurement
Ruminative Response Questionnaire
4
Description
Depression Score in Beck Questionnaire and Hamilton Grading Scale
Timepoint
At the beginning of the study, after the study (after the end of the intervention) and two months after the study
Method of measurement
Beck Depression Inventory and Hamilton's Grading Scale for Depression
Secondary outcomes
1
Description
Quality of Life Score
Timepoint
Study beginning, after study, two months after study
Method of measurement
Beck Depression Inventory
2
Description
Life expectancy score
Timepoint
Study beginning, after study, two months after study
Method of measurement
Beck Depression Inventory
3
Description
Changing the cost of treatment
Timepoint
Study beginning, after study, two months after study
Method of measurement
Beck Depression Inventory
Intervention groups
1
Description
Intervention group: For eight weeks in addition to antidepressants they also receive cognitive therapy based on mind-awareness.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Farabi Hospital
Full name of responsible person
Dr. Vahid Farnia
Street address
Farabi Hospital, Dolat Abad Square
City
Kermanshah
Province
Kermanshah
Postal code
49564-39936
Phone
+98 83 3822 6451
Email
vfarnia@yahoo.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
Taleghani Hospital, Oil Field
City
Kermanshah
Province
Kermanshah
Postal code
4562388887
Phone
+98 83 3838 4180
Email
fnajafi@kums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Ghazaleh Azar
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Kermanshah, Faculty of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
7574169936
Phone
+98 74 3246 3548
Fax
Email
ghazalehazar.8540@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Ali Akbar Foroughi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Kermanshah university of medical science., medical school, Parastar Blvd
City
Kermanshah
Province
Kermanshah
Postal code
671451568
Phone
+98 83 3837 4371
Fax
Email
aliakbar.foroughi@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Ghazaleh Azar
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Kermanshah university of medical science., medical school, Parastar Blvd
City
Kermanshah
Province
Kermanshah
Postal code
7574169936
Phone
+98 74 3246 3548
Fax
Email
ghazalehazar.8540@gmail.com
Web page address
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