This study aimed to evaluate the efficacy of mindfulness based emotional balance self-help program on reduction of depression, anxiety and stress.The main inclusion criterion is being student in Kermanshah University of Medical Sciences at the time of study conduction and main inclusion criteria is doing mindfulness exercises regularly or study of workbook before participating in the study. 80 students were randomly assigned to the experimental group (n = 40) or control group (n = 40). Intervention is mindfulness based emotional balance workbook (Colen and Brito Pons, 2015) that deliver to experimental group after translation to Persian. The primary outcome variables are stress, anxiety and depression. Emotion dysregulation and self-compassion had been selected as secondary outcome variables.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017022010063N6
Registration date:2017-03-06, 1395/12/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-03-06, 1395/12/16
Registrant information
Name
Kheirollah Sadeghi
Name of organization / entity
Kermanshah University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 83 1826 0700
Email address
khsadeghi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2017-04-04, 1396/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of mindfulness based emotional balance self-help program on psychopathology indicators, mindfulness and self-compassion in students
Public title
Efficacy of mindfulness based emotional balance self-help program on psychopathology indicators, mindfulness and self-compassion in students
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Studying in Kermanshah University of Medical Sciences At the time of study; at least 18 years old; Currently do not get any type of psychotherapy; Do not suffer from a serious mental disorder (eg, psychotic or mood disorders)
Exclusion criteria: Not having tools to listen to audio files related to meditation; regular practice of mindfulness exercises before participating in the study (once a week or more); Study of workbook before participating in the study
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kermanshah University of Medical Sciences
Street address
Headquarter, Shahid Beheshti Blvd, Kermanshah
City
Kermanshah
Postal code
Approval date
2017-02-20, 1395/12/02
Ethics committee reference number
KUMS.REC.1395.657
Health conditions studied
1
Description of health condition studied
Depression
ICD-10 code
F32.9
ICD-10 code description
Depressive episode, unspecified
2
Description of health condition studied
Anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified
3
Description of health condition studied
Stress
ICD-10 code
Z73.3
ICD-10 code description
Stress, not elsewhere classified
Primary outcomes
1
Description
Depression
Timepoint
pre-test, post-test, two months follow up
Method of measurement
depression, anxiety and stress scale
2
Description
Anxiety
Timepoint
pre-test, post-test, two months follow up
Method of measurement
depression, anxiety and stress scale
3
Description
stress
Timepoint
pre-test, post-test, two months follow up
Method of measurement
depression, anxiety and stress scale
Secondary outcomes
1
Description
emotion dysregulation
Timepoint
pre-test, post-test, two months follow up
Method of measurement
difficulties in emotion regulation scale
2
Description
Self-compassion
Timepoint
pre-test, post-test, two months follow up
Method of measurement
Self-compassion Scale
Intervention groups
1
Description
Interventional group:eight-week self-help program using mindfulness based emotion balance workbook (Colen and Pons, 2015). This book include 195 pages and conduct in 8 weeks.
Category
Behavior
2
Description
Control group: no intervention (wait-list)
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Kermanshah University of Medical Sciences
Full name of responsible person
Meysam Bazani
Street address
-medical school, next to Emam Reza hospital, Shahid Shiroudi Avld, Kermanshah
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Behruz Hamzeh
Street address
Headquarte, Shahid Beheshti Blvd, Kermanshah
City
Kermanshah
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
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Meysam Bazani
Position
MSc
Other areas of specialty/work
Street address
medical Schoo, Next to Imam Reza hospital, Shahid Shirudi Avld, Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 4622 0118
Fax
Email
bazani.misam@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Meysam Bazani
Position
MSc
Other areas of specialty/work
Street address
medical school, next to Emam Reza hospital, Shahid Shirudi Avld, Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 4622 0118
Fax
Email
bazani.misam@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Kheirollah Sadeghi
Position
Assistant Professor
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)