The aim of this study is to examine the Effectiveness of Mindfulness-based stress reduction on pathological worry in non-clinical population.Design: General plan of this study is consisted of experimental pre-test and post-test with follow-up period.Setting and conduct: The study population were female undergraduate students in Shahed University that have not any psychological disorder and they did not receive any treatment in the last year. Then these people were randomly divided into two groups: experimental(Mindfulness-based stress reduction) and control group. Each group were completed scales considered; as a pre-test, post-test, one month and three months after the completion of their intervention.The main conditions of inclusion and exclusion criteria of participants: Inclusion criteria: gender of female,Engagement with education in undergraduate and Lack of psychological disorders.Exclusion criteria: Absence of the inclusion criteria. Interventions: Mindfulness-based stress reduction is designed at 8 weekly 2-hour session. Control group do not receive any psychotherapy. Main outcome measures: In this study the main variables are pathological worry and meta worry.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016090329648N1
Registration date:2016-11-26, 1395/09/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-11-26, 1395/09/06
Registrant information
Name
Elham Mirzaei
Name of organization / entity
Shahed University
Country
Iran (Islamic Republic of)
Phone
+98 51 3622 6484
Email address
mirzaeie2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahed University
Expected recruitment start date
2012-09-15, 1391/06/25
Expected recruitment end date
2012-12-19, 1391/09/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of mindfulness-based stress reduction on reduction on pathological worry in Non-clinical population
Public title
The efficacy of mindfulness on worry
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Engagement with education in undergraduate, gender of female, Being in the age range of 18to 24,Obtain a score of above Cut-off point in PSWQ (Cut-off point: 50),Do not receive drug or psychological treatment and or consulting in last year, Lack of generalized anxiety disorder or other psychological disorder.
Exclusion criteria: Absence of the above conditions.
Age
From 18 years old to 24 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
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
Shahed University
Street address
Shahed University, In front of Shrine, Persian Gulf Freeway, shahed university
City
Tehran
Postal code
3319118651
Approval date
2012-09-10, 1391/06/20
Ethics committee reference number
130/23417
Health conditions studied
1
Description of health condition studied
Pathological worry
ICD-10 code
F54
ICD-10 code description
Psychological and behavioural factors associated with disorders or diseases classified elsewhere
2
Description of health condition studied
Pathological worry
ICD-10 code
F43.2
ICD-10 code description
Adjustment disorders
3
Description of health condition studied
Pathological worry
ICD-10 code
F48.0
ICD-10 code description
Neurasthenia
Primary outcomes
1
Description
Pathological worry
Timepoint
Pre - post test, folllow up
Method of measurement
Penn State Worry Questionnaire (PSWQ), GAD-7
2
Description
Meta worry
Timepoint
Pre- post worry, follow up
Method of measurement
Wells Anxiety Thoughts Inventory
Secondary outcomes
1
Description
positive and negative affect
Timepoint
Pre - post test, folllow up
Method of measurement
Positive and Negative Affect scale (PANAS)
2
Description
Symptoms of depression
Timepoint
Pre - post test, folllow up
Method of measurement
Beck Depression Inventory (II)
Intervention groups
1
Description
The control group in the study do not recieve intervention (no action).
Category
N/A
2
Description
The experimental group recieved 8 sessions of mindfulness-based stress reduction model (in two mounts, each week one session, 2-2.5 hours).
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
All colleges of Shahed University
Full name of responsible person
Elham Mirzaee, MA of Clinical psychology
Street address
Tehran, Shahed University,Persian Gulf Freeway, In front of Shrine
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahed University
Full name of responsible person
Mohammadhadi Shoaei
Street address
In front of Shrine, Persian Gulf Freeway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University
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
Shahed University
Full name of responsible person
Dr.Mohammadreza Shairi
Position
PhD in Clinical Psychology, Associate Professor of Clinical psychology
Other areas of specialty/work
Street address
Tehran, Shahed University,Persian Gulf Freeway, In front of Shrine
City
Tehran
Postal code
Phone
+98 21 5121 2470
Fax
Email
Shairigm@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Elham Mirzaee
Position
MA of Clinical psychology
Other areas of specialty/work
Street address
Tehran, Shahed University,Persian Gulf Freeway, In front of Shrine
City
Tehran
Postal code
Phone
+98 21 5121 2470
Fax
Email
mirzaeeelham88@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Elham Mirzaee
Position
MA of Clinical psychology
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
mirzaeeelham88@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)