The aim of this study is developmental comparison of mindfulness based cognitive therapy and cognitive behavioral therapy on generalized anxiety of girl students. The present study is a clinical trial. The statistical population includes all third grade female students of public elementary schools and secondary grade female students of public guidance schools in 2012 in Isfahan. After identifying students with generalized anxiety disorder, they were randomly divided into three groups (the students of elementary schools in three groups and students of guidance schools in another three groups). Two groups received cognitive-behavioral and mindfulness based cognitive therapy (MBCT-C) while the control group didn't receive any training. All subjects completed the Pennsylvania State Worry Questionnaire-Child version, Revised Children’s Manifest Anxiety Scale, Children’s Depression Inventory, before and after the intervention.
General information
Acronym
MBCT-C
IRCT registration information
IRCT registration number:IRCT2013062013726N1
Registration date:2013-12-02, 1392/09/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-12-02, 1392/09/11
Registrant information
Name
Fahimeh Dehghani
Name of organization / entity
University of Isfahan
Country
Iran (Islamic Republic of)
Phone
+98 31 1793 2567
Email address
dehghani@edu.ui.ac.ir
Recruitment status
Recruitment complete
Funding source
By researcher
Expected recruitment start date
2013-02-20, 1391/12/02
Expected recruitment end date
2013-03-13, 1391/12/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Delevopmental comparison of mindfulness therapy and cognitive behavioral therapy on generalized anxiety of girl students
Public title
Comparative effect of mindfulness and cognitive-behavioral therapy on generalized anxiety disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : girls is studying in the third degree of elementary school and second degree of guidance school; received a diagnosis of generalized anxiety disorder; willingness to participate in sessions
Exclusion criteria: using anti anxiety drugs or other treatment before or during the interventions; absence of more than 4 sessions.
Age
From 9 years old to 13 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
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
Isfahan University of Medical Science
Street address
Isfahan-Hezar Jerib Street-Isfahan University of Medical Science
City
Isfahan
Postal code
Approval date
2013-02-20, 1391/12/02
Ethics committee reference number
491009
Health conditions studied
1
Description of health condition studied
Generalized anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
Worry
Timepoint
Before the intervention, After the intervention, 2 months after the intervention
Method of measurement
Pennsylvania State Worry Questionnaire
2
Description
Anxiety
Timepoint
Before the intervention, After the intervention, 2 months after the intervention
Method of measurement
Revised Children’s Manifest Anxiety Scale
3
Description
Depression
Timepoint
Before the intervention, After the intervention, 2 months after the intervention
Method of measurement
Children’s Depression Inventory
Secondary outcomes
empty
Intervention groups
1
Description
Including 12 sessions of mindfulness-based cognitive therapy
Category
Behavior
2
Description
Including 12 sessions of cognitive behaviour therapy
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Elementary schools
Full name of responsible person
Street address
City
Isfahan
2
Recruitment center
Name of recruitment center
Guidance schools
Full name of responsible person
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Isfahan
Full name of responsible person
Dr. Mohammad Rabbani
Street address
University of Isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Isfahan
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
University of Isfahan
Full name of responsible person
Fahimeh Dehghani
Position
MA (Phd student)
Other areas of specialty/work
Street address
Isfahan- Hezar Jerib Street- University of Isfahan
City
Isfahan
Postal code
Phone
+98 31 1793 2567
Fax
+98 31 1793 2500
Email
fahimeh_dehghani@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Isfahan
Full name of responsible person
Fahimeh Dehghani
Position
MA (Phd student)
Other areas of specialty/work
Street address
Isfahan-Hezar Jerib Street
City
Isfahan
Postal code
Phone
+98 31 1793 2567
Fax
+98 31 1793 2500
Email
fahimeh_dehghani@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
University of Isfahan
Full name of responsible person
Fahimeh Dehghani
Position
MA (Phd student)
Other areas of specialty/work
Street address
City
Postal code
Phone
+98 31 1793 2567
Fax
+98 31 1793 2500
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)