The comparison of the efficacy of Metacognitive therapy, Applied Relaxation, Buspirone and Venlafaxine in the treatment of women with Generalized Anxiety Disorder.
The purpose of this study is comparison of the efficacy of Metacognitive therapy, Applied Relaxation, Buspirone and Venlafaxine in the treatment of women with Generalized Anxiety Disorder. Single-case experimental design will be used in this study. The study sample will include women with generalized anxiety disorder (GAD) referred to counseling centers and psychiatric clinics in Tabriz. 16 women will be selected by the purposive sampling and replaced at random into four metacognitive therapy treatment groups, Applied Relaxation, Venlafaxine and Buspirone. Inclusion criteria: age, at least 18 years and maximum 50 years; generalized anxiety disorder diagnoses based on structured clinical interview based on DSM-VI-TR and confirm the diagnosis according to a psychiatrist or clinical psychologist; having a minimum qualification cycle and ability to read and write and speak fluently. Exclusion criteria: psychotic disorder; obsessive - compulsive disorder; drug dependence; epilepsy syndrome and using any recreational drug and mental health three months before the first treatment session. All patients will be treated for 12 weeks and 3 months will also follow up. Possible outcome would be the treatment of anxiety and worry.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201204239544N1
Registration date:2012-05-06, 1391/02/17
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-05-06, 1391/02/17
Registrant information
Name
Asghar Arfaee
Name of organization / entity
Tabriz University of Medical Scieces
Country
Iran (Islamic Republic of)
Phone
+98 41 1557 2628
Email address
arfaia@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Psychiatry and Behavioral Sciences Research Center - Tabriz University of Medical Sciences
Expected recruitment start date
2012-06-04, 1391/03/15
Expected recruitment end date
2012-11-21, 1391/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the efficacy of Metacognitive therapy, Applied Relaxation, Buspirone and Venlafaxine in the treatment of women with Generalized Anxiety Disorder.
Public title
the effect of psychotherapy and pharmacotherapy on anxiety
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion citeria: Age, at least 18 years and maximum 50 years; generalized anxiety disorder diagnoses based on structured clinical interview based on DSM-VI-TR and confirm the diagnosis according to a psychiatrist or clinical psychologist; having a minimum qualification cycle and ability to read and write and speak fluently. Exclusion criteria: psychotic disorder; obsessive - compulsive disorder; drug dependence; epilepsy syndrome and using any recreational drug and mental health three months before the first treatment session.
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
16
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
Tabriz University of Medical Sciences Ethics Committee
Street address
University Sq
City
Tabriz
Postal code
Approval date
2011-12-19, 1390/09/28
Ethics committee reference number
5/4/7636
Health conditions studied
1
Description of health condition studied
Genelized anxiety disorder
ICD-10 code
F41.1
ICD-10 code description
Anxiety that is generalized and persistent but not restricted to, or even strongly predominating in, any particular environmental circumstances (i.e. it is
Primary outcomes
1
Description
Anxiety
Timepoint
Before treatment, after treatment, 3 month after treatment
Method of measurement
Beck anxiety inventory
Secondary outcomes
1
Description
Worry
Timepoint
Before treatment, after treatment, 3 month after treatment
Method of measurement
Pennsylvania State Worry Questionnaire
Intervention groups
1
Description
relaxation therapy, 12 weekly session,
Category
Behavior
2
Description
meta cognitive therapy, 12 weekly session,
Category
Behavior
3
Description
Buspirone, 10 mg oral tablet, three times a day for three months.
Category
Treatment - Drugs
4
Description
venlafaxine, 75 mg oral tablet, three times a day for three months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Dr. Arfaie
Full name of responsible person
Dr. Arfaie
Street address
City
Tabriz
2
Recruitment center
Name of recruitment center
Counseling Center of Allameh Amini
Full name of responsible person
Hossein Gholizadeh
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Clinical Psychiatric Research Center- tabriz university of medical science
Full name of responsible person
Mrs. Alizadeh
Street address
El goli st. Razi hospital, department of psychiatry
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Clinical Psychiatric Research Center- tabriz university of medical science
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
Welfare organization
Full name of responsible person
Hossein Gholizadeh
Position
Master of science - psychologist
Other areas of specialty/work
Street address
Counseling Center of allame amini, agha ali all, 17 shahrivar st
City
Tabriz
Postal code
Phone
+98 41 1556 3817
Fax
Email
hossein.gholizad@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Welfare oraganization
Full name of responsible person
Hossein Gholizade
Position
Master of science
Other areas of specialty/work
Street address
Counseling Center at Allameh Amini
City
Tabriz
Postal code
Phone
+98 41 1557 2628
Fax
Email
hossein.gholizade@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Welfare Organization
Full name of responsible person
Hossein Gholizadeh
Position
MSc- Psychologist
Other areas of specialty/work
Street address
Counseling center of Allame Amini, Agha Ali alley, 17 shahrivar st.
City
Tabriz
Postal code
Phone
+98 41 1556 3817
Fax
Email
hossein.gholizade@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)