General anxiety disorder (GAD) as one of the chronic anxiety disorders has an high prevalence in clinical and general population. This study will done for evaluationing of the Efficacy of the combined treatment based Acceptance and commitment therapy (ACT) with exposure techniques in patients with general anxiety disorder. This clinical trial design is a kind of non-congruent multiple baseline single case study. In this regard, along with diagnostic interview and Structured Clinical Interview for DSM-V, four women with Generalized Anxiety Disorder (GAD) will be selected from patients of Mahabad two university counseling and psychiatric service centers by using purposeful sampling method. Patients enter treatment process after being eligible for treatment as a primary diagnosis of generalized anxiety disorder in Axis I and the lack of co-infection with other anxiety disorders. Finally, members of the combined intervention ACT and meet for 12 sessions over a period of three months will be one hour session. Protocol efficacy will be assessed in 3-phase treatment step (baseline, 12 sessions treatment and 6 weeks follow-up) by evaluating the symptoms of generalized anxiety disorder, the worry and anxiety severity and damage.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015111610512N4
Registration date:2015-12-21, 1394/09/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-12-21, 1394/09/30
Registrant information
Name
Sirvan Atashak
Name of organization / entity
Islamic Azad University-Mahabad Branch
Country
Iran (Islamic Republic of)
Phone
+98 44 2244 8301
Email address
s.atashak@iau-mahabad.ac.ir
Recruitment status
Recruitment complete
Funding source
none
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2014-10-23, 1393/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of combination therapy based on Acceptance and Commitment (ACT) and exposure techniques in patients with generalized anxiety disorder
Public title
Effect of psychotherapy on generalized anxiety disorders
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: The original diagnosis of generalized anxiety disorder in axis I; having read and write; aged 18 years to 61 years without comorbid diagnosis of generalized anxiety disorder (GAD); lack of co-infection with other anxiety disorders or organic disorders (based on records); avoiding the use of psychiatric drugs simultaneously and without history of hospitalization and psychological treatment, and exclusion criteria also include: comorbid disorders listed in the criteria for inclusion; participation in counseling and psychotherapy at the same time; the history of the hospital and get treatment psychological; receiving medication and having three consecutive absences.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
4
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz university
Street address
Tabriz, 29 bahman street
City
Tabriz
Postal code
Approval date
2014-10-12, 1393/07/20
Ethics committee reference number
01593
Health conditions studied
1
Description of health condition studied
General Anxiety Disorder
ICD-10 code
F91
ICD-10 code description
Emotional disorders with onset specific to childhood
Primary outcomes
1
Description
GAD Symptoms
Timepoint
Before, during intervention, after intervention
Method of measurement
GAD-7 Questionnaire
2
Description
Worry
Timepoint
Before, during intervention, after intervention
Method of measurement
PSWQ Questionnaire
3
Description
severity and injury of anxiety
Timepoint
Before, during intervention, after intervention
Method of measurement
OASIS Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
ACT treatment is one of the third wave behavioral therapy 6 is central to the process leading to psychological flexibility, this 6 process are: acceptance, fault isolation or cognitive, as background, knowledge of the time, brightening the values, commitment to action (6). As well as model-based treatment techniques face to face that worries about disorder GAD targets. In this model, through training, visualization, repeated exposure control with catastrophic results of thoughts and ideas of any areas of concern, cause habituation of anxiety that area of concern (10). In this study, the combination of these two therapeutic models were used in 12 sessions that brought summary proceedings in the table.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Mahabad Psychiatric Service Center
Full name of responsible person
Faeze Sohrabi
Street address
Vafayi Three-way, Shapour Street, Mahabad
City
Mahabad
2
Recruitment center
Name of recruitment center
Mahabad Branch of Islamic Azad University Counseling Center
Full name of responsible person
Faeze Sohrabi
Street address
Mahabad Branch of Islamic Azad University, Mahabad, West Azarbayjan
City
Mahabad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz university
Full name of responsible person
Faeze Sohrabi
Street address
29 Bahman street,Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz university
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Mahabad Branch of Islamic Azad University
Full name of responsible person
Faeze Sohrabi
Street address
Mahabad branch of Islamic Azad University, University Square
City
Mahabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mahabad Branch of Islamic Azad University
Proportion provided by this source
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
Islamic Azad University of Mahabad
Full name of responsible person
Dr Sirvan Atashak
Position
Assistant Professor
Other areas of specialty/work
Street address
Department of Physical Education & Sports Science, Islamic Azad University, Mahabad, West Azarbayjan
City
Mahabad
Postal code
Phone
+98 444422341002
Fax
Email
atashak_sirvan@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University
Full name of responsible person
Faeze Sohrabi
Position
Phd Student in Psychology
Other areas of specialty/work
Street address
Tabriz University, 29 Bahman Street, Tabriz, East Azarbayjan
City
Tabriz
Postal code
Phone
+98 44 4244 8301
Fax
Email
sohrabi_faeze@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University
Full name of responsible person
Faeze Sohrabi
Position
PHD Student
Other areas of specialty/work
Street address
Tabriz university, Tabriz, East Azarbayjan
City
Tabriz
Postal code
Phone
00
Fax
Email
sohrabi_faeze@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)