Protocol summary

Summary
Locus of control is one of the known personality variables, refers to judgment of causality or causation's embodied of events, necessary for the prognosis of psychotherapies. The aim of this study was to investigate the relationship between locus of control and therapeutic effect of cognitive-behavior therapy and relaxation, in patients with Generalized Anxiety Disorder. For this purpose, 30 patients who have been diagnosed with generalized anxiety disorder by clinical interview using DSM-IV-TR, using convenience sampling chose and assigned randomly into two groups, one experimental and one control group each contains 15 members. For one of the groups during twelve sessions (one hour a week) cognitive behavior therapy and for the other group eight sessions (one hour a week) relaxation training applied. At the start and the end of the process, they tested on the Rotter Locus of Control scale and Beck Anxiety inventory. Result analyzed according to the patient's locus of control using ANCOVA to determine the role of locus of control in the therapeutic effects.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014052517839N1
Registration date: 2014-08-15, 1393/05/24
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-08-15, 1393/05/24
Registrant information
Name
Hiwa Karimi
Name of organization / entity
Kurdistan University
Country
Iran (Islamic Republic of)
Phone
+98 87 5322 8494
Email address
foh@uok.ac.ir
Recruitment status
Recruitment complete
Funding source
Myself
Expected recruitment start date
2013-01-19, 1391/10/30
Expected recruitment end date
2013-04-19, 1392/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Moderating role of locus of control on the effectiveness of Cognitive – Behavior Therapy and Relaxation in 30 patients with generalized anxiety disorder
Public title
Role of locus of control on the effectiveness of Cognitive – Behavior Therapy in patients with generalized anxiety disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age between 18 and 45 years, minimum education 9th, and clinical diagnosis of generalized anxiety disorder according to the DSM-IV-TR. Exclusion criteria included: Drug addiction, physical disease, and personality disorders.
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Method of randomization: After selecting 30 patients using convenience sampling, the first patient using coin assigned in cognitive - behavior group. Consequently, second patient assigned in the relaxation group, third in cognitive – behavior Group and so on ...

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kurdistan University
Street address
Kurdistan University, Pasdaran Ave. Pasdaran Blvd. Sanandaj
City
Sanandaj
Postal code
6617715175
Approval date
2013-05-22, 1392/03/01
Ethics committee reference number
112/9518

Health conditions studied

1

Description of health condition studied
Generalized 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.

Primary outcomes

1

Description
Anxiety
Timepoint
Before intervention and immediately after intervention
Method of measurement
Beck anxiety inventory

2

Description
Locus of control
Timepoint
Before intervention and immediately after intervention
Method of measurement
Rotter locus of control scale

Secondary outcomes

empty

Intervention groups

1

Description
Cognitive - Behavior therapy applied during twelve sessions, one hour a week and based on Beck's cognitive therapy. At the end of each session, homework gave to patients and the beginning of the next session the performance and results discussed.
Category
Behavior

2

Description
Relaxation training applied during eight sessions, one hour a week based on Ost's applied relaxation. At the end of each session, homework gave to patients and the beginning of the next session the performance and results discussed.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Marivan Welfare center
Full name of responsible person
Aram Ranginkaman
Street address
Behzisti Ave. Ebadat Blvd. Marivan Welfare center
City
Mariwan

2

Recruitment center
Name of recruitment center
Tolo Counseling Center
Full name of responsible person
Fatah Rezaie
Street address
Beside Maharat driving education center, Ebadat Blvd. Mariwan
City
Mariwan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Kurdistan University
Full name of responsible person
Abdollah Salimi
Street address
Vice chancellor for research, Kurdistan University, Pasdaran Ave. Pasdaran Blvd. Sanandaj
City
Sanandaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kurdistan 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
Kurdistan University
Full name of responsible person
Hiwa Karimi
Position
MSc. in clinical psychology
Other areas of specialty/work
Street address
No. 34, Taleqani Ave. Bahonar Ave. Mariwan
City
Mariwan
Postal code
6671639550
Phone
+98 87 5322 6939
Fax
Email
kaziva.kaziva@yahoo.com
Web page address
foh@uok.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kurdistan University
Full name of responsible person
Hiwa Karimi
Position
MSc. in clinical psychology
Other areas of specialty/work
Street address
No. 34, Taleqani Ave. Bahonar Ave. Mariwan
City
Mariwan
Postal code
6671639550
Phone
+98 87 5322 6939
Fax
Email
KAZIVA.KAZIVA@YAHOO.COM
Web page address
foh@uok.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kurdistan University
Full name of responsible person
Hiwa Karimi
Position
MSc. in Clinical Psychology
Other areas of specialty/work
Street address
Kudristan University, Pasdaran Blvd. Sanandaj
City
Sanandaj
Postal code
6617715175
Phone
+98 87 1666 4600
Fax
Email
kaziva.kaziva@yahoo.com
Web page address
foh@uok.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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