Objective: This study was conducted to evaluate the efficacy of two treatment approaches of self-hypnosis combined with citalopram on state- trait anxiety and quality of life in patients with Generalized Anxiety Disorder.
Design: The Design of the research is the randomized clinical trial ( pretest-post test) with control group.
Setting and conduct: The instrument of the study was Spielberger's State-trait Anxiety Inventory and World Health Organization Quality of Life Questionnaire , filled out by both groups.
Participants including major eligibility criteria: This Randomized clinical Trial was conducted on 80 patients with anxiety disorders presenting to psychology clinic (Ferdowsi University, Mashhad city, 2013-2014). On the basis of DSM-IV-TR diagnostic criteria, twenty of them were diagnosed with Generalized Anxiety Disorder. And they were divided into two groups: experimental and control. Inclusion criteria: Diagnosis of Generalized Anxiety Disorder (GAD) by psychiatrist; Without comorbid disorders; To have not severe physical illness.
Exclusion criteria: Under treatment or other educational program ; The absence of more than two sessions. All patients filled Informed Consent in the beginning.
Intervention: Both groups received Citalopram(20 mg/d) for two months and were monitored by a psychiatrist from the interview to the end of the study.The experimental group underwent self-hypnosis group training through behavioral cognitive method in addition to taking the medicine for 6 weeks. Follow-up was done 2 months after the treatment ended. The data were analyzed with repeated measures analysis of variance.
Main outcome measures (variables): Both groups completed Spielberger Stait- Treit Anxiety Questionnaire and the World Health Organization Quality of Life Questionnaire in the first week and the sixth week and two months after treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015091023966N1
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
Zahra Moghanizadeh
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 915 766 7517
Email address
moghaniz2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Semnan University
Expected recruitment start date
2013-09-23, 1392/07/01
Expected recruitment end date
2014-06-10, 1393/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Self-hypnosis combined with Citalopram on the Anxiety in patients with Generalized Anxiety Disorder and Quality of Life
Public title
Efficacy of Self-hypnosis combined with Citalopram on the Stait- Trait Anxiety in patients with Generalized Anxiety Disorder and Quality of Life
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Diagnosis of Generalized Anxiety Disorder (GAD) by psychiatrist; Without comorbid disorders; To have not severe physical illness
Exclusion criteria: Under treatment or other educational program ; The absence of more than two sessions
Age
No age limit
Gender
Both
Phase
2-3
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
Using a Table of Random Numbers
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Semnan University
Street address
Faculty of Psychology & Education Mehdishahr , Semnan University , Darband, Mehdishahr, Semnan, Iran.
City
Mahdishahr
Postal code
356411156
Approval date
2012-09-22, 1391/07/01
Ethics committee reference number
No Issues
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 (i.e. it is
Primary outcomes
1
Description
Generalized Anxiety Disorder
Timepoint
Baseline-After intervention-Two months after intervention
Method of measurement
Spielberger's State-Trait Anxiety Inventory
2
Description
Quality of Life
Timepoint
Baseline- After the intervention-Two months after the intervention
Method of measurement
The World Health Organization Quality of Life Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Self hypnosis Training: for experimental groups and for 6 weeks.
Category
Behavior
2
Description
Citalopram: In this research in the form of tablets of 20 mg was prescribed once a day for 6 weeks for both of experimental and control groups.
Category
Treatment - Drugs
3
Description
Without self-hypnosis training sessions: for the Control group as a shame of interview for 6 weeks
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Ferdowsi University of Mashhad
Full name of responsible person
Zahra Moghanizadeh
Street address
Faculty of Education and Psychology, Ferdowsi University of Mashhad. Azadi square
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Semnan University
Full name of responsible person
Ali Haghighi Asl
Street address
Department of Chemical Engineering of Oil and Gas, Opposite the park Svkan, , Semnan University
City
Semnan
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, Semnan 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
Mashhad University of Medical Sciences
Full name of responsible person
Zahra Moghanizadeh
Position
Master of Clinical Psychology
Other areas of specialty/work
Street address
Faculty of Health, Daneshgah Ave. #18, Mashhad-Iran
City
Mashhad
Postal code
Iran
Phone
+98 513854464333
Fax
Email
moghaniz2@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zahra Moghanizadeh
Position
Master of Clinical Psychology
Other areas of specialty/work
Street address
Daneshgah Ave. #18, Mashhad-Iran
City
Mashhad
Postal code
Iran
Phone
+98 513854464333
Fax
Email
moghaniz2@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zahra Moghanizadeh
Position
Master of Clinical Psychology
Other areas of specialty/work
Street address
Daneshgah Ave. #18, Mashhad-Iran
City
Mashhad
Postal code
Phone
+98 51 3854 4633
Fax
Email
moghaniz2@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)