Protocol summary

Summary
The purpose of this study was to evaluate the efficacy of group hypnotherapy in reducing anxiety in women with generalized anxiety disorder. The method was a pre-test – post-test with control group. The population included women with general anxiety disorder that referred to psychiatric clinics of Imam Khomeini Hospital in Sari. They were randomly divided in two groups (17 control) and (17 Experimental) group. The experimental group received 6 sessions of group hypnotherapy and the control group received 6 sessions imagery without any emphasis on relaxation and suggestion. For assessment of anxiety Spielberger State-Trait Anxiety and The Penn State Worry Questionnaire (PSWQ) was used. All calculations were done by SPSS18. Inclusion criteria:1- Diagnostic criteria for generalized anxiety disorder according to DSM-5; 2- Lack of debilitating diseases (Liver and kidney failure);3-Lack of self-harm and suicidal thoughts;4- The absence of acute psychosis and aggressive behavior;5- No history of seizures; Exclusion criteria1- During the study the volunteers can be excluded whenever they want;2- In case of having suicidal and homicidal thoughts;

General information

Acronym
The effect of hypnotherapy on Generalized Anxiety Disorder
IRCT registration information
IRCT registration number: IRCT2016062114928N4
Registration date: 2016-08-21, 1395/05/31
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-08-21, 1395/05/31
Registrant information
Name
Mehdi Pourasghar
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3327 3024
Email address
m.pourasghar@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Resaercher
Expected recruitment start date
2014-12-31, 1393/10/10
Expected recruitment end date
2016-01-30, 1394/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of group hypnotherapy on anxiety in women with Generalized Anxiety Disorder
Public title
The Effect of group hypnotherapy on anxiety in women with Generalized Anxiety Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
. Inclusion criteria - Diagnostic criteria for generalized anxiety disorder according to DSM-V; - Lack of debilitating diseases (Liver and kidney failure); - Lack of self-harm and suicidal thoughts; - The absence of acute psychosis and aggressive behavior; - No history of seizures; Exclusion criteria - During the study the volunteers can be excluded whenever they want; - In case of having suicidal and homicidal thoughts;
Age
From 20 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 34
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
poket

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Sari Azad University
Street address
7 km SeaRoad,
City
Sari
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
105145

Health conditions studied

1

Description of health condition studied
General 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 in the first session and after the last intervention at an interval of one month and a half in the last session
Method of measurement
Spielberger State-Trait Anxiety

2

Description
State Anxiety
Timepoint
Before intervention in the first session and after the last intervention at an interval of one month and a half in the last session
Method of measurement
Spielberger State-Trait Anxiety

3

Description
Trait Anxiety
Timepoint
Before intervention in the first session and after the last intervention at an interval of one month and a half in the last session
Method of measurement
Spielberger State-Trait Anxiety

4

Description
worry
Timepoint
Before intervention in the first session and after the last intervention at an interval of one month and a half in the last session
Method of measurement
Penn State Worry Questionnair (PSWQ)

Secondary outcomes

empty

Intervention groups

1

Description
The experimental group received six sessions of hypnosis.
Category
Treatment - Other

2

Description
the control group 6 meeting imagery without any emphasis on relaxation and suggestion, received.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital- Sari, Iran
Full name of responsible person
Mehdi Pourasghar
Street address
Amirmazandarani St- Sari, Mazandaran
City
Sari

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
researcher
Full name of responsible person
Mehdi Pourasghar
Street address
Zare Hospital, Pychiatry and Behavioral Sciences Research Center, Addiction Institute, Mazandaran University of Medical Sciences
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
researcher
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
Mazandaran University of Medical Sciences
Full name of responsible person
Mehdi Pourasghar@yahoo.com
Position
Psychiatrist
Other areas of specialty/work
Street address
Psychiatry and Behavioral Science Research Center- Addiction Institute
City
Sari
Postal code
4843185774
Phone
+98 11 3327 3024
Fax
+98 33285109
Email
me_pourasghar@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mehdi Pourasghar@yahoo.com
Position
Psychiatrist
Other areas of specialty/work
Street address
Psychiatry and Behavioral Rsearch Center- Addiction Institute, Zare Hospital
City
Sari
Postal code
4843185774
Phone
+98 11 3327 3024
Fax
+98 33285109
Email
me_pourasghar@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Susan Salari
Position
MA Clinical Psychology
Other areas of specialty/work
Street address
Psychiatry and Behavioral Science research Center, Addiction Institute, Zare Hospital
City
Sari
Postal code
4843185774
Phone
+98 11 3327 3024
Fax
+98 33285109
Email
salarisusan@gmail.com
Web page address

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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