Determination of the efficacy of integrated transdiagnostic treatment on reducing the symptoms in individuals with general anxiety disorder and its co-morbidity
Design
Clinical trial with control ,Not blind, randomized
Settings and conduct
Farabi Hospital in Kermanshah-Patients receive 12 sessions of integrated transdiagnostic treatment individually.
Participants/Inclusion and exclusion criteria
The main inclusion criterion:The person has a generalized anxiety disorder as the primary diagnosis
The main inclusion criteria:The current diagnosis of any mental disorder is consistent in Diagram 1 and 2 based on a psychiatrist's diagnostic interview, with the exception of emotional disturbances
Intervention groups
12 patients receive transdiagnostic and drug treatment, and 12 receive drug treatment.
Main outcome variables
Symptoms of generalized anxiety disorder and its co-morbidity
General information
Reason for update
Acronym
UTT
IRCT registration information
IRCT registration number:IRCT20120619010063N7
Registration date:2018-05-11, 1397/02/21
Registration timing:retrospective
Last update:2018-05-11, 1397/02/21
Update count:0
Registration date
2018-05-11, 1397/02/21
Registrant information
Name
Kheirollah Sadeghi
Name of organization / entity
Kermanshah University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 83 1826 0700
Email address
khsadeghi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-04, 1397/01/15
Expected recruitment end date
2018-05-05, 1397/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy effect of integrated transdiagnostic treatment on reducing the symptoms in individuals with general anxiety disorder and its co-morbidity
Public title
Efficacy transdiagnostic therapy in the treatment of generalized anxiety disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having at least 18 years of age
Have at least 3rd grade education
A person experiences generalized anxiety disorder as the primary diagnosis based on a psychiatrist's diagnosis and a diagnostic interview by a psychologist
Motivation and satisfaction for participation during treatment and research implementation
Exclusion criteria:
The current diagnosis of any mental disorder is consistent in Diagrams 1 and 2 based on a psychologist's diagnostic interview, with the exception of emotional disturbances
The current risk of suicide
Not receiving psychological treatment in the past year
Abuse history or substance dependence currently and over a year before the start of treatment
Unwillingness to attend research meetings
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment to intervention and control groups (simple randomization),Twenty-four patients with generalized anxiety disorder using random numbers table assigned to one of the intervention or control groups. Patients are assigned individually in groups.
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
Ethic's committee of Kermanshah University of Medical Sciences
Street address
Headquarter, Shahid Beheshti Blvd , Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2018-02-14, 1396/11/25
Ethics committee reference number
KUMS.REC.1396.617
Health conditions studied
1
Description of health condition studied
generalized anxiety disorder
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
genralized anxiety
Timepoint
pre-test, post-test, two months follow up
Method of measurement
Penn State Worry Questionnaire.
Secondary outcomes
1
Description
Depression
Timepoint
pre-test, post-test, two months follow up
Method of measurement
Beck Depression Inventory - Second Edition
2
Description
social anxiety
Timepoint
pre-test, post-test, two months follow up
Method of measurement
Social Interaction Anxiety Scale
3
Description
Health Anxiety
Timepoint
pre-test, post-test, two months follow up
Method of measurement
Short Form-Health Anxiety Inventory
4
Description
sleep quality
Timepoint
pre-test, post-test, two months follow up
Method of measurement
Pittsburgh Sleep Quality Index
5
Description
work and Social Adjustment
Timepoint
pre-test, post-test, two months follow up
Method of measurement
work and Social Adjustment Scale
Intervention groups
1
Description
Intervention group: 12 sessions of integrated transdiagnostic treatment of Barlow and colleagues-It has 5 main sections(Teaching awareness of emotions, cognitive flexibility, emotional avoidance and emotion-driven behaviors , awareness and tolerance of physical sensations and facing the emotions in the position ) and 3 sub-sections (Increased motivation and passion for change and participation in treatment,train the nature of emotions and review the progress of treatment and strategies to prevent relapse) and target key aspects of emotional processing and regulation of emotional experiences. treatment sessions are done weekly and within 3 months. Patients are simultaneously treated with approximately the same drugs, such as benzodiazepines
Category
Behavior
2
Description
Control group: no intervention (Medicine alone)-Patients are only treated with approximately the same drugs as benzodiazepines.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kermanshah University of Medical Sciences
Full name of responsible person
Mohsen Mohammadpour
Street address
Kermanshah-Shahid Shiroodi Blvd.-Imam Reza Hospital- Medical school
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3835 5925
Email
mohammdpour5711@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
Headquarte, Shahid Beheshti Blvd, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3835 5925
Email
fnajafi@kums.ac.ir
Grant name
Kermanshah University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mohsen Mohammadpour
Position
MSc
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Kerma Hospital- nshah-Shahid Shiroodi Blvd.-Imam Reza Medical School
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3835 5925
Email
mohammdpour5711@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mohsen Mohammadpour
Position
MSc
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Kermanshah-Shahid Shiroodi Blvd.-Imam Reza Hospitantel- Medical School
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3835 5925
Email
mohammdpour5711@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Kheirollah Sadeghi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Kermanshah-Shahid Shiroodi Blvd.-Imam Reza Hospital- Medical School
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3835 5925
Email
khirollahsadeghi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD