Comparative effects of cognitive behavioral therapy focused on intolerance of uncertainty and pharmacotherapy among patients with generalized anxiety disorder
The purpose of the study: comparative effects of cognitive behavioral therapy focused on intolerance of uncertainty and pharmacotherapy among patients with generalized anxiety disorder. Design of the study: random.
The study population: included all patients referred to private and public institutions are the city of Sanandaj, Iran by clinicians and psychiatrist receive GAD diagnose.
The main inclusion criteria of the study: the age range of between 18 to 35 years; female gender; GAD diagnosis according to DSM-5 criteria.
The main exclusion criteria of the study: comorbidity with other mental disorders; psychotic symptoms (hallucinations, delusions); having a physical illness.
The sample size is 30, based on clinical interviews and diagnostic criteria for DSM-5 diagnosis of GAD are receiving. Interventions studied: group I (CBT), group II (pharmacologic treatment) took the intervention: 6 months.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016020626397N1
Registration date:2016-03-06, 1394/12/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-03-06, 1394/12/16
Registrant information
Name
Negar Beheshti
Name of organization / entity
University of Kurdistan
Country
Iran (Islamic Republic of)
Phone
+98 83 3835 4502
Email address
n.beheshti@hum.uok.ac.ir
Recruitment status
Recruitment complete
Funding source
University of Kurdistan
Expected recruitment start date
2016-01-21, 1394/11/01
Expected recruitment end date
2016-06-21, 1395/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative effects of cognitive behavioral therapy focused on intolerance of uncertainty and pharmacotherapy among patients with generalized anxiety disorder
Public title
Compare psychological and pharmacological treatment of generalized anxiety disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 18 and 35 years old; female gender; diagnosis of GAD according to DSM-5 criteria, and that so far have not received any treatment, including psychological and medical treatments.
Exclusion criteria: comorbidity with other mental disorders; psychotic symptoms (hallucinations, delusions); having a physical illness.
Age
From 18 years old to 35 years old
Gender
Female
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
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kurdistan University of Medical Sciences
Street address
Kurdistan University of Medical Sciences, Abidar St.
City
Sanandaj
Postal code
6618634683
Approval date
2016-02-03, 1394/11/14
Ethics committee reference number
MUK.REC.1394.309
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
Anxiety
Timepoint
Before the intervention, after the intervention and 1 month after intervention
Method of measurement
Beck Anxiety Inventory
Secondary outcomes
1
Description
Intolerance of Uncertainty
Timepoint
Before the intervention, after the intervention and 1 month after intervention
Method of measurement
Intolerance of Uncertainty Scale
2
Description
Worry
Timepoint
Before the intervention, after the intervention and 1 month after intervention
Method of measurement
Penn State Worry Questionnaire-Why Worry-II-Questionnaire
3
Description
Cognitive Avoidance
Timepoint
Before the intervention, after the intervention and 1 month after intervention
Method of measurement
Cognitive Avoidance Questionnaire
4
Description
Negative Problem Orientation
Timepoint
Before the intervention, after the intervention and 1 month after intervention
Method of measurement
Negative Problem Orientation Questionnaire
Intervention groups
1
Description
Type of intervention: a cognitive behavioral intervention group (intervention intolerance of uncertainty) is carried out which consists of twelve weekly 60-minute sessions.
Category
Behavior
2
Description
Control group: group medication (anti-anxiety medications appropriate dose, under the Psychiatric) is performed.