Comparison of the efficacy of drug therapy with cognitive-behavioral therapy with the drug in reducing the symptoms and sings of type 2 bipolar disorder.
Identify the signs and symptoms that drug medication or cognitive-behavioral therapy with the drug has in reducing or improving them.
Design
Twenty patients with type 1 bipolar mood disorder who were admitted to the psychiatric ward were selected.They were randomly (A random number table) assigned to TAU (N=10) or CBT with TAU (N=10). Each group will be receive its own therapy.
Settings and conduct
Intervention and control groups consist of type 1 bipolar patients that were admitted to the psychiatric ward of Fatemi Hospital in Ardebil . At first, bipolar patients were randomly assigned to two groups of drug therapy(control group) and cognitive-behavioral therapy with drug(Intervention group).
Participants/Inclusion and exclusion criteria
Including critria: -Age minimum 18 and maximum 50 years ; Minimum education third grade middle school; Minimum standards DSM-V criteria; First episode of disease
Excluding critria: Having substance abuse and active thoughts of suicide; psychotic disorder and OCD and personality disorder; impulse control disorder and aggression; pregnant; history of any psychiatric treatment in the past 6 months
Intervention groups
The drug treatment group will receive treatment as usual ( TAU) treatment. And in the patients of the cognitive behavioral therapy group along with the drug receive TAU treatment and cognitive-behavioral therapy for 8 weeks based on the JC Wright method.
Main outcome variables
High mood; sexual interests; sleep; thought content; aggressive behavior; irritability; speech impairment; appearance; insight; motor activity; speech speed
General information
Reason for update
Acronym
none
IRCT registration information
IRCT registration number:IRCT20170103031741N2
Registration date:2018-09-11, 1397/06/20
Registration timing:retrospective
Last update:2018-09-11, 1397/06/20
Update count:0
Registration date
2018-09-11, 1397/06/20
Registrant information
Name
nikou salmani aghdam
Name of organization / entity
Ardebil University of medical sience
Country
Iran (Islamic Republic of)
Phone
+98 45 3333 1797
Email address
ni.salmani@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Educational Assistant University of Medical Sciences
Ardabil
Expected recruitment start date
2018-06-10, 1397/03/20
Expected recruitment end date
2018-09-01, 1397/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of drug therapy with cognitive-behavioral therapy with the drug in reducing the symptoms and sings of type 2 bipolar disorder.
Public title
The effect of cognitive behavioral therapy (CBT) for reducing signs and symptoms of bipolar disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age minimum 18 years and maximum 50 years
Minimum education third grade middle school
Minimum standards DSM-V criteria for the diagnosis of bipolar disorder type
People who experience a first episode of disease
Chronic patients who had at least 2 weeks of discontinuation And a new episode of recurrent disease and had been hospitalized.
Exclusion criteria:
Having substance abuse
Having active thoughts of suicide
Having any comorbidity disorder accompanied by a psychotic clinical presentation.
Having OCD
Having any personality disorder.
Having impulse control disorder and aggression.
Any pregnant.
History of any psychiatric treatment in the past 6 months.
Hospitalized patients have a history of drug treatment without discontinuing the drug.
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
A sample of bipolar patients is a type of admission in the psychiatric ward in an accessible manner, of which 20 will be contributed. Patients with Bipolar Mood Disorder in the department (based on psychiatric diagnosis) are divided into two groups of drugs and cognitive-behavioral therapy with the drug randomly.
The accident method will be simple. A random number table is a collection of numbers that are generated without a specific pattern or order and completely randomized. To use a random number table, we first set the table numbers to read, for example, top, bottom, left, or right. The second default considering numbers for different groups for example, pair numbers for intervention A (drug treatment group) and individual numbers for intervention B (cognitive behavioral therapy group with medication).
-Randomization: Individual.
-Randomization Tool: Random Number Tables.
-Allocation concealment: Numbered drug containers
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
Ethical Committee of Ardabil University of Medical Sciences
Street address
Ardebil University of medical sciences.,University Square.,University Avenue.,Ardebill
City
Ardebil
Province
Ardabil
Postal code
56189-85991
Approval date
2016-10-31, 1395/08/10
Ethics committee reference number
IR.ARUMS.REC.1395.57
Health conditions studied
1
Description of health condition studied
Bipolar Mood Disorder type one
ICD-10 code
Chapter V
ICD-10 code description
F31
Primary outcomes
1
Description
High Mood
Timepoint
At the beginning of the study and 2 months after the intervention
Method of measurement
Yang Mania Scale Response; Hamilton Test
2
Description
Sexual interests
Timepoint
At the beginning of the study and 2 months after the intervention
Method of measurement
Yang Mania Scale Response; Hamilton Test
3
Description
Sleep
Timepoint
At the beginning of the study and 2 months after the intervention
Method of measurement
Yang Mania Scale Response; Hamilton Test
4
Description
Thought content
Timepoint
At the beginning of the study and 2 months after the intervention
Method of measurement
Yang Mania Scale Response; Hamilton Test
5
Description
Aggressive behavior
Timepoint
At the beginning of the study and 2 months after the intervention
Method of measurement
Yang Mania Scale Response; Hamilton Test
6
Description
Irritability
Timepoint
At the beginning of the study and 2 months after the intervention
Method of measurement
Yang Mania Scale Response; Hamilton Test
7
Description
Speech impairment
Timepoint
At the beginning of the study and 2 months after the intervention
Method of measurement
Yang Mania Scale Response; Hamilton Test
8
Description
Appearance
Timepoint
At the beginning of the study and 2 months after the intervention
Method of measurement
Yang Mania Scale Response; Hamilton Test
9
Description
Insight
Timepoint
At the beginning of the study and 2 months after the intervention
Method of measurement
Yang Mania Scale Response; Hamilton Test
10
Description
Motor activity
Timepoint
At the beginning of the study and 2 months after the intervention
Method of measurement
Yang Mania Scale Response; Hamilton Test
11
Description
Speech speed
Timepoint
At the beginning of the study and 2 months after the intervention
Method of measurement
Yang Mania Scale Response; Hamilton Test
Secondary outcomes
1
Description
Quality of life
Timepoint
At the beginning of the study and 2 months after the intervention
Method of measurement
FS36 Score
Intervention groups
1
Description
Intervention group : will be receive cognitive-behavioral therapy (12 sessions,Based on JC Wright method) with a common drug treatment such as sodium valproate (15mg/kg/Daily, PO) and lithium(400mg daily,PO) for 2 month .
Category
Behavior
2
Description
Control group: will be receive a common drug treatment such as sodium valproate (15mg/kg/Daily, PO) and lithium(400mg daily,PO) for 2 month .