Clinical trial of the effectiveness of group cognitive behavior therapy on improving drug compliance, quality of life and decreasing anxiety in female patients with bipolar mood disorder type I
(1) Objectives: The aim of this study is to determine the effect of cognitive group therapy on the quality of life, anxiety and drug compliance in female patients with bipolar mood disorder type I hospitalized in psychiatric ward of Tabriz psychiatric center in 2012. (2) Design: This research is a quasi-experimental study with “pre-test and post-test with control group” design. (3) Setting and conduct: The sample size of this study has been estimated 70 persons with 35 persons in control group and 35 persons in experimental group allocated randomly. The data for this study will be gathered through Zung self report Anxiety scale, quality of life questionnaire (SF36) and health belief model questionnaire. (4) Participants inclusion criteria: being in the age range between 20 and 40, having at least high school degree, being in relative recovery phase of disorder and lack of brain injuries, mental retardation, substance abuse and epilepsy. (5) Intervention: First, the pre-test will be done in both groups. The experimental group will attend 12 sessions of 90-minutes group therapy, but the control group will not receive any intervention. Both of the groups will receive drug therapy according to the psychiatrist’s order. Finally, the post-test will be done in both of the groups and the results will be compared. (6) The main outcome variable: Improving the quality of life and drug compliance and decreasing anxiety.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112108359N1
Registration date:2013-07-14, 1392/04/23
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-07-14, 1392/04/23
Registrant information
Name
Farnaz Rrahmani
Name of organization / entity
Tabriz nursing and midwifery school
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
frahmani@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2013-10-12, 1392/07/20
Expected recruitment end date
2013-11-11, 1392/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effectiveness of group cognitive behavior therapy on improving drug compliance, quality of life and decreasing anxiety in female patients with bipolar mood disorder type I
Public title
The effectiveness of group cognitive behavior therapy on drug compliance, quality of life and anxiety in patients with bipolar mood disorder
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Women patients with bipolar mood disorder type I hospitalized in women ward, being in the age range 20 to 40, having at least high school degree in education, not being in acute phase of illness, being in relative recovery phase of disorder and lack of brain injuries, mental retardation, substance abuse and epilepsy.
Age
From 20 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Random assignment of subjects into two groups: First, subjects' names will be written on paper and will be read randomly, then the subjects will be randomly divided into two groups of experimental and control.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences, Vice chancellor for research
Street address
Third floor, central building- No 2 of Tabriz University of Medical Sciences, vice chancellor for research, Golgasht street, Tabriz, Iran.
City
Tabriz
Postal code
Approval date
2011-06-14, 1390/03/24
Ethics committee reference number
5/4/2324
Health conditions studied
1
Description of health condition studied
Bipolar affective disorder
ICD-10 code
f31.1
ICD-10 code description
Bipolar affective disorder
Primary outcomes
1
Description
Anxiety
Timepoint
Before intervention, after intervention and every mount until 3 mounts
Method of measurement
Zung Self-Rating Anxiety Scale
2
Description
Quality of life
Timepoint
Before intervention, after intervention and every mount until 3 mounts
Method of measurement
Quality of life questionnaire (SF36)
3
Description
Drug compliance
Timepoint
Before intervention, after intervention and every mount until 3 mounts
Method of measurement
Health Belief Model questionnaire
Secondary outcomes
1
Description
Age
Timepoint
Pre-test
Method of measurement
Personal-social questionnaire
2
Description
Marital status
Timepoint
Pre-test
Method of measurement
Personal-social questionnaire
3
Description
Illness duration
Timepoint
Pre-test
Method of measurement
Personal-social questionnaire
Intervention groups
1
Description
Intervention group: First, the pre-test will be done. The experimental group will participate in 12 sessions of cognitive group therapy managed by the researcher. During the sessions, the researcher will try to improve the insight of the patients toward the drug compliance and solve their problems relating to their illness. Then, the post-test will be done and the results of the pre-test and the post-test will be compared.
Category
Other
2
Description
Control group: This group will not receive any intervention. Both of the groups will receive drug therapy. The difference of the quality of life, anxiety and drug compliance of the pre-test and the post-test will be measured and compared with each other.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi hospital of Tabriz
Full name of responsible person
Farnaz Rahmani
Street address
Elgholi street, Razi hospital of Tabriz, Tabriz, Iran
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Reza Rashidi
Street address
Third floor, central building- No 2 of Tabriz University of Medical Sciences, vice chancellor for research, Golgasht street. Tabriz, Iran.
City
Tabriz
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, Tabriz University of Medical Sciences
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
Razi hospital of Tabriz University of Medical Sciences