This study aimed to determine the efficacy of group psycho-education on medication adherence , insight and quality of life in patients with bipolar disorder . In this study, the statistical samples included patients with bipolar disorder in Zanjan. The samples were selected from patients who referred to psychiatric private clinics and governmental centers of Zanjan University of Medical Sciences, Beheshti hospital. Sampling was based on availability. There were several inclusion criteria for in this study: having the euthymic mood during the study and being diagnosed as bipolar disorder based on diagnostic interview. The exclusion criteria of the study was being at the acute phase of the disease or being an active drug abuser. After checking the inclusion and exclusion criteria 20 patients with bipolar disorder were selected and categorized into two groups: the experimental group (n=10), the control group (n=10). The content of psycho-educational group program consisted of bipolar disorder definition and its causes, an introduction to the symptoms of mania and hypomania, the process and prognosis of the disease, medications for treatment of mania and depression, learning early identification of disorder. The control group continued their routine treatment. Primary outcome measure was adherence to drug. Secondary outcome measures were insight and quality of life. Medication adherence , Quality of life and insight scale of the Two groups were evaluated before and After the intervention, One month after the intervention using Morisky Medication Adherence Scale , Short form of quality of life and Mood Disorder Insight Scale.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016061928533N1
Registration date:2016-08-13, 1395/05/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-08-13, 1395/05/23
Registrant information
Name
Arezu Nahid Sahlan
Name of organization / entity
Medical Science of Zanjan
Country
Iran (Islamic Republic of)
Phone
+98 41 3266 4793
Email address
arezu.nahid@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Social Determinants of Health Research Center Valiasr Zanjan hospital
Expected recruitment start date
2016-04-29, 1395/02/10
Expected recruitment end date
2016-06-04, 1395/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of group pcycho-education program on bipolar patients' adherence to drug, insight and quality of life
Public title
Effectiveness of pcychoeducation program in bipollar patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : being diagnosed as bipolar disorder based on diagnostic interview and SCID-I/CV test results. Being in the age range of 18 to 50, having the euthymic mood during the study (score less than or equal to 7 for Hamilton scale and score less than or equal to 6 for Young Mania scale). Exclusion criteria : being at the acute phase of the disease or being an active drug abuser, having mental retardation, having the full criteria for Scizofrenia diagnosed by psychiatrist and according to SCID-I.
Age
From 18 years old to 50 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
Zums.ac.ir
Secondary trial Id
Zums.REC.1395.61
Registration date
1395-11-21, 777/01/-849
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of University of Medical Sciences.
Street address
Zanjan Univercity Of Medical Science, Azadi Blvd, Zanjan
City
Zanjan
Postal code
45156-13191
Approval date
2016-05-31, 1395/03/11
Ethics committee reference number
zums.rec.1395.61
Health conditions studied
1
Description of health condition studied
bipollar disorder
ICD-10 code
F31.7
ICD-10 code description
Bipolar affective disorder, currently in remission
2
Description of health condition studied
bipollar disorder
ICD-10 code
F31.7
ICD-10 code description
Bipolar affective disorder, currently in remission
Primary outcomes
1
Description
Adherence to drug
Timepoint
before therapy, after therapy, after a month
Method of measurement
morisky medication adherence scale
Secondary outcomes
1
Description
insight and quality of life
Timepoint
before therapy, after therapy, a month after therpy
Method of measurement
mood disorder insight scale, world health organization questionaire
Intervention groups
1
Description
Group 1: A psycho-educational program was conducted for the psycho-educational group( Combined intervention pcychoeducation Plus Medication) during 5 weekly sessions.
Category
Other
2
Description
group (2): Pharmachotherapy
They received as usual treatment (Medication)
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Zanjan Beheshti Hospital
Full name of responsible person
Arezu Nahid
Street address
Zanjan Ark- the martyr Beheshti Hospital in Zanjan
City
Zanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Medical Science Of Zanjan
Full name of responsible person
Vice chancellor for research, Zanjan Univercity Of Medical Science
Street address
Zanjan Univercity Of Medical Science, Azadi Blvd, Zanjan
City
zanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Medical Science Of Zanjan
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
Zanjan University of Medical Science
Full name of responsible person
Arezu Nahid sahlan
Position
masters student in clinical pcychology
Other areas of specialty/work
Street address
Tabriz. shahid garre baghi street. ismailli deadlock. no 169
City
Zanjan
Postal code
5146948331
Phone
+98 41 3266 4793
Fax
Email
Arezu.nahid@zums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Medical Science Of Zanjan
Full name of responsible person
Arezu Nahid Sahlan
Position
Masters student on clinical pcychology
Other areas of specialty/work
Street address
No 169, Ismaili Dead End, Shahid Garrebahi ST, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3266 4793
Fax
Email
Arezu.nahid@zums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Science
Full name of responsible person
Arezu Nahid Sahlan
Position
Masters Student of Clinical Pcychology
Other areas of specialty/work
Street address
No 169, Ismaili Dead End, Shahid Garrebahi ST, Tabriz
City
Tabriz
Postal code
51469-48331
Phone
+98 41 3266 4793
Fax
Email
Arezu.Nahid@zums.ac.ir.
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)