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Comparing the effect of continuous care model and supportive psychoeducation package on self-care in patients with bipolar disorder type 1

Protocol summary

Summary
Objectives: Comparing the effect of continuous care model and supportive psychoeducation package on self-care in patients with bipolar disorder type 1. Design: this study was performed on 90 patients with type 1 bipolar disorder (which is in the process of stabilization) by available sampling method. Then, they will be assigned randomly according to the random numbers table into three groups: continuous care model, supportive psychoeducation package and control. Methodology: in the continuous care model, patients will be trained in four stages of awareness (a two-hour session), sensitization (6 sessions per 2 hours), control (once every two weeks), and evaluation (at each stage) For 12 weeks. In supportive psychoeducation package group, patients will receive standard training package in the form of a booklet and CD during a one-hour session after discussing on bipolar disorder. The control group will receive the usual training. Major eligibility criteria for participants: at least high school level, lack of mental retardation, confirmation of bipolar disorder by psychiatrist, not having chronic physical illness simultaneously, not having cognitive impairment simultaneously, living with the caregiver. Major criteria for no eligibility: unwillingness to continue participating in the study, Missing more than one session at training sessions, having a degree in medicine, nursing, psychology

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT2017071735141N1
Registration date: 2017-08-26, 1396/06/04
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-08-26, 1396/06/04
Registrant information
Name
Azam Mohammady
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3459 1375
Email address
mohammadya1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Mashhad University of Medical Sciences
Expected recruitment start date
2017-07-06, 1396/04/15
Expected recruitment end date
2017-10-07, 1396/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of continuous care model and supportive psychoeducation package on self-care in patients with bipolar disorder type 1
Public title
Comparing the effect of continuous care model and psychoeducation package on self-care
Purpose
Supportive
Inclusion/Exclusion criteria
Major eligibility criteria for participants: at least high school level; lack of mental retardation; confirmation of bipolar disorder by psychiatrist; not having chronic physical illness simultaneously; not having cognitive impairment simultaneously; living with the caregiver. Exclusion criteria: unwillingness to continue participating in the study; Missing more than one session at training sessions; having a degree in medicine, nursing, psychology
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Patients with type 1 bipolar disorder were selected according to the physician's approval at the mood stabilization stage

Secondary Ids

1

Registry name
-
Secondary trial Id
-
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad university of medical sciences
Street address
Vice chancellor for research, Mashhad University of Medical Sciences, next to the Hovezeh Cinema, University avenue, Mashhad
City
Mashhad
Postal code
00985138430249
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
IR.MUMS.REC.1396.119

Health conditions studied

1

Description of health condition studied
Bipolar Disorder type 1
ICD-10 code
F31
ICD-10 code description
Bipolar affective disorder

Primary outcomes

1

Description
self- care
Timepoint
before intervention, two months after intervention
Method of measurement
Roldán-Merino self-care needs questionnaire

2

Description
self- efficacy
Timepoint
before intervention, two months after intervention
Method of measurement
Lorig chronic disease self-efficacy scales

Secondary outcomes

empty

Intervention groups

1

Description
The control group will receive the usual training
Category
Other

2

Description
Continuous care mode group: patients will be trained in four stages of awareness (a two-hour session), sensitization (6 sessions per 2 hours), control (once every two weeks), and evaluation (at each stage) For 12 weeks
Category
Other

3

Description
Supportive psychoeducation package group: patients will receive a standard training package in the form of a booklet and CD during a one-hour session after discussing on bipolar disorder
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ibn Sina psychiatric hospital, Mashhad
Full name of responsible person
Dr Fateme Mohareri
Street address
Next Astan Ghods Naghlie, end Hor Ameli of the street, Mashhad
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Vice chancellor for research, Mashhad University of Medical Sciences, next to the Hovezeh cinema, Daneshgah avenue, Mashhad
City
Mashhad
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 of Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Azam Mohammady
Position
Msc in psychiatric nursing
Other areas of specialty/work
Street address
Mashhad University of Medical Sciences, next to the Hovezeh cinema, Daneshgah avenue, Mashhad
City
Mashhad
Postal code
Phone
+98 51 3843 0249
Fax
Email
Mohammadya1@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Azam Mohammady
Position
Msc in psychiatric nursing
Other areas of specialty/work
Street address
Mashhad University of Medical Sciences, next to the Hovezeh cinema, Daneshgah avenue, Mashhad
City
Mashhad
Postal code
Phone
+98 51 3843 0249
Fax
Email
mohammadya1@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Azam Mohammady
Position
Msc in psychiatric nursing
Other areas of specialty/work
Street address
Mashhad University of Medical Sciences, next to the Hovezeh cinema, Daneshgah avenue, Mashhad
City
Mashhad
Postal code
Phone
+98 51 3843 0249
Fax
Email
mohammadya1@mums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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