Evaluation of the effectiveness of the Community Reentry Program (CRP) in adherence to treatment and control of symptoms of Bipolar Mood Disorder (BMD) in patients admitted to the psychiatric ward
Determining the effectiveness of CRP in bipolar type 1 patients admitted to male and female psychiatric wards.
Design
The type of study is an intervention with a control group. Receives an intervention group (CRP). And the control group does not receive any intervention. The intervention consists of 8-12 sessions, 4 sessions per week. Evaluation is done before and after the intervention and is followed up 3 months after discharge. Each person is evaluated for significant variables every two weeks and evaluated using the Yang Mania and SCL25 tests.
Settings and conduct
This study will be performed in the psychiatric ward of Fatemi Hospital in Ardabil.
Participants/Inclusion and exclusion criteria
The study population will be all patients with BMD disorder. A sample of bipolar type I patients admitted to the psychiatric ward of Dr. Fatemi Hospital in Ardabil. Took. A sample size of 50 will be selected and 25 people in each group will be included. Inclusion criteria: Having BMD disorder age 20-50 years, Exclusion criteria: mental retardation, schizophrenia, other psychotic disorders, duration less than 6 months, addiction.
Intervention groups
25 people in the intervention group will receive CRP interventions individually. The interventions will be presented individually in 8 to 12 sessions.
Main outcome variables
Adherence therapy
aggression
Mania symptoms
Community Relations
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211121053134N1
Registration date:2022-09-14, 1401/06/23
Registration timing:registered_while_recruiting
Last update:2022-09-14, 1401/06/23
Update count:0
Registration date
2022-09-14, 1401/06/23
Registrant information
Name
Mehriar Nadermohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3352 1932
Email address
m.nadirmohammadi@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-05, 1401/02/15
Expected recruitment end date
2022-09-21, 1401/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of the Community Reentry Program (CRP) in adherence to treatment and control of symptoms of Bipolar Mood Disorder (BMD) in patients admitted to the psychiatric ward
Public title
Evaluation of the effectiveness of the Community Reentry Program (CRP) in adherence to treatment and control of symptoms of Bipolar Mood Disorder (BMD).
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having BMD disorder
Hospitalization in the psychiatric ward
Exclusion criteria:
Comorbidity with mental retardation
Comorbidity with schizophrenia
Comorbidity with other psychotic disorders
Duration of the disorder less than 6 months
Comorbidity with addiction
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization will be used. In this way, the patient randomly picks a card with two letters written on it. The letter I stands for intervention and the letter C stands for control. If a person takes a card that is I-C, that person will be placed in the intervention group, but the next person will be in the control group. If he takes the C-I card, that person will be placed in the control group and the next person will be placed in the intervention group. This action causes the number of groups to increase in parallel.
Blinding (investigator's opinion)
Single blinded
Blinding description
All patients in the intervention and control groups receive the intervention. But only the intervention group receives CRP. Individuals in the control group receive unrelated training. Neither patient in the two groups is informed of what the main intervention is.
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ardabil University of Medical Sciences
Street address
Address: Ardabil, Daneshgah st. Ardabil Complex Univesity
City
Ardabil
Province
Ardabil
Postal code
56189-85991
Approval date
2021-11-16, 1400/08/25
Ethics committee reference number
IR.ARUMS.REC.1400.244
Health conditions studied
1
Description of health condition studied
Bipolar Mood Disorder (BMD-I)
ICD-10 code
296/41
ICD-10 code description
296/41
Primary outcomes
1
Description
Signs and symptoms of bipolar disorder, drug adherence, aggression, and social relationships are outcome variables that are assessed with the following questionnaires. 1- Young Mania 2- Morisky Drug Adherence Questionnaire 3- Phillips Social Support Questionnaire 4- Bass Perry Aggression Questionnaire.
Timepoint
Before each intervention session (8 to 12 sessions) and after discharge from the ward (up to 2 months each week)
Method of measurement
Use a self-report questionnaire: 1- Young Mania 2- Morisky Drug Adherence Questionnaire 3- Phillips Social Support Questionnaire 4- Bass Perry Aggression Questionnaire.
Secondary outcomes
empty
Intervention groups
1
Description
The Community Reenter Program (CRP) is a subset of the more comprehensive program, The Independent and Social Life Skills Program, developed by the Psychiatric Rehabilitation Clinical Research Center at UCLA, for people with long-term and recurrent mental disorders, especially schizophrenia. "Bipolar disorder and major depression are designed. The purpose of the Return to Community program is to provide patients with the information and skills necessary for an independent social life and to enable them to benefit from psychosocial rehabilitation services." The Return to Community program combines new educational materials in discharge planning and application in the community with areas of drug treatment management, symptom self-management, and leisure and recreation programs. Is used.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemi Hospital - Psychiatric Department
Full name of responsible person
Dr. Fariba Sadeghi Movahed
Street address
Ardabil - Sarein Station; Imam Khomeini St., not far from Shariati Square, Fatemi Educational and Medical Center
City
Ardabil
Province
Ardabil
Postal code
5614733775
Phone
+98 45 3323 2520
Fax
+98 45 3323 2670
Email
fatemi@arums.ac.ir
Web page address
https://fatemi.arums.ac.ir/fa
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr. Farhad Pourfarzi
Street address
Ardabil: The end of Daneshgah Street, the administrative complex of Ardabil University of Medical Sciences
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۸۹-۸۵۹۹۱
Phone
+98 45 3353 4790
Fax
+98 45 3353 4773
Email
info@arums.ac.ir
Web page address
https://www.arums.ac.ir/fa#
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil University of Medical Sciences
Proportion provided by this source
50
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
مهریار ندرمحمدی
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Ardabil - Sarein Station; Imam Khomeini St., not far from Shariati Square, Fatemi Educational and Medical Center
City
Ardabil
Province
Ardabil
Postal code
5614733775
Phone
+98 45 3323 2520
Fax
+98 45 3323 2670
Email
mehriar46@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Mehriar Nader Mohammadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Ardabil - Sarein Station; Imam Khomeini St., not far from Shariati Square, Fatemi Educational and Medical Center
City
Ardabil
Province
Ardabil
Postal code
5614733775
Phone
+98 45 3323 2520
Fax
+98 45 3323 2670
Email
mehriar46@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Mehriar Nadermohammadi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Ardabil city - University Street - Milad Town - Keshavarzi Town - in front of Sabalan University Non-Profit Education Complex
City
Ardabil
Province
Ardabil
Postal code
5614733775
Phone
+98 45 3352 1932
Fax
+98 45 3323 2670
Email
m.nadirmohammadi@arums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The overall results will be published in the article that will be published
When the data will become available and for how long
Unlimited
To whom data/document is available
All
Under which criteria data/document could be used
To design similar studies or launch CRP services
From where data/document is obtainable
Related scientific journals
What processes are involved for a request to access data/document
Written request to the responsible author specifying the scientific and clinical status