Determination of the efficacy of public logo therapy on general health promotion in people with type 2 diabetes
Design
This is a randomized clinical trial study with control group which the subjects are randomly divided into intervention and control groups.
Settings and conduct
This study is carried out in the city of Joveyn. The research population are people with type 2 diabetes referred to Joveyn health care centers.
Participants/Inclusion and exclusion criteria
The entry requirements: 1) Age older than 30 years; 2) Consent to participate in the research; 3) Have a minimum degree of diploma; 4) Those with a public health score over 23.
Conditions of non-arrival: 1- Use of psychological treatments in the past months 2. Communication disorders such as vision or auditory problems 3. Severe physical diseases 4. Diagnosis of mental disorders.
Intervention groups
Study of the efficacy of group logo therapy on public health, which is carried out on 18 individuals with type 2 diabetes, in 10 sessions of 90 minutes duration twice a week, and in each session one topic of logo therapy is discussed such as freedom and responsibility of choice, familiarity with a variety of values, meaning through the creation of values and responsibility, familiarity with the types of anxiety and the meaning of death, self-healing, self-excellence, familiarity with existential isolation and sin. This study is done by a researcher under a master of science psychologist supervision who is familiar with logo therapy. There is no intervention to the control group. After finishing the sessions a post-test will be done on the intervention and control groups. Then the results will be used for statistical analysis software.
Main outcome variables
Promotion of public health level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181106041583N1
Registration date:2019-01-03, 1397/10/13
Registration timing:prospective
Last update:2019-01-03, 1397/10/13
Update count:0
Registration date
2019-01-03, 1397/10/13
Registrant information
Name
Akram Korozhdeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4522 0592
Email address
akramkorozhdeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-15, 1397/10/25
Expected recruitment end date
2019-06-15, 1398/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of group logo therapy on public health promotion in people with type 2 diabetes
Public title
The efficacy of group logo therapy on public health promotion in people with type 2 diabetes
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
People older than 30 years
Consent and inclination to participate in research
Having at least diploma certificate
People who get 23 score or more in public health examination
Exclusion criteria:
Diagnosis of mental disorder
Use of other psychological treatments in the past 6 months
Having communication problems such as visual or auditory debilitating disorders
Having severe physical diseases which disturbs their presence in the therapeutic sessions
Age
From 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization by permutation block allocation method
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
Ethics Committee of Sabzevar University of Medical Sciences
Street address
Tohid Shahr town, further up Anonymous Martyrs tomb, Campus complex, School of Medical and Paramedical Sciences
City
sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Approval date
2018-12-09, 1397/09/18
Ethics committee reference number
IR.MEDSAB.REC.1397.072
Health conditions studied
1
Description of health condition studied
public health
ICD-10 code
F80-89
ICD-10 code description
Disorders of psychological
Primary outcomes
1
Description
Promotion of public Health level in Public Health Questionnaire (GHQ 28)
Timepoint
Before the intervention (pre-test) immediately after 10 sessions of intervention (post-test).
Method of measurement
Public Health Questionnaire (GHQ 28)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention is done for the experimental group in 10 sessions of 90 minutes duration twice a week. The Intervention sessions are designed based on literature review and available resources and are related to issues of logo therapy such as freedom and responsibility of choice, familiarity with a variety of values, meaning through the creation of values and responsibility, familiarity with the types of anxiety and the meaning of death, self-healing, Self excellence, familiar with existential isolation and sin.
Category
Other
2
Description
Control group: There is no intervention to the control group.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Healthcare centers in Jovein city
Full name of responsible person
Koshky Davood
Street address
Atamalek Cooperative Building, 3th floor
City
Neghab
Province
Razavi Khorasan
Postal code
9647134967
Phone
+98 51 4522 0747
Email
JOV_SH_HEALTH@YAHOO.COM
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Koshan Mohsen
Street address
Tohid Shahr town, further up the Anonymous Martyrs tomb, Campus complex, School of Medical and Paramedical Sciences
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4401 8300
Email
mkoshan42@gmail.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar University of Medical Sciences
Proportion provided by this source
100
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
Sabzevar University of Medical Sciences
Full name of responsible person
Korozhdeh akram
Position
Nursing staff at Ghamar Bani Hashem Hospital
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ghamar Bani Hashem Hospital، km 3 Railroad
City
Neghab
Province
Razavi Khorasan
Postal code
9647117178
Phone
+98 51 4522 0592
Email
akramkorozhdeh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Korozhdeh akram
Position
Nursing staff at Ghamar Bani Hashem Hospital
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ghamar Bani Hashem Hospital، km 3 Railroad
City
Neghab
Province
Razavi Khorasan
Postal code
9647117178
Phone
+98 51 4522 0592
Email
akramkorozhdeh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Korozhdeh akram
Position
Nursing staff at Ghamar Bani Hashem Hospital
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ghamar Bani Hashem Hospital، km 3 Railroad
City
Neghab
Province
Razavi Khorasan
Postal code
9647117178
Phone
+98 51 4522 0592
Email
akramkorozhdeh@gmail.com
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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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