Determining the effect of spiritual group therapy on anxiety and hope in patients with type 2 diabetes
Design
The sample size was divided into two groups of control and intervention by randomized blocks method. The total sample size was 108 in control and intervention groups.
Settings and conduct
Spiritual group therapy will be held in a class of the Hamadan Diabetes Association Center in groups of 8 to 12 people , for 8 weeks and 1 session per week.
Participants/Inclusion and exclusion criteria
Inclusion criteria include having type 2 diabetes, literacy for reading and writing, consent to participate in the research, speaking Persian language, Islamic religion, lack of crisis experience and psychiatric drug use in the last three months, Not attending psychotherapy sessions in the last six months, no psychiatric disorder, a lack of severe non-diabetic physical illness, exclusion criteria include absent more than two sessions.
Intervention groups
The eight sessions of spiritual group therapy are as follows: Session 1: Statement of goals. Session 2: Awareness with the meaning of spirituality. Session 3: Awareness with the meaning of anxiety and ways to control it. Session 4: Getting to know the concept of hope and ways to increase it. Session 5: Practice prayer and trust and understand forgiveness and repentance. Session Six: Forgiving and generalizing it to control anger and patience. Seventh Session: Thanksgiving and appreciation for positive changes in spirituality. Eighth Session: Kindness and compassion . The control group does not receive any counselling.
Main outcome variables
Anxiety and hope
General information
Reason for update
Acronym
DM
IRCT registration information
IRCT registration number:IRCT20170411033378N7
Registration date:2019-10-11, 1398/07/19
Registration timing:prospective
Last update:2019-10-11, 1398/07/19
Update count:0
Registration date
2019-10-11, 1398/07/19
Registrant information
Name
Efat Sadeghian
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0150
Email address
sadeghian_e@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-22, 1398/09/01
Expected recruitment end date
2020-05-21, 1399/03/01
Actual recruitment start date
2019-11-22, 1398/09/01
Actual recruitment end date
2020-05-21, 1399/03/01
Trial completion date
2020-07-21, 1399/04/31
Scientific title
The effective of spiritual group therapy on anxiety and hope in patients with type 2 diabetes
Public title
The effective of spiritual group therapy on anxiety and hope in patients with type 2 diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of type 2 diabetes based on medical records
At least 20 years of age
Literacy of reading and writing
Has not taken any psychiatric medication in the three months recent
Not attending psychotherapy sessions in the past 6 months
Speaking Persian language
Having Islam religion
Consent to participate in the research
No psychiatric disorder according to medical record
Not having a serious physical illness other than diabetes
Lack of crisis experience in the three months recent
Exclusion criteria:
Absent more than 2 sessions
Age
From 20 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
108
Actual sample size reached:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be selected by available method with considering inclusion criteria, then divided into two intervention and control groups by randomized allocation. Random allocation will be by permuted block randomization. It is individual randomization. First, a random list is generated using R software in which the intervention group (A) and the control group (B) are based on blocks such as ABAB. And AABB, ABBA and ... are randomly generated based on the number of samples. Then these lists are put into an envelope and one of the envelopes is randomly selected by referring patients and then individuals are assigned to group A Or B are allocated. Due to the educational intervention and having the control and experimental group there is no possibility of blinding the participants.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamadan University of Medical Sciences
Street address
In front of People's Park, Shahid Fahmideh Boulevard, Hamadan University of Medical Sciences, Hamadan, Iran
City
Hamadan
Province
Hamadan
Postal code
6517838698
Approval date
2019-09-15, 1398/06/24
Ethics committee reference number
IR.UMSHA.REC.1398.469
Health conditions studied
1
Description of health condition studied
Diabetes, Spiritual Health, Anxiety, Hope
ICD-10 code
3
ICD-10 code description
Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism
Primary outcomes
1
Description
Anxiety score of the Cattell Anxiety Scale Hope Score of the Snyder Hope Scale
Timepoint
Measurement of anxiety before intervention, immediately after intervention and one month after intervention Measurement of hope before intervention, immediately after intervention and one month after intervention
Method of measurement
Cattell Anxiety Scale Snyder Hope Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Group counseling based on spiritual health in 8 sessions 80-minute, using a spirituality package provided by the researcher.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamadan Diabetes Association Center
Full name of responsible person
Efat Sadeghian
Street address
In front of People's Park, Shahid Fahmideh Boulevard, Hamadan University of Medical Sciences, Hamadan, Iran
City
Hamadan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3838 0535
Email
sadeghianefat@gmailo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
In Front Of People's Park, Shahid Fahmideh Boulevard, Hamadan University of Medical Sciences, Hamadan, Iran
City
Hamadan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3838 0535
Email
sadeghianefat@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Foreign
Category of foreign source of funding
Sponsor: country of origin
Country of origin
IR
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Efat Sadeghian
Position
Assistance professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursing
Street address
In Front Of People's Park, Shahid Fahmideh Boulevard, Hamadan University of Medical Sciences, Hamadan, Iran
City
Hamadan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3838 0535
Email
Sadeghianefat@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Efat Sadeghian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hamadan, Mahdye Street-Shahid Fahmedeh Bolvar-Hamadan University of Medical Sciences
City
Hamdan
Province
Hamadan
Postal code
65178-38698
Phone
+98 81 3838 0150
Email
Sadeghianefat@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Efat Sadeghian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hamadan-Mahdye Street-Shahid Fahmedeh Bolvar-Hamadan University of Medical Sciences
City
Hamadan
Province
Hamadan
Postal code
65178-38698
Phone
+98 81 3838 0150
Email
sadeghianefat@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The whole data will be published after the unidentifiable individuals are shared. which will be published as the final report and artical.
When the data will become available and for how long
Start of access period 6 months after printing results
To whom data/document is available
Researchers working in academic and scientific institutions and people in the industry can apply for them.
Under which criteria data/document could be used
Anyone who would like to use cited articles is possible by email.
From where data/document is obtainable
Applicants can email their request for receving the relevent documents and data to sadeghianefat@gmail.com or send it to postal address Hamadan; Shahid Fahmideh Street, Front of Mardom park; Faculty of Nursing and Midwifery; Psychiatric Nursing Department, Dr Effat Sadeghian; Postal code: 38698-65178; or Call: 38380535-081 and Fax: 38380447-081.
What processes are involved for a request to access data/document
Applicants can email their request for receving the relevent documents and data to sadeghianefat@gmail.com or send it to postal address Hamadan; Shahid Fahmideh Street, Front of Mardom park; Faculty of Nursing and Midwifery; Psychiatric Nursing Department, Dr Effat Sadeghian; Postal code: 38698-65178; or Call: 38380535-081 and Fax: 38380447-081. The response will be sent to the Applicants at least one week after reviewing the request.