Developing a Logo Therapy Focused Program for Individual with Common Variable Immunodeficiency Disease (CVID): Efficacy on Resilience and Quality of Life
Evaluation of the effect of treatment protocol based on Logo Therapy on resilience and quality of life in patients with Common Variable Immunodeficiency Disease
Design
Clinical trial with a control group that was assigned to the experimental and control groups randomly. Each group has 16 patients and the intervention is performed on the experimental group
Settings and conduct
On the intervention group, 10 sessions of 90-minute Logo Therapy are performed online by the researcher. selecting online sessions is due to the limitations created by Covid-19 as well as the sensitivity of the immunodeficiency patient group. In each session, patients are taught LogoTherapy. The structure of the intervention is briefly as follows:
Session 1: Performing pre-tests, providing basic information about Logo Therapy, teaching the awareness of values. Session 2: Clarifying creative values. Session 3: Clarifying Empirical Values. Session 4: Clarifying Attitude Values. Session 5:Check the list of values , setting goals. Session 6: Analyzing goals in order to set personal values. Session 7: teaching Dereflection . Session 8: Practicing Dereflection and teaching the Paradoxical intention . Session 9: Practicing the paradoxical intention. Session 10: Summarizing the intervention and Investigating the changes, performing post-tests
Participants/Inclusion and exclusion criteria
Inclusion criteria include: definitive diagnosis of CVID, age between 18-45 years, at least 3 years after diagnosis and initiation of IVIG blood transfusion, education is at least a diploma, does not include the diagnosis of psychotic disorders
Intervention groups
Logo Therapy
Main outcome variables
Improving the psychological condition and quality of life of patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210202050218N1
Registration date:2021-02-20, 1399/12/02
Registration timing:registered_while_recruiting
Last update:2021-02-20, 1399/12/02
Update count:0
Registration date
2021-02-20, 1399/12/02
Registrant information
Name
Shaghayegh Kahrizi
Name of organization / entity
University of Tehran
Country
Iran (Islamic Republic of)
Phone
+98 31 3670 1839
Email address
kahrizi.64@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-20, 1399/12/02
Expected recruitment end date
2021-02-25, 1399/12/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Developing a Logo Therapy Focused Program for Individual with Common Variable Immunodeficiency Disease (CVID): Efficacy on Resilience and Quality of Life
Public title
Developing a Logo Therapy Focused Program for Individual with Common Variable Immunodeficiency Disease (CVID): Efficacy on Resilience and Quality of Life
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis of CVID
age between 18-45 years
at least 3 years after diagnosis and initiation of IVIG blood transfusion
Minimum diploma education
Satisfaction to participate in research
Exclusion criteria:
diagnosis of psychotic disorders
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
40 patients are introduced by the Immunodeficiency Research Center of Isfahan University of Medical Sciences according to the inclusion criteria. A simple randomization method using lottery is used to select the intervention and control groups. Patients' names are written on paper and then placed in a lottery bag. Then, by the uninformed person, 20 names for the intervention group and 20 names for the control group are selected from the papers in the bag.
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 University of Tehran
Street address
Faculty of Psychology and Education, University of Tehran, Jalal Ale-Ahmad Ave.,
City
Tehran
Province
Tehran
Postal code
1445983861
Approval date
2021-01-02, 1399/10/13
Ethics committee reference number
IR.UT.PSYEDU.REC.1399.044
Health conditions studied
1
Description of health condition studied
Common Variable Immunodeficiency
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Resilience
Timepoint
Before the intervention, after the end of the intervention, 1 month after the end
Before the intervention, after the end of the intervention, 1 month after the end
Method of measurement
Common Variable Immune Deficiency Quality of Life Questionnaire (CVID_QoL)
Secondary outcomes
empty
Intervention groups
1
Description
Before the intervention, the online pre-test is performed and the questionnaires are sent to the patients as a link. LogoTherapy is performed in 10 sessions of 90 minutes and online by the researcher on the intervention group. In each session, the concepts and topics derived from Logo Therapy are taught to patients. After the end of the post-test sessions. The structure of the sessions is as follows: Session 1: Performing pre-tests, providing basic information about Logo Therapy, teaching the awareness of values. Session 2: Clarifying creative values. Session 3: Clarifying Empirical Values. Session 4: Clarifying Attitude Values. Session 5:Check the list of values , setting goals. Session 6: Analyzing goals in order to set personal values. Session 7: teaching Dereflection . Session 8: Practicing Dereflection and teaching the Paradoxical intention . Session 9: Practicing the paradoxical intention. Session 10: Summarizing the intervention and Investigating the changes, performing post-tests
Category
Behavior
2
Description
Control group:This group does not receive any intervention. Pre-tests and post-tests will be sent to them as a link.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Immunodeficiency Research Center of Isfahan University of Medical Science
Full name of responsible person
Shaghayegh Kahrizi
Street address
Isfahan University of Medical Science,Sofe blvd.
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱۸۱۷۴۶
Phone
+98 31 3792 3928
Email
iirc@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Tehran
Full name of responsible person
Dr.Mohammad Rahimian
Street address
16 Azar St .Enghelab St.Central Campus of the University of Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۶۱۴۴۱۱
Phone
+98 21 6640 0059
Fax
Email
research@ut.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Tehran
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
University of Tehran
Full name of responsible person
Shaghayegh Kahrizi
Position
Phd.Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No 61. Esteghlal Ave. Mardavij
City
Isfahan
Province
Isfehan
Postal code
8168753116
Phone
+98 31 3221 7361
Email
kahrizi_1364@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Tehran
Full name of responsible person
Shaghayegh Kahrizi
Position
PhD. Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No61, Esteghlal,Mardavij
City
Isfahan
Province
Isfehan
Postal code
8168753116
Phone
+98 31 3221 7361
Email
kahrizi_1364@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
University of Tehran
Full name of responsible person
Shaghayegh Kahrizi
Position
PhD.Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No 61. Esteghlal Ave. Mardavij
City
Isfahan
Province
Isfehan
Postal code
8168753116
Phone
+98 31 3221 7361
Email
kahrizi_1364@yahoo.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
Results of statistical analysis of questionnaire scores
When the data will become available and for how long
6 months after publishing the results
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Similar research
From where data/document is obtainable
E-mail
What processes are involved for a request to access data/document