Investigating the effect of mobile -based Logotherapy on depressive symptoms, suicidal ideation and hoplessness in patients with major depressive disorder reffered to clinics affiliated with Shiraz University of Medical Sciences,1400
Determining the effect of mobile-based sign therapy on depressive symptoms, suicidal ideation and despair of patients with major depression referred to clinics affiliated to Shiraz University of Medical Sciences, 1400
Design
A double-blind randomized clinical trial with a pretest-posttest and follow-up design with a control group. The research sample, considering 20% of the loss, will include 70 people who will be placed in one of the experimental or control groups by a simple random sampling method using randomization software.
Settings and conduct
This research is a double-blind clinical trial in clinics affiliated with Shiraz University. First, patients with major depression who meet the inclusion criteria will be referred to the research team by a psychiatrist patient. After completing the informed consent form, the questionnaires will be provided to the participants online. they will be placed in one of the experimental or control groups by a simple random method. The experimental group will receive logotherapy and the control group will receive drug therapy via mobile. Immediately and 3 months later, both groups will be tested again and the results will be analyzed
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having a diagnosis of major depression based on the opinion of a psychiatrist according to DSM-V criteria
Intervention groups
.The experimental group will receive 8 semantic therapy training packages in 8 weeks by attending the virtual group via mobile and WhatsApp programs. The content of these training packages will be a collection of texts, sounds, images, and purposeful educational videos that will be available to people on a daily basis. The control group will remain on the waiting list until the end of the study and will receive only sertraline drug therapy training.
Main outcome variables
Symptoms of depression;
Disappointment;
Suicidal thoughts.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210622051664N1
Registration date:2021-07-24, 1400/05/02
Registration timing:registered_while_recruiting
Last update:2021-07-24, 1400/05/02
Update count:0
Registration date
2021-07-24, 1400/05/02
Registrant information
Name
Marzieh Shemiran
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3824 2810
Email address
farzanehsh80@email.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-23, 1400/05/01
Expected recruitment end date
2021-10-23, 1400/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of mobile -based Logotherapy on depressive symptoms, suicidal ideation and hoplessness in patients with major depressive disorder reffered to clinics affiliated with Shiraz University of Medical Sciences,1400
Public title
Investigating the effect of mobile -based Logotherapy on depressive symptoms, suicidal ideation and hoplessness in patients with major depressive disorder
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Having a diagnosis of major depression based on the opinion of a psychiatrist according to DSM-V criteria
Having a depression score of 8 or higher based on the short form of the Beck Depression Inventory
Have a hoplessness score of 9 or higher based on the Beck Disappointment Questionnaire
Having suicidal ideation based on Beck Suicide Thought Questionnaire screening questions
Start treatment with the antidepressant drug sertraline based on a psychiatrist's prescription
Internet accessible mobile phone
Exclusion criteria:
Reluctance to participate in the study
Presence of psychotic symptoms in the patient
Having other chronic mental disorders such as personality disorders, bipolar disorder or mental retardation in the patient
Having chronic physical illnesses such as diabetes or MS
Unforeseen physical or mental problems during the intervention
Taking other antidepressants except sertraline by the patient
The need to hospitalize the patient for any reason, including the high risk of suicide in the patient according to the psychiatrist
Incompetence in completing the consent form (such as lack of knowledge of the time, place, person and the presence of psychotic symptoms)
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random method using randomization software (from software
Random allocation).
First, the list of participants is obtained, then each of them is assigned a score or number, and using simple randomization software and using a table of random numbers, participants are divided into two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Study participants, statistical analysts, and questionnaire reviewers will have no information about the status of individuals in the groups and the type of training provided in the groups.
Participants in the groups have no knowledge of whether they are in the experimental or control group. Participants only know that they are receiving training but are not aware of the type of intervention they are receiving. Researchers, statistical analysts, and questionnaire reviewers are also unaware of the type of intervention
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Karim Khan Zand St., in front of Palestine St., the central building of Shiraz University of Medical Sciences and Health Services
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2021-06-19, 1400/03/29
Ethics committee reference number
IR.SUMS.REC.1400.238
Health conditions studied
1
Description of health condition studied
Depression
ICD-10 code
F32
ICD-10 code description
Major depressive disorder, single episode
2
Description of health condition studied
suicidal ideations
ICD-10 code
R45.851
ICD-10 code description
Suicidal ideations
Primary outcomes
1
Description
Depression
Timepoint
Before the intervention, immediately after the intervention, 3 months later
Method of measurement
Beck Depression Inventory: BDI-11
2
Description
hoplessness
Timepoint
Before the intervention, immediately after the intervention, 3 months later
Method of measurement
Beck hopelessness scale(BHS)
3
Description
Suicidal thoughts
Timepoint
Before the intervention, immediately after the intervention, 3 months later
Method of measurement
Beck Scale for Suicide Ideation (BSSI)
Secondary outcomes
empty
Intervention groups
1
Description
Control group: The control group will remain on the waiting list until the end of the study and will receive only sertraline drug therapy training.
Category
Other
2
Description
Intervention group: Receive semantic therapy training. The purpose of semantic therapy in this study is to provide 8 semantic therapy training packages in 8 consecutive weeks for patients with major depression based on the treatment methods suggested by Frankel and his followers, taken from The book "Man in Search of Meaning" is presented. Participants will receive 8 semantic therapy training packages in 8 weeks by attending the virtual group via mobile and WhatsApp program. The content of these training packages will be a collection of texts, sounds, images and educational videos. Which will be available to people on a daily basis.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ibn Sina Hospital Clinic
Full name of responsible person
Dr. Ebrahim Moghimi Sarani
Street address
next to 13 Aban Park ,Hafez St
City
Shiraz
Province
Fars
Postal code
1433671348
Phone
+98 71 3228 9600
Email
sinahosp@sums.ac.ir
2
Recruitment center
Name of recruitment center
Hafez Hospital Clinic
Full name of responsible person
Dr. Arvin Hedayati
Street address
Chamran Street, beginning of Abivardi
City
Shiraz
Province
Fars
Postal code
7194634786
Phone
+98 71 3647 9531
Email
Hafez@sums.ac.ir
3
Recruitment center
Name of recruitment center
Imam Reza Clinic
Full name of responsible person
Dr. Mani Ramsey
Street address
Namazi Square, next to Namazi Hospital
City
Shiraz
Province
Fars
Postal code
7134814734
Phone
+98 71 2127 0000
Email
motahari@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mehrzad Lotfi
Street address
Karim Khan Zand Street, in front of Palestine Street
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3323 3236
Email
President_d@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Marzieh Shemiran
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No3.3rd floor.saeed bulding.16th Alley.20 meters from Imam Khomeini Street
City
Shiraz
Province
Fars
Postal code
7178897901
Phone
+98 71 3824 2810
Email
farzanehsh80@email.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Marzieh Shemiran
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No3.3rd floor.saeed bulding.16th Alley.20 meters from Imam Khomeini Street
City
Shiraz
Province
Fars
Postal code
7178897901
Phone
+98 71 3824 2810
Email
farzanehsh80@email.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Marzieh Shemiran
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No3.3rd floor.saeed bulding.16th Alley.20 meters from Imam Khomeini Street
City
Shiraz
Province
Fars
Postal code
7178897901
Phone
+98 71 3824 2810
Email
farzanehsh80@email.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
Anonymous study data will be shared in correspondence with the project manager
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Researchers working in scientific and academic institutions
Under which criteria data/document could be used
A closer look at the data of patients with major depression
From where data/document is obtainable
Correspondence via email
What processes are involved for a request to access data/document
After obtaining permission from the security unit and the university's vice chancellor for research, the data will be made available to the individual.