The Comparison of the effectiveness group counseling through group therapy with group cognitive-behavioral therapy on the feeling of loneliness and life expectancy among students suffering from depression disorder at Islamic Azad University of Rasht
Determining the effectiveness of cognitive-behavioral group counseling on loneliness and life expectancy in students with depression
Design
Controlled randomized clinical trial on 45 students with active medical records given by a psychiatrist for depression.
Settings and conduct
students with depressive disorder referred to Islamic Azad University Counseling Center in Rasht.45 students with active medical records given by the psychiatrist diagnosed with depression. who wish to attend this course. The lowest scores in the three research tools (feeling alone, depressed, and life expectancy) were chosen by 45 individuals and were randomly assigned to 3 groups of 15 individuals (experimental group meaning therapy, cognitive-behavioral experimental group, and control group).
Participants/Inclusion and exclusion criteria
Having diagnostic criteria for depression according to psychiatrist and conscious desire to participate in research. Exclusion criteria for any personality disorder such as paranoid, antisocial personality and any obvious psychological illness such as obsessive-compulsive disorder, bipolar disorder, and significant medical disorder
Intervention groups
students with active therapeutic records provided by the psychiatrist for the diagnosis of depression. 45 people will be selected and will be randomly assigned to 3 groups of 15 people (experimental group of meaning therapy, cognitive-behavioral experimental group and control group). Then the counseling sessions will be conducted on the experimental groups and after the training course all three groups will be re-tested. One month after the post-test, the follow-up test will be administered to all 3 groups.
Main outcome variables
Life expectancy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190728044355N1
Registration date:2019-09-02, 1398/06/11
Registration timing:prospective
Last update:2019-09-02, 1398/06/11
Update count:0
Registration date
2019-09-02, 1398/06/11
Registrant information
Name
Touba Seghati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3355 4060
Email address
sh.seghati@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-06, 1398/06/15
Expected recruitment end date
2019-12-26, 1398/10/05
Actual recruitment start date
2019-09-06, 1398/06/15
Actual recruitment end date
2019-12-26, 1398/10/05
Trial completion date
2020-01-05, 1398/10/15
Scientific title
The Comparison of the effectiveness group counseling through group therapy with group cognitive-behavioral therapy on the feeling of loneliness and life expectancy among students suffering from depression disorder at Islamic Azad University of Rasht
Public title
"The effect of Cognitive-behavioral therapy on depression"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmed depression according to the psychiatrist
Informed consent to participate in research
Age between 20-35 years
Exclusion criteria:
Any personality disorder
Any obvious psychological illness such as obsessive-compulsive disorder
Patient with bipolar disorder
Age
From 20 years old to 35 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
75
Actual sample size reached:
75
Randomization (investigator's opinion)
Randomized
Randomization description
The study sample will be selected from students with active therapeutic records provided by the psychiatrist for the diagnosis of depression. The procedure is as follows: After visiting the University Counseling Center and announcing a call to students who wish to participate in this course, in addition to having the entry and exit criteria, the lowest scores in the three research instruments (feeling alone, Depression and life expectancy (45) will be selected and will be randomly assigned to 3 groups of 15 individuals (experimental group meaning therapy, cognitive-behavioral experiment group and control group). Subsequently, group counseling sessions on cognitive-behavioral therapy and cognitive-behavioral therapy will be conducted on the experimental groups for 10 sessions of 90 minutes, one session per week. One month after the post-test, the follow-up test will be administered to all 3 groups
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 Ahvaz Branch Islamic Azad University
Street address
No. 9, shahid rajaei Blvd., 38 Town
City
Rasht
Province
Guilan
Postal code
4155856333
Approval date
2019-07-26, 1398/05/04
Ethics committee reference number
IR.IAU.AHVAZ.REC.1398.007
Health conditions studied
1
Description of health condition studied
Depressive episode
ICD-10 code
F32
ICD-10 code description
Major depressive disorder, single episode
Primary outcomes
1
Description
Life expectancy
Timepoint
10 weeks (90 minutes each session) once a week, one month follow-up
Method of measurement
Beck Depression Inventory, Loneliness Questionnaire (UCLA), Miller Life Expectancy Questionnaire
Secondary outcomes
1
Description
"Loneliness score"
Timepoint
30 day
Method of measurement
BDI-II (Beck Depression Depression Inventory) 21 Questionnaire, UCLA 48 Questionnaire, Miller Life Expectancy Questionnaire 20
2
Description
"Life expectancy score"
Timepoint
30 day after intervention
Method of measurement
BDI-II (Beck Depression Depression Inventory) 21 Questionnaire, Miller Life Expectancy Questionnaire 20
Intervention groups
1
Description
Intervention group 1 will receive meaning therapy, 90 minutes for 10 weekly sessions.
Category
Treatment - Other
2
Description
The second intervention group will receive cognitive-behavioral intervention 90 minutes for 10 weekly sessions.
Category
Treatment - Other
3
Description
Control group will not receive any intervention.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Medical and Psychological Services Center of Rasht Azad University
Full name of responsible person
Abdollah Shafiabady
Street address
No. 9, shahidrejaee Blvd., 38Town
City
Rasht
Province
Guilan
Postal code
4155856333
Phone
+98 13 3355 4060
Email
sh.seghati@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sayed Mozafar Mirbargkar
Street address
Lakan
City
Rasht
Province
Guilan
Postal code
۴۱۴۷۶۵۴۹۱۹
Phone
+98 13 3342 2153
Email
mir.bargkar.m@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Abdollah Shafiabady
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No. 09, Line 38, Shahid Rejaei Blvd.
City
Rasht
Province
Guilan
Postal code
4155856333
Phone
+98 13 3355 4060
Email
ashafiabady@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mansour Sodani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Shahid Chamran University Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
4155856333
Phone
+98 13 3355 4060
Email
Sodani_m@suc.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Touba Seghati
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 9, shahid rejaee Blvd., 38Town
City
Rasht
Province
Guilan
Postal code
4155856333
Phone
+98 13 3355 4060
Email
sh.seghati@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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is 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
Article
When the data will become available and for how long
"6 months after printing the results"
To whom data/document is available
University and science centers, psychology centers, counseling centers and psychological services
Under which criteria data/document could be used
Reference to scientific and research articles
From where data/document is obtainable
By Phone and Email:
09118358191
sh.seghati@gmail.com
What processes are involved for a request to access data/document