The effectiveness of behavioral activation group therapy in severity of depression, repetitive thoughts and functions of students with major depressive disorder: A double blind randomized clinical trial
The effectiveness of behavioral activation group therapy in severity of depression, repetitive thoughts and functions of students
Design
This double blind randomized clinical trial has an intervention and a control group.
Settings and conduct
After a diagnostic interview by a psychiatrist, patients who are diagnosed with major depressive disorder are randomly assigned to intervention and control groups, also assessments will done in one, three, and six months after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Being university student
2. Residence in Zanjan while researching
3. Tending to participate in research
4. Scores between 15 - 25 in beck depression inventory second edition and major depressive disorder diagnosis by the psychiatrist.
Exclusion criteria:
1. Having a history of psychosis, substance abuse, bipolar mood disorder and personality disorders
2. Depression related to medical condition
3. Previous psychological intervention specially cognitive behavioral therapy more than five sessions
4. Consume psychotropic drugs
5. The history of hospitalization and receiving electroconvulsive therapy (ECT)
Intervention groups
Intervention group will receive behavioral activation group therapy; and control group will receive only behavioral activation booklet.
Main outcome variables
Depression severity, repetitive thoughts and educational social function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181128041782N1
Registration date:2019-03-04, 1397/12/13
Registration timing:registered_while_recruiting
Last update:2019-03-04, 1397/12/13
Update count:1
Registration date
2019-03-04, 1397/12/13
Registrant information
Name
Soleiman Saberi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 910 472 0804
Email address
S.saberipsy@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of behavioral activation group therapy in severity of depression, repetitive thoughts and functions of students with major depressive disorder: A double blind randomized clinical trial
Public title
The effectiveness of behavioral activation group therapy in severity of depression, repetitive thoughts and functions of students
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being university student
Residence in Zanjan while researching
Tending to participate in research
Scores between 15 - 25 in beck depression inventory second edition and dajor depressive disorder diagnosis by the psychiatrist
Exclusion criteria:
Having a history of psychosis, substance abuse, bipolar mood disorder and personality disorders
Depression related to medical condition
Previous psychological intervention specially cognitive behavioral therapy more than five sessions
Consume psychotropic drugs
The history of hospitalization and receiving electroconvulsive therapy (ECT)
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
After diagnosis by the psychiatrist, using the random number generator V 1.3 patients will assign to two treatment and control groups; so that all participants have equal chance of being in the groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
After sampling, any of participant will not aware from randomization and allocation to groups. The data analyzer is selected outside of the study and all of datas will be given to him as a code.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Scienses
Street address
Zanjan University of Medical Sciences, Azadi Square
City
Zanjan
Province
Zanjan
Postal code
45156-13191
Approval date
2018-11-27, 1397/09/06
Ethics committee reference number
IR.ZUMS.REC.1397.255
Health conditions studied
1
Description of health condition studied
Major Depressive Disorder - Mild
ICD-10 code
F32.0
ICD-10 code description
Major depressive disorder, single episode, mild
2
Description of health condition studied
Major Depressive Disorder - Moderate
ICD-10 code
F32.1
ICD-10 code description
Major depressive disorder, single episode, moderate
Primary outcomes
1
Description
Depression Severity
Timepoint
Pre-test, Post-test and follow up (One, Three and six months after post-test)
Method of measurement
Beck Depression Inventory-II (BDI-II)
Secondary outcomes
1
Description
Repetitive thoughts
Timepoint
Pre-test, Post-test and Follow up (One, Three and Six months after post- test)
Method of measurement
Repetitive Thinking Questionnaire-31
2
Description
Function of students
Timepoint
Pre-test, Post-test and Follow up (One, Three and Six months after post- test)
Method of measurement
Work (Educational) and Social Adjustment Scale
Intervention groups
1
Description
Intervention group will receive fourteen session of Behavioral Activation Group Therapy. This intervention based on C. W. Lejuez and Derek R. Hopko's protocol and includes psycho-education, activity monitoring, activity planning and values clarification.
Category
Behavior
2
Description
Control group will receive only behavioral activation booklet، which contains the same topics with the intervention group and will be checked weekly by internet and and guidance will be provide if needed.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Zanjan University of Medical Sciences
Full name of responsible person
Omid Saed
Street address
Zanjan University of Medical Sciences, Azadi Square
City
Zanjan
Province
Zanjan
Postal code
45156-13191
Phone
+98 24 3342 0670
Fax
+98 24 3354 2403
Email
info@zums.ac.ir
Web page address
http://zums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Alireza Shoghli
Street address
Zanjan University of Medical Sciences, Azadi Blvd
City
zanjan
Province
Zanjan
Postal code
45136-15788
Phone
+98 24 3342 0651
Email
info@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Soleiman Saberi
Position
Masters Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Department of Clinical Psychology, Beheshti Hospital, Besat Ave, Arg Square
City
Zanjan
Province
Zanjan
Postal code
45136-15788
Phone
+98 24 3354 2403
Email
s.saberipsy@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Omid Saed
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Department of Clinical Psychology, Beheshti Hospital, Besat Ave, Arg Square
City
zanjan
Province
Zanjan
Postal code
۱۵۷۸۸-۴۵۱۳۶
Phone
+98 24 3354 2403
Email
o.saed@zums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Soleiman Saberi
Position
Masters Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Department of Clinical Psychology, Beheshti Hospital, Besat Ave, Arg Square
City
zanjan
Province
Zanjan
Postal code
۱۵۷۸۸-۴۵۱۳۶
Phone
+98 24 3354 2403
Email
s.saberipsy@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
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
Title and more details about the data/document
All of the information related to main outcome will be published.
When the data will become available and for how long
Start the access period from 2020
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Access to documents is possible to inform other researchers. Access to documents is possible to work with the researcher.
From where data/document is obtainable
1. Dr. Beheshti Hospital, Zanjan, Department of Clinical Psychology, Dr Omid Saed
2. Dr. Beheshti Hospital, Zanjan, Department of Clinical Psychology, Soleiman Saberi, Mobile: +989396467172
What processes are involved for a request to access data/document
Documents will be shared only when the reason for the request is announced by phone or e-mail.