Assessment of the effectiveness of group behavioral activation on trajectories of change in depressive symptoms in patients diagnosed with major depressive disorder
Assessment of the effectiveness of group behavioral activation on trajectories of change in depressive symptoms among patients suffering from major depression
Design
Single group, non-blinded, non-randomized trial with a sample size of 60
Settings and conduct
An interventional study in the psychiatry department of Farschian (Sina) Hospital in Hamedan
Participants/Inclusion and exclusion criteria
Inclusion criteria: being at the age of 18-65 years; minimum education level of primary school (5 years); definite diagnosis of major depressive disorder; presence of moderate to severe depression; Participant's tendency to participate in group therapy. Non-inclusion criteria: history of major neurological disorders (e.g. Epilepsy, multiple sclerosis); history of substance or alcohol use in the recent 12 months; history of manic or hypomanic episodes; history of psychosis.
Intervention groups
Patients will receive behavioral activation during 10 weeks, the major aim is to recognize patterns of avoidance and replace them with mastery and pleasure behaviors to reduce depressive symptoms.
Main outcome variables
Depression scores based on Beck Depression Inventory (II)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200120046203N1
Registration date:2020-03-12, 1398/12/22
Registration timing:registered_while_recruiting
Last update:2020-03-12, 1398/12/22
Update count:0
Registration date
2020-03-12, 1398/12/22
Registrant information
Name
Latif Moradveisi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3827 4185
Email address
l.moradveisi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-09, 1398/11/20
Expected recruitment end date
2020-09-20, 1399/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the effectiveness of group behavioral activation on trajectories of change in depressive symptoms in patients diagnosed with major depressive disorder
Public title
Trajectories of change in depressive symptoms during group behavioral activation
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having the minimum age of 18 and maximum age of 65
Having the diagnosis of major depressive disorder based on clinical interview and Structured Clinical Interview for DSM 5 (SCID)
Participants tendency to participate in group versus individual therapy
Presence of moderate to severe depression based on Beck Depression Inventory II (BDI-II)
Minimum education level of primary school (5 years)
Exclusion criteria:
Presence or history of major neurological disorders (e.g. epilepsy, multiple sclerosis)
Presence of prolonged interpersonal issues hindering participation in group
Diagnosis of obsessive compulsive disorder
Diagnosis of antisocial personality disorder
Current or prior substance or alcohol use in the recent 12 months
Prior history of hypomanic or manic episode
Current or prior history of psychosis
History of organic brain damage
Simultaneous participation in other psychological therapies
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamedan University of Medical Sciences
Street address
Farshchian Hospital, Mirzadeh Eshghi Street
City
Hamedan
Province
Hamadan
Postal code
6516848741
Approval date
2019-09-15, 1398/06/24
Ethics committee reference number
IR.UMSHA.REC.1398.463
Health conditions studied
1
Description of health condition studied
Major depressive disorder
ICD-10 code
F32
ICD-10 code description
Major depressive disorder, single episode
2
Description of health condition studied
Major depressive disorder
ICD-10 code
F33
ICD-10 code description
Major depressive disorder, recurrent
Primary outcomes
1
Description
depression score in Beck Depression Inventory
Timepoint
Assessment of depression score at baseline, week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, and 1 month after the last week
Method of measurement
Beck Depression Inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: behavioral activation, in 10 weeks, in 7 to 10 participant groups, the sessions content is as follows: First session learning patterns (groups introduction, introducing the concept of behavioral activation, starting self-monitoring), second session start changing patterns (relating self-monitoring to avoidance, introducing functional analysis of avoidance), third session taking action (changing avoidance into action, setting plans), fourth session understanding challenges (to learn about barriers of change), fifth session rumination (understanding rumination as a barrier to become active, learning the difference between productive and unproductive thinking, analysis of what makes individual ruminate, identifying behaviors to replace rumination), sixth session mindfulness and being present in the moment (introducing techniques to help individual become engaged in routine activities), seventh session empathizing with self (identifying how individuals speak to themselves that lead to rumination, findings ways to change it to a compassionate voice), eighth session planning ahead ( review of previous sessions and individual gains, working on barriers on the way of introduced techniques, plan for the future), ninth session values (aid participants to cope with their life situations through mindful ways of living rather than focusing on the outcome), tenth session resilience (to review future application of learned strategies in times of emotional distress, plan for living a more enjoyable life, giving feedback on participation in group)
Vice-chancellor for research and technology, Hamedan University of Medical Sciences, in front of Mardom Park
City
Hamedan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0717
Email
bashirian@umsha.ac.ir
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
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
Hamedan University of Medical Sciences
Full name of responsible person
Latif Moradveisi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Farschian (Sina) Hospital, Mirzadeh Eshghi Avenue
City
Hamedan
Province
Hamadan
Postal code
6516848741
Phone
+98 81 3827 4184
Email
l.moradveisi@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Sara Sardashti
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Farschian Sina Hospital, Mirzadeh Eshghi Avenue
City
Hamedan
Province
Hamadan
Postal code
6516848741
Phone
0098138274184
Email
sarasardashti@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Sara Sardashti
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Farschian Sina Hospital, Mirzadeh Eshghi Avenue
City
Hamedan
Province
Hamadan
Postal code
6516848741
Phone
+98 81 3827 4184
Email
sarasardashti@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not 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
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
No - There is not a plan to make this available
Title and more details about the data/document
All acquired data can be shared after identifying information being omitted and it will be shared with the academic and research centers as well as the Ministry of Health and Education if necessary.
When the data will become available and for how long
Accessible in 6 months after publication of results
To whom data/document is available
Academic staff, health policy makers
Under which criteria data/document could be used
For assessment of usability in similar studies, for planning to improve health outcomes at community level
From where data/document is obtainable
Sara Sardashti, through email contact
What processes are involved for a request to access data/document
Assessment by the person in charge, confirmation by the principal investigator