Our purpose in this study is comparing two treatment approaches, behavioral activation and treatment as usual. 80 patients, age 18 to 70 year old in Kurdistan province is randomly selected into two equal groups. The first group will receive Sertraline 25 mg daily for the first week, 50 mg for the second and third weeks, 75 mg for the fourth and fifth weeks and 100 mg for the sixth week and until the end of the treatment. The second group will receive 16 session behavioral activation for the three months. The success of the depression treatment and the rate of relapse after one year of treatment will be compared to each other.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138807192573N1
Registration date:2010-01-16, 1388/10/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-01-16, 1388/10/26
Registrant information
Name
Latif Moradveisi
Name of organization / entity
Maastricht University, the Netherlands-Medical University of Kurdistan
Country
Iran (Islamic Republic of)
Phone
+98 87 1728 7047
Email address
latif.moradveisi@maastrichtuniversity.nl
Recruitment status
Recruitment complete
Funding source
Medical University of Kurdistan and Maastricht University.
Expected recruitment start date
2009-10-22, 1388/07/30
Expected recruitment end date
2010-09-14, 1389/06/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Randomized Controlled Trial of Behavioral Activation and Treatment As Usual in the Acute Treatments of Adults with Major Depressive Disorder.
Public title
A Randomized Controlled Trial of Behavioral Activation and Treatment As Usual in the Acute Treatments of Adults with Major Depressive Disorder.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : diagnosis of major depression according to the SCID-I, severity above 19 on the BDI and 13 on the HRSD, age 18-70, written consent to participate with the study.
Exclusion criteria : if they have a life time diagnosis of bipolar disorder, organic brain syndrome, psychosis or mental retardation. Additional exclusion criteria are: substantial and imminent suicide risk; a current (e.g., within the past six months) or primary diagnosis of alcohol or drug abuse or dependence or a positive toxicology screen; a primary diagnosis of panic disorder, obsessive-compulsive disorder, psychogenic pain disorder, anorexia, or bulimia. In addition, participants who did not respond favorably within the preceeding year to medication will be excluded. Participants who have unstable medical condition and using any medication that would complicate the administration of antidepressant medication (medication in my study), or have a known allergy to medication in this study will be excluded. Moreover, women who are pregnant or maybe want to be pregnant will be excluded. Lastly, participants have to able to read and understand the questionnaires and interviews used in the study.
Age
From 18 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Committee of Medical Ethics, Second Session
Street address
Medical University of Kurdistan,Ghods Hospital, Ghods Avenue, Pasdaran Street, Sanandaj. Kurdistan. Iran
City
Sanandaj
Postal code
Approval date
empty
Ethics committee reference number
پ 14 پ 8017
Health conditions studied
1
Description of health condition studied
Major Depressive Disorder
ICD-10 code
F32
ICD-10 code description
Depressive episode
Primary outcomes
1
Description
Treatment of major depressive disorder
Timepoint
Before intervention, in the middle of Intervention (45 days after starting treatment) and after treament ( after 3 months treatment duration).).
Method of measurement
In BA, by BDI-II and In TAU, HRSD is used.
Secondary outcomes
1
Description
Prevention and relapse of major depressive disorder
Timepoint
One year after termination of the treatment
Method of measurement
In BA, by BDI-II and In TAU, HRSD is used.
Intervention groups
1
Description
In behavioral activation group, 16 sessions of BA treatment, for the first month every week two sessions 50 minutes and for the second and third months of the treatment, every week one session will be held.
Category
Behavior
2
Description
Sertraline 25 mg daily for the first week, 50 mg for the second and third weeks, 75 mg for the fourth and fifth weeks and 100 mg for the sixth week and until the end of the treatment.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghods Hospital
Full name of responsible person
Latif Moradveisi
Street address
Sanandaj
City
Sanandaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Medical university of Kurdistan and Maastricht University
Full name of responsible person
Mohamadzadeh and Gharibi- Reserach center
Street address
Sanandaj- Medical University of Kurdistan
City
sanandaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Medical university of Kurdistan and Maastricht University
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Maastricht University
Full name of responsible person
Latif Moradveisi
Position
PhD student.
Other areas of specialty/work
Street address
Sanandaj
City
Sanandaj
Postal code
Phone
+98 918 784 8047
Fax
Email
latif.moradveisi@maastrichtuniversity.nl
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Medical University of Kurdistan And Maastricht University
Full name of responsible person
Latif Moradveisi
Position
PhD Student
Other areas of specialty/work
Street address
Sanandaj, Medical University of Kurdistan
City
Sanandaj
Postal code
Phone
+98 87 1728 7047
Fax
Email
lmoradveisi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Maastricht University and Medical University of Kurdistan
Full name of responsible person
Latif Moradveisi
Position
PhD student
Other areas of specialty/work
Street address
Sanandaj, Medical University of Kurdistan
City
Sanandaj
Postal code
Phone
+98 87 1728 7047
Fax
lmoradveisi@gmail.com
Email
lmoradveisi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)