This is a randomized controlled trial. The aim of the trial was to assess the efficacy of combination of behavioural activation and drug treatment therapies in depressed inpatients. For this purpose we compared three intervention groups including: Behavioral activation group receiving behavioral activation + drug treatment; Movie group participating in sessions to watch movies instead of behavioural activation to neutralize the therapist’s effect + drug treatment; and Control group with no behavioral intervention receiving only drug treatment. 24 depressed inpatients were recruited. Inclusion criteria: Minimum guidance school education (total educational years of at least 8 years), age between 20 and 50, diagnosis of depression. Exclusion criteria: Having the features of psychosis, be a candidate for electroconvulsive therapy, having suicidal thoughts. Level of depression was assessed before and after intervention in each patient. The measurements were repeated 2 month after intervention as well. The Beck Depression inventory was used to measure depression. The results were compared in the three groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201009184770N1
Registration date:2010-11-08, 1389/08/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-11-08, 1389/08/17
Registrant information
Name
Samad Fereidooni
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 0218
Email address
fearidonys@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2010-04-21, 1389/02/01
Expected recruitment end date
2010-06-22, 1389/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of combination of behavioural activation and drug treatment therapies in depressed inpatients
Public title
The efficacy of combination of behavioural activation and drug treatment therapies in depressed inpatients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Minimum guidance school education (total educational years of at least 8 years), age between 20 and 50, diagnosis of depression.
Exclusion criteria: Having the features of psychosis, be a candidate for electroconvulsive therapy, having suicidal thoughts.
Age
From 20 years old to 50 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
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
IUMS- Tehran Psychiatric Institute
Street address
Tehran Psychiatric Institute
City
Tehran
Postal code
1443813444
Approval date
2010-03-10, 1388/12/19
Ethics committee reference number
312آ
Health conditions studied
1
Description of health condition studied
Depression
ICD-10 code
F32
ICD-10 code description
Depressive episode
Primary outcomes
1
Description
Depression
Timepoint
pre test, post test, 2 month follow up
Method of measurement
Beck Depression Inventory-II
Secondary outcomes
empty
Intervention groups
1
Description
Behavioral intervention group: N=8, they received 7 sessions of behavioral activation each lasting 90 minutes over a 4 weeks period and their standard drug treatment
Category
Behavior
2
Description
Movie watching group: N=8, they received 7 sessions of watching movies the same as the behavioral intervention group to neutralize the therapist’s effect over a 4 weeks period plus their standard drug treatment
Category
Behavior
3
Description
Control group with no behavioral intervention: N=8 the received only the standard drug treatment
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz Psychiatric Hospital
Full name of responsible person
Samad Fereidooni (post graduate student)
Street address
Shiraz Psychiatric Hospital
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of medical science
Full name of responsible person
Dr Abbas Motavallian, Vice Chancellor for research
Street address
Iran University of medical science - Tehran Psychiatric Institute
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Iran University of medical science
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
Shiraz Psychiatric Hospital
Full name of responsible person
Samad Fereidooni
Position
post graduate student
Other areas of specialty/work
Street address
Shiraz Psychiatric Hospital
City
Shiraz
Postal code
7144193355
Phone
+98 71 1647 0218
Fax
Email
PSYSAMAD@GMAIL.COM
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran Psychiatric institute
Full name of responsible person
Samad Fereidooni and Banafsheh Gharaei
Position
post graduate student, psychological doctorate
Other areas of specialty/work
Street address
Tehran Psychiatric institute
City
Tehran
Postal code
1443813444
Phone
+98 21 6655 1668
Fax
Email
psysamad@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
SAMAD FEREIDOONI
Position
post graduate student in clinical psychology
Other areas of specialty/work
Street address
Shiraz Psychiatric hospital
City
Shiraz
Postal code
7144193355
Phone
+98 71 1647 0218
Fax
Email
fearidonys@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)