This is a clinical trial study to elucidate the effect of the behavioral cognitive group therapy on the suicidal ideation and self esteem in patents that suffer from major depression. The study are established in Rajaei hospital in Yasouj city. Among all the hospitalized patients, 40 patients participate in this project and all are selected randomly. The volunteers arrange in control and experimental groups. In brief, inclusion criteria is depression score higher than 29 according to "Beck depression questionnaire" and exclusion criteria are no tendency in patient to participate in the study. After getting informed consent, data collection will establish by "Beck depression questionnaire". Moreover, the intervention in experimental group includes cognitive behavioral group therapy in 8 sessions. Both groups continue their drug therapy in all steps of study. The variables are: suicidal ideation and self-esteem.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016013026263N1
Registration date:2016-11-30, 1395/09/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-11-30, 1395/09/10
Registrant information
Name
Amin Haghgoo
Name of organization / entity
Yasouj University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 74 1333 7251
Email address
amin.haghgoo@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Yasouj University of Medical Sciences
Expected recruitment start date
2015-03-20, 1393/12/29
Expected recruitment end date
2015-11-01, 1394/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of cognitive behavior group therapy on suicidal ideation and self-esteem in patients with mojor depression
Public title
How does suicidal thoughts and self-esteem can affected by cognitive behavior group therapy in patients who suffer from major depression?
Purpose
Treatment
Inclusion/Exclusion criteria
The following are the criteria for inclusion to the study:
1- Patients who have been diagnosed with major depression by an expert specialist physician (psychiatrist) according to the DSM V criteria for major depression.
2- Patients who have Beck depression score higher than 29.
3- Patients who have Beck suicidal score higher than 4.
4- Before enrolling the patients into the clinical trial all of them have to consent to participate in this study. So, informed consent is collected according to guidelines from the fields of medical ethics and research ethics.
Also, the exclusion factors are listed below:
1- Patients who have been diagnosed with other psychiatric disorders by an expert specialist physician (psychiatrist).
2- Lack of tendency of the patients to continue participation in the study or moving to other clinics.
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Due to the sample size, random number table uses. So, patients who have odd numbers classified in the experimental (interventional) and who have even number classified in control group.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yasuj University of Medical Sciences
Street address
Yasuj University of Medical Sciences, No. 105, Blvd. Shahid Motahari, Yasouj, Iran
City
Yasuj
Postal code
7591741417
Approval date
2014-11-01, 1393/08/10
Ethics committee reference number
93080108
Health conditions studied
1
Description of health condition studied
Major Depression
ICD-10 code
F92.0
ICD-10 code description
Depressive conduct disorder
Primary outcomes
1
Description
Suicide ideation
Timepoint
Pre-intervention , One week after intervention , One month after intervention
Method of measurement
Beck suicide ideation questionaire
Secondary outcomes
1
Description
Self-esteem
Timepoint
Pre-intervention , One week after intervention , One month after intervention
Method of measurement
Rozenberg self-esteem questionaire
Intervention groups
1
Description
In experimental group beside the routine drug therapy that was prescribed by the relevant psychiatrist, the group therapy with a behavioral cognitive approach will establish by clinician or a clinical technician (a clinical psychologist or an expert nurse). In addition, this intervention includes 2 session per week for 4 continuous weeks. It should be noted that each session group therapy will be 90 minutes.
Category
Behavior
2
Description
The control group will continue to take their routine drugs that was prescribed by the relevant psychiatrist. So, unlike the experimental group there is no intervention for this group.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajai hospitals and health clinic of Shahid Mofateh