Protocol summary

Summary
(1) Objectives: The aim of this study is to examine the effect of spiritual and religious group psychotherapy on suicidal ideation in depressed patients. (2) Design: This research is an experimental study with “pre-test and post-test with control group” design. (3) Setting and conduct: The sample size of this study estimated 54 persons that randomly 27 persons in control group and 27 persons in experimental group allocated. Instruments for data gathering are Demographic Questionnaire, Beck Suicide Scale Ideation and Beck Depression Inventory. (4) Participants including major eligibility criteria: Patients with diagnosis of depression and suicidal thoughts; with age range 18 to 60 years old; have the ability to listen and sit in group therapy sessions; have the ability to respond to written questions; and are not in the acute phase of depression according to the diagnosis of psychiatrist. Exclusion Criteria including the Patients who discharge before the completion of group therapy sessions; have the Alcohol and Drug Dependency; and have Mental retardation. (5) Intervention: Firstly the pre-test will be done in both groups. The experimental group will attend 6 sessions of 90 minutes in group therapy. The control group will not receive any intervention in this duration. Finally the post-test will be done in both groups and the results of two groups will be compared with together. (6) The main outcome variable: Decreasing of suicidal ideation of depressed patients.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201206206834N4
Registration date: 2012-11-14, 1391/08/24
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-11-14, 1391/08/24
Registrant information
Name
Hossein Ebrahimi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1475 1709
Email address
ebrahimih@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2012-11-05, 1391/08/15
Expected recruitment end date
2013-02-03, 1391/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Spiritual and Religious group psychotherapy on suicidal ideation in depressed patients
Public title
The Effect of Spiritual and Religious group psychotherapy on suicidal ideation in depressed patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria including the Patients with diagnosis of depression and suicidal thoughts; with age range 18 to 60 years old; have the ability to listen and sit in group therapy sessions; have the ability to respond to written questions; are not in the acute phase of depression according to the diagnosis of psychiatrist. Exclusion Criteria including the Patients who discharge before the completion of group therapy sessions; have the Alcohol and Drug Dependency; and have Mental retardation.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 54
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences, Vice chancellor for research
Street address
Third floor, Central Building- No 2, Golgasht Street
City
Tabriz
Postal code
Approval date
2012-10-15, 1391/07/24
Ethics committee reference number
91121

Health conditions studied

1

Description of health condition studied
Affective disorder, Symptoms and signs involving emotional state
ICD-10 code
F31, F32,
ICD-10 code description
Depression, Suicidal ideation

Primary outcomes

1

Description
suicidal ideation
Timepoint
Before intervention and one week after finishing intervention
Method of measurement
Beck Scale for Suicidal Ideation (BSSI)

Secondary outcomes

1

Description
Depression
Timepoint
Before intervention and one week after finishing intervention
Method of measurement
Beck Depression Inventory

Intervention groups

1

Description
Intervention group: First, the pre-test will be done. Intervention group will receive 6 sessions group therapy. Then, the post-test will be done. Finally, the differences of pre-test and post-test are compared with each other.
Category
Prevention

2

Description
Control group: This group will not receive any intervention. The differences of pre-test and post-test are measured and are compared with each other.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi Psychiatric Hospital
Full name of responsible person
Dr Arash Mohaggegi
Street address
Tabriz Razi Psychiatric Hospital, Elgoli Boulevard
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Dr Kazem Shakouri
Street address
Third floor, No 2 Building of Tabriz University of Medical Sciences, Golgasht Ave
City
Tabriz
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, Tabriz University of Medical Sciences
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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Hossein Ebrahimi
Position
PhD in nursing
Other areas of specialty/work
Street address
Psychiatric Nursing Group, Tabriz Nursing and Midwifery Faculty, South Shariati Street
City
Tabriz
Postal code
Phone
+98 41 1479 0364
Fax
Email
Ebrahimih@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Raheleh Modabernaha
Position
MS in Psychiatric Nursing, Student
Other areas of specialty/work
Street address
Psychiatric Nursing Group, Tabriz Nursing and Midwifery Faculty, South Shariati Street
City
Tabriz
Postal code
Phone
+98 41 1479 0364
Fax
Email
R_modaber@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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