Effectiveness of RSIT on the reduction of death distress in GAD outpatients
Design
A randomised, blinded, controlled clinical trial, outcome assessment, and followed for two months
Settings and conduct
Case finding by psychiatrist or an announcement in the clinic; selection of 60 outpatient patients with generalized anxiety disorder using available sampling and semi-structured interview; obtaining written consent, implementation of Death Anxiety ُScale, Death Obsession Scale, and Death Depression Scale; selection of 30 patients randomly among the patients who obtained the highest scores in the scales; training of two clinical psychologists with Msc degrees by the researcher alternately for implementing and scoring the scales; placement of selected patients randomly in two experimental and control groups, each group 15 patients;. re-evaluating participated patients in the treatment as well as the control group after the completion of the treatment, with the mentioned scales; and follow up patients after two months.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Outpatients; Generalized Anxiety Disorder's patients; and no receiving of treatment/training
Exclusion criteria: Chronic physical illness; primary diagnosis of other anxiety disorders; primary diagnosis of Major Depression Disorder; psychotic disorder;
drug dependence disorders
Intervention groups
Religious spiritual integrated therapy include relaxation, cognitive reconstruction, thought stopping, forgiveness, anxious behaviors stopping, behavioral activation, sleep health, problem solving along with religious spiritual methods in 8 sessions weekly. For control group no receiving treatment and being in waiting list.
Main outcome variables
Death anxiety; death obsession; death depression
General information
Reason for update
Acronym
RSIT
IRCT registration information
IRCT registration number:IRCT20180310039024N1
Registration date:2018-05-11, 1397/02/21
Registration timing:registered_while_recruiting
Last update:2018-05-11, 1397/02/21
Update count:0
Registration date
2018-05-11, 1397/02/21
Registrant information
Name
Mehrdad Kazemzadeh Atoofi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6655 1666
Email address
atoofi.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-19, 1397/01/30
Expected recruitment end date
2018-09-22, 1397/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of religious spiritual integrated therapy on the reduction of death distress in outpatients with generalized anxiety disorder
Public title
Effectiveness of religious spiritual integrated therapy on the reduction of death distress in outpatients with generalized anxiety disorder
Chronic physical illness
Primary diagnosis of other anxiety disorders
Primary diagnosis of Major depression Disorder
Psychotic disorder
Drug dependence disorders
No individually/group psychological treatment or training
Age
From 18 years old to 65 years old
Gender
Both
Phase
1
Groups that have been masked
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
In the first step, the simple randomization method is based on a random number table, and first to read of numbers their direction will be determined that in this study it will be on the right direction.
In the second step, the random allocation concealment will be done, which it will be used by envelops shuffling with random sequence through using of SNOSE method.
In the third stage, the random allocation process will be implemented and to prevent the bias, it will be included selection an individual who is separated from other researchers to develop a random program in order to reduce probable bias.
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher will be blind of the scores of patients on the scales in each of the two stages.
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
No. 1, Sattarkhan St., Mansouri Ave.,Tehran
City
Tehran
Province
Tehran
Postal code
1445613111
Approval date
2017-12-05, 1396/09/14
Ethics committee reference number
IR.IUMS.REC 1396.31073
Health conditions studied
1
Description of health condition studied
Generalized anxiety disorder
ICD-10 code
F41.1
ICD-10 code description
F41.1
Primary outcomes
1
Description
Death distress
Timepoint
Before of therapy, 2 weeks after of therapy, and 2 months after of therapy
Method of measurement
Death Anxiety Scale; Death Obsession Scale;, Death Depression Scale Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic at the School of Behavioral Sciences and Mental Health
Full name of responsible person
Dr.Jaafar Bolhari
Street address
No. 1,Mansouri Ave., Sattarkhan St., Tehrann
City
Tehran
Province
Tehran
Postal code
1445613111
Phone
+98 21 6655 1666
Email
bolharij@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Kazem Malakouti
Street address
No. sattarkhan St., Mansouri Ave., Tehran
City
Tehran
Province
Tehran
Postal code
1445613111
Phone
+98 21 8670 2503
Email
malakouti@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Merdad Kazemzadeh Atoofi
Position
Deputy of School, Clinical Psychologist
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 1, Sattarkhan St., Mansouri Ave., Tehran
City
Tehran
Province
Tehran
Postal code
1445613111
Phone
+98 21 6655 1666
Email
atoofi.m@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mahboubeh Dadfar
Position
Clinical psychologist
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No. 1, Sattarkhan St., Mansouri Ave., Tehran
City
Tehran
Province
Tehran
Postal code
1445613111
Phone
+98 21 6655 1666
Email
mahboubehdadfar@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mahboubeh Dadfar
Position
Clinical psychologist
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No. 1, Sattarkhan St., Mansouri Ave., Tehran
City
Tehran
Province
Tehran
Postal code
1445613111
Phone
+98 21 6655 1666
Email
mahboubehdadfar@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Using of future studies by researchers
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not 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
Only part of data related to main consequence will be available.
When the data will become available and for how long
6 months after publishing of the results
To whom data/document is available
Academic and scientific researchres
Under which criteria data/document could be used
Study citation
From where data/document is obtainable
Mehrdad Kazemzadeh Atoofi
What processes are involved for a request to access data/document