Protocol summary

Study aim
Determining the effectiveness of attentional control training on the level of death anxiety, attentional bias towards death-related stimuli, and the level of sensitivity to mortality salience
Design
Clinical trial with control group and parallel groups, simply randomized
Settings and conduct
First we assign the participants who have all been selected from Shahid Beheshti University of Medical Sciences's students randomly to 3 groups (2 intervention groups and 1 control group). At pre-intervention stage, participants' death anxiety will be assessed using 1) death anxiety questionnaire 2) modified stroop test and 3) mortality salience. Then the participants in intervention groups will receive attentional control training. At post-intervention and 3-months follow-up, death anxiety will be assessed again, using the methods described above. The results at 3 stages will be compared to reveal the effects of intervention and their sustainability.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Having sufficient ability to use a computer Exclusion Critertia: Having difficult to cure or incurable physical illnesses; Having a traumatic experience in the past year; Encountering the death of an acquaintance in the past year; Having close people (or the responsibility to care for people) dealing with imminent death
Intervention groups
Intervention group 1: Receives attentional control training for death-related stimuli Intervention group 2: Receives attentional control training for negative stimuli unrelated to death Control group: Receives no intervention
Main outcome variables
Attention bias towards death-related stimuli; Level of death anxiety; Level of sensitivity to mortality salience

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190406043181N1
Registration date: 2020-01-03, 1398/10/13
Registration timing: retrospective

Last update: 2020-01-03, 1398/10/13
Update count: 0
Registration date
2020-01-03, 1398/10/13
Registrant information
Name
Saeed Nasiry
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3328 8724
Email address
snasiry@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2019-10-06, 1398/07/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Attentional Control Training on Attentional Bias Towards Death-Related Stimuli, the Level of Death anxiety, and the Level of Sensitivity to Mortality Salience
Public title
Effect of Attentional Control Training on Death Anxiety
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having sufficient ability to use a computer
Exclusion criteria:
Having difficult to cure or incurable physical illnesses Having a traumatic experience in the past year Encountering the death of an acquaintance in the past year Having close people (or the responsibility to care for people) dealing with imminent death
Age
From 18 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization in individual unit, using table of random numbers
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
Iran National Committee for Ethics in Biomedical Research
Street address
Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town
City
Tehran
Province
Tehran
Postal code
5486213654
Approval date
2019-08-27, 1398/06/05
Ethics committee reference number
IR.SBMU.MSP.REC.1398.539

Health conditions studied

1

Description of health condition studied
Death Anxiety
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Attentional bias towards death-related stimuli
Timepoint
Pre-intervention, post-intervention, 3-months follow-up
Method of measurement
Modified stroop test

2

Description
Level of death anxiety
Timepoint
Pre-intervention, post-intervention, 3-months follow-up
Method of measurement
Multidimensional fear of death scale

3

Description
Level of sensitivity to mortality salience
Timepoint
Pre-intervention, post-intervention, 3-months follow-up
Method of measurement
Moral disengagement scale after causing mortality salience through writing two sentences about one's death

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Receive the computerized attentional control training program for death-related stimuli in 4 sessions across 2 weeks. In each session of this program, the participants face a mixture of death-related images or words and neutral images or words, and practice to change their attention from death-related stimuli to neutral ones, and also from the content of each stimulus to the color of its background or border.
Category
Treatment - Other

2

Description
Intervention group: Receive the computerized attentional control training program for negative stimuli unrelated to death, in 4 session across 2 weeks. In each session of this program, the participants face a mixture of negative images or words unrelated to death, and neutral images or words, and practice to change their attention from negative stimuli to neutral ones, and also from the content of each stimulus to the color of its background or border.
Category
Treatment - Other

3

Description
Control group: Receive no intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Medical University
Full name of responsible person
Saeed Nasiry
Street address
Tehran, Evin, Arabi St.
City
Tehran
Province
Tehran
Postal code
8456623514
Phone
+98 21 4862 1543
Email
snresearch@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Saeed Nasiry
Street address
Tehran, Evin, Arabi St.
City
Tehran
Province
Tehran
Postal code
8456623514
Phone
+98 21 4862 1543
Email
snresearch@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Saeed Nasiry
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 2, Moghaddam De., South Ramin Ave., East Ferdows Blvd.
City
Tehran
Province
Tehran
Postal code
8456623514
Phone
+98 86 3328 8724
Fax
Email
snasiry@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Saeed Nasiry
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 2, Moghaddam De., South Ramin Ave., East Ferdows Blvd.
City
Tehran
Province
Tehran
Postal code
8456623514
Phone
+98 86 3328 8724
Fax
Email
snasiry@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Saeed Nasiry
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 2, Moghaddam De., South Ramin Ave., East Ferdows Blvd.
City
Tehran
Province
Tehran
Postal code
8456623514
Phone
+98 86 3328 8724
Fax
Email
snasiry@sbmu.ac.ir

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
No further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
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