Investigating the Effect of Behavioral Activation Training on Suicidal Ideation and Rumination in patients referred to the Emergency ward of a Psychiatric Hospital
Determination the Effect of Behavioral Activation Training on Suicidal Ideation and Rumination in patients referred to the Emergency ward of a Psychiatric Hospital
Design
Clinical trial with control group, Randomized, with parallel groups, unblinded, on 92 patients. The rand function of Excel software will be used for randomization.
Settings and conduct
By referring to 505 AJA Hospital, two intervention and control groups are randomly selected from among the referring patients who meet the conditions for entering the study, and blinding is not done.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Willing to participate in research, Ability to communicate, Going through an acute period of suicide. Exclusion criteria: Refusal to continue cooperation, Being less than 18 years old and over 60 years old, Alcohol and drugs use.
Intervention groups
Intervention group: For the intervention group, 8 sessions of 60-minute weekly Behavioral Activation Training will be conducted face-to-face for two months. Control group: will receive only the usual training.
Main outcome variables
Suicidal Ideation, Rumination
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231129060225N1
Registration date:2024-07-08, 1403/04/18
Registration timing:registered_while_recruiting
Last update:2024-07-08, 1403/04/18
Update count:0
Registration date
2024-07-08, 1403/04/18
Registrant information
Name
maryam askari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2293 3734
Email address
maryamaskari999@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2024-09-22, 1403/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effect of Behavioral Activation Training on Suicidal Ideation and Rumination in patients referred to the Emergency ward of a Psychiatric Hospital
Public title
Investigating the Effect of Behavioral Activation Training on Suicidal Ideation and Rumination
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Willing to participate in research
Ability to communicate
Going through an acute period of suicide
Exclusion criteria:
Age less than 18 and more than 60 years
Alcohol and drug use
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method will initially be convenience; The samples will then be placed in quadruple blocks by block random sampling. The blockage is usually used to balance the number of samples allocated to each of the studied groups. This feature helps researchers to equalize the number of samples allocated to each of the studied groups in cases where intermediate analyzes are required during the sampling process. All blocks are the same size, and in this two-group experiment, we will have 4 blocks (including 2 participants in the intervention group and 3 participants in the control group). Random allocation software is also used to randomize random sequence production software (Random allocation software). To conceal, we use Allocation concealment, which refers to the method used to perform a random sequence on study participants, so that the assigned group is not identified before the individual is assigned. Using non-transparent envelopes sealed with random sequences (Sequentially numbered, sealed, opaque envelopes). They are placed in order. In order to maintain the random sequence, numbering is done on the outer surface of the envelopes in the same way. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants in the study, one of the envelopes of the letter will be opened in order and the assigned group of the participant will be revealed.
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
Ethics committee of Artesh University of Medical Sciences
Street address
Shahid Etemadzadeh Street, West Fatemi Street, Tehran
City
Tehran
Province
Tehran
Postal code
1411718541
Approval date
2024-01-28, 1402/11/08
Ethics committee reference number
IR.AJAUMS.REC.1402.200
Health conditions studied
1
Description of health condition studied
Suicide
ICD-10 code
Z91.5
ICD-10 code description
Personal history of self-harm
Primary outcomes
1
Description
Suicidal Ideation
Timepoint
Before and one month after the intervention
Method of measurement
Beck Scale for Suicide Ideation (BSSI)
2
Description
Rumination
Timepoint
Before and one month after the intervention
Method of measurement
Nolen-Hoeksema & Morrow Rumination Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For the Intervention group, 8 sessions of 60-minute weekly behavioral activation training will be carried out face-to-face for two months using the social problem solving method of D'Zurilla & Goldfried include: Getting to know the framework of meetings, emotions and feelings, strengthening coping skills, focusing on the five senses, planning, fluidity of thoughts, healthy lifestyle, achievement of activities, efficient dealing with problems and controlling behavior.
Category
Rehabilitation
2
Description
Control group: will receive only the usual training
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
505 Aja Hospital
Full name of responsible person
Dr. Vahid Donyavi
Street address
ُُThe end of Shahid Mozhdi Boulevard (Oshan), Artesh Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1956944141
Phone
+98 21 2293 3734
Email
info@scanteb.com
Web page address
https://bima505.ajaums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Dr. Reza Mosaed
Street address
Shahid Etemad Zadeh Street, West Fatemi Street, Tehran
City
Tehran
Province
Tehran
Postal code
1698615848
Phone
+98 21 2293 3734
Email
maryamaskari999@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh 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
Artesh University of Medical Sciences
Full name of responsible person
Maryam Askari
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Etemad Zadeh Street, West Fatemi Street, Tehran
City
Tehran
Province
Tehran
Postal code
1698615848
Phone
+98 21 7750 0929
Email
maryamaskri999@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Maryam Askari
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Etemadzadeh Street, Fatemi West Street, Tehran
City
Tehran
Province
Tehran
Postal code
1698615848
Phone
+98 21 7750 0929
Email
maryamaskari999@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Maryam Askari
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Etemadzadeh Street, Fatemi West Street,Tehran
City
Tehran
Province
Tehran
Postal code
1698615848
Phone
+98 21 7750 0929
Email
maryamaskari999@gmail.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
There is no further information.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available