Determining the effect of safety planning intervention in preventing repeated suicide attempts in type 1 bipolar patients.
Design
Clinical trial with control group or parallel group, double blind, randomized on 96 patients
Settings and conduct
Place: Shahid Beheshti Hospital, Kerman, patients in two control groups (without training) and intervention group (receiving training in 6 areas including: 1) detection of warning signs of an imminent suicide crisis
2) Using internal coping strategies
3) Using social contacts and social situations as a means to divert from suicidal thoughts
4) Using family members or friends to help resolve the crisis
5) Contact mental health professionals or agencies
6) Eliminating or limiting access to deadly devices in patients' environments)
Participants/Inclusion and exclusion criteria
Inclusion: confirm the diagnosis of bipolar disorder type 1 based on DSM 5 criteria
Age range from 18 to 60 years
Written consent to participate in the study
Exclusion:: treatment with ECT (Electroconvulsive therapy) in the last 2 months
Moderate to severe mental retardation
Patients with a known history of dementia and are being treated
Existence of a type 1 bipolar disorder, such as anxiety disorders, obsessive-compulsive disorder
Intervention groups
Control group: patients with type 1 bipolar disorder who were admitted to the hospital after attempting suicide and did not receive any training.
Intervention group: patients with type 1 bipolar disorder who were admitted to the hospital following a suicide attempt and receive training in 6 areas.
Main outcome variables
Suicide
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240621062199N1
Registration date:2024-08-05, 1403/05/15
Registration timing:registered_while_recruiting
Last update:2024-08-05, 1403/05/15
Update count:0
Registration date
2024-08-05, 1403/05/15
Registrant information
Name
Parichehr Golkar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3211 1398
Email address
parichehrgolkar1990@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-22, 1403/05/01
Expected recruitment end date
2025-03-19, 1403/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the safety planning intervention in preventing repeated suicide attempts in type 1 bipolar patients
Public title
Investigating the intervention of educational planning in the prevention of repeated suicide attempts in bipolar patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Confirming the diagnosis of bipolar disorder type 1 based on DSM 5 criteria
Age range from 18 to 60 years
Written consent to participate in the study
Exclusion criteria:
Treatment with ECT (Electroconvulsive therapy) in the last 2 months
Moderate to severe mental retardation
Patients with a known history of dementia and are being treated
Existence of a type 1 bipolar disorder, such as anxiety disorders, obsessive-compulsive disorder
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Using permuted block randomization, patients are divided into two control and intervention groups. Randomization using the block method
It is done as 24 blocks of four (two control patients and two intervention patients). The individual randomization unit is done using a table of random numbers (produced online) in order to hide the training-non-training allocation, the lists are placed in sealed and numbered envelopes (to preserve the order of the sequence). When an eligible patient is introduced, the next envelope is opened and the patient is assigned to the intervention or control group based on the information in the envelope.
Blinding (investigator's opinion)
Double blinded
Blinding description
At the time of follow-up, patients are only evaluated based on the code assigned to the patient and the registered contact number, and the follow-up person is not aware that the patient was in the intervention or control group, nor is the data analyst aware of the type of grouping.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Afzalipour Hospital - Kerman University of Medical sciences
Street address
Clinical Research Development Unit, Afzalipour Hospital, Kerman University of Medical Sciences, Kerman, Iran
City
kerman
Province
Kerman
Postal code
7616913911
Approval date
2024-05-06, 1403/02/17
Ethics committee reference number
IR.KMU.AH.REC.1403.025
Health conditions studied
1
Description of health condition studied
Bipolar disorder
ICD-10 code
F31
ICD-10 code description
Bipolar disorder
Primary outcomes
1
Description
Suicide
Timepoint
3 and 6 months after discharge
Method of measurement
Interview
Secondary outcomes
1
Description
Manic intensity
Timepoint
At the beginning of the study, 3 and 6 months after discharge
Method of measurement
Mania Young Questionnaire
2
Description
Depression score
Timepoint
At the beginning of the study, 3 and 6 months after discharge
Method of measurement
Beck depression questionnaire
3
Description
Sleep quality score
Timepoint
At the beginning of the study, 3 and 6 months after discharge
Method of measurement
Pittsburgh Sleep Quality Questionnaire
4
Description
Drug compliance
Timepoint
3 and 6 months after discharge
Method of measurement
Interview
Intervention groups
1
Description
Control group: patients with type 1 bipolar disorder who were admitted to the hospital after attempting suicide and did not receive any training.
Category
N/A
2
Description
Intervention group: patients with type 1 bipolar disorder who were admitted to the hospital following a suicide attempt and receive training in 6 areas(1) Recognizing the warning signs of an impending suicidal crisis, which can be described as red flags for patients. 2) Using internal coping strategies. During this stage, patients list coping strategies that they can use without contact with another person. These strategies should serve to keep patients' minds away from the suicidal crisis. 3) Using social contacts and social situations as a means of diversion from suicidal thoughts 4) Using family members or friends to help resolve the crisis. At this stage, a person who can be informed of the crisis and the need for help is contacted. 5) contact mental health professionals or agencies. Patients are encouraged to list their professional, therapist or psychiatrist and emergency resources. 6) Eliminating or limiting access to lethal devices in patients' environments).
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
At the end of the study, a part of the information including the investigation of safety planning intervention in the prevention of repeated suicide attempts in type 1 bipolar patients after deidentifying people, will be shared with those interested in the field of health and treatment. .
When the data will become available and for how long
6 months to a year after the statistical analysis of the data
To whom data/document is available
Researchers in the field of medical and health
Under which criteria data/document could be used
In order to use the results and during the written request
From where data/document is obtainable
Abdolreza Sabahi- Email (abdsaba@kmu.ac.ir)
What processes are involved for a request to access data/document
The purpose of accessing and using the data is to request an email to the author, a second email in case of no response as a reminder, confirmation of the requester's identity by the general respondent, sending the documentation file.