The Comparison of the effects of positive psychotherapy in two ways, face-to-face and virtual reality, on the meaning of life, self-criticism and suicidal thoughts in hospitalized adolescents with suicidal thoughts.
Comparison of the effect of positive psychotherapy using virtual reality on the meaning of life, self-criticism and suicidal thoughts in adolescent patients with suicidal thoughts.
Design
A clinical trial with two-way blind parallel groups, where 111 patients will be placed in three intervention 1, intervention 2 and control groups by cluster randomization method. In this study, random allocation of departments in the hospital will be done by someone outside the study using randomization software
Settings and conduct
Patients with suicidal thoughts are admitted to neuropsychiatric hospitals in Shiraz. They are randomly placed into one of three groups: intervention group 1 receives virtual reality treatment, intervention group 2 receives in-person treatment, and the control group receives usual hospital treatments. Participants complete questionnaires before and after the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Willingness to participate in the study
Preparedness and favorable psychological conditions of the patient to participate in the intervention
Having suicidal thoughts based on the information in the patient's file
Exclusion criteria:
Refusal to continue participating in the study (during the study)
Occurrence of unexpected physical or mental problems during study
Inability to actively participate in the treatment process (for reasons such as slowness of thinking, slowness of speech, etc.)
Intervention groups
All patients with the entry criteria assigned to the two intervention groups will receive 4 sessions of positive psychotherapy through virtual reality and face-to-face, and the control group will receive the usual hospital treatment.
Main outcome variables
Suicidal ideation, meaning of life, self-criticism
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201001048893N9
Registration date:2023-10-07, 1402/07/15
Registration timing:prospective
Last update:2023-10-07, 1402/07/15
Update count:0
Registration date
2023-10-07, 1402/07/15
Registrant information
Name
Maryam Shaygan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3626 7345
Email address
m2620.shaygan@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-19, 1402/08/28
Expected recruitment end date
2024-09-21, 1403/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison of the effects of positive psychotherapy in two ways, face-to-face and virtual reality, on the meaning of life, self-criticism and suicidal thoughts in hospitalized adolescents with suicidal thoughts.
Public title
The Investigating the effect of positive psychotherapy in both face-to-face and virtual reality methods on the meaning of life, self-criticism and suicidal thoughts in hospitalized adolescents with suicidal thoughts.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study
Preparation and favorable psychological conditions of the patient to participate in the intervention (for example: absence of psychotic symptoms and aggression)
Having suicidal thoughts based on the information in the patient file and diagnostic interview screening questions (CIDI) by a senior psychiatric nursing student.
Exclusion criteria:
Opting out of continuing to participate in the study (during the study)
Occurrence of unexpected physical or mental problems during study
Inability to actively participate in the treatment process (for reasons such as slowness of thinking, slowness of speech, etc.)
Age
From 12 years old to 24 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
111
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, cluster controlled randomization method is used, where hospital departments (instead of individuals) will be considered as the randomization unit. In this study, random assignment of departments in the hospital will be done by someone outside the study using randomization software. In other words, the numbers of the sections will be entered into the randomization software, and this software will place the sections in one of the intervention or control groups completely randomly and by coding. The reason for choosing the cluster randomization method is to prevent and protect against data contamination that can occur in the randomization of people.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, in order to blind and prevent possible bias, interpretation of questionnaires and data entry and analysis will be done by someone outside the study. Also, the 28 clinical caregiver does not know how to assign people and the type of training of people. In order to prevent data contamination in this study, hospital departments will be randomized instead of individuals, and in fact, department numbers will be entered into the randomization software, and this software will be completely random and by coding the departments into one of two groups. control or intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in the Research of Nursing and Midwifery, Management and Medical Information-Shiraz
Street address
School of Nursing and Midwifery, Nemazee Square, Zand St., Shiraz, Iran
City
SHIRAZ
Province
Fars
Postal code
71936-13119
Approval date
2023-07-15, 1402/04/24
Ethics committee reference number
IR.SUMS.NUMIMG.REC.1402.066
Health conditions studied
1
Description of health condition studied
Suicidal ideation
ICD-10 code
R45.851
ICD-10 code description
Suicidal ideations
Primary outcomes
1
Description
Meaning in life
Timepoint
Before and immediately after the intervention
Method of measurement
Purpose in life questioner
Secondary outcomes
1
Description
Self-criticism
Timepoint
Before and immediately after the intervention
Method of measurement
Self-Criticism-Reassurance Scale
2
Description
Suicidal ideation
Timepoint
Before and immediately after the intervention
Method of measurement
Suicide cognitions questionnaire
Intervention groups
1
Description
Intervention group 1: receiving four sessions of positive psychotherapy through virtual reality including teaching positive psychotherapy modules such as forgiveness, kindness and gratitude. These trainings for the intervention group will be done by virtual reality glasses and software designed specifically for these glasses. By using these glasses, the patient will be placed in a 3D and virtual environment and will also hear the voice of the psychotherapist who communicates with him through the headset. The mentioned content will be broadcast to the patient four times a day and the patient will complete the questionnaires before and after the intervention.
Category
Other
2
Description
Intervention group: Receiving four sessions of positive psychotherapy including modules of kindness, gratitude and forgiveness in person and face to face. The patient will receive the mentioned trainings by the project partner, senior psychiatric nursing student, in person and in four sessions every other day. These patients will also complete the questionnaires before and after the end of the intervention.
Category
Other
3
Description
Control group: They will receive the usual hospital treatments for 4 sessions, every other day.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ebne Sina Hospital
Full name of responsible person
Sepideh Alipour
Street address
8th Street, Hafez street, Shiraz
City
Shiraz
Province
Fars
Postal code
14336 - 71348
Phone
+98 71 3228 9604
Email
sinahosp@sums.ac.ir
2
Recruitment center
Name of recruitment center
Hafez hospital
Full name of responsible person
Sepideh Alipour
Street address
Hafez educational and therapeutic center, Abiverdi beginning, Chamran street, Shiraz
City
Shiraz
Province
Fars
Postal code
7194634786
Phone
+98 71 3645 9531
Email
Hafez@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Roksana JanGHorban
Street address
Vice Chancellor for Research and Technology, Zand St.Central Building of Shiraz University of Medical Sciences, 7th floor,
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3212 2430
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Dr Maryam Shaygan
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
psychology
Street address
Community-based Psychiatric Care Research Center, 2nd Floor, Fatemeh PBUH School of Nursing and Midwifery, Building 3,Namazi Teaching Hospital, Namazi Square, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
13119–71936
Phone
+98 71 3647 4254
Email
m2620.shaygan@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Maryam Shaygan
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
psychology
Street address
Community-based Psychiatric Care Research Center, 2nd Floor, Building 3,Fatemeh PBUH School of Nursing and Midwifery, Namazi Teaching Hospital, Namazi Square, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71936-13119
Phone
+98 71 3367 4254
Email
m2620.shaygan@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Maryam Shaygan
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
psychology
Street address
Community-based Psychiatric Care Research Center, 2nd Floor, Fatemeh PBUH School of Nursing and Midwifery, Building 3,Namazi Teaching Hospital, Namazi Square, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71936-13119
Phone
+98 71 3367 4254
Email
m2620.shaygan@gmail.com
Sharing plan
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
Anonymous study data will be shared in correspondence with the project manager
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Systematic reviews and meta-analyses
From where data/document is obtainable
Contact via email: m2620.shaygan@gmail.com
What processes are involved for a request to access data/document
After obtaining permission from the security unit and the university's vice chancellor for research, the data will be made available to the individual.