Investigating the effectiveness of mindfulness-based schema therapy on the level of suicidal ideation, self-criticism, self-disgust, and psychological inflexibility in individuals with suicidal ideation.
Determining the effectiveness of mindfulness-based schema therapy on the level of suicidal ideation, self-criticism, self-disgust, and psychological inflexibility in individuals with suicidal ideation.
Design
This is a randomized, single-blind, parallel-group controlled clinical trial (Phase ...) involving 50 patients. Randomization will be conducted using a table of random numbers.
Settings and conduct
The study will take place in counseling centers. It is a single-blind study where questionnaire data collection will be performed by a person other than the therapist. Mindfulness-based schema therapy will be implemented in the intervention group.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Individuals with suicidal ideation (score of 4-14 on the Beck Scale for Suicidal Ideation).
Age above 18 years and a maximum age of 50 years.
Having a minimum level of reading and writing literacy.
Having informed consent to participate in the research.
Having motivation and willingness to participate in the research.
Non-substance use.
Not having a plan to attempt suicide.
Exclusion Criteria:
Having a plan to attempt suicide.
Occurrence of a suicide attempt.
Need for any change in the treatment process.
Lack of willingness to cooperate.
Intervention groups
The intervention and control groups included individuals with suicidal ideation who scored between 4 and 14 on the Beck Scale for Suicidal Ideation.
Main outcome variables
This study investigates whether mindfulness-based schema therapy can reduce suicidal ideation, self-criticism, self-disgust, and psychological inflexibility in individuals with suicidal ideation. It is expected that scores for suicidal ideation, self-criticism, and self-disgust will decrease, while scores for psychological flexibility will increase.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250219064773N1
Registration date:2025-05-19, 1404/02/29
Registration timing:registered_while_recruiting
Last update:2025-05-19, 1404/02/29
Update count:0
Registration date
2025-05-19, 1404/02/29
Registrant information
Name
Yasaman Mogoie
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 919 522 7822
Email address
yasamanmogoieyas@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-04-09, 1404/01/20
Expected recruitment end date
2026-01-20, 1404/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of mindfulness-based schema therapy on the level of suicidal ideation, self-criticism, self-disgust, and psychological inflexibility in individuals with suicidal ideation.
Public title
Investigating the effectiveness of mindfulness-based schema therapy on the level of suicidal ideation, self-criticism, self-disgust, and psychological inflexibility in individuals with suicidal ideation.
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Individuals with suicidal ideation (score of 4-14 on the Beck Scale for Suicidal Ideation).
Having a minimum level of reading and writing literacy.
Having motivation and informed consent to participate in the research.
Non-substance use.
Not having a plan to attempt suicide.
Exclusion criteria:
Having a plan to attempt suicide.
Occurrence of a suicide attempt.
Need for a change in the treatment process.
Lack of willingness to cooperate.
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
groups: the experimental group (receiving mindfulness-based schema therapy) and the control group. Simple randomization using a table of random numbers was employed for group allocation. First, a list of eligible participants was prepared, and each individual was assigned a unique number. Then, starting from a randomly selected point in the random number table, the numbers were read sequentially. Based on whether the number was even or odd, participants were assigned to either the experimental group (even numbers) or the control group (odd numbers). This method was used to prevent allocation bias and to enhance the internal validity of the study.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kashan University of Medical Sciences.
Street address
Kashan University of Medical Sciences, Pezeshk Blvd, Qotb Ravandi Blvd, Kashan, Isfahan Province, Iran.
City
Kashan
Province
Isfehan
Postal code
8715973474
Approval date
2025-02-23, 1403/12/05
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1403.236
Health conditions studied
1
Description of health condition studied
Individuals with suicidal ideation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Mindfulness-based schema therapy has a positive effect on reducing the level of suicidal ideation in individuals with such thoughts.
Timepoint
Measurement will occur initially before the start of therapy sessions and immediately after the completion of therapy sessions.
Method of measurement
Suicidal Ideation: The Beck Scale for Suicidal Ideation (BSS) standard questionnaire will be used to assess the intensity and frequency of suicidal thoughts at pre-test and post-test.Self-Criticism: The Levels of Self-Criticism Scale (LOSC) standard questionnaire by Thompson and Zuroff will be used at pre-test and post-test.Self-Disgust: The Self-Disgust Scale-Revised (SDS-R) standard questionnaire by Powell et al. will be used at pre-test and post-test.Psychological Inflexibility: The Acceptance and Action Questionnaire-II (AAQ-II) standard questionnaire by Bond et al. will be used at pre-test and post-test.
Secondary outcomes
1
Description
Mindfulness-based schema therapy has a positive effect on reducing the level of suicidal ideation in individuals with such thoughts.
Timepoint
Pre-test: Before the start of the intervention. Post-test: After the completion of therapy sessions.
Method of measurement
suicidal Ideation: Measurement Tool: Beck Scale for Suicidal Ideation (BSSI)Method: Using the standard 19-item BSSI questionnaire to assess the intensity and frequency of suicidal thoughts at pre-test and post test. Self-Criticism: Measurement Tool: Levels of Self-Criticism Scale (LOSC) by Thompson and Zuroff (22 items)Method: Scoring the Levels of Self-Criticism Scale to measure the degree of self-criticism in participating individuals at pre-test and post-test. Psychological Inflexibility: Measurement Tool: Acceptance and Action Questionnaire-II (AAQ-II) by Bond et al. (10 items)Self-Disgust: Self-Disgust Scale-Revised (SDS-R) by Powell and colleagues... (The sentence is incomplete here.)
Intervention groups
1
Description
Intervention Group: The intervention group will receive 8 sessions of 90-minute mindfulness-based schema therapy based on the protocol presented by Michael van Vreeswijk and colleagues.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashan University of Medical Sciences
Full name of responsible person
yasaman mogoie
Street address
Kashan University of Medical Sciences, Pezeshk Blvd, Qotb Ravandi Blvd, Kashan, Isfahan Province, Iran.
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5510 9999
Email
yasamanmogoieyas@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Kashan University of Medical Sciences
Street address
Kashan University of Medical Sciences, Pezeshk Blvd, Qotb Ravandi Blvd, Kashan, Isfahan Province, Iran.
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5510 9999
Email
yasamanmogoieyas@gmailcom
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Dr. Zahra Zanjani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Kashan University of Medical Sciences, Pezeshk Blvd, Qotb Ravandi Blvd, Kashan, Isfahan Province, Iran.
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5510 9999
Email
z-zanjani2005@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Zahra Zanjani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Kashan University of Medical Sciences, Pezeshk Blvd, Qotb Ravandi Blvd, Kashan, Isfahan Province, Iran.
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5510 9999
Email
z-zanjani2005@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Zahra Zanjani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Kashan University of Medical Sciences, Pezeshk Blvd, Qotb Ravandi Blvd, Kashan, Isfahan Province, Iran.
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5510 9999
Email
z-zanjani2005@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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