Comparing the effectiveness of pharmacotherapy and Mindfulness-integrated Cognitive Behavior Therapy (MiCBT) in suicidal adults following hospitalization
To compare the effectiveness of Mindfulness-integrated CBT versus medication in improving symptoms among suicide attempters.
Design
A randomized clinical trial with two parallel groups (intervention and control) was conducted on 30 participants using simple randomization (lottery method), the study was single-blinded, with the clinical evaluator being blinded to group assignments
Settings and conduct
The interventions will be conducted at the psychology clinic of Ghods Hospital in Sanandaj, Iran, and participants will not be required to pay any fees for the treatments received.
The groups will be evaluated at three stages. The collected data will be coded and provided to a statistical evaluator who will be blinded to the group assignments.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Willingness to participate in the study,
2- At least a basic literacy level (minimum early middle school education),
3- History of suicide attempts.
Exclusion criteria:
1- No psychotic symptoms or intellectual/cognitive impairment,
2- No substance or alcohol use disorders,
3- Not currently undergoing any other psychotherapy during this study
Intervention groups
The present study includes two groups.
The first group receives 8 sessions MiCBT.
Main outcome variables
Beck Scale for Suicidal Ideation
Depression, Anxiety and stress scale
Billings-and-Mouse-Coping-Strategies-Questionnaire
General information
Reason for update
Acronym
Mindfulness integrated CBT (MiCBT)
IRCT registration information
IRCT registration number:IRCT20220113053705N3
Registration date:2025-07-09, 1404/04/18
Registration timing:prospective
Last update:2025-07-09, 1404/04/18
Update count:0
Registration date
2025-07-09, 1404/04/18
Registrant information
Name
Fateh Sohrabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3371 8025
Email address
f.sohrabi20@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-07-23, 1404/05/01
Expected recruitment end date
2025-07-23, 1404/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of pharmacotherapy and Mindfulness-integrated Cognitive Behavior Therapy (MiCBT) in suicidal adults following hospitalization
Public title
Comparing the effectiveness of pharmacotherapy and Mindfulness-integrated Cognitive Behavior Therapy (MiCBT) on suicide
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Providing consent to participate in the study,
Having at least middle school literacy,
Having a history of suicide attempts,
Absence of psychotic symptoms or intellectual/cognitive impairment,
No substance or alcohol dependence or abuse,
Not participating in any other psychotherapy simultaneously with the current study
Exclusion criteria:
Withdrawal from the study,
Substance or alcohol dependence or abuse,
Diagnosis of psychotic disorders,
Intellectual or cognitive impairment before or during the study,
Suicide attempts, and the need for hospitalization
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
After selecting the participants, all of them will be randomly assigned to the control and intervention groups through a simple lottery method. To do this, each participant’s code will be written on identical cards, which will then be randomly drawn to allocate them to the two study groups. This way, all participants will have an equal chance of being placed in either group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The statistical evaluator of the results will be blinded to the group assignments and will not know which group is the intervention or control.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Kurdistan University of Medical Sciences
Street address
Kurdistan University of Medical Sciences., Pasdaran Ave.
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Approval date
2025-06-10, 1404/03/20
Ethics committee reference number
IR.MUK.REC.1404.090
Health conditions studied
1
Description of health condition studied
Suicide
ICD-10 code
T14.91
ICD-10 code description
Suicide attempt
Primary outcomes
1
Description
Suicide
Timepoint
Measurement of suicide before the start of the intervention (Pre-assessment), after the completion of the intervention (Post-assessment), and two months after the last intervention session (Follow-up).
Method of measurement
Beck Scale for Suicidal Ideation
2
Description
Depression, Anxiety and Stress
Timepoint
Measurement of Depression, Anxiety, and Stress before the start of the intervention (Pre-assessment), after the completion of the intervention (Post-assessment), and two months after the last intervention session (Follow-up).
Method of measurement
Depression, Anxiety and Stress scale
3
Description
Coping-Strategies
Timepoint
Measurement of Coping-Strategies before the start of the intervention (Pre-assessment), after the completion of the intervention (Post-assessment), and two months after the last intervention session (Follow-up).
Intervention group: This group will receive 8 to 10 psychotherapy sessions based on the mindfulness-integrated cognitive-behavioral therapy protocol.
Category
Treatment - Other
2
Description
Control group: The control group will continue only their pre-prescribed medication treatment and will not receive any specific psychotherapy concurrently.
Kurdistan University of Medical Sciences., Pasdaran Ave.
City
Sanandaj
Province
Kurdistan
Postal code
66177-13141
Phone
+98 87 3366 4653
Email
Research@muk.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj 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
Sanandaj University of Medical Sciences
Full name of responsible person
Dr Fateh Sohrabi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Clinical Psychology Branch., Faculty of Medicine., Kurdistan University of Medical Sciences., Pasdaran Ave.
City
Sanandaj
Province
Kurdistan
Postal code
66177-13141
Phone
+98 87 3366 4664
Email
F.sohrabi20@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Dr Fateh Sohrabi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Clinical Psychology Branch., Faculty of Medicine., Kurdistan University of Medical Sciences., Pasdaran Ave.
City
Sanandaj
Province
Kurdistan
Postal code
66177-13141
Phone
+98 87 3366 4664
Email
F.sohrabi20@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Dr Fateh Sohrabi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Clinical Psychology Branch., Faculty of Medicine., Kurdistan University of Medical Sciences., Pasdaran Ave.
City
Sanandaj
Province
Kurdistan
Postal code
66177-13141
Phone
+98 87 3366 4664
Email
F.sohrabi20@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
No - There is not a plan to make this available
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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Data related to the study will be provided in response to legitimate requests from the relevant organizations.
When the data will become available and for how long
6 month after publication of the related paper
To whom data/document is available
Academic researchers can access the data upon submitting a formal and justified request.
Under which criteria data/document could be used
The individual must have a verified identity and submit the request through an official or academic organization. They must accept responsibility for maintaining confidentiality and not disclosing the data without permission, in accordance with ethical principles.
From where data/document is obtainable
They can correspond via the following email to make a request: F.sohrabi20@gmail.com
What processes are involved for a request to access data/document
After receiving the email and reviewing it through official channels, the request will be responded to as soon as possible.