Protocol summary

Study aim
Determining the effectiveness of dialectical behavior therapy on intolerance of uncertainty, resilience, and irrational beliefs in students with anxiety symptoms
Design
Clinical trial in two experimental and control groups, unblinded, phase on 30 students, simple randomization using a random number table such that people with even numbers are placed in the experimental group and people with odd numbers are placed in the control group.
Settings and conduct
The experimental group will undergo dialectical behavior therapy intervention, which will be held in the form of 8 45-minute sessions, twice a week at Ferdows Azad University; during this period, the control group did not receive any intervention. Blinding was not performed in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having conditions such as mental health and not taking medication and being between the ages of 20 and 50. Exclusion criteria: Individuals whose questionnaire score is less than 26. Absence of more than two sessions during the intervention process under investigation.
Intervention groups
After the initial analysis of the questionnaires, 30 students who obtained the highest sports scores were randomly divided into two experimental and control groups (15 students in each group). First, a pre-test was taken from both groups. Then, the group underwent a dialectical behavior therapy intervention test, which was held in the form of 8 45-minute sessions, twice a week. During this period, the control group did not receive any intervention. Finally, a post-test was administered to both groups and analyzed using SPSS 23 software.
Main outcome variables
Irrational Beliefs (dependent variable) Intolerance of Uncertainty (dependent variable) Resilience (dependent variable)

General information

Reason for update
Acronym
DBT (dialectical behavior therapy)
IRCT registration information
IRCT registration number: IRCT20250702066332N1
Registration date: 2025-09-28, 1404/07/06
Registration timing: prospective

Last update: 2025-09-28, 1404/07/06
Update count: 0
Registration date
2025-09-28, 1404/07/06
Registrant information
Name
Faezeh Imaninezhad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 1746 3273
Email address
faezehimani33@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-10-07, 1404/07/15
Expected recruitment end date
2026-01-05, 1404/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of dialectical behavior therapy on intolerance of uncertainty, resilience and irrational beliefs of students with anxiety
Public title
The effect of a psychological therapy method on reducing stress and enhancing coping with problems in students
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having conditions such as mental health and not taking medication Being between the ages of 20 and 50
Exclusion criteria:
People whose questionnaire score is less than 26. Absence of more than two sessions during the intervention process under investigation
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Using simple random sampling, questionnaires were distributed based on the list of students' names, and the first 30 were randomly divided into two experimental and control groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee, Islamic Azad University of Birjand
Street address
Islamic Azad University, Birjand Branch, Ayatollah Ghaffari Street, Birjand
City
Birjand
Province
South Khorasan
Postal code
9717811111
Approval date
2025-04-15, 1404/01/26
Ethics committee reference number
IR.IAU.BIRJAND.REC.1404.018

Health conditions studied

1

Description of health condition studied
Reducing uncertainty, increasing resilience, and correcting irrational beliefs
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Intolerance of uncertainty
Timepoint
After 8 sessions held twice a week, an intervention evaluation is conducted.
Method of measurement
Uncertainty Tolerance Questionnaire - Anxiety Questionnaire

2

Description
Resilience
Timepoint
After 8 sessions held twice a week, an intervention evaluation is conducted.
Method of measurement
Resilience Questionnaire _ Anxiety Questionnaire

3

Description
Irrational beliefs
Timepoint
After 8 sessions held twice a week, an intervention evaluation is conducted.
Method of measurement
Irrational Belief Questionnaire _ Anxiety Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: First, a pre-test was administered to both groups. Then, the experimental group underwent dialectical behavior therapy intervention, which was held in the form of 8 45-minute sessions, twice a week; during this period, the control group did not receive any intervention. Finally, a post-test was administered to both groups and the resulting data were analyzed using SPSS 23 software.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Ferdows Azad University
Full name of responsible person
faezeh imani nezhad
Street address
Ferdows Azad University, Homafaran Street, Ferdows
City
Ferdows
Province
South Khorasan
Postal code
9771848664
Phone
+98 56 3272 4901
Email
info@ferdowsiau.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Masoumeh Ebrahimi
Street address
Ferdows Azad University, Homafaran Street, Ferdows
City
Ferdows
Province
South Khorasan
Postal code
9771848664
Phone
+98 56 3272 4901
Email
info@ferdowsiau.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
faezeh imaninezhad
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Corner of Shohada 4, Riab Village, Gonabad
City
Gonabad
Province
Razavi Khorasan
Postal code
9691196025
Phone
+98 51 5746 3273
Email
faezehimani33@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Masoumeh Ebrahimi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Ferdows Azad University, Homafaran Street, Ferdows
City
Ferdows
Province
South Khorasan
Postal code
9771848664
Phone
+98 56 3272 4901
Email
mebrahimi1354@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
faezeh imaninezhad
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Corner of Shohada 4, Riab Village, Gonabad
City
Gonabad
Province
Razavi Khorasan
Postal code
9691196025
Phone
+98 51 5746 3273
Email
faezehimani33@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
اطلاعات بیشتری وجود ندارد
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
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
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