Determining the effectiveness of reality therapy on distress tolerance and rumination about loss in students with emotional breakdown
Design
A randomized, placebo-controlled clinical trial on 30 female students with emotional breakdown. Simple randomization was used for randomization.
Settings and conduct
This study is being conducted at Semnan Branch of Islamic Azad University and involves students with emotional breakdown. Participants are randomly divided into two groups: the experimental group that receives the reality therapy intervention and the control group that only follows their routine programs and usual care.
Participants/Inclusion and exclusion criteria
Inclusion criteria: experiencing emotional breakdown in the past three months, age between 18 and 35 years, high scores on rumination and distress tolerance measures, and willingness and commitment to participate in all treatment intervention sessions. Exclusion criteria: having severe psychiatric disorders, taking effective psychiatric medications, and experiencing severe stressful events in the past three months.
Intervention groups
In this study, the intervention group will undergo reality therapy intervention. This intervention will be held in 5 120-minute sessions, held weekly. The content of the sessions is designed based on the principles and techniques of reality therapy. The control group will not receive any specific therapeutic intervention and will only receive usual and standard care, which includes general counseling services or other standard services available.
Main outcome variables
Tolerating turmoil, ruminating about loss
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250106064293N1
Registration date:2025-01-27, 1403/11/08
Registration timing:prospective
Last update:2025-01-27, 1403/11/08
Update count:0
Registration date
2025-01-27, 1403/11/08
Registrant information
Name
Delara Doustmohammadi
Name of organization / entity
Islamic Azad University, Semnan Branch
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4040
Email address
jb.delara2000@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-02-14, 1403/11/26
Expected recruitment end date
2025-03-16, 1403/12/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of reality therapy on distress tolerance and rumination about loss in students with emotional breakdown
Public title
The effect of reality therapy on distress tolerance and rumination about loss in students with emotional breakdown
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Experience of emotional breakdown in the past three months based on student self-report.
Age between 18 and 35 years.
Obtaining high scores on rumination and disturbance tolerance assessment tools (based on the specified cutoff point).
Willingness and commitment to participate in all therapeutic intervention sessions.
No use of other psychological or psychiatric treatments during the research period.
Exclusion criteria:
Having severe psychiatric disorders such as bipolar disorder or schizophrenia (based on medical diagnosis history).
Taking psychiatric medications that may affect tolerance to agitation or rumination.
Experiencing other severe stressful events in the past three months (such as the loss of a loved one, a serious accident, or job loss).
The presence of any acute or chronic physical conditions that may prevent effective participation in intervention sessions.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a simple randomization method was used to randomize participants. After selecting 30 people as a sample, each participant was randomly assigned to one of two intervention groups (real therapy) or control group. For this purpose, the numbers 1 to 30 were assigned to the participants and, using a random number table or random number generation software, the numbers corresponding to each participant were selected and assigned to one of the two groups. Randomization was performed individually, meaning that each participant was independently assigned to the intervention or control group. This method ensures that there is no bias in the assignment of individuals to the groups and that each person has an equal chance of being placed in each of the groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Semnan Azad University
Street address
Islamic Azad University, University Town, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3513137111
Approval date
2024-12-30, 1403/10/10
Ethics committee reference number
IR.IAU.SEMNAN.REC.1403.097
Health conditions studied
1
Description of health condition studied
Emotional Breakdown
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Distress Tolerance
Timepoint
Before the start of the intervention and after completing 5 intervention sessions
Method of measurement
Simons and Gahr's Distress Tolerance Questionnaire (2005)
2
Description
Rumination about loss
Timepoint
Before the start of the intervention and after completing 5 intervention sessions
Method of measurement
Rumination Questionnaire Eisma et al (2014)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The experimental group will undergo a reality therapy intervention, which will be held in 5 120-minute sessions in a month. This intervention is designed to increase tolerance for distress and reduce rumination about loss caused by emotional breakdown. Initially, the feelings caused by loss and emotional breakdown are identified and accepted, and clients are introduced to the importance of the realities in life and their personal responsibilities. Then, reality therapy techniques are taught, including making changes in attitudes and beliefs, encouraging focus on present and future decisions, and strengthening a sense of meaning in life. In the next stages, clients will learn skills to manage and reduce rumination and mental turmoil through cognitive and behavioral strategies. Finally, the changes are consolidated and exercises to maintain the gains and prevent a return to previous patterns are made available to clients.
Category
Treatment - Other
2
Description
Control group: This group will not receive any treatment related to the study and will serve as a benchmark for comparison with the experimental group. Members of this group will simply follow the routine programs and standard care that they would normally receive. No program or intervention related to reality therapy will be provided to this group during the study. The goal is to keep the control group conditions unchanged so that the effects of the reality therapy intervention on distress tolerance and rumination can be accurately and reliably examined.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Islamic Azad University, Semnan Branch
Full name of responsible person
Maryam Heydari
Street address
Islamic Azad University, University Town, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3513137111
Phone
+98 23 3365 4045
Email
Haydari86_maryam@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University, Semnan Branch
Full name of responsible person
Shahab Moradi
Street address
Islamic Azad University, University Town, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3513137111
Phone
+98 23 3365 4040
Email
shahabmoradi66@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University, Semnan Branch
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, Semnan Branch
Full name of responsible person
Delara Doustmohammadi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 6, Unit 1, Mozhgan Alley, Homayoun Alley, South Dibaji St, Dolat St.
City
Tehran
Province
Tehran
Postal code
1959976191
Phone
+98 23 3365 4040
Email
Jb.delara2000@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University, Semnan Branch
Full name of responsible person
Sakineh Izadi Mazidi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Islamic Azad University, Semnan branch
City
Semnan
Province
Semnan
Postal code
3513137111
Phone
+98 23 3365 4040
Email
Maryam.izadi.psy@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University, Semnan Branch
Full name of responsible person
Delara Doustmohammadi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 6, Unit 1, Mozhgan Alley, Homayoun Alley, South Dibaji St, Dolat St.
City
Tehran
Province
Tehran
Postal code
1959976191
Phone
+98 23 3365 4040
Email
Jb.delara2000@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
Demographic data and the main outcome results of the research can be shared after de-identification and preserving the privacy of individuals.
When the data will become available and for how long
The data will be available one month after the results are published and after personally identifiable information has been removed.
To whom data/document is available
Research data and documentation will be available to researchers and scholars working in reputable academic and scientific institutions. In addition, researchers working in industry related to the research topic can also apply to receive data and documentation.
Under which criteria data/document could be used
For the purpose of studying or conducting research, citing the source.
From where data/document is obtainable
If you need data, please contact Jb.delara2000@gmail.com.
What processes are involved for a request to access data/document
After receiving the request and reviewing it by the principal investigator, the data will be sent to the applicant within a maximum of one week, along with a commitment not to publish the data without the name of the principal investigator.