Determining the Effectiveness of the Self-Working Package Educational-Therapeutic Program on Quality of Life, Psychological Flexibility, and Psychological Well-Being of Students at Khatam Al-Nabia University of Technology, Behbahan
Design
This pilot phase randomized clinical trial with a control group employed a parallel-group design and was conducted without blinding (open-label) on 30 participants. Randomization was performed using the RV.UNIFORM function within the Compute Variable command of SPSS software, and participants were equally allocated into the intervention and control groups.
Settings and conduct
Following the initial sampling and a structured clinical interview conducted by a psychologist to ensure the absence of personality disorders, individuals who completed the informed consent form to participate in this phase of the study were randomly assigned to two groups and received treatment by a clinical psychologist. All participants were assessed both before and after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Willingness to participate in the study, minimum age of 19 years. Exclusion Criteria: Diagnosis of personality disorders.
Intervention groups
In the present study, the Self-Working Package educational-therapeutic program will be implemented in a way that participants will attend two two-hour therapeutic sessions per week. Before the main therapy sessions, an introductory session will be held to explain the study, establish rapport, conduct the pre-test (administering assessments), collect information, and introduce the Self-Working educational-therapeutic model.
Main outcome variables
Quality of Life; Psychological Flexibility; Psychological Well-Being
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250228064878N1
Registration date:2025-08-04, 1404/05/13
Registration timing:prospective
Last update:2025-08-04, 1404/05/13
Update count:0
Registration date
2025-08-04, 1404/05/13
Registrant information
Name
Saeed Ranginkaman
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 5282 4455
Email address
saeed.ranginkaman@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-08-23, 1404/06/01
Expected recruitment end date
2025-09-22, 1404/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Self-Working Package on Quality of Life, Psychological Flexibility, and Psychological Well-Being among University Students
Public title
The Effectiveness of Self-Working Package on Quality of Life, Psychological Flexibility, and Psychological Well-Being
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having tendency to participate in research
Exclusion criteria:
Having a personality disorder
Age
From 19 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The statistical population of the present study consists of all students enrolled at Khatam Al-Anbia University of Technology in Behbahan. From this population, a total of 30 participants will be selected through a multi-stage cluster random sampling method. In the first stage, one faculty will be randomly selected, followed by the random selection of one class from that faculty. To ensure random assignment of participants into experimental and control groups, a list of all students in the selected class will be prepared and entered into SPSS software. Using the Compute Variable function and the formula RV.UNIFORM(0,1), a new variable will be generated for each participant, assigning a random value between 0 and 1. The data will then be sorted based on these random values, and participants will be assigned sequentially into two equal groups—15 in the experimental group and 15 in the control group. This procedure guarantees that each participant has an equal probability of being placed in either group, thereby ensuring unbiased group allocation.
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
Research Ethics Committee of Islamic Azad University - Ahvaz Branch
Street address
Islamic Azad University of Ahvaz, Farhangshahr, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
۶۱۳۴۹۳۷۳۳۳
Approval date
2025-07-21, 1404/04/30
Ethics committee reference number
IR.IAU.AHVAZ.REC.1404.202
Health conditions studied
1
Description of health condition studied
Quality of Life, Psychological Flexibility, and Psychological Well-Being
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Quality of life is defined as an individual’s perception of their position in life within the context of the culture and value systems in which they live, and in relation to their goals, expectations, standards, and concerns. This concept encompasses multiple dimensions, including physical health, psychological state, level of independence, social relationships, personal beliefs, and the individual’s relationship with salient features of their environment (World Health Organization, 1997).
Timepoint
At the beginning of the study (prior to the intervention) and after the completion of the intervention (14 weeks after its initiation).
Method of measurement
In this study, the scores obtained by the participants are derived from the short form of the World Health Organization Quality of Life questionnaire (WHOQOL-BREF, 1998).
2
Description
Psychological flexibility is defined as an individual’s ability to modify or shift from ineffective thoughts to more effective ones. This construct comprises three components: the ability to consider multiple alternative perspectives on life events and human behaviors, a willingness to interpret difficult situations as manageable, and the ability to generate multiple alternative solutions to challenging situations (Dennis & Vander Wal, 2010).
Timepoint
At the beginning of the study (prior to the intervention) and after the completion of the intervention (14 weeks after its initiation).
Method of measurement
In this study, the scores are obtained by the participants from the Cognitive Flexibility Inventory (CFI).
3
Description
Psychological well-being is defined as a positive state of mental health, characterized by having a positive attitude toward oneself and others, a sense of purpose and meaning in life, satisfying and positive relationships, a sense of autonomy, environmental mastery, and personal growth. This concept was developed by Ryff (1989) as an indicator for assessing psychological health and individual functioning across various domains of life.
Timepoint
At the beginning of the study (prior to the intervention) and after the completion of the intervention (14 weeks after its initiation).
Method of measurement
In this study, the scores are obtained by the participants from the short form of the Ryff Psychological Well-Being Scale.
Secondary outcomes
empty
Intervention groups
1
Description
Control group: No intervention is provided. They only complete the pre-test and post-test simultaneously with the experimental group.
Category
Lifestyle
2
Description
Intervention group: They will receive the Self-Working Package therapeutic training program for 14 weeks, with two 2-hour sessions held each week. Additionally, before the main sessions, a single session will be conducted to establish rapport and explain the Self-Working therapeutic training model.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Khadem al-Anbia University of Technology
Full name of responsible person
Saeed Ranginkaman
Street address
Beginning of Bandar Deylam Rd., Khadem al-Anbia University of Technology
City
behbahan
Province
Khouzestan
Postal code
6361663973
Phone
+98 61 5272 1230
Email
info@bkatu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Pejman Taghipour Birgani
Street address
Farhangshahr, Islamic Azad University, Ahvaz Branch
City
Ahwaz
Province
Khouzestan
Postal code
6134937333
Phone
+98 61 3334 8324
Email
info@iauahvaz.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
Saeed Ranginkaman
Position
Master's
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 4, Shahid Farazmand St.
City
Behbahan
Province
Khouzestan
Postal code
6361747254
Phone
+98 61 5282 4455
Fax
Email
saeed.ranginkaman@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Reza Joharifard
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Islamic Azad University of Ahvaz, Farhangshahr, Golestan Blvd.
City
Ahwaz
Province
Khouzestan
Postal code
6134937333
Phone
+98 61 3334 8420
Fax
+98 61 3332 9200
Email
rjoharifard@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Saeed Ranginkaman
Position
Master's Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 4, Shahid Farazmand St.
City
Behbahan
Province
Khouzestan
Postal code
6361747254
Phone
+98 61 5282 4455
Email
saeed.ranginkaman@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
Ensuring the maximum confidentiality of the information of individuals involved in the research.
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
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The data, in the form of participants' scores on pre- and post-treatment evaluations for both groups, will be presented in an Excel file where the individuals' identifiers are anonymized.
When the data will become available and for how long
The access period will begin 6 months after the publication of the results and will be available for one year.
To whom data/document is available
The information is available for specialists, researchers, and therapists in the fields of psychology, psychiatry, and cognitive sciences.
Under which criteria data/document could be used
Researchers in the field of mental health with the following conditions:
A written request with an explanation regarding the purpose of the research. Assurance of data confidentiality and non-disclosure. Data will not be used for writing scientific research articles or participating in scientific conferences.