The effectiveness of mindfulness training based on stress reduction on quality of life and mental well-being in students with generalized anxiety disorder
The main aim of this study is to determine the effectiveness of mindfulness training based on stress reduction on quality of life and mental well-being in students with generalized anxiety disorder.
Design
Clinical trial with control group with parallel groups, no blinding. Non-random assignment to intervention and control groups with a sample size of 40 people.
Settings and conduct
The MBSR training sessions will be held at the Islamic Azad University, Tonekabon Branch. This training will be an eight-week course, with one session per week, and the duration of each session will be 30 to 45 minutes. The fixed order of each session will include reviewing the homework assignments from the previous session, feedback on resolving existing questions and problems, teaching the intended materials and techniques, meditation skills, discussing stress and coping methods, and assigning homework.
Participants/Inclusion and exclusion criteria
Entry criteria: All individuals who are currently studying in the nursing field at the Islamic Azad University, Tonekabon Branch, at the undergraduate level.
Those who achieve the quorum score on the Spitzer et al. Generalized Anxiety Disorder Test.
Written consent to participate in the study.
Exclusion criteria: No psychiatric medication in the past 6 months until the time of the study
No psychotherapy in the past 6 months until the time of the study
No consent to participate in the study
Intervention groups
The intervention group consists of students with generalized anxiety disorder who receive a mindfulness-based stress reduction intervention. The comparison group consists of students with generalized anxiety disorder who receive no intervention.
Main outcome variables
Mental well-being, quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250827067020N1
Registration date:2025-10-06, 1404/07/14
Registration timing:prospective
Last update:2025-10-06, 1404/07/14
Update count:0
Registration date
2025-10-06, 1404/07/14
Registrant information
Name
MOBINA SADEGHIFAR
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 5422 7267
Email address
mobina.sadeghifarr@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-10-07, 1404/07/15
Expected recruitment end date
2025-12-06, 1404/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of mindfulness training based on stress reduction on quality of life and mental well-being in students with generalized anxiety disorder
Public title
The effectiveness of mindfulness training based on stress reduction on quality of life and mental well-being
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All individuals are studying at the undergraduate level in the nursing department of Islamic Azad University, Tonekabon Branch.
Those who achieve a quorum score on the Spitzer et al. Generalized Anxiety Disorder Test.
Written consent to participate in the study
Exclusion criteria:
No psychiatric medication in the past 6 months up to the time of the study
Not receiving psychotherapy in the past 6 months up to the time of the study
Refusal to participate in the study
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Ethtics Committee of Islamic Azad University-Tonekabon Branch
Street address
5 kilometers to Tonekabon City - Vali Abad, Tonekabon, Mazandaran, Iran
City
Tonekabon
Province
Mazandaran
Postal code
4684761167
Approval date
2025-07-22, 1404/04/31
Ethics committee reference number
IR.IAU.TON.REC.1404.123
Health conditions studied
1
Description of health condition studied
Generalized anxiety disorder
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
Anxiety score on the Spitzer et al. Generalized Anxiety Disorder Questionnaire
Timepoint
Anxiety score was measured using the Spitzer et al. Generalized Anxiety Disorder Questionnaire at the beginning of the study and before the start of the mindfulness-based stress reduction intervention.
Method of measurement
Spitzer et al. General Anxiety Inventory
Secondary outcomes
1
Description
Quality of life score
Timepoint
At the beginning and before the intervention begins and at the end after the intervention ends
Method of measurement
Short Form Quality of Life Questionnaire 36-question, SF-36
2
Description
Mental well-being score
Timepoint
At the beginning and before the intervention begins and at the end after the intervention ends
Method of measurement
Keyes and Magyarmo's Subjective Well-Being Questionnaire(sws)
Intervention groups
1
Description
Mindfulness-based stress reduction is a group program developed by Jon Kabat-Zinn in the 1970s to treat patients struggling with life problems and physical or mental illnesses. Mindfulness-based stress reduction is an 8-week training program that uses formal and informal mindfulness exercises. The standard order of each session will include a review of homework from the previous session, feedback on resolving existing questions and problems, teaching the intended content and techniques, meditation skills, discussing stress and coping methods, and assigning homework. The content presented during the 8 sessions will include the following: introduction to mindfulness training, training and doing exercises related to the state of mindfulness exercises, practicing paying attention to breathing, doing body scan exercises, doing sitting meditation, doing yoga movements, practicing mindful eating, practicing mindful walking meditation, and creating a personal mindfulness plan. Participants are asked to do mindfulness exercises for 45 minutes daily as homework. Number of treatment sessions: 8 sessions, 30 to 60 minutes, once a week, treatment is done individually.
Category
Lifestyle
2
Description
Control group: will not receive any intervention until the research project is fully completed.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Islamic Azad University, Tonekabon Mazandaran Branch
Full name of responsible person
MOBINA SDEGHIFAR
Street address
5 kilometers to Tonekabon City - Vali Abad
City
TONEKABON
Province
Mazandaran
Postal code
4684161167
Phone
+98 11 5427 1105
Email
mobina.sadeghifarr@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
KHADIJEH HATAMIPOUR
Street address
5 kilometers to Tonekabon City - Vali Abad
City
TONEKABON
Province
Mazandaran
Postal code
4684161167
Phone
+98 11 5427 1105
Email
mobina.sadeghifarr@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Results, tables and treatment protocol
When the data will become available and for how long
6 months after results are published
To whom data/document is available
Applicants from qualified individuals (general practitioners, medical specialists, psychiatrists, psychologists)
Under which criteria data/document could be used
The use of the documentation of this trial will only be possible for academic and scientific researchers on a limited basis and with permission from the person responsible for this trial.
From where data/document is obtainable
Correspondence via email address mobina.sadeghifarr@gmail.com
What processes are involved for a request to access data/document
Any request for access to data or documentation from this study must be made by sending a formal written request to the principal investigator or supervisor. This request must include the applicant's details, the purpose of using the data, the type of data required, and how to ensure the confidentiality of the information. After receiving the request, the following will be reviewed: Verification of the applicant's scientific identity and organizational affiliation Evaluation of the research purpose and its alignment with the ethical principles of the study Final approval by the principal investigator and, if necessary, the university ethics committee If approved, the data will be provided to the applicant in an anonymized and limited to the requested items, in a scientifically usable format. Use of the data is permitted only with acknowledgement of the source and observance of the confidentiality of the participants' information.