Protocol summary

Study aim
the effectiveness of mindfulness-based training on loneliness, psychological well-being, and spiritual experiences of female heads of households covered by welfare in Rasht city.
Design
Population, Sample and Sampling Method The statistical population of the study consists of all female heads of households covered by the Rasht City Welfare Organization in [1404]. The sample size was determined based on statistical power analysis and considering a confidence level of 95 and a test power of 80, 40 people (20 people in the experimental group and 20 people in the control group). After completing the demographic questionnaire and obtaining informed consent, eligible participants were randomly assigned to two experimental groups and Controls will be replaced.
Settings and conduct
, mindfulness training is defined as a standard intervention package. This package consists of 8 90-minute training sessions held weekly for the experimental group. The content of these sessions is designed based on validated protocols such as mindfulness-based stress reduction or mindfulness-based cognitive therapy and includes exercises such as breathing meditation, body scanning, and mindfulness in daily activities. The success of participants in this intervention is measured by their attendance and active participation in the sessions.
Participants/Inclusion and exclusion criteria
Willingness to participate in research,No drug or alcohol addiction,Absence of specific mental and physical problem،Literacy up to diploma,Age 20 to 50years
Intervention groups
The experimental group will undergo a mindfulness-based training program in 8 90-minute sessions (one session per week).
Main outcome variables
Feelings of loneliness; psychological well-being; spiritual experiences

General information

Reason for update
Acronym
AMK
IRCT registration information
IRCT registration number: IRCT20251210068278N1
Registration date: 2026-06-02, 1405/03/12
Registration timing: registered_while_recruiting

Last update: 2026-06-02, 1405/03/12
Update count: 0
Registration date
2026-06-02, 1405/03/12
Registrant information
Name
Fatemeh Kamrani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 912 396 5279
Email address
fatemekam123@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-05-29, 1405/03/08
Expected recruitment end date
2026-06-21, 1405/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of mindfulness training on loneliness, psychological well-being, and spiritual experiences of women-headed households
Public title
Investigating the effect of mindfulness training on feelings of loneliness, psychological well-being, and spiritual experiences
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in research No drug or alcohol addiction Absence of specific mental and physical problems Age 20 to 50 years Age 20 to 50 years
Exclusion criteria:
UnWillingness to participate in research Having and addiction Having a severe physical or mental problem Age over 60 Illiterate
Age
From 20 years old to 60 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Due to the lack of access to the entire community, they will be selected based on the willingness of individuals and the conditions of participation in the research using the convenience method. Convenience sampling is a method that can select the most accessible individuals for the study. Since it is not possible to have access to the entire community of female head of household, convenience sampling will be used to facilitate the work and be accessible to the community of female head of household of Rasht Welfare. After that, individuals will be selected for the experimental and control groups using a simple random method. Each of them will be given special codes and using a random number table (equal chances), 20 people will be placed in the experimental group and another 20 in the control group.
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
Ethics committee of Tonekabon Azad University of Medical Sciences
Street address
Maskanmehr
City
Rasht
Province
Guilan
Postal code
4196955385
Approval date
2026-05-23, 1405/03/02
Ethics committee reference number
IR.IAU.TON.REC.1405.019

Health conditions studied

1

Description of health condition studied
focuses on the psycho-social vulnerability of female-headed households."
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Loneliness is an unpleasant subjective psychological experience arising from an individual's perception of a discrepancy between their desired and actual social relationships (Russell et al., 1984).
Timepoint
The research design is a quasi-experimental pretest-posttest design with a control group. The experimental group will participate in an 8-session mindfulness-based training program, consisting of one 90-minute session per week.
Method of measurement
In this study, loneliness is measured by the total score obtained from the Russell, Peplau, and Cortona Loneliness Scale (20-item version). The scores achieved by each participant on this scale serve as the operational indicator of their level of loneliness, with higher scores indicating a greater degree of loneliness.

2

Description
Psychological well-being extends beyond mere happiness or the absence of mental illness. Based on Carol Ryff's (1989) theory, this concept refers to positive functioning and personal growth across six key dimensions: autonomy, environmental mastery, personal growth, positive relations with others, purpose in life, and self-acceptance. This perspective links mental health to the continuous development and realization of an individual's potential.
Timepoint
The research design is a quasi-experimental pretest-posttest design with a control group. The experimental group will participate in an 8-session mindfulness-based training program, consisting of one 90-minute session per week.
Method of measurement
In this study, psychological well-being is measured using the total score and subscale scores from the Ryff Scales of Psychological Well-being (18-item short form). The scores achieved by each participant on this scale serve as the operational indicator of their level of psychological well-being, with higher scores indicating a greater degree of well-being."

3

Description
Spiritual experiences refer to personal subjective and emotional experiences, which include a sense of connection to something greater than oneself (such as God, nature, or the universe), finding meaning and purpose in life, and experiencing feelings of awe, peace, and oneness (Andrewood & Tracy, 2002).
Timepoint
The research design is a quasi-experimental pretest-posttest design with a control group. The experimental group will participate in an 8-session mindfulness-based training program, consisting of one 90-minute session per week.
Method of measurement
In this study, spiritual experiences are measured by the total score obtained from the Daily Spiritual Experience Scale (DSE) by Andrewood and Tracy (16-item version). The score achieved by each participant on this scale serves as the operational indicator of the extent and frequency of their spiritual experiences. Higher scores indicate more frequent and intense spiritual experiences.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Intervention group: The experimental group will undergo a mindfulness-based training program based on the book Attention Awareness Workbook by John Teasdale, Mark Williams, and Zindel Segal, translated by Dr. Anousheh Aminzadeh, in 8 90-minute sessions (one session per week). In these sessions, the main mindfulness techniques will be taught by Fatemeh Kamrani. The control group will not receive any psychological intervention during this time period.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
بهزیستی کل استان گیلان
Full name of responsible person
Fatemeh Kamrani
Street address
Maskanmehr
City
Rasht
Province
Guilan
Postal code
۴۱۹۶۹۵۵۳۸۵
Phone
+98 21 2232 8397
Email
fatemekam@gmail.com
Web page address
http://fatemehkamrani.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Masoud Qane
Street address
Maskanmehr
City
Rasht
Province
Guilan
Postal code
۴۱۹۶۹۵۵۳۸۵
Phone
+98 21 2232 8397
Email
fatemekam123@gmail.com
Web page address
http://fatemehkamrani.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Welfare of Gilan Province
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
Fatemeh Kamrani
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Maskanmehr
City
Rasht
Province
Guilan
Postal code
۴۱۹۶۹۵۵۳۸۵
Phone
+98 912 396 5279
Email
fatemekam123@gmail.com
Web page address
http://fatemehkamrani.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fatemeh kamrani
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Maskanmehr
City
Rasht
Province
Guilan
Postal code
۴۱۹۶۹۵۵۳۸۵
Phone
+98 21 2232 8397
Email
fatemekam123@gmail.com
Web page address
http://fatemehkamrani.ir/

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fatemeh Kamrani
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Maskanmehr
City
Rasht
Province
Guilan
Postal code
۴۱۹۶۹۵۵۳۸۵
Phone
+98 21 2232 8398
Email
fatemekam123@gmail.com
Web page address
http://fatemehkamrani.ir/

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
The participants are female heads of households covered by the Welfare Department, and permission to publish the participants has not been granted by the Welfare Department or the participating individuals.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
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