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The Effectiveness of Body-Oriented Mentalization-Based Therapy on Quality of Life, Worry, Body Awareness, and Psychological Distress in Patients with Asthma

Protocol summary

Study aim
To determine the effectiveness of body-oriented mentalization-based treatment on quality of life, worry, body awareness, and psychological distress in patients with asthma.
Design
A quasi-experimental study with a control group, pre-test, post-test, and three-month follow-up design will be conducted on 36 patients randomly allocated to two parallel groups using computer-based randomization. No blinding will be applied.
Settings and conduct
The study will be conducted in healthcare centers in Isfahan, Iran. A total of 36 participants will be recruited through convenience sampling and randomly assigned to intervention and control groups (18 per group). The intervention group will receive a 12-session Body-Oriented Mentalization program, while the control group will receive no intervention. Both groups will complete pre- and post-intervention assessments. No blinding will be applied.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Confirmed asthma diagnosis, age over 18, basic literacy, willingness to participate, ability to attend sessions, and no concurrent psychological treatment. Exclusion Criteria: Development of a new significant chronic illness or a history of medical conditions requiring specific medications or dietary restrictions.
Intervention groups
Intervention Group: Participants will receive a 12-session body-oriented mentalization program focusing on bodily awareness, mindfulness, emotion regulation, attachment, interpersonal skills, personal boundaries, and social support, including experiential exercises and homework. Control Group: Participants in the control group will receive no intervention during the study period and will continue their usual care.
Main outcome variables
Quality of life, worry, body awareness, psychological distress.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20251129068145N10
Registration date: 2026-11-08, 1405/08/17
Registration timing: prospective

Last update: 2026-11-08, 1405/08/17
Update count: 0
Registration date
2026-11-08, 1405/08/17
Registrant information
Name
Mohammadreza Gorji Azghandi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3872 0567
Email address
gorji@article-lab.com
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2026-11-22, 1405/09/01
Expected recruitment end date
2027-01-21, 1405/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Body-Oriented Mentalization-Based Therapy on Quality of Life, Worry, Body Awareness, and Psychological Distress in Patients with Asthma
Public title
The Effectiveness of Body-Oriented Mentalization-Based Therapy on Quality of Life, Worry, Body Awareness, and Psychological Distress in Patients with Asthma
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmed diagnosis of asthma. Age over 18. Physical ability to attend the scheduled sessions. Willingness to participate in the study and provide written informed consent. Basic literacy (ability to read and write). Not receiving any other psychological treatment during the study.
Exclusion criteria:
Occurrence of a significant medical event during the study, such as the development of another chronic physical illness. History of physical conditions requiring specific medications or dietary regimens.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 36
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will initially be recruited using convenience sampling based on the study’s eligibility criteria. After obtaining informed consent and completing the baseline assessments, eligible participants will be randomly allocated to either the experimental group or the control group in a 1:1 ratio. The random allocation sequence will be generated using computer-based random number generation software to ensure an unpredictable assignment process. Each participant will be assigned a unique study identification number, and group allocation will be determined according to the pre-generated randomization sequence. This procedure will help minimize selection bias and ensure an unbiased allocation of participants to the study 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
Research Ethics Committee of Islamic Azad University- Najafaba Branch
Street address
Islamic Azad University, Najafabad Branch, University Boulevard, Najafabad, Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
۸۵۱۴۱۴۳۱۳۱
Approval date
2026-10-22, 1405/07/30
Ethics committee reference number
IR.IAU.NAJAFABAD.REC.1405.282

Health conditions studied

1

Description of health condition studied
Asthma
ICD-10 code
J45
ICD-10 code description
Asthma

Primary outcomes

1

Description
Quality of Life
Timepoint
Quality of life will be assessed at baseline (pre-intervention) and immediately after completion of the 12-session intervention (post-intervention).
Method of measurement
Quality of life will be assessed using the 26-item World Health Organization Quality of Life Questionnaire (WHOQOL-BREF). The questionnaire evaluates four domains: physical health, psychological health, social relationships, and environmental health. Responses are rated on a 5-point Likert scale. Items 3, 4, and 26 are reverse-scored. Domain scores are calculated according to the standardized scoring guidelines, with higher scores indicating better quality of life.

2

Description
Worry
Timepoint
Worry will be assessed at baseline (pre-intervention) and immediately after completion of the 12-session intervention (post-intervention).
Method of measurement
Worry will be assessed using the 16-item Penn State Worry Questionnaire (PSWQ). This self-report questionnaire measures the severity, frequency, and uncontrollability of excessive and persistent worry. Items are rated on a 5-point Likert scale, ranging from 1 (not at all typical of me) to 5 (very typical of me). Five items are reverse-scored, and total scores range from 16 to 80, with higher scores indicating greater levels of worry.

3

Description
Body Awareness
Timepoint
Body awareness will be assessed at baseline (pre-intervention) and immediately after completion of the 12-session intervention (post-intervention).
Method of measurement
Body awareness will be assessed using the 18-item Body Awareness Questionnaire (BAQ), developed by Shields et al. (1989). The questionnaire measures individuals' awareness of normal bodily processes, changes in bodily sensations, and physiological responses. Items are rated on a 9-point Likert scale, ranging from 1 (does not apply to me at all) to 9 (applies to me completely). The total score is calculated according to the instrument's scoring guidelines, with higher scores indicating greater body awareness.

4

Description
Psychological distress is defined as a general negative emotional state associated with symptoms of depression, anxiety, and stress.
Timepoint
Depression, anxiety, and stress will be assessed at baseline (pre-intervention) and immediately after completion of the 12-session intervention (post-intervention).
Method of measurement
Depression, anxiety, and stress will be assessed using the 21-item Depression, Anxiety, and Stress Scale (DASS-21), developed by Lovibond and Lovibond (1995). The questionnaire consists of three 7-item subscales measuring depression, anxiety, and stress. Items are rated on a 4-point Likert scale, ranging from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time). Subscale scores are calculated by summing the relevant items and multiplying the results by two, with higher scores indicating greater symptom severity.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Participants in the intervention group will take part in a 12-session body-oriented mentalization-based educational and therapeutic program. The sessions will focus on developing skills in bodily awareness, mindfulness, emotion recognition and regulation, identifying and understanding the window of tolerance, body-oriented mentalization, recognizing attachment patterns and interpersonal interaction styles, establishing personal boundaries, engaging in committed action, and effectively utilizing social support systems. Each session will include experiential exercises and homework assignments tailored to its specific content.
Category
Treatment - Other

2

Description
Control group: Participants in the control group will receive no intervention during the study period and will continue their usual care.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr. Ebrahim Abbasi Monjezi’s Private Practice
Full name of responsible person
Dr. Ebrahim Abbasi Monjezi
Street address
Shahid Mohammadi Alley, Next to Dr. Kazemi Pharmacy, Past Shahrdari Intersection, Najafabad, Isfahan Province, Iran.
City
Isfahan
Province
Isfehan
Postal code
8163713111
Phone
+98 937 048 7432
Email
eamonjezi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University, Najafabad Branch
Full name of responsible person
Dr. Iman Sadeghkhani
Street address
Islamic Azad University Najafabad Branch, Daneshgah Blvd., Najafabad, Isfahan Province.
City
Najafabad
Province
Isfehan
Postal code
8514143131
Phone
+98 31 4229 3086
Email
sadeghkhani@pel.iaun.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, Najafabad 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, Najafabad Branch
Full name of responsible person
Dr. Gholamreza Talebi
Position
َAssistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Islamic Azad University Najafabad Branch, Daneshgah Blvd., Najafabad, Isfahan Province.
City
Najafabad
Province
Isfehan
Postal code
8135866531
Phone
+98 31 3237 1841
Fax
Email
rezatalebi@iau.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University, Najafabad Branch
Full name of responsible person
Dr. Gholamreza Talebi
Position
َAssistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Islamic Azad University Najafabad Branch, Daneshgah Blvd., Najafabad, Isfahan Province.
City
Najafabad
Province
Isfehan
Postal code
8135866531
Phone
+98 31 3237 1841
Fax
Email
rezatalebi@iau.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University, Najafabad Branch
Full name of responsible person
Maryam Khadem
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Islamic Azad University Najafabad Branch, Daneshgah Blvd., Najafabad, Isfahan Province.
City
Najafabad
Province
Isfehan
Postal code
8135866531
Phone
+98 31 3666 0169
Fax
Email
1273441729@iau.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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
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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