Protocol summary

Study aim
To compare the effects of Mindfulness-Based Stress Reduction (MBSR) and Cognitive Behavioral Therapy (CBT) on work-related rumination, mental fatigue, experiential avoidance, and psychological symptoms (anxiety and depression) among nurses
Design
A phase III, randomized, controlled, parallel-group clinical trial involving 60 nurses. Randomization will be performed using the Sealed Envelope randomization website.
Settings and conduct
This study will be conducted among 60 nurses working in healthcare centers in Kashan in 2026. After screening and baseline assessment, participants will be randomly allocated to the MBSR, CBT, or control group. Following the interventions and post-intervention assessment, changes in work-related rumination, mental fatigue, experiential avoidance, and psychological symptoms will be compared across the three groups.
Participants/Inclusion and exclusion criteria
Holding at least a bachelor's degree in Nursing; Being between 22 and 50 years of age; Being employed at a hospital; Absence of acute or chronic physical disorders; Not participating in any other educational program concurrently; Scoring above 8 on the anxiety subscale or above 13 on the depression subscale of the DASS-21 questionnaire.
Intervention groups
1. Mindfulness-Based Stress Reduction (MBSR) group: Eight weekly 120-minute group sessions involving mindfulness exercises, meditation, acceptance of thoughts and emotions, and home practice. 2. Cognitive Behavioral Therapy (CBT) group: Weekly group sessions involving identification and modification of dysfunctional thoughts, coping skills training, problem-solving, and occupational stress management. 3. Control group: No structured psychological intervention during the study; participants will complete the research assessments.
Main outcome variables
Work-related rumination; mental fatigue; experiential avoidance; psychological symptoms.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20261004071288N1
Registration date: 2026-10-28, 1405/08/06
Registration timing: registered_while_recruiting

Last update: 2026-10-28, 1405/08/06
Update count: 0
Registration date
2026-10-28, 1405/08/06
Registrant information
Name
Zahra Sakeni
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5527 7126
Email address
sakeni-z@kaums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-10-23, 1405/08/01
Expected recruitment end date
2027-01-20, 1405/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparative Study of the Effects of Mindfulness-Based Stress Reduction (MBSR) and Cognitive Behavioral Therapy (CBT) on Work-Related Rumination, Mental Fatigue, Experiential Avoidance and Psychological Symptoms among Nurses
Public title
Comparison of the effects of mindfulness training and cognitive behavioral therapy on work-related rumination, mental fatigue, avoidance of unpleasant experiences, and psychological symptoms in nurses
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Holding at least a bachelor's degree in Nursing. Being between 22 and 50 years of age. Being employed at a hospital. Scoring above 8 on the anxiety subscale or above 13 on the depression subscale of the DASS-21 questionnaire.
Exclusion criteria:
Having acute or chronic physical disorders, including cancer and multiple sclerosis (MS) Having any hearing, speech, or visual impairment Concurrent participation in another educational program
Age
From 22 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
First, the first intervention group will be coded as A, the second intervention group as B, and the control group as C. Then, a randomization list will be generated using the website www.sealedenvelope.com/simple-randomiser/v1/lists, with a total sample size of 60 participants (three groups of 20 participants each) and a balanced block randomization method with a block size of six. Subsequently, the participants enrolled in the study will be assigned to one of the three groups according to the generated randomization list. For example, suppose the allocation sequence for the first block of six participants is CCABBA. Accordingly, the first and second participants will be assigned to group C, the third and sixth participants to group A, and the fourth and fifth participants to group B. This procedure will continue in the same manner until the final participant (the 60th participant) has been assigned to a group.
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 Committees of Islamic Azad University- Arak Branch
Street address
Amirkabir University Campus, 3rd km of Khomein Road, Imam Khomeini Blvd., Imam Khomeini Sq., Arak, Iran
City
Arak
Province
Markazi
Postal code
9131138361
Approval date
2026-09-27, 1405/07/05
Ethics committee reference number
IR.IAU.ARAK.REC.1405.224

Health conditions studied

1

Description of health condition studied
Work-related rumination
ICD-10 code
F00–F99
ICD-10 code description
Mental and behavioural disorders

2

Description of health condition studied
mental fatigue
ICD-10 code
F00–F99
ICD-10 code description
Mental and behavioural disorders

3

Description of health condition studied
experiential avoidance
ICD-10 code
F00–F99
ICD-10 code description
Mental and behavioural disorders

4

Description of health condition studied
psychological symptoms
ICD-10 code
F00–F99
ICD-10 code description
Mental and behavioural disorders

Primary outcomes

1

Description
Work-related rumination
Timepoint
Before the start of the study and immediately after the final intervention session
Method of measurement
15-item Work-Related Rumination Questionnaire (WRRQ)

2

Description
mental fatigue
Timepoint
Before the start of the study and immediately after the final intervention session
Method of measurement
20-item Multidimensional Fatigue Inventory (MFI)

3

Description
experiential avoidance
Timepoint
Before the start of the study and immediately after the final intervention session
Method of measurement
10-item Acceptance and Action Questionnaire–II (AAQ-II)

4

Description
psychological symptoms
Timepoint
Before the start of the study and immediately after the final intervention session
Method of measurement
21-item Depression, Anxiety and Stress Scale (DASS-21)

Secondary outcomes

empty

Intervention groups

1

Description
Mindfulness-Based Stress Reduction (MBSR): This intervention is based on the Kabat-Zinn (2013) protocol and consists of eight weekly group sessions, each lasting 90 minutes. Sessions include mindfulness education, practical exercises, group discussions, and home assignments. The content covers body scanning, sitting meditation, breathing awareness, mindful yoga, mindful eating and daily activities, observation and acceptance of thoughts and emotions, stress and anger management, interpersonal relationship improvement, and emotion regulation. At the end of the program, strategies for maintaining regular practice and setting short-term and long-term goals are introduced.
Category
Behavior

2

Description
Cognitive Behavioral Therapy (CBT): This intervention is based on the therapeutic framework of Wildermuth (2008) and consists of nine weekly group sessions, each lasting 60–90 minutes. The sessions cover group orientation, relaxation and stress management, identification and recording of automatic thoughts, identification and modification of dysfunctional thoughts and beliefs, cognitive restructuring, problem-solving and assertiveness training, activity scheduling, review of learned skills, and relapse prevention.
Category
Behavior

3

Description
Control group: They will not receive any structured psychological intervention as part of the study and will only participate in the research assessments.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti hospital
Full name of responsible person
Hamed Pahlavani
Street address
Qotb-e Ravandi Boulevard, Parastar Street, Shahid Beheshti hospital
City
Kashan
Province
Isfehan
Postal code
8715973447
Phone
+98 31 5500 9999
Email
beheshtihospital@kaums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University, Arak Branch
Full name of responsible person
Seyed Mohammad Mehdi Najafizadeh
Street address
Amirkabir University Campus, Km 3 Khomein Rd., Imam Khomeini Blvd., Arak, Iran
City
Arak
Province
Markazi
Postal code
9131138361
Phone
+98 86 3341 2240
Email
info@iau-arak.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, Arak 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
Kashan University of Medical Sciences
Full name of responsible person
Zahra Sakeni
Position
Employee
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Shahed Street, Shahid Najafzadeh Alley
City
Kashan
Province
Isfehan
Postal code
8714793177
Phone
+98 31 5527 7126
Email
sakeni-z@kaums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zahra Zanjani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Kashan University of Medical Sciences, Pezeshk Blvd., Ghotbe Ravandi Blvd., Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5558 9399
Email
zanjani-z@kaums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zahra Sakeni
Position
Employee
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Shahed Street, Shahid Najafzadeh Alley
City
Kashan
Province
Isfehan
Postal code
8714793177
Phone
+98 31 5527 7126
Email
sakeni-z@kaums.ac.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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