To evaluate the effectiveness of mindfulness integrated cognitive behavioral therapy on episodic and semantic memory in breast cancer survivors
Design
Two arm randomized controlled trial with parallel design. Individual random allocation. Total sample size 30 participants. Simple randomization with allocation concealment
Settings and conduct
The intervention will be delivered as eight sessions of MiCBT for the intervention group at Motahari Clinic, Shiraz. Data will be collected at baseline and post intervention using standardized questionnaires.
Participants/Inclusion and exclusion criteria
Female breast cancer survivors; age 18 to 50 years; at least 6 months post treatment; literacy in Persian; no severe psychiatric disorders; no concurrent structured psychological treatment
Intervention groups
MiCBT intervention group and a no intervention control group
Main outcome variables
Episodic memory; semantic memory
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20260522069488N1
Registration date:2026-06-24, 1405/04/03
Registration timing:registered_while_recruiting
Last update:2026-06-24, 1405/04/03
Update count:0
Registration date
2026-06-24, 1405/04/03
Registrant information
Name
Marjan Rasekhi pour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3225 8554
Email address
marjan.rasekhipour@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-06-22, 1405/04/01
Expected recruitment end date
2026-08-16, 1405/05/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of mindfulness-integrated cognitive behavioral therapy (MiCBT) on episodic and semantic memory among breast cancer survivors
Public title
The effect of mindfulness-based cognitive behavioral therapy on memory in breast cancer survivors
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Female breast cancer survivors
Age between 18 and 50 years
At least 6 months since completion of primary cancer treatment (surgery, chemotherapy, or radiotherapy)
Ability to read and write in Persian
No current severe psychiatric disorders (e.g., psychosis or severe bipolar disorder)
Not receiving concurrent structured psychological treatmen
Willingness to participate and provide informed consent
Exclusion criteria:
Diagnosis of severe psychiatric disorders (e.g., psychotic disorders or bipolar I disorder
Severe cognitive impairment or neurological disorders affecting participation
Current substance or alcohol dependence
Unstable or acute medical conditions during study period
Inability to attend intervention sessions regularly (e.g., more than 2 missed sessions)
Withdrawal of consent at any stage of the study
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be randomly assigned to either the MiCBT intervention group or the control group using a simple randomization method (e.g., computer-generated random numbers or drawing lots). Each participant will be allocated to a group without any systematic order.
To prevent prediction of group assignment, the allocation sequence will not be disclosed to the researcher in advance.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This study is a two-arm randomized controlled trial with a parallel design. Participants will be randomly allocated to either the MiCBT intervention group or the control group. Outcome assessments will be conducted at baseline (pre-test) and after the intervention (post-test). The intervention will be delivered through structured psychotherapy sessions, while the control group will not receive the specific intervention. Outcomes will be measured using standardized self-report questionnaires.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Islamic Azad University-Marvdasht Branch
Street address
Islamic Azad University, Marvdasht Branch, Kilometer 3, Takht-e Jamshid Boulevard, Marvdasht, Fars Province, Iran
City
Marvdasht
Province
Fars
Postal code
7371113119
Approval date
2026-06-08, 1405/03/18
Ethics committee reference number
IR.IAU.M.REC.1405.178
Health conditions studied
1
Description of health condition studied
Breast Cancer Survivors
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Episodic Memory Score in Breast Cancer Survivors
Timepoint
Assessment at Baseline (Before the Intervention) and After Completion of the Intervention Sessions
Method of measurement
Episodic memory will be assessed using the California Verbal Learning Test Second Edition, the Logical Memory Subtest of the Wechsler Memory Scale Fourth Edition, and the Autobiographical Recollection Test.
2
Description
Semantic Memory Score in Breast Cancer Survivors
Timepoint
Assessment at Baseline (Before the Intervention) and After Completion of the Intervention Sessions
Method of measurement
Semantic memory will be assessed using the Semantic Verbal Fluency Test.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Participants in this group will receive Mindfulness Integrated Cognitive Behavioral Therapy (MICBT). The intervention consists of eight structured group sessions. Each session includes mindfulness training, cognitive restructuring, attentional exercises, and related homework assignments. Sessions will be conducted weekly in an outpatient clinical setting.
Category
Behavior
2
Description
Control group: Participants in this group will not receive any specific psychological intervention and will only complete the baseline and post intervention assessments. They may continue to receive their usual care if needed.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahari Clinic
Full name of responsible person
Dr. Mohsen Arefian
Street address
Motahari Clinic, Karim Khan Zand Boulevard, Shiraz, Fars Province, Islamic Republic of Iran
City
Shiraz
Province
Fars
Postal code
-
Phone
+98 71 3612 1000
Email
motahari@sums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Azad University Of Marvdasht
Full name of responsible person
Dr. Ahmadreza Oji Nezhad
Street address
Islamic Azad University, Marvdasht Branch, Kilometer 3, Takht-e Jamshid Boulevard, Marvdasht, Fars Province, Iran
City
Marvdasht
Province
Fars
Postal code
7371113119
Phone
+98 917 918 2372
Email
aoji62@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Azad University Of Marvdasht
Proportion provided by this source
50
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Jahrom University
Full name of responsible person
Dr. Mohsen Arefian
Position
Assistant Professor, Jahrom University
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Jahrom University, jahrom, Fars province, Iran
City
jahrom
Province
Fars
Postal code
7414785318
Phone
+98 71 5437 2252
Email
M.arefian92@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Jahrom University
Full name of responsible person
Dr. Mohsen Arefian
Position
Assistant Professor, Jahrom University
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Jahrom University, jahrom, Fars province, Iran
City
jahrom
Province
Fars
Postal code
-
Phone
+98 917 392 0656
Fax
Email
M.arefian92@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Azad University Of Marvdasht
Full name of responsible person
Marjan Rasekhi pour
Position
M.Sc. Student in Clinical Psychology
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 5, 4th Floor, Eastern Saheli St., Alley 4, between Imam Ali Bridge and Karandish
City
Shiraz
Province
Fars
Postal code
7145735678
Phone
+98 938 597 4307
Email
marjan.rasekhipour@gmail.com
Sharing plan
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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is 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
Yes - There is a plan to make this available
Title and more details about the data/document
Individual participant data include demographic characteristics, scores of fear of cancer recurrence, body image, post-traumatic growth questionnaires, and psychological test scores at baseline and post intervention. Data will be shared after removal of all personal identifiers (de-identified dataset).
When the data will become available and for how long
Data will be available 6 months after publication of the study results and will remain accessible for 5 years.
To whom data/document is available
Access to data will be granted to researchers affiliated with academic or research institutions with legitimate scientific objectives. Requests from non-academic or commercial entities will not be considered.
Under which criteria data/document could be used
Data will be used only for non-commercial research purposes. Any analysis must comply with ethical research standards, and secondary analyses must align with approved scientific objectives. Redistribution of data is not permitted.
From where data/document is obtainable
Requests should be submitted via the principal investigator’s email. After scientific review and approval, de-identified data will be shared in digital format with the requester.
What processes are involved for a request to access data/document
Requests will be reviewed by the research team. If approved, data will be provided within 30 working days. A Data Use Agreement may be required prior to data sharing.
Comments
All datasets will be fully de-identified and no personal identifiers will be shared.