comparison of effectiveness of group internet-delivered Mindfulness Based Cognitive Therapy in anxiety , depression and level of mindfulness in breast cancer patients receiving chemotherapy with the control group: a randomized controlled clinical trial
Determining the effectiveness of group Internet delivered Mindfulness Based Cognitive Therapy on Anxiety, Depression and Mindfulness level in breast cancer patients receiving chemotherapy
Design
A clinical trial with two experimental and control groups was conducted on 60 patients with randomization on www.random.org and allocation concealment with sealed opaque envelopes.
Settings and conduct
60 breast cancer patients receiving chemotherapy referred to the outpatient oncology department of Panj Azar Hospital in Gorgan in 2024 are divided into two experimental and control groups. The Experimental group recieve Group Internet delivered Mindfulness Based Cognitive Therapy.In both groups pretest and post test are taken for measurement of anxiety, depression and mindfulness level and the results are compared.
Participants/Inclusion and exclusion criteria
Inclusion criteria were having breast cancer, age 20 to 55 years, having basic skills of working with the internet and access to the internet at a suitable speed.
Exclusion criteria were the presence of another concurrent cancer, having full criteria for other psychological disorders, being under drug or nondrug treatment for psychiatric diseases, drug or alcohol abuse, having suicidal or homicidal thoughts, Low Performance level related to cancer(Equation ECOG 3 and 4).
Intervention groups
The experimental group recieve eight sessions of ninety minute weekly Group Internet delivered Mindfulness Based Cognitive Therapy by the researcher under the supervision of a clinical psychologist, and the control group does not receive any intervention.
Main outcome variables
Severity of Anxiety; Severity of Depression; Level of mindfulness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240311061251N1
Registration date:2024-07-16, 1403/04/26
Registration timing:registered_while_recruiting
Last update:2024-07-16, 1403/04/26
Update count:0
Registration date
2024-07-16, 1403/04/26
Registrant information
Name
Nazli sharbaf
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3234 9206
Email address
shaarbaf@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2024-07-22, 1403/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of effectiveness of group internet-delivered Mindfulness Based Cognitive Therapy in anxiety , depression and level of mindfulness in breast cancer patients receiving chemotherapy with the control group: a randomized controlled clinical trial
Public title
Effect of Group Internet-Delivered Mindfulness Based Cognitive Therapy (MBCT) in Breast Cancer Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Breast cancer diagnosed by oncologist and based on pathology report
The person must have basic internet and computer skills
Access to the Internet at a suitable speed
Age 20 to 55 years
Exclusion criteria:
The presence of another concurrent cancer
Having full criteria for other psychological disorders based on the researcher's clinical interview in accordance with DSM5 criteria
Being under drug or non-drug treatment for psychiatric diseases
Substance or alcohol abuse
Having Active Suicidal or Homicidal ideas
Low Performance Level related to cancer (equation ECOG 3 and 4) , which is determined by the Oncologist based on the ECOG Scale (the Eastern Cooperative Oncology Group Scale)
Age
From 20 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
randomization technique is simple randomization. unit of randomization is individual participants. randomization tool is table of random numbers. Before starting of the study, Random numbers are generated using www.random.org by a member of the team who does not participate in the study.
allocation concealment is done by sealed opaque envelopes. generated random numbers will be kept in sealed opaque envelopes until the start of the study. Allocation concealment will be maintained until the participant completes the demographic checklist. At this stage, the interviewer opened the sealed envelope to reveal the study 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
Ethics committee of Golestan University of Medical Sciences
Street address
No.14, 3rd Amini Alley, 14 janbaz Ave.,Janbazan Blvd.,Gorgan Town
City
Gorgan
Province
Golestan
Postal code
4916657661
Approval date
2024-03-06, 1402/12/16
Ethics committee reference number
IR.GOUMS.REC.1402.509
Health conditions studied
1
Description of health condition studied
اختلال خلقی ناشی از وضعیت فیزیولوژیک شناخته شده با خصوصیات افسردگی
ICD-10 code
F06.31
ICD-10 code description
Mood disorder due to known physiological condition with depressive features
2
Description of health condition studied
اختلال اضطرابی ناشی از وضعیت فیزیولوژیک شناخته شده
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
Primary outcomes
1
Description
Anxiety score in Beck Anxiety Inventory
Timepoint
The beginning of the study (before the intervention) and the end of the study (after the intervention)
Method of measurement
Beck Anxiety Inventory
2
Description
Depression score in Beck depression Inventory - second edition
Timepoint
The beginning of the study (before the intervention) and the end of the study (after the intervention)
Method of measurement
Beck depression Inventory - second edition
3
Description
Mindfulness level in Five Facet Mindfulness Questionnaire
Timepoint
The beginning of the study (before the intervention) and the end of the study (after the intervention)
Method of measurement
Five Facet Mindfulness Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group : Pre-test with Beck Depression Inventory - Second Edition (BDI-II), Beck Anxiety Inventory (BAI) and Five Facet Mindfulness Questionnaire (FFMQ) will be implemented in both intervention and control groups. The intervention group are subjected to eight sessions of ninety minute weekly group internet-delivered Mindfulness Based Cognitive Therapy (iMBCT) in two groups of 15 participants. The iMBCT program is taken from the original version of Mindfulness-Based Cognitive Therapy from Segal et al.,2013 Handbook. then the post-tests will be administered in both groups.
Category
Treatment - Other
2
Description
Control group: Pre-test with Beck Depression Inventory - Second Edition (BDI-II), Beck Anxiety Inventory (BAI) and Five Facet Mindfulness Questionnaire (FFMQ) will be implemented. During period of time that intervention group is recieving therapy, the control group is under usual care and does not receive any intervention. then the post-tests will be administered in both intervention and control groups.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Gorgan 5azar hospital
Full name of responsible person
Nazli shaarbaf
Street address
5Azar hospital, 5azar Ave., Gorgan Town
City
Gorgan
Province
Golestan
Postal code
4917761551
Phone
+98 17 3232 7910
Fax
+98 17 3223 8363
Email
modir-5azar@goums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Narges beygom Mirbehbahani
Street address
Golestan university of medical sciences, shastkola Ave. entrance , Gorgan Town
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 1660
Email
mirbeh@goums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?