Determining the effectiveness of mindfulness-based therapy in reducing depression and anxiety in breast cancer patients
Design
Clinical trial, with parallel groups, without blinding, phase three, randomized, which will be performed on 48 patients randomly.
Settings and conduct
The study population will be women with breast cancer referring to Ayatollah Rouhani Babol educational and therapeutic center. The patients will be randomly divided into intervention and control groups by computer using the random number table method, and the intervention will be performed on them.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Patients in the 2 and 3 stages of breast cancer, Ability to answer the questionnaire and reading and writing literacy, obtaining the minimum anxiety and depression score based on the Hospital Anxiety and Depression Scale (HADS)
Exclusion criteria: Failure to attend more than two sessions out of a total of 8 intervention sessions, using psychoactive drugs to reduce the symptoms of anxiety and depression Disease recurrence or metastasis in other parts of the body during research Cognitive disorders and delirium and dementia Taking other psychiatric drugs or substance dependence.
Intervention groups
Intervention group: Escitalopram (Escitalopram) of Abidi Pharmaceutical Company at the rate of 10 mg daily along with therapeutic intervention based on mindfulness for 8 weeks (1 session per week)
Control group: Escitalopram (Escitalopram) of Abidi Pharmaceutical Company, 10 mg daily.
Main outcome variables
Reducing depression, anxiety and improving sleep
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190317043079N3
Registration date:2023-01-17, 1401/10/27
Registration timing:prospective
Last update:2023-01-17, 1401/10/27
Update count:0
Registration date
2023-01-17, 1401/10/27
Registrant information
Name
farzan kheirkhah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3229 1951
Email address
f.kheirkhah@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-21, 1401/11/01
Expected recruitment end date
2023-04-21, 1402/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of mindfulness-based therapy in reducing depression, anxiety and improving sleep in breast cancer patients
Public title
The effect of mindfulness-based therapy in reducing depression, anxiety and improving sleep in breast cancer patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients in the 2 and 3 stages of breast cancer
Ability to answer the questionnaire and reading and writing literacy
Obtaining the minimum anxiety and depression score based on the Hospital Anxiety and Depression Scale (HADS)
Exclusion criteria:
Failure to attend more than two sessions out of a total of 8 intervention sessions
Using psychoactive drugs to reduce the symptoms of anxiety and depression
Disease recurrence or metastasis in other parts of the body during research
Cognitive disorders and delirium and dementia
Taking other psychiatric drugs or substance dependence
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization will be done using permutation blocks of size 4 (AABB). In this way, blocks of 4 will consist of random combinations of 2. Patients will be randomly assigned to two groups of 24 using 12 blocks of size 4 and 1:1 ratio. Creating a random sequence in the blocks will be done by a statistician.
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 Babol University of Medical Siences
Street address
Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
4717647745
Approval date
2022-08-15, 1401/05/24
Ethics committee reference number
IR.MUBABOL.REC.1401.084
Health conditions studied
1
Description of health condition studied
Breast Cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
Psychological problems (depression, anxiety)
Timepoint
Before starting the intervention, after 4 weeks and finally 8 weeks
Method of measurement
Hospital Anxiety and Depression Standard Questionnaire (HADS)
2
Description
Sleep Quality
Timepoint
Hospital Anxiety and Depression Standard Questionnaire (HADS)
Method of measurement
Petersburg Sleep Questionnaire (PSQI)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Escitalopram (Escitalopram) of Abidi Pharmaceutical Company at the rate of 10 mg daily along with therapeutic intervention based on mindfulness for 8 weeks (1 session per week)
Category
Treatment - Drugs
2
Description
Control group: Escitalopram (Escitalopram) of Abidi Pharmaceutical Company, 10 mg daily
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Rouhani Hospital
Full name of responsible person
Farzan Kheirkhah
Street address
Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
47176-41367
Phone
+98 11 3233 8301
Email
f.kheirkhah@mubabol.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mehdi Rajabnia
Street address
Vice-chancellor Of Research, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
47176-41367
Phone
+98 11 3219 7667
Email
m.rajabnia@mubabol.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?