The present study aimed to investigate the effectiveness of acceptance and commitment therapy (ACT) on the mental health and psychological well-being of women with breast cancer.
Design
Clinical trials with control group, pre-test and post-test, with parallel, blind, randomized groups, the sample size is 60 people and randomly based on the number of paired cases in the experimental group and the individual numbers in the control group.
Settings and conduct
After obtaining a license from the Kermanshah University of Medical Sciences Research and Technology Dept. and coordinating with the officials of Ayatollah Taleghani Hospital in Kermanshah, a researcher will select among all the women who will be eligible for inclusion in the study.Then, treatment sessions at the Taleghani hospital were conducted for participants in the experimental group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Married, diagnosis of breast cancer by oncology specialist, age 20 to 50, breast removal.
Exclusion criteria: Receive simultaneous psychological treatments.
Intervention groups
Experimental group: acceptance and commitment treatment
Control group: They do not receive any psychological treatment.
Main outcome variables
Mental Health, Psychological Well-being
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171126037630N1
Registration date:2018-09-27, 1397/07/05
Registration timing:registered_while_recruiting
Last update:2018-09-27, 1397/07/05
Update count:0
Registration date
2018-09-27, 1397/07/05
Registrant information
Name
fateme dehghan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3432 1439
Email address
dehghan.fatemeh@razi.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-21, 1397/06/30
Expected recruitment end date
2018-11-21, 1397/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Acceptance and Commitment Therapy on Mental Health and Psychological Well-being in Mothers Breast Cancer Patients
Public title
The Effectiveness of Acceptance and Commitment Therapy on Mental Health and Psychological Well-being in Mothers Breast Cancer Patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Being married
Diagnosis of Breast Cancer by Oncology Specialist
20 to 50 years of age
Breast removal
consent to participate in the program
Exclusion criteria:
Receive simultaneous psychological treatments
Age
From 20 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Subjects were randomly assigned according to the patient file number so that the pair numbers in the test group and the individual numbers in the control group are replaced.
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 Kermanshah University of Medical Sciences
Street address
Research and Technology Dept, No. 2, Kermanshah University of Medical Sciences, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2018-07-31, 1397/05/09
Ethics committee reference number
IR.KUMS.REC.1397.238
Health conditions studied
1
Description of health condition studied
Breast Cancer
ICD-10 code
C50.9
ICD-10 code description
Malignant neoplasm of breast of unspecified site
Primary outcomes
1
Description
Mental Health
Timepoint
Before treatment and 2 weeks after treatment
Method of measurement
General Health Questionnaire (GHQ-28)
2
Description
Psychological Well-being
Timepoint
Before treatment and 2 weeks after treatment
Method of measurement
Ryff's Psychological Well-being scale (PWB)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Acceptance and commitment therapy (ACT), in eight 90-minute sessions once a week. Session 1: The limits of control (short and long-term costs and benefits; finger traps), focus on experience (body scan). Session 2: Values (what you care about, how you want to live your life).Session 3: Cognitive diffusion (observing thoughts without trying to evaluate or change them). Session 4: Mindfulness (being in the moment, raisin exercise). Session 5: Committed action (‘‘road map’’ connecting values, goals, actions, obstacles,and strategies). Session 6: Self as context. Metaphor: “Chessboard”. Session 7: Review and continued action in support of values.Session 8: Moving forward.
Category
Behavior
2
Description
Control group:Lack of psychological services
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Taleghani Educational Center
Full name of responsible person
Fateme Dehghan
Street address
Taleghani Hospital , Beheshti Blvd, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3432 1439
Email
fateme.dehghan1368@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Fared Najafi
Street address
Research and Technology Dept, No. 2, Kermanshah University of Medical Sciences, Beheshti Blvd, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
k.hamzei@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
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
Kermanshah University of Medical Sciences
Full name of responsible person
Marziyeh Kaboudi
Position
Assistant Professor, Department of Midwifery, School of Nursing and Midwifery, Kermanshah University
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, Dolatabad, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6717698563
Phone
+98 83 3827 9394
Email
kaboudim@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Fateme Dehghan
Position
faculty member, Department of Midwifery, School of Nursing and Midwifery, Kermanshah University of M
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Faculty of Nursing and Midwifery, Dolatabad, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6717698563
Phone
+98 83 3432 1439
Email
fateme.dehghan1368@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Fateme Dehghan
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Faculty of Nursing and Midwifery, Dolatabad, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6717698563
Phone
+98 83 3432 1439
Email
fateme.dehghan1368@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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The total potential data can be shared after unidentifiable people.
When the data will become available and for how long
2019
To whom data/document is available
Researchers working in academia and academia
Under which criteria data/document could be used
In order to know and use the researchers
From where data/document is obtainable
Fateme Dehghan
What processes are involved for a request to access data/document