Effect of acceptance and commitment group psychotherapy on wellbeing and affective structure of breast cancer patients who participate in group therapy compared to matched control group who do not participate in group therapy
This study is designed to improve wellbeing and affective structure of breast cancer patients. The patients will be randomly categorized in two groups: control and those who participate in group therapy sessions. 30 women will participate in this study: two groups of 15 patients. Inclusion criteria:age between 18-60; lack of disabling psychiatric disorder; they educated at least elementary level; under therapy now; maximum 3 years after diagnosis; at stage 2 or 3 of cancer. Exclusion criteria: not participating in group therapy; not consenting to participate in group therapy;
patient does not participate in group therapy due to medical condition. Patients participate 8 session of group therapy during 1 month. It is expected that negative emotions decrease and quality of life and hope increase in patients who participating in group therapy.
General information
Acronym
ACT: acceptance and commitment therapy
IRCT registration information
IRCT registration number:IRCT2016122131512N1
Registration date:2017-04-02, 1396/01/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-04-02, 1396/01/13
Registrant information
Name
Zahra Mehdipour
Name of organization / entity
Psychiatry department, Shiraz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 71 3627 9319
Email address
mehdipourz@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Science, central building of Shiraz University of Medical Science, zand Blvd., shiraz, fars
Expected recruitment start date
2016-10-22, 1395/08/01
Expected recruitment end date
2017-02-18, 1395/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of acceptance and commitment group psychotherapy on wellbeing and affective structure of breast cancer patients who participate in group therapy compared to matched control group who do not participate in group therapy
Public title
Effect of acceptance and commitment group psychotherapy on wellbeing and affective structure of breast cancer patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age between 18-60; lack of disabling psychiatric disorder; they educated at least elementary level; under therapy now; maximum 3 years after diagnosis; at stage 2 or 3 of cancer
Exclusion criteria:
no participation in group therapy; not consenting to participate in group therapy;
patients do not participate in group therapy due to medical condition
Age
From 18 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
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 commitee of Shiraz University of Medical Science
Street address
Shiraz University of Medical Science main building, Zand Blvd.
City
Shiraz
Postal code
Approval date
2015-08-05, 1394/05/14
Ethics committee reference number
IR.SUMS.med.REC.1394.39
Health conditions studied
1
Description of health condition studied
psychological status in breast cancer patients
ICD-10 code
ّF54
ICD-10 code description
Psychological and behavioural factors associated with disorders or diseases classified elsewhere
Primary outcomes
1
Description
affective structure (negative and positive emotion)
Timepoint
before intervention, after end of intervention
Method of measurement
PANAS questionnaire
2
Description
wellbeing structure
Timepoint
before intervention, after end of intervention
Method of measurement
quality of life questionnaire
Secondary outcomes
1
Description
hope
Timepoint
before intervention, after ending intervantion
Method of measurement
hope questionnaire
2
Description
improve mental health
Timepoint
before intervention, after ending intervantion
Method of measurement
quality of life questionnaire
Intervention groups
1
Description
patients participate in acceptance and commitment group psychotherapy at 1 month for 8 sessions.
Category
Treatment - Other
2
Description
control group do not participate in group therapy and only receive booklets
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
ُُُShiraz Motahari poly clinic
Full name of responsible person
Sara Hosseini
Street address
Matahari poly clinic, Namazi Square, Zand Blvd.
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Medical Science
Full name of responsible person
Ali Poostfroosh
Street address
Shiraz University of Medical Science building, Zand Blvd.
City
Shiraz
Grant name
Grant code / Reference number
9189-01-01-94
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shiraz University of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ali Poostforosh
Position
Research assistant of Shiraz University of Medical Science
Other areas of specialty/work
Street address
Shiraz University of Medical Science building, Zand Blvd.