The present study will be conducted with the aim of investigating the effectiveness of Acceptance and Commitment Therapy (ACT) on reducing anger and frustration in infertile couples.
Design
The present one is semi-experimental. The semi-experimental design used in this research will be a two-group design (one experimental group and one control group) with pre-test and post-test. The statistical population of this research will include all couples suffering from infertility between the ages of 20 and 45 in the infertility center of Shahid Beheshti Hospital in Kashan city, among which 30 infertile couples were selected as available after obtaining written informed consent. Using the random assignment method, they will be divided into two groups of 15 people, experimental and control.
Settings and conduct
In this research, the blinding method will be used for the people who measure the variables, so that the researcher or the group of researchers will not knowingly or unknowingly cause errors in the study. In this way, the information that can distort the test result remains hidden from the participant's view, but the person responsible for conducting the test is aware of them.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Satisfaction of clients, presence of infertility, absence of other untreated psychiatric problems and education of at least 8 years.
Exclusion criteria: Using other psychotherapy at the same time as starting the desired treatment and two absent sessions for each person.
Intervention groups
A number of 30 infertile couples were selected by available sampling method and will be randomly assigned to two experimental and control groups (15 people in each group). The experimental group will receive ACT treatment in 8 sessions of 90 minutes, while the control group will not receive any training.
Main outcome variables
Anger and failure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170312033023N3
Registration date:2023-09-01, 1402/06/10
Registration timing:registered_while_recruiting
Last update:2023-09-01, 1402/06/10
Update count:0
Registration date
2023-09-01, 1402/06/10
Registrant information
Name
Behrooz Afshari
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5558 1833
Email address
behrooz.afshari71@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-01, 1402/06/10
Expected recruitment end date
2023-09-15, 1402/06/24
Actual recruitment start date
2023-09-01, 1402/06/10
Actual recruitment end date
2023-09-15, 1402/06/24
Trial completion date
2023-11-24, 1402/09/03
Scientific title
Investigating the effectiveness of acceptance and commitment therapy on frustration and anger in infertile couples
Public title
the effect of acceptance and commitment therapy on infertile couples
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Client satisfaction
Infertility
No other untreated psychiatric problems
At least 8 years of education
Exclusion criteria:
Using other psychotherapy at the same time as starting the desired treatment
Two absentee sessions
Age
From 20 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
Investigator
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Among all the people who meet the inclusion criteria, 30 people are randomly included in the study, and then 15 people are selected for each group using random numbers generated by the computer. Random allocation in clinical trial studies refers to the process of dividing participants into different groups randomly. Randomization gives each participant an equal chance to be placed in each of the groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this research, the blinding method will be used for the people who measure the variables, so that the researcher or the group of researchers will not knowingly or unknowingly cause errors in the study. In this way, the information that can distort the test result remains hidden from the participant's view, but the person responsible for conducting the test is aware of them.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kashan University of Medical Sciences
Street address
Qutb Ravandi Boulevard, Kashan, Isfahan, Iran
City
Kashan
Province
Isfehan
Postal code
8715973474
Approval date
2018-05-22, 1397/03/01
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1397.018
Health conditions studied
1
Description of health condition studied
Treatment of failure and anger of infertile couples
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Anger and failure
Timepoint
Pre-test, post-test, follow-up
Method of measurement
Spielberger's Anger Questionnaire and Gilbert and Allen's Feeling of Failure Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: They will receive ACT treatment in 8 sessions of 90 minutes.
Category
Treatment - Other
2
Description
Control group: The control group did not undergo any training.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashan University of Medical Sciences
Full name of responsible person
Behrooz Afshari
Street address
Kashan, Mofatteh BLV
City
Kashan
Province
Isfehan
Postal code
8714858955
Phone
+98 910 990 8462
Email
behrooz.afshari71@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Kashan University of Medical Sciences
Street address
Qutb Ravandi Boulevard, Kashan, Isfahan, Iran
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5558 9444
Email
info@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Behrooz Afshari
Position
Clinical psychologist
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Mofatteh BLV
City
Kashan
Province
Isfehan
Postal code
8714858955
Phone
+98 910 990 8462
Email
behrooz.afshari71@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Behrooz Afshari
Position
Clinical Psychologist
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Mofatteh BLV
City
Kashan
Province
Isfehan
Postal code
8714858955
Phone
+98 910 990 8462
Email
behrooz.afshari71@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Behrooz Afshari
Position
Master of Clinical Psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Kashan, Mofatteh BLV
City
Kashan
Province
Isfehan
Postal code
8714858955
Phone
+98 910 990 8462
Email
behrooz.afshari71@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
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Only part of the data, such as the information related to the treatment result, can be shared.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Our data will only be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
Psychologists, counselors and psychiatrists will have access to the research results
From where data/document is obtainable
Applicants can refer to the clinical psychology department of Kashan University of Medical Sciences and access the research results
What processes are involved for a request to access data/document
Applicants can access the research results after referring to the clinical psychology department of Kashan University of Medical Sciences