The effect of counseling based on acceptance and commitment therapy on mental health and quality of life in infertile couples: a randomized controlled trial
Determining the effect of counseling based on acceptance and commitment on mental health and quality of life in infertile couples referring to the infertility center of Besat city of Sanandaj
Design
A randomized controlled clinical trial with parallel groups of 54 infertile couples referring to the Sanandaj Infertility Clinic in 1396
Settings and conduct
The researcher contacted the clients of the Infertility Clinic of Besat in Sanandaj city and, meanwhile a Brief description of the research, invite them to cooperate.Written consent is obtained from individuals wishing to participate in the study.Then, individual social questionnaire, GHQ-28 questionnaire and FertiQoL questionnaire will be completed.
These samples are randomly assigned to counseling and control groups and will be scheduled for consultation sessions. One month after the intervention, the questionnaires will be completed and analyzed.
Participants/Inclusion and exclusion criteria
Entry requirements:
1) Primary infertility
2) Have a history of one to ten years of primary infertility.
3) Couples aged 20 to 45 years.
4) Have at least reading and writing education
Non-arrival conditions:
1) Positive pregnancy test during the sampling and intervention.
2) The incidence of adverse events during the 6 months before the study (death or acute illness of close relatives)
3) A person's mental or physical illness (such as diabetes, depression, etc.)
4) Participate in another intervention study
5) Receive a high score of 41 from the mental health questionnaire
Intervention groups
For the intervention group: With couples in groups of 8 to 12-member, Consultation sessions based on acceptance and commitment approach will be held. Eight weekly counseling sessions, Each session is 90 minutes.
Main outcome variables
Mental Health status
fertility Quality of life status
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111122008170N13
Registration date:2018-06-11, 1397/03/21
Registration timing:retrospective
Last update:2018-06-11, 1397/03/21
Update count:0
Registration date
2018-06-11, 1397/03/21
Registrant information
Name
Jamileh Malakouti
Name of organization / entity
Nursing Faculty
Country
Iran (Islamic Republic of)
Phone
+98 41 1477 2699
Email address
malakoutij@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-04-04, 1396/01/15
Expected recruitment end date
2017-06-22, 1396/04/01
Actual recruitment start date
2017-06-22, 1396/04/01
Actual recruitment end date
2017-09-23, 1396/07/01
Trial completion date
empty
Scientific title
The effect of counseling based on acceptance and commitment therapy on mental health and quality of life in infertile couples: a randomized controlled trial
Public title
The effect of counseling on infertile couples
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Couples with initial infertility of 1 to 10 years
Couples 20 to 45 years old
Have at least reading and writing education
At least once failed treatment of infertility experience
Exclusion criteria:
Earning a score of 41 from the mental health questionnaire
Occurrence of an adverse event during the 6 months before the study (death or acute illness of relatives)
they have no known mental or physical illness such as diabetes, depression (According to the participant)
Participate in another intervention study
Positive pregnancy test during the sampling and intervention
Age
From 20 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
108
Actual sample size reached:
108
Randomization (investigator's opinion)
Randomized
Randomization description
individuals selected will be assigned by random blocking using the RAS software with blocks 4 and 6 with a ratio of 1: 1 to two groups (Consultation recipient and control, 54 people for each group), the type allocation will be written on the paper and placed in the opaque packets numbered down, the pockets will be opened in the order of the individuals entering the study and the type of group will be specified. The allocation sequence will be performed by the person not involved in the sampling and collecting of data
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 Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences Research & Technology, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
51665118
Approval date
2016-12-13, 1395/09/23
Ethics committee reference number
IR.TBZMED.REC.1395.1179
Health conditions studied
1
Description of health condition studied
infertility
ICD-10 code
N46
ICD-10 code description
Male infertility
Primary outcomes
1
Description
Mental Health Status
Timepoint
Before intervention and one month after the intervention
Method of measurement
Goldberg general health questionnaire 28
2
Description
Quality of Fertility life
Timepoint
Before intervention and one month after the intervention
Method of measurement
Fertility Quality of Life Questionnaire (FertiQoL)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 8 weekly 90-minute sessions based on acceptance and commitment.Acceptance and Commitment Therapy(ACT, typically pronounced as the word "act") is a behavioral therapy that uses mindfulness, acceptance and cognitive defusion skills to increase psychological flexibility and promote behavior change in the direction of chosen values."Psychological flexibility" is the main goal of act. Psychological flexibility is established through six core ACT processes: Acceptance, Cognitive Defusion, Being Present, Self as Context, Values and Committed Action. These 6 processes will be explained in consultation sessions With exercises and related metaphors. A session on reproductive process and infertility treatment will be explained.
Category
Prevention
2
Description
Control group: Get routine care
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat clinic of infertility
Full name of responsible person
Masoumeh Hosseinpanahi
Street address
Kurdistan, Sanandaj, Abidar Street
City
Sanandaj
Province
Kurdistan
Postal code
6618634683
Phone
+98 21 3322 2441
Email
masume.hosseinpanahi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Abolgasem Jouyban
Street address
Tabriz University of Medical Sciences, Gulgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 7310
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Malakouti.Jamileh
Position
Master of Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, South Shariati Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
66156-15733
Phone
+98 41 3479 6770
Email
jamilehmalakouti@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Malakouti.Jamileh
Position
Master of Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, South Shariati Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
66156-15733
Phone
+98 41 3479 6770
Email
jamilehmalakouti@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Masoumeh.hosseinpanahi
Position
Student of Master in Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Imam Khomeini Hospital.Divandareh
City
Divandareh
Province
Kurdistan
Postal code
6641733841
Phone
+98 87 3872 3984
Email
masume.hosseinpanahi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The results of the clinical study will be published as a paper.
When the data will become available and for how long
Immediately after printing the results
To whom data/document is available
All researchers
Under which criteria data/document could be used
Scientific use with reference to article
From where data/document is obtainable
E-mail: malakoutij@tbzmed.ac.ir
What processes are involved for a request to access data/document