Determining the effect of intervention based on problem-solving skills on stress, anxiety and depression associated with infertility on infertility couples
between two group and inside each of them ,before and after intervention
Design
A clinical control trial with two intervention and control groups, based on problem-solving skills, is randomized[gs
Settings and conduct
counseling sessions will be held at Urmia Shahid Motahari Hospital
Participants/Inclusion and exclusion criteria
Infertile couples who have high grade of stress and anxiety and can attend counseling sessions They are between 18 and 40 so far they have no children and they have no physical or mental illness
Intervention groups
The intervention includes five sessions)every is 90 min) the first two sessions are for general information about infertility and problem-solving skills run for all participants together, and the other three sessions will be run on problem-based issues like as couple counseling
The control group will also undergo a routine infertility treatment process
Main outcome variables
scores of stress , anxiety and depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151004024340N14
Registration date:2018-09-19, 1397/06/28
Registration timing:retrospective
Last update:2018-09-19, 1397/06/28
Update count:0
Registration date
2018-09-19, 1397/06/28
Registrant information
Name
Hamideh Mohaddesi
Name of organization / entity
Urmia University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 44 3275 4963
Email address
mohaddesi.h@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-05, 1397/02/15
Expected recruitment end date
2018-09-06, 1397/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assesing the Effect of problem solving skill based intervention on Stress, Anxiety and Depression associated with infertility in Infertile couples
Public title
the Effect of problem solving skill based intervention on Stress, Anxiety and Depression associated with infertility in Infertile couples
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Being Iranian Resident of urmia Ages 18 to 40Minimum elementary education Primary infertility The first couple visit for the infertility treatment Earning a score below 28 from the GHQ-28 questionnaire Earn a minimum score of milder and higher grades based on the DASS questionnaire sub-scales Having no child The possibility of spouse joining in meetings notice about the infertility factor Being a single wife Not having a medical condition Non-use of narcotic's drug, and alcohol The absence of a history or current condition for mental problems No severe stressful incident occurred during the last 6 months, except for the diagnosis of infertility Having a mobile phone
Exclusion criteria:
Age over 40 years
Secondary infertility
Residents of cities other than Urmia
Illiteracy
History of mental illness
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was done in a simple way.
Our randomized units were paired in this study
the randomization method was using sealed envelopes.
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 Urmia University of Medical Sciences
Before intervention and 1 month after intervention
Method of measurement
Depression ,Anxiety and Stress 42 (DASS42) Questionnaire
2
Description
Anxiety
Timepoint
Before start the intervention and 1 month after finished the intervention
Method of measurement
Depression , Anxiety and Stress 42 (DASS42) Questionnaire
3
Description
Depression DASS-42 questionnaire
Timepoint
Before start the intervention and 1 month after finished the intervention
Method of measurement
Depression , Anxiety and Stress 42 (DASS42) Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:The intervention includes five sessions)every is 90 min) the first two sessions are for general information about infertility and problem-solving skills run for all participants together, and the other three sessions will be run on problem-based issues like as couple counseling .First session :introduction , presentation of information about infertility, explanation of cognitive-behavioral counseling and discussion of positive and negative thoughts, A.B.C training. Teaching conflict management techniques and challenging inefficient thoughts.second Session: Complete problem solving skills training and multiple practice exercises with couples and provide a checklist as a homework assignment.third Session: Diagnostic interviews and identification of beliefs and types of coping ways of couples specificly against problems.Fourth Session: Teaching Mindfulness Techniques to Improve Couple's Consciousness in Addressing the Issues Fifth Session : summarizing and reviewing the contents of the sessions.