Protocol summary

Summary
Background: Considering the high prevalence of psychiatric disorders among infertile women, it seems that gynecologists, psychiatrists and psychologists should be more attentive to identify and treat these disorders. The aim of the study is to determine whether of E- cognitive group therapy with emotional disclosure on mental health of infertile women who receiving assisted reproduction Method: For implement this study, statistically society select. They include 800 infertile couples that visit to gynecologic Clinics, Jahrom University, for ART approach. Infertility define as at least 1 year of unprotected coitus without conception. Sampling is from women who have inclusion criteria to our study. All of the participants who have primary infertility, no somatic and psychiatric problem, jahrom residents, between 20-40 years of age, have a privet mobile, ability to reading massage and interest to participate in regular group meetings will select to research. 800 consecutive infertile women includ in hormonal therapy or other ART and who participant have including criteria randomly allocat either to receive Cognitive-Behavioral Treatment (CBT Group) or (Observation Group). CBT include the recognition of negative thinking to help the participants distinguish phobia from reality, cognitive reconstructing, thought blocking, spirituality, and the behavioral techniques included muscle relaxation exercises, imagination exercises, expressing feelings, biofeedback in 2 hour weekly to 12 session. All of participant will receive positive massage about cognitive reconstructing , change the negative thought and how to induce positive thought about their infertility and brief massage about result of session .30 late session , all of participant have emotional disclosure. Participant express positive or negative feeling about their problem and their peers feedback them. In some of session participant paint their families as art therapy to emotional disclosure. All of these painting will analyze by specialist and participant will receive feedback from group leader about their emotional feeling individually, also all of them will present the tive and negative emotional feeling about their problem as a written task or express them into the group. In 2 additional sessions and in the first of session we will use interactive video about infertility medical approach and response to personal question about these interventional approaches by specialist. useing the DASS Test and Pen worry state of inventory will use For gathering data. The aim of this study is the assessing the effect of cognitive behavioral therapy on infertile psychological distress(Anxiety- depression- stress) and infertile worry . indepebdent variable into this research is cognitive behavioral therapy and dependent variable is infertile worry stste and infertile psychological distresss. Key words: Assisted reproductive therapy RT; Cognitive behavioral therapy; Psychological distress, stress; & Infertile women.

General information

Acronym
Cognitive Behavioral Therapy
IRCT registration information
IRCT registration number: IRCT201108247407N2
Registration date: 2011-09-14, 1390/06/23
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-09-14, 1390/06/23
Registrant information
Name
Leili Mosalanejad
Name of organization / entity
Jahrom University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 79 1334 1131
Email address
mossla_1@yahoo.com
Recruitment status
Recruitment complete
Funding source
Jahrom University of Medical Sciences
Expected recruitment start date
2011-04-04, 1390/01/15
Expected recruitment end date
2011-07-06, 1390/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Look out for the secret wound:the effect of e- cognitive group therapy with emotional disclosure on infertile mental health
Public title
The impact of E-cognitive behavioral therapy on infertility
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: the participants who had primary infertility history; Jahrom residents age between 20-40 years; have a privet mobile line; ability to reading massage and interested to participate in regular group Exclusion criteria: somatic and psychiatric problem
Age
From 20 years old to 40 years old
Gender
Female
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size: 800
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Jahrom University of Medical Sciences
Street address
Main campus-Jahrom University of Medical Sciences- Motahari Street- Jahrom- Fars-Iran
City
Jahrom
Postal code
74148
Approval date
2011-03-11, 1389/12/20
Ethics committee reference number
آ/د/1387

Health conditions studied

1

Description of health condition studied
Infertility
ICD-10 code
N 97
ICD-10 code description
Female Infertility

Primary outcomes

1

Description
The impact of e cognitive beahavioral therapy with emotional self disclusure on infertile mental health
Timepoint
Before and after intervention
Method of measurement
Questionnaire and observation

Secondary outcomes

1

Description
The impact of E_CBT with emotional self disclusure on rate of pregnancy
Timepoint
Baseline, 6 and 12 months later
Method of measurement
Document

Intervention groups

1

Description
experiment group:E- Cognitive Behavioral Therapy BT with Emotional Disclusure
Category
Treatment - Other

2

Description
control group : no any intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Gynechology and Maternity clinic related to Jahrom University of Medical Sciences
Full name of responsible person
Leili Mosalanejad
Street address
Motahari Street- Jahrom University of Medical Sciences-Jahrom- Fars- Iran
City
Jahrom

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Kavos solhjo
Street address
-General Office- Main campus-Jahrom University of Medical Sciences- Motahari Street- Jahrom- Fars-Iran
City
Jahrom
Grant name
پژوهشی
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jahrom University of Medical Sciences
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
Jahrom University of Medical Sciences
Full name of responsible person
Leili Mosalanejad
Position
PhD, Faculty member
Other areas of specialty/work
Street address
Leili Mosalanejad-General Office- Main campus-Jahrom University of Medical Sciences- Motahari Street- Jahrom- Fars-Iran
City
Jahrom
Postal code
74148
Phone
+98 79 1334 1508
Fax
+98 79 1334 1508
Email
mossla_1@yahoo.com; saedparsa2012@gmail.com
Web page address
www.jums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Leili Mosalanejad
Position
PHD, Scientific Faculty Member
Other areas of specialty/work
Street address
Leili Mosalanejad-General Office- Main campus-Jahrom University of Medical Sciences- Motahari Street- Jahrom- Fars-Iran
City
Jahrom
Postal code
74148
Phone
+98 79 1334 1508
Fax
+98 79 1334 1508
Email
mossla_1@yahoo.com; saedparsa2012@yahoo.com
Web page address
www,jums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Jahrom University of Medical Sciences, Psychiatric Department
Full name of responsible person
Leili Mosalanejad
Position
PhD, Faculty Member
Other areas of specialty/work
Street address
Leili Mosalanejad-General Office- Main campus-Jahrom University of Medical Sciences- Motahari Street- Jahrom- Fars-Iran
City
Jahrom
Postal code
74148
Phone
+98 79 1334 1508
Fax
+98 79 1334 1508
Email
mossla_1@yahoo.com; seadparsa2012@gmail.com
Web page address
www.jums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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