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Comparison of effectiveness positive Iranian – Islamic therapy with Acceptance and Commitment Therapy on Depression, Anxiety, Stress and Psychological Well-being of Infertile Women in Isfahan City

Protocol summary

Summary
This study aims to develop a positive Iranian – Islamic therapy package and compare it’s effectiveness with acceptance and commitment therapy on depression, anxiety, stress and psychological well-being of infertile Women in Isfahan city. This research is a three- group quasi-experimental study with a pretest-posttest and three- month follow-up. 45 infertile women referring to Isfahan Fertility and Infertility Center will select by purposeful sampling and randomly assigned to experimental and control groups (ACT, IIPT, control). Inclusion criteria include from the study: informed consent, age range 20 to 40 years, minimum education cycle, residing in Isfahan city, receiving infertility treatment, non-use of psychiatric and/ or psychoactive drugs at least two weeks before starting treatment, lack of severe physical or mental illness and a score of depression, anxiety, and stress moderate to severe symptom range on DASS-42 questionnaire. Exclusion criteria from the study include: being absent in two consecutive or non-consecutive sessions, not doing of home assignments and exercises during three consecutive non-consecutive sessions, use of psychiatric and/ or psychoactive drugs during study. The data collection tools are Depression, Anxiety and Stress Scale- 42 (DASS 42) and Ryff Psychological Well-being Questionnaire (PWBQ).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016022826811N1
Registration date: 2016-04-22, 1395/02/03
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-04-22, 1395/02/03
Registrant information
Name
Parvin Jamshidian Ghaleh Shahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5826 4150
Email address
p.jamshidian@khuisf.ac.ir
Recruitment status
Recruitment complete
Funding source
Provider of funding source is researcher: Parvin Jamshidian Qaleh Shahi, Facualty of Education & Psychology, Azad Islamic University of Isfahan, Khorasgan Branch, Iran.
Expected recruitment start date
2016-04-03, 1395/01/15
Expected recruitment end date
2016-04-18, 1395/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effectiveness positive Iranian – Islamic therapy with Acceptance and Commitment Therapy on Depression, Anxiety, Stress and Psychological Well-being of Infertile Women in Isfahan City
Public title
Comparison of effectiveness positive Iranian – Islamic therapy with Acceptance and Commitment Therapy on Depression, Anxiety, Stress and Psychological Well-being
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria include: informed consent; age range 20 to 40 years; minimum education cycle; residing in Isfahan city; receiving infertility treatment; non-use of psychiatric and/ or psychoactive drugs at least two weeks before starting treatment; lack of severe physical or mental illness; a score of depression, anxiety, and stress moderate to severe symptom range on DASS-42 questionnaire. Exclusion criteria from the study include: being absent in two consecutive or non-consecutive sessions; not doing of home assignments and exercises during three consecutive non-consecutive sessions; use of psychiatric and/ or psychoactive drugs during study.
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
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
Secretariat of the academic committee of ethics in biomedical researches of Isfahan University of Me
Street address
Room 208, Second Floor, Building No. 4, University Staff, Hezar Jarib St, Azadi Square, University of Isfahan
City
Isfahan
Postal code
Approval date
2016-01-23, 1394/11/03
Ethics committee reference number
IR.MUI.REC.1394.4.123

Health conditions studied

1

Description of health condition studied
Female infertility
ICD-10 code
N97,
ICD-10 code description
inability to achieve a pregnancy

Primary outcomes

1

Description
Depression
Timepoint
Before intervention, after intervention, three months after intervention
Method of measurement
Depression, Anxiety and Stress Scale- 42 (DASS 42)

2

Description
Anxiety
Timepoint
Before intervention, after intervention, three months after intervention
Method of measurement
Depression, Anxiety and Stress Scale- 42 (DASS 42)

3

Description
Stress
Timepoint
Before intervention, after intervention, three months after intervention
Method of measurement
Depression, Anxiety and Stress Scale- 42 (DASS 42)

4

Description
Psychological Well-being
Timepoint
Before intervention, after intervention, three months after intervention
Method of measurement
Ryff Psychological Well-being Questionnaire (PWBQ).

Secondary outcomes

empty

Intervention groups

1

Description
Control group: non treatment (C)
Category
N/A

2

Description
Experimental group 1: positive Iranian – Islamic therapy(PIIT)
Category
Behavior

3

Description
Experimental group 2: Acceptance and Commitment Therapy(ACT)
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan Fertility and Infertility Center
Full name of responsible person
Parvin Jamshidian Qaleh Shahi
Street address
No 23, Corner of Behesht St, Salman Farsi (Second Moshtagh) St, Bozorgmehr Square, Isfahan
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
investigater: Parvin Jamshidian Qaleh Shahi, Islamic Azad University, Isfahan (Khorasgan) Branch
Full name of responsible person
Parvin Jamshidian Qaleh Shahi
Street address
University Blvd, Arqavanieh, Eastern Jey Street , Isfahan
City
Khorasgan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
investigater: Parvin Jamshidian Qaleh Shahi, Islamic Azad University, Isfahan (Khorasgan) Branch
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
Islamic Azad University, Isfahan (Khorasgan) Branch
Full name of responsible person
Parvin Jamshidian Qaleh Shahi
Position
Psychology phd student
Other areas of specialty/work
Street address
University Blvd, Arqavanieh, Eastern Jey Street , Isfahan.
City
Khorasgan
Postal code
Phone
+98 31 3535 4001
Fax
Email
p.jamshidian@khuisf.ac.ir
Web page address
www.khuisf.ac.ir/prof/Pa.Jamshidian

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University, Isfahan (Khorasgan) Branch
Full name of responsible person
Dr. Asghar Aghaei
Position
phd in clinical Psychology
Other areas of specialty/work
Street address
University Blvd, Arqavanieh, Eastern Jey Street , Isfahan.
City
Khorasgan
Postal code
Phone
+98 31 3535 4001
Fax
Email
aghaeipsy@gmail.com
Web page address
www.khuisf.ac.ir/prof/a.aghaei

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University, Isfahan (Khorasgan) Branch
Full name of responsible person
Parvin Jamshidian Qaleh Shahi
Position
Psychology phd student
Other areas of specialty/work
Street address
University Blvd, Arqavanieh, Eastern Jey Street , Isfahan.
City
Khorasgan
Postal code
Phone
+98 31 3535 4001
Fax
Email
p.jamshidian@khuisf.ac.ir
Web page address
www.khuisf.ac.ir/prof/Pa.Jamshidian

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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