Protocol summary

Study aim
Comparison the Effectiveness of Cognitive Behavioral Therapy and Mindfulness-Based Stress Reduction on Anxiety, Psychological Well-being, Marital Satisfaction and Maternal Neonatal Outcomes of Nuliparous women
Design
A randomized controlled clinical trial with parallel groups, Randomized block, sample size 45 (15 persons per group)
Settings and conduct
Prior to the start of the sessions and obtaining a license, all three groups completed the Anxiety Questionnaire, Psychological Welfare, and Marital Satisfaction. Then, the experimental group A (mindfulness-based stress reduction) and experimental group B (cognitive-behavioral therapy) were grouped weekly among women in the Tehran Health Center. The control group did not intervene. The study is being held at the Tehran Health Center.
Participants/Inclusion and exclusion criteria
Inclusion Criteria were being Iranian, age 35-20 years, being primitive, literacy, no history of miscarriage or intrauterine death and infertility, no pregnancy problems (blood pressure, bleeding, diabetes, thyroid disease, Congenital anomalies, fetal anomalies), no adverse events over the past 6 months, no addiction, and no treatment for psychiatric disorders. Exclusion Criteria were lack of cooperation of the sample group in each stage of research and having physical and physical problems and a history of psychiatric problems.
Intervention groups
For the first Mindfulness-based stress reduction, for the second group cognitive behavior therapy, and in the third group, no intervention will be performed.
Main outcome variables
Anxiety, psychological well-being, marital satisfaction and maternal consequences

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200514047449N1
Registration date: 2020-06-28, 1399/04/08
Registration timing: registered_while_recruiting

Last update: 2020-06-28, 1399/04/08
Update count: 0
Registration date
2020-06-28, 1399/04/08
Registrant information
Name
Elahe Shahtaheri
Name of organization / entity
Islamic azad university kish,iran
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 5703
Email address
e.shahtaheri@iaukishint.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-11, 1398/09/20
Expected recruitment end date
2020-07-15, 1399/04/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the Effectiveness of Cognitive Behavioral Therapy and Mindfulness-Based Stress Reduction on Anxiety, Psychological Well-being, Marital Satisfaction and Maternal Neonatal Outcomes of Nuliparous women
Public title
Comparison the Effectiveness of Cognitive Behavioral Therapy and Mindfulness-Based Stress Reduction on Anxiety, Psychological Well-being, Marital Satisfaction and Maternal Neonatal Outcomes of Nuliparous women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Being Iranian Age range 20 to 35 years Being primitive Have literacy No history of miscarriage or intrauterine death and infertility Absence of pregnancy problems (blood pressure, bleeding, diabetes, thyroid disease, placenta previa, fetal anomalies) No accidents during the last 6 months Not addicted and not being treated for psychiatric disorders
Exclusion criteria:
No cooperation of the sample group at each stage of the study Having physical and physical problems and a history of psychiatric problems
Age
From 20 years old to 35 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
Using the block randomization method by the statistical consultant, the following randomization is done in 3 groups of cognitive behavior therapy (CBT), Mindfulness-based stress reduction (MBSR) and control: First, the list of names of qualified people is provided and coded. In block randomization, the number of participants in all groups will be very close, this is done by building blocks of sequences and intersections so that the same number of participants are allocated to study groups within each group. First, we encode the groups based on the Latin letters as follows: A =cognitive behavior therapy, B = Mindfulness-based stress reduction and C control group In this study, with three groups A, B and C, we create the following six groups and assign the numbers 1 to 6 to each: ABC-ACB-BAC-BCA-CAB-CBA Then, using the table of random numbers, we contract that if the numbers 1, 2, 3, 4, 5, 6, and 6 appear in order, one of these blocks will be selected, and if another number appears, we will assume it to be null and void and move on to the next selection. In fact, we have obtained a random sequence of numbers with a table of random numbers, which we consider the order of the assigned allocation for each number. In this way, the number of people in the groups will be almost equal.
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 Hormozgan University of Medical Sciences
Street address
No. 64, Janbazan Ave., North Karegar Street
City
Kish
Province
Hormozgan
Postal code
1437697419
Approval date
2019-12-07, 1398/09/16
Ethics committee reference number
IR.HUMS.REC.1398.337

Health conditions studied

1

Description of health condition studied
Pregnancy
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Anxiety
Timepoint
Measurement will be done in pre-test, post-test and follow-up three months after post-test
Method of measurement
Beck Anxiety Inventory

2

Description
Psychological well-being
Timepoint
Measurement will be done in pre-test, post-test and follow-up three months after post-test
Method of measurement
Psychological well-being Questionnaire

3

Description
Marital satisfaction
Timepoint
Measurement will be done in pre-test, post-test and follow-up three months after post-test
Method of measurement
Marital satisfaction Questionnaire

4

Description
Infant Maternal Consequences
Timepoint
Measurement will be done in pre-test, post-test and follow-up three months after post-test
Method of measurement
Checklist of Infant Maternal Consequences

Secondary outcomes

empty

Intervention groups

1

Description
First Intervention Group: MBSR-based stress reduction training was conducted for 8 weekly sessions (120 minutes each session) for the experimental group. The regular routine of each session included reviewing the homework of the previous session, feedback on existing questions and problems, teaching the intended materials and techniques, meditation skills, discussing stress and coping techniques, and presenting homework.
Category
Treatment - Other

2

Description
Second Intervention Group: Cognitive Behavioral Therapy refers to the training that is performed once a week for 10 sessions and for 45 minutes each session for mothers. Familiarity with the process of childbirth is marital satisfaction.
Category
Treatment - Other

3

Description
Control group: No Intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran Health Center
Full name of responsible person
Elahe Shahtaheri
Street address
No. 11, West Azerbaijan Ave., Valiasr Blvd.
City
Tehran
Province
Tehran
Postal code
2578695784
Phone
+98 21 8457 9643
Email
elishah1348@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Alireza Roosta
Street address
Kish Island, Sana'i Boulevard, Free Zone Organization Square, Islamic Azad University of Kish International Branch.
City
Kish
Province
Hormozgan
Postal code
7941775883
Phone
+98 76 4442 2720
Email
Info@Iaukishint.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Elahe Shahtaheri
Position
Student
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Nombr 26, #4 Alley Ali hosseini ST, Niazzadeh ST, Zaferanieh AVE, valieasr, Tehran
City
Tehran
Province
Tehran
Postal code
2578695784
Phone
+98 21 2243 5703
Fax
Email
e.shahtaheri@iaukishint.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Elahe Shahtaheri
Position
Student
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Nombr 26, #4 Alley, Ali hosseini ST, Niazzadeh ST, Zaferanieh AVE, valieasr, Tehran
City
Tehran
Province
Tehran
Postal code
2578695784
Phone
+98 21 2243 5703
Fax
Email
e.shahtaheri@iaukishint.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Elahe Shahtaheri
Position
Student
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Nombr 26, #4 Alley, Ali hosseini ST, Niazzadeh ST, Zaferanieh AVE, valieasr, Tehran
City
Tehran
Province
Tehran
Postal code
2578695784
Phone
+98 21 2243 5703
Fax
Email
e.shahtaheri@iaukishint.ac.ir

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
Yes - There is a plan to make this available
Title and more details about the data/document
Only part of the data, such as information about the main outcome or the like, can be shared.
When the data will become available and for how long
Start of access period 6 months after printing results
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
Any type of analysis on the data delivered is permitted
From where data/document is obtainable
Elahe Shahtaheri Adress: No. 11, West Azerbaijan Ave., Valiasr Blvd. Tel: +98 21 8457 9643
What processes are involved for a request to access data/document
The request will be sent by email to: elishah1348@gmail.com
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