Protocol summary

Study aim
Effect of acceptance and commitment therapy counseling on postpartum depression in unwanted pregnancies
Design
This study is clinical trial and double blind. We divided 40 patients randomly in two groups. We do 20 person in intervention group and 20 person in control group.
Settings and conduct
This study is clinical trial and double blind. We divided 40 patients randomly in two groups. We do 20 person in intervention group and 20 person in control group. Population of this study is women referring to health care centers in Arak for receiving postpartum care.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 18-45 years; women in duration one and six months after childbirth; minimum diploma education; not psychiatric disease; absence of medical conditions; no history of previous depression Exclusion criteria: failure to follow up
Intervention groups
For the intervention group, we hold up treatment based on acceptance and commitment therapy counseling each week in 8 sessions (each sessions 90-minute) in Arak health center hall. There is no intervention for the control group.
Main outcome variables
Effect of acceptance and commitment therapy counseling on postpartum depression in unwanted pregnancies

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180118038424N1
Registration date: 2018-04-10, 1397/01/21
Registration timing: registered_while_recruiting

Last update: 2018-04-10, 1397/01/21
Update count: 0
Registration date
2018-04-10, 1397/01/21
Registrant information
Name
Samaneh Shojaeifar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 7850
Email address
s.shojaiefar@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-12-22, 1397/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of acceptance and commitment therapy counseling on postpartum depression in unwanted pregnancies
Public title
Effect of acceptance and commitment therapy counseling on postpartum depression in unwanted pregnancies
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
18-45 years Women in duration one and six months after childbirth Minimum diploma education Not psychiatric disease Absence of medical conditions No history of previous depression
Exclusion criteria:
Failure to follow up
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with random number tables
Blinding (investigator's opinion)
Double blinded
Blinding description
Participant and data analyzer are unaware of grouping(double blind).
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee Arak University Of Medical Sciences
Street address
Vice chancellor for research, Payambar azam complex, Basij squre, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3814957558
Approval date
2017-11-26, 1396/09/05
Ethics committee reference number
IR.ARAKMU.REC.1396.175

Health conditions studied

1

Description of health condition studied
Unwanted pregnancy
ICD-10 code
Z64.0
ICD-10 code description
Problems related to unwanted pregnancy

Primary outcomes

1

Description
Depression
Timepoint
Before and after sessions of consultation and two months after end of the sessions
Method of measurement
Questionnaire of Beck Depression

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: For the intervention group, we hold up treatment based on acceptance and commitment therapy counseling each week in 8 sessions (each sessions 90-minute) in Arak health center hall.
Category
Treatment - Other

2

Description
Control group: There is no intervention for the control group.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
health care centers in Arak
Full name of responsible person
Naeeme Akbari Torkestani
Street address
Payambar azam complex, Basij squre, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3914334911
Phone
+98 86 3417 3505
Fax
+98 86 3417 3638
Email
S.shojaiefar@arakmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Arjmandzadegan
Street address
Vice chancellor for research, Payambar azam complex, Basij squre, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3417 3638
Fax
+98 86 3417 3638
Email
arjmandzadegan@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr Hamidreza Jamilian
Position
Assisstant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Amirkabir hospital, parastar squre
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3313 7515
Fax
+98 86 3313 7515
Email
jamilian@arakmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Naeeme Akbari Torkestani
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Midwifery and nursing school, Payambar azam complex, Basij squre, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3417 3505
Fax
+98 86 3417 3638
Email
Torkestani@arakmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Samane Shojaiefar
Position
Student Master
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Midwifery and nursing school, Payambar azam complex, Basij squre, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3417 3505
Fax
+98 86 3417 3638
Email
S.shojaiefar@arakmu.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
When we publish article in journal.
When the data will become available and for how long
After the article is published
To whom data/document is available
researcher in university
Under which criteria data/document could be used
If there are additional questions
From where data/document is obtainable
Mrs Naeeme Akbari Torkestani
What processes are involved for a request to access data/document
They have to write letters to the professors and the university
Comments
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