The aim of this study was to evaluate the effect of computerized cognitive behavioral therapy on postpartum depression.
Design
Clinical trial with control group, Randomized. The sample size in each intervention and control group is 38 depressed mothers.
Settings and conduct
Health Centers in Kerman Province.
Blinding is not performed.
Participants/Inclusion and exclusion criteria
inclusion criteria : Having Edinburgh's depression test score greater than 13, passing 4-6 weeks of delivery.
exclusion criteria : Not having smart phones, using antidepressants or psychotherapy.
Intervention groups
In the intervention group, depressed mothers used computerized cognitive behavioral therapy during a two-month period. In the control group, depressed mothers did not use computerized cognitive behavioral therapy.
Main outcome variables
Edinburgh Depression Test
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171017036845N1
Registration date:2018-07-30, 1397/05/08
Registration timing:retrospective
Last update:2018-07-30, 1397/05/08
Update count:0
Registration date
2018-07-30, 1397/05/08
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5700
Email address
n.janati@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-04, 1397/01/15
Expected recruitment end date
2018-06-05, 1397/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Computerized Cognitive behavioral therapy for recovery of postpartum depression: randomized controlled trial
Public title
Cognitive Behavioral Therapy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Have an Edinburgh Depression Score of over 13
Mothers in postpartum period
Exclusion criteria:
Not having smart phone
Unwilling to participate in the study
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization : All mothers who referred to health centers had the Equal chance of being selected.Mother's National Code was written on paper, placed in a container and stirred well. Then the sample was selected with a given volume.
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 kerman University of Medical Sciences
Street address
Haft-Bagh Highway, Kerman, Iran
City
kerman
Province
Kerman
Postal code
7616913555
Approval date
2018-07-24, 1397/05/02
Ethics committee reference number
IR.KMU.REC.1397.143
Health conditions studied
1
Description of health condition studied
postpartum depression
ICD-10 code
F53.0
ICD-10 code description
Mild mental and behavioural disorders associated with the puerperium, not elsewhere classified
Primary outcomes
1
Description
Edinburgh Depression Test Score
Timepoint
Before the intervention begins,End of intervention (2 months later)
Method of measurement
Using the Edinburgh Depression questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: mothers who had postpartum depression used the cognitive behavioral therapy program for 2 months
Category
Behavior
2
Description
Control group: Depressed mothers in the control group did not use any cognitive behavioral therapy program.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Kerman Health Center
Full name of responsible person
Nazanin Jannati
Street address
Shafa Street
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3121 5600
Email
n.janati@kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Koros Divsalar
Street address
Somayeh Road, at the beginning of Jihad Boulevard, at the beginning of Ibn Sina Street, opposite Besat Clinic
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 4180
Email
kerman.neuroscience@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Nazanin Jannati
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Medical Informatics
Street address
Modares Street
City
Kerman
Province
Kerman
Postal code
76176636636
Phone
+98 34 3334 1334
Email
nazaninjannati@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Nazanin Jannati
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Medical Informatics
Street address
Modares street
City
Kerman
Province
Kerman
Postal code
7616636636
Phone
+98 34 3334 1334
Email
nazaninjannati@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Nazanin Jannati
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Medical Informatics
Street address
Modares Street
City
Kerman
Province
Kerman
Postal code
7616636636
Phone
+98 34 3334 1334
Email
nazaninjannati@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Demographics of patients and their depression test score are shared without their identification information.
When the data will become available and for how long
6 months after printing results
To whom data/document is available
Researchers working in academia and academia
Under which criteria data/document could be used
In order to compare the data from this method with other methods, the data can be shared with other researchers.
From where data/document is obtainable
Dr Leila Ahmadian, ahmadianle@yahoo.com , kerman university of medical science
What processes are involved for a request to access data/document
To receive the data, please contact Dr. Ahmadian's email. After reviewing a request, 4-7 business days are requested upon request