This study compares the effect of problem solving and relaxation training on depressive symptoms in the postpartum period. In this clinical trial, women in the 20-15days postpartum are enrolled with the Edinburgh depression score 10 or higher and Beck Depression Inventory score 28-14with twin single healthy infant weighing 2500 g or higher. Women with symptoms of postpartum disease, history of medical illnesses, chronic neurological disorders, history of previous depression or mother or infant in a hospital bedridden and there stressful events in life are excluded. Women in the third week after delivery of health centers in Mashhad randomly select three groups of problem solving skills, relaxation and control. Problem solving training group, five stages of problem solving is implemented to reduce symptoms of depression appeared in person weekly for 6 weeks. Relaxation group, in addition, progressive muscle exercises is implemented for about 15-10 minutes during the four weeks daily at home, as well as guided imagery for about 20-10 minutes Weekly in Health Center. Beck Depression Inventory will be completed and scores in the three groups will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138810152956N2
Registration date:2011-01-02, 1389/10/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-01-02, 1389/10/12
Registrant information
Name
Masoumeh Kordi
Name of organization / entity
Nursing and Midwifery Schoo, Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1859 1511
Email address
kordim@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2009-12-28, 1388/10/07
Expected recruitment end date
2010-11-28, 1389/09/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of the effect of problem solving skills training and relaxation on severity of depression symptoms in postpartum period
Public title
Problem solving training, relaxation, severity of postpartum depression symptoms
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Monogamy, Edinburgh depression score10 and higher, Beck Depression Inventory score of 14 to 28, gestational age 42-38 weeks, birth weight above 2500 grams, infants apparently healthy, single infant.
Exclusion criteria: symptoms of postpartum blues, chronic medical disease and neurological disorders, previous history of depression, medication, hospitalization of baby or mother in the hospital after delivery, stressful life events.
Age
From 18 years old to 35 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Ethics Committee of Mashhad University of Medical Sciences
Street address
Ghoreishi building, Daneshgah ave, Mashhad
City
Mashhad
Postal code
Approval date
2009-12-16, 1388/09/25
Ethics committee reference number
88361
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
severity of depression symptoms
Timepoint
9 weeks after delivery
Method of measurement
beck depression inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention 1: In the problem solving group, problem solving skills is performed for women third week after delivery during the six sessions for 45-50 minutes weekly. Each session is run based on Depressive symptoms of person. Reduce symptoms, is presented solutions by the woman and selected best solution among them to solve and performed by her. At the beginning of each session, questioned feedback for improving the symptoms of the person. Beck Depression Inventory is again completed 9 weeks after delivery.
Category
Behavior
2
Description
Intervention 2: In relaxation group, progressive muscle relaxation (contracting and relaxing 16 muscle groups) is taught by the researcher during the first two sessions and then is done daily for 10-15 minutes using training tapes by mothers at home within 4 weeks. Visualization of beach, forest, pilgrimage places, green space and environmental good climate is executed for 10-20 minutes weekly during the 4 session on health centers. Beck Depression Inventory is again completed 9 weeks after delivery.
Category
Behavior
3
Description
Intervention 3: In the control group, conventional obstetric care is done per week 2, 6 and 8 after delivery for women according to the manual application specific of native country safe midwife - general practitioner. Also, women recorded daily checklist of symptoms of depression and refferd severe major depression and suicidal thoughts. Beck Depression Inventory is again completed 9 weeks after delivery.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Selected Health Centers -Regions of 2 and 3 in Mashhad
Full name of responsible person
Massomeh Kordi
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad, University of Medical Sciences, Mashhad, Iran
Full name of responsible person
Vice chancelloer for research
Street address
Mashhad Faculty of Nursing and Midwifery, Ebne sina St., Chaharah Doktora Crossing
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad, University of Medical Sciences, Mashhad, Iran
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
Mashhad Faculty of Nursing and Midwifery
Full name of responsible person
Massomeh Kordi
Position
M.Sc. of Midwifery
Other areas of specialty/work
Street address
Mashhad Faculty of Nursing and Midwifery, Ebne sina St., Chaharah Doktora Crossing
City
Mashhad
Postal code
Phone
+98 51185915113
Fax
Email
kordim@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad Faculty of Nursing and Midwifery
Full name of responsible person
Massomeh Kordi
Position
M.Sc. of Midwifery
Other areas of specialty/work
Street address
Mashhad Faculty of Nursing and Midwifery, Ebne sina St., Chaharah Doktora Crossing
City
Mashhad
Postal code
Phone
+98 51 1859 1511
Fax
Email
kordim@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Nursing and Midwifery
Full name of responsible person
Massomeh Kordi
Position
M.Sc. of Midwifery
Other areas of specialty/work
Street address
Mashhad Faculty of Nursing and Midwifery, Ebne sina St., Chaharah Doktora Crossing
City
Mashhad
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)