Comparing the Effectiveness of Training in Cognitive Behavior Therapy (CBT) and Acceptance and Commitment Therapy (ACT) on Anxiety and Depression among the Mothers with Premature Infants and Assessment of the Prevalence Rate of these Disorders
Objective: To compare the effectiveness of CBT and ACT therapies education on depression and anxiety of mothers with preterm infants
Study design: Random (shuffle bags method), without placebo control, single central.
Experimental population: all fertility females in aged 18-45 years
Inclusion criteria: alive premature infants; the baby will be single; Lack of comorbidities; non-use drug and psychotropic drug abuse and not using alcoholic beverages; having ability of write and read; non-use of drug; three days have passed since childbirth
Exclusion criteria: absence of two or more in treatment sessions; lack of answer to five or more question of the questionnaire.
Sample size, intervention, intervention time and outcome of the study: sample size of this study is 45 persons will be divided into three groups with 15 persons (2 groups are intervention and one group is control).
First intervention group (CBT- cognitive behavioral therapy): Treatment sessions in 10 sessions (1 session per week, each session about 60 minutes during 2 months) will be performed according to the protocol (Kennedy et al, 2012). The measurements will be perform in before and after treatment.
Second intervention group (ACT- Acceptance and commitment treatment): Treatment sessions in 10 sessions (1 session per week, each session about 60 minutes during 2 months) will be performed according to the protocol (Forman & Herbert, 2008). The measurements will be perform in before and after treatment.
Control group: In the control group (15 persons) will not performed any intervention just the results compared with experimental group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017073125732N21
Registration date:2017-08-25, 1396/06/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-08-25, 1396/06/03
Registrant information
Name
Alireza Emadi
Name of organization / entity
Semnan University of Medical Sciences, Semnan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 1336
Email address
are20935@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Semnan Branch, Islamic Azad University
Expected recruitment start date
2017-07-25, 1396/05/03
Expected recruitment end date
2018-05-22, 1397/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Effectiveness of Training in Cognitive Behavior Therapy (CBT) and Acceptance and Commitment Therapy (ACT) on Anxiety and Depression among the Mothers with Premature Infants and Assessment of the Prevalence Rate of these Disorders
Public title
Comparing the Effectiveness of Training in Cognitive Behavior Therapy (CBT) and Acceptance and Commitment Therapy (ACT) on Anxiety and Depression among the Mothers with Premature Infants and Assessment of the Prevalence Rate of these Disorders
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: alive premature infants; the baby will be single; Lack of comorbidities; non-use drug and psychotropic drug abuse and not using alcoholic beverages; having ability of write and read; non-use of drug; three days have passed since childbirth
Exclusion criteria: absence of two or more in treatment sessions; lack of answer to five or more question of the questionnaire.
Age
From 18 years old to 45 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
Ethics Committee, Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Postal code
3514799442
Approval date
2017-07-24, 1396/05/02
Ethics committee reference number
IR.semums.REC.1396.103
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified
Primary outcomes
1
Description
Depression
Timepoint
Before and after intervention
Method of measurement
Questionnaire Postpartum depression, Edinburgh
2
Description
Anxiety
Timepoint
Before and after intervention
Method of measurement
Questionnaire Anxiety zank
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group (CBT- cognitive behavioral therapy): Treatment sessions in 10 sessions (1 session per week, each session about 60 minutes during 2 months) will be performed according to the protocol (Kennedy et al, 2012). The measurements will be perform in before and after treatment.
Category
Diagnosis
2
Description
Second intervention group (ACT- Acceptance and commitment treatment): Treatment sessions in 10 sessions (1 session per week, each session about 60 minutes during 2 months) will be performed according to the protocol (Forman & Herbert, 2008). The measurements will be perform in before and after treatment.
Category
Diagnosis
3
Description
Control group: In the control group (15 persons) will not performed any intervention just the results compared with experimental group.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Hospital
Full name of responsible person
Roghayeh Omrani
Street address
Blvd Mostafa Khomeini, Semnan
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Semnan University of Medical Sciences
Full name of responsible person
Dr Mohammad Reza Asgari
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Semnan University of Medical Sciences
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
Semnan Branch, Islamic Azad University
Full name of responsible person
Abolfazl Karami
Position
PhD in Psychology
Other areas of specialty/work
Street address
Islamic Azad University, Damghan 5 km Road, Semnan
City
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Fax
Email
are20935@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan Branch, Islamic Azad University
Full name of responsible person
Abolfazl Karami
Position
PhD in Psychology
Other areas of specialty/work
Street address
Islamic Azad University, Damghan 5 km Road, Semnan
City
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Fax
Email
are20935@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan Branch, Islamic Azad University
Full name of responsible person
Abolfazl Karami
Position
PhD in Psychology
Other areas of specialty/work
Street address
Islamic Azad University, Damghan 5 km Road, Semnan
City
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)