Comparison of effectiveness of computerized stress inoculation therapy (SIT) with Part-time face-to-face SIT in improvement of symptoms of anxiety, depression and stress in pregnant women with psychological distress
Comparison of effectiveness of computerized Stress Inoculation Therapy (SIT) with Part-time face-to-face SIT in improvement of symptoms of anxiety, depression and stress in pregnant women with psychological distress
Design
A non-inferiority randomized controlled clinical trial with two parallel arms
Settings and conduct
Pregnant women who go to Rouhani and Yahya Nejad Hospitals in Babol for routine prenatal care are selected by availability and then complete the BSI-18 Psychiatric Distress Screening Questionnaire. Pregnant women with a T-score above 63 on the Global Severity Index (GSI) are diagnosed with psychological distress. At the same clinic, a nurse or midwife outside the research team first completes the NuPDQ-17 Pregnancy Stress Questionnaire and the General Perceived Stress Questionnaire (PSS-14). Then, they are randomly assigned to the intervention and routine pregnancy care groups in a block method.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Being in the 14-32 weeks of pregnancy, at least a third year of middle school, Internet access and the ability to use a computer, not using psychotherapy services right now
Exclusion criteria: women with mental disabilities, severe psychiatric disorders, drug abuse
Intervention groups
Intervention group A will be received computerized SIT. Intervention group B receives individually Part-time face-to face SIT. Group B receives treatment sessions with 3 face-to-face sessions and 3 computer sessions as one in between. Both groups receive routine prenatal care. The duration of treatment for both groups is similar, 6 sessions, once a week for 60 minutes.
Main outcome variables
Psychological symptoms of the BSI-18 and the specific stress of pregnancy NuPDQ-17.
A secondary outcome is generalized perceived stress (PSS-14).
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200122046228N1
Registration date:2020-10-28, 1399/08/07
Registration timing:prospective
Last update:2020-10-28, 1399/08/07
Update count:0
Registration date
2020-10-28, 1399/08/07
Registrant information
Name
Fatemeh Nasiri Amiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3230 2823
Email address
f.nasiri@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-31, 1399/08/10
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effectiveness of computerized stress inoculation therapy (SIT) with Part-time face-to-face SIT in improvement of symptoms of anxiety, depression and stress in pregnant women with psychological distress
Public title
The effect of computerized stress inoculation therapy (SIT) vs Part-time face-to-face SIT on anxiety , depression , and stress in pregnant women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study
Being in the 14th-32nd week of pregnancy
No current psychotherapy services
Lack of a history of psychiatric disorder
At least a third year of middle school
Internet access and the ability to use of computer
Exclusion criteria:
People with mental disabilities
Severe psychiatric disorders such as Psychotic disorder, Bipolar disorder, Suicide risk,
Drug abuse
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
After checking inclusion and exclusion criteria, participants are allocate randomly into two groups by permuted block randomization method. The block size is 4 and by using the statistical software, 4 part blocks will be produced 24 times. Due to the fact that sampling is done in two centers, two samples of 96-list will be produced. Using this randomly generated list, participants are divided into two groups of 48 people.
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 Babol University of Medical Sciences
Street address
Ganj Afrooz St., Babol University of Medical Sciences
Before the intervention and immediately after the intervention
Method of measurement
Anxiety and depression and somatization with Brief Symptom Inventory–18 (BSI-18) pregnancy-specific stress questionnaire ( NuPDQ-17) for pregnancy-specific stress
Secondary outcomes
1
Description
General perceived stress
Timepoint
Before the intervention and immediately after the intervention
Method of measurement
Cohen General Perceived Stress Questionnaire (PSS-14)
Intervention groups
1
Description
Intervention group 1: The participants in this group at 14 to 34 weeks of pregnancy in addition to receiving prenatal care, receive computerized Stress Inoculation Therapy (SIT), 6 session , 60 minutes, once a week. Content of SIT: Session 1: Introducing and explaining the goals, describing the symptoms and their effects on mother and baby, conceptualizing the problem, explaining how this method reduces distress and anxiety. Session 2: Teaching body relaxation and continuing these exercises at home in Intervals between sessions, Session 3: Relaxing the body, challenging stressful thoughts, learning to talk to yourself and identifying the role of negative thoughts in creating these feelings, assign homework and practice body relaxation at home. Session 4: Body relaxation, teaching problem solving skills, assigning tasks, and practicing body relaxation at home, Session 5: Relaxation of the body, training techniques of concentration and distraction of the mind, away from unsolvable stressful issues, assigning homework and practicing body relaxation at home, Session 6: Practicing the skills learned in previous sessions in the training session and then gradually in real life events, especially in stressful situations
Category
Treatment - Other
2
Description
Intervention group 2: The participants in this group at 14 to 34 weeks of pregnancy in addition to receiving prenatal care, receive individually Part-time face-to-face stress inoculation therapy, 6 sessions, 60 minutes, once a week. They receive treatment sessions with 3 face-to-face sessions and 3 computer sessions as one in between. Content and duration of treatment for both groups is similar, 6 sessions, once a week for 60 minutes.