This study is a randomized controlled clinical trial that was performed on 102 primiparous women referred to South Health Centers affiliated to Tehran University of Medical Sciences. The participants were assigned into two groups of experimental and control, from June 1st, 2019 to April 21st, 2020.
The sample size calculation was based on Mir Molaei et al. study (18) that showed a standard deviation of 1.11 and 0.86 for anxiety in intervention and control groups respectively, and to discover a minimum difference of 2.48 among the three groups. Finally, with considering an attrition rate of 20%, the total sample size was calculated as 105 (35 in each group).
Inclusion criteria include: being primiparous, gestational age of 25-28 weeks, being able to read and write, having singleton pregnancy, having contact number, wanted pregnancy, score of 11-20 from Beck’s Depression Inventory (mild depression), mild depression based on the depression subscales', mild to moderate stress and anxiety based on the stress and anxiety subscales' from DASS21 questionnaire.
Exclusion criteria include: having mental problems before pregnancy, using psychotropic drugs, alcohol and cigarette, having high-risk pregnancies that put a lot of stress on the mother, such as (diabetes, cancer, high blood pressure, kidney disease, MS, lupus), having family history of congenital anomalies or fetal abnormalities in the current pregnancy, reporting occurrence of acute stressful events in the last 6 months and during the study (such as the death of relatives, spouse, sudden economic problems, marital problems, and divorce), intrauterine death in the current pregnancy, delivery earlier than 37 weeks of pregnancy during the study, maternal death, unwillingness to continue cooperation for any reason, and writing less than twice a week.
Random allocation, concealment, and blinding
Random allocation was done by a statistician, using an online generated randomization list (provided by sealedenvelope.com). It was done based on random blocking and 6 blocks. A randomized list of researchers conducting assessment and intervention in pregnant women was hidden by sealed envelopes. In this study, the analyst was blind, so he was unaware of the type of grouping and the type of intervention received.
Outcomes and Research Tools
The data were collected using demographic questionnaires, Beck’s Depression Inventory and DASS21. The demographic form included seven questions on age, mother’s education, mother’s occupation, spouse’s occupation, financial status, and marriage duration and gestational age.
The Beck’s Depression Inventory contains 21 items. These items are related to various symptoms of depression. The participants were asked to rate the severity of these symptoms on a 4-point Likert scale from 0 to 3. These tests are self-assessment and range from 0 to 63. (22). The reliability and validity of this standard inventory have already been examined and approved in several Iranian studies including Ghasemzadeh et al.(23).
The DASS 21 self-report questionnaire was used to measure stress, anxiety, and depression. This is the short form of the DASS42. This questionnaire consists of 7 questions for all three subscales. The scoring for each question is based on a Likert-type scale from “not at all” (0) to “very high” (3) (24). The validity of the Persian version of this questionnaire was confirmed and approved by Mollahadi (2010) and its reliability was confirmed using Cronbach's alpha method of α = 0.91 (25).
First, the demographic questionnaire and then Beck’s Depression Inventory were given to the individuals for clinical depression screening. If they obtained a score of 11-20 (mild depression) from this questionnaire and were meeting other inclusion criteria, they would enter the next stage. Cases of moderate to severe depression were referred to a psychological consultant.
In the next step, mothers of three groups were given a DASS21 questionnaire. In case of mild depression on the depression subscale, mild to moderate anxiety on the anxiety subscale and mild to moderate stress on the stress subscale, the samples were included in the study.
Mothers in expressive writing group were instructed to write twice a week for 2 months about their deep feelings and thoughts about pregnancy, the fetus, and the issues that made them anxious and or happy during this period. Do not worry about spelling and grammatical mistakes. Mothers should write in a quiet environment to stay focused, and they should continue writing for 15-20 minutes. Mothers should pay attention to this point that really should bring their deepest feelings to paper.
Instructions were given to mothers of daily activity writing group and according to these instructions, they were instructed to merely write down their daily activities and they should continue writing for twice a week for two months each time without time limit. Mothers in this group should avoid engaging their thoughts and feelings while writing. The researcher was in contact with the mothers of both test groups every week and supervised their activities and if the participants had any problems or questions, she would answer them.
The control group received routine care according to national guidelines and did not receive any intervention.
All three groups completed the DASS21 questionnaire before the intervention, four and eight weeks after the intervention.
Chi-square and Fisher tests were used to analyze qualitative variables and ANOVA test was used to analyze quantitative variables