This open-label randomized clinical trial was performed from 2019 to 2020. Random sampling was conducted among the mothers who had just given birth and met the criteria for the study. They were randomly assigned to two groups using the method of randomized blocks with sealed envelopes. The weighing person did not know about group assignments. Postpartum depression was evaluated using the Edinburgh Postpartum Depression Questionnaire, which includes 10 questions. The total score is 30, and scores higher than 10 indicate postpartum depression. The researchers have reported the validity of the Persian version of the scale test is 0.8 and Cronbach’s alpha of 0.77, with a sensitivity of 95.3% and specificity of 87.9% (
21).
Considering the significance of a 200 g difference between the mean weight changes and the standard deviation of 300 grams in each group, with the test power of 90% and the type 1 error probability of 5%, based on the following formula, 48 cases were needed in each group. Considering the 10% dropout rate, we included 55 people in each study group.
The inclusion criteria were singleton pregnancies, the Edinburgh questionnaire score of more than nine, and being able to utilize social media applications like Telegram. Also, multi-gravid women and those with complicated conditions, such as hypertensive disorder of pregnancy, diabetes, and delivery bleeding, were excluded from the study. In total, 1,034 women completed the Edinburgh questionnaire, and only 129 had a score of more than nine (10 or more) and filled out the informed consent form. Nine patients were excluded due to no access to social media applied in this study. Fourteen women were excluded due to pregnancy complications, i.e., preeclampsia and diabetes. In addition, four other cases were excluded due to multiple birth, stillbirth, neonatal death, and prior depression. Finally, 102 cases were randomly divided into two groups, including 52 in ICBT and 55 in drug therapy groups.
In this study, the Declaration of Helsinki was respected throughout the study. Also, this study was approved by the Ethics Committee of the Tehran University of Medical Sciences (IRB code: 9421744011). Baseline data, including age, pregnancy weight gain, body mass index (BMI), and infant’s birth weight, sex, and feeding data, were recorded. The subjects were randomly assigned to receive either medical treatment (sertraline 50 mg/day) or ICBT (cognitive behavioral therapy including depression symptoms, controlling anxiety and depression, coping strategies, the role of negative thoughts and their relationships with emotions, problem-solving skills, monitoring mood and improving depressed mood, relaxation training, and teaching effective behavioral styles). Virtual content was sent via text messages through Telegram.
The facilitator visited all patients in person three times during the study period. The first meeting was to explain the plan and the type of treatment. The second visit was performed when the baby was two months old, and the third was done at four months old. The purpose of the second and third visits was to find the cases of exacerbation or suicidal thoughts. So, if the patient suffered from those problems, she could no longer participate in this study; however, there were no such cases. If people had a problem with the treatment, it would be considered. During this period, telephone counseling was available to patients five days a week, and they could call in case of any problem. In the follow-up, the weight of infants in both groups was assessed by a calibrated Seca scale at the age of two and four months, and the mothers completed the Edinburgh questionnaire.
Statistical analyses were accomplished by SPSS version 24.0 (Chicago, Illinois, United States). Depression status and infants’ weight at different time points were analyzed using repeated-measures ANOVA and independent-sample t test. The p-values of less than 0.05 were considered statistically significant. All numerical data are represented as mean ± standard deviation (SD).