Study procedure and participants
This study was an interventional study that was conducted from August 2021 to March 2022. The target population were depressed pregnant Iranian women in their 20 to 28 weeks of pregnancy who were followed up to 6 months after delivery. The intervention was carried out in healthcare centers and health stations located in the south of Tehran and affiliated with Tehran University of Medical Sciences. The South Tehran Health Center includes 29 healthcare centers, each covering two to five health stations (14). It also has four health houses, two counseling centers for behavioral diseases, and a specialized psychiatric center for primary health services. The health stations provide primary health services such as maternal care, infant care, school health, and nutrition; the healthcare centers, however, provide medical, dental, psychological, and environmental health services in addition to the former (15). Each health station covers up to 12,500 people. Services for pregnant women are provided by a healthcare provider (midwife) with a bachelor's degree. In most healthcare centers, there is a psychologist who provides psychological services to children, adolescents, pregnant women, and older adults (16).
The inclusion criteria for this study were: depressed pregnant women in 20 to 28 weeks of pregnancy with no prior or present psychiatric disorders that require medical intervention such as schizophrenia, bipolar disorder, etc. based on psychiatrist/psychologist diagnosis, singleton pregnancy, Iranian citizenship, minimum reading and writing literacy, absence of chronic diseases, access to a smartphone and WhatsApp use. The required evaluations were made by examining the mothers' health records, posing questions to the mothers, and recruiting the psychologist to diagnose any mental illnesses in the mother. The exclusion criteria were: unwillingness to participate in the study, adverse events (death of a close relative, severe accidents, etc.), stillbirth, or infant death.
To recruit eligible pregnant women, the researcher was provided with an inventory of pregnant women and their phone numbers by the authorities in charge, and made phone calls and briefed the candidates on the program, then the Beck’s Depression Inventory-II (BDI-II) andThe Edinburgh Postnatal Depression Scale(EDPS) were sent to them through WhatsApp application. The researcher then reviewed the completed questionnaires, and if the mothers scored 13 or higher on EDPS (17), and 16 or higher on BDI-II (18), they were considered as depressed, and were invited to participate in the study. If the mothers were willing to participate, an informed consent form was completed by each of them.
Health Liaisons
In Iran's health system and in urban and rural health centers, there are people with the title of health liaison. These people cooperate with health centers on a voluntary basis. Health liaisons are periodically trained by midwives and health care workers in health centers to perform some of the tasks assigned to them. The main activities of the health liaisons include: covering up to 50 households, identifying people who need health care in the covered households, regular attendance in public education classes, identifying and following up the health problems of the neighborhood and reporting them to the officials of the health center, conveying educational material and messages to households and other members of society, group participation in cultural and social artistic activities.
According to the protocol of the World Health Organization, the implementation of THP should be done by people who are not experts in the field of psychology, because its goal is to fill the gap in mental health services and integrate them into primary health care at the lowest cost in low- and middle-income countries. This program has been carried out in different countries with the same method and has been successful
To administer the program, the researcher went to the health centers, and obtained the list of health liaisons from the relevant official and the liaisons who were qualified (minimum diploma education, high motivation and good service record) were selected, and contacted; while introducing the work and program, they were asked to declare their readiness if they wanted to cooperate. Then, healthcare liaisons received 10 sessions of training in the form of group discussion, role playing, question and answer, etc. under the supervision of a psychology professor and the researcher who had completed a CBT course and 80 hours of online training offered by an experienced psychologist. After the end of the course, their competence was determined through the ENACT checklist and the intervention was started by them. Also, continuous monitoring of their performance was implemented.
After obtaining permission from the original developers of ENACT (ENhancing Assessment of Common Therapeutic Factors) for translating and using their tool, the researcher received the latest version of this tool and carried out the standard procedures of its localization for Iran. This checklist was used to check the competence of the healthcare liaisons for administering THP, and those who scored 70% or higher (19) were deemed eligible.
Intervention
The mothers in the intervention group (n = 40) received the WHO's THP, which has been localized in Iran and some changes have been made in it, and is an evidence-based intervention with CBT strategies (11, 20, 21). The intervention was performed from the second trimester of pregnancy and lasted up to 6 months after delivery in the form of 4 modules: the first module consists of 4 sessions during pregnancy, each of the second, third and fourth modules were administered in 3 sessions with intervals of 2 to 4 weeks in the postpartum period. Due to the COVID-19 pandemic conditions, the program was implemented online through WhatsApp application by five healthcare liaisons. This group also received the MoHME protocol for the care of depressed pregnant women in addition to the routine care provided to pregnant women by healthcare workers.
The intervention consisted of a face-to-face introductory session in which the mothers were given a health calendar plus training on it; there were also four virtual training modules using WhatsApp, the first module was conducted from the second trimester of pregnancy to the 40th week of pregnancy, or delivery (four sessions), and the other three modules were presented until six months post-partum; the 2nd, 3rd, and 4th module at 2, 4, and 6 months after birth respectively (each module was covered over three sessions). The intervention was administered by video calls on WhatsApp.
After the diagnosis of depression, the mothers in the control group (n = 40) were introduced to a female healthcare worker to administer the MohME protocol devised for depressed pregnant women, and the researcher conducted a follow-up on the conclusion of these sessions. The control group also received routine pregnancy care by healthcare workers.
The healthcare liaisons administering the program were regularly and daily supervised by the experienced psychologist and the researcher by holding face to face meetings or getting feedback and reporting daily performance from health liaisons; during the intervention, various meetings were held with them to examine the problems and challenges they encountered.
Sampling, randomization, and blinding
Healthcare centers were selected from the south of Tehran by using a table of random numbers. The participants were selected by simple convenience sampling through the researcher’s visit to healthcare centers and health stations and preparing a list of eligible pregnant women with the help of the health workers in charge. After a phone call to the pregnant women and a brief explanation on the study, the candidates were registered if they orally consented to participate. After registering the participants and getting the depression score based on the scores of the questionnaires, their written consents were obtained, and they were randomly assigned to the experimental or control groups using a table of random numbers (Random Allocation). Randomization was performed by a researcher who was not involved in the registration of the participants. The experimental group participants were randomly divided among five healthcare liaisons. It was not possible to blind the healthcare liaisons or the participants in the experimental group, but the healthcare liaisons had no contact with the randomization team or the control group.
Follow-up
Women who did not wish to continue participating in the study, or experienced stillbirth or infant death or needed drug treatment (and were treated according to the protocol of the Ministry of Health) were excluded. Intervention sessions were conducted by health liaisons with prior coordination with pregnant mothers according to the THP program via WhatsApp. If the mother was not ready for the meeting, scheduling was promptly organized with the mother as soon as it was possible. In each meeting, the tasks related to the health calendar were checked by the interventionist through WhatsApp (provided by the mother). A group of mothers was formed on WhatsApp, and through this, mothers expressed their questions or their feelings and thoughts. The supervisor also participated in this group and provided answers and guidance to the mothers if needed. At the end of the first module which was 4 sessions and continued for every 2 to 4 weeks from the second trimester of pregnancy until delivery, the participants of both groups completed BDI-II and EDPS once more.
After delivery, the newborns’ anthropometric measurements were recorded in both groups from their health cards. The infants’ status in terms of jaundice, respiratory problems and hospitalization was also examined.
The second module was held from 2 weeks to 2 months after delivery in 3 sessions with an interval of 2 to 4 weeks, and the third module was conducted from 2 months to 4 months after delivery with an interval of 2 to 4 weeks. At the end of the third module (4 months after birth), the infant measurements at four months of age were recorded from the health cards, and their parents completed the ASQ at four months. At six months of age, the infants’ measurements, exclusive breastfeeding, experience of at least one bout of diarrhea (diarrhea defined as three or more loose diarrheal stools over 24 hours) and respiratory diseases were recorded, and ASQ was completed by the parents again.
In general, in this study after the recruitment of 80 pregnant women with depression and their random allocation to the two groups, THP was administered by healthcare liaisons with the continuous supervision of a psychology professor and the researcher. The introductory session was held in person, and 13 sessions were offered online to 40 mothers in the intervention group; and the mothers of both groups completed the questionnaires during and after the intervention, and the data obtained were then analyzed (Flowchart 1).
Sample size
In a 2005 study (22), Hosseinisazi et al. obtained the mean and standard deviation of the BDI-II score in pregnant women as 11.43 ± 7.57. Using this score, with a confidence level of 5% and power of 80%, the sample size was estimated as 40 mothers per study group.
Statistical analysisdepression
This instrument consists of ten items. The response options range from low to high severity (items 1, 2, 4) or vice versa (items 3, 5, 6, 7, 8, 9, and 10) and are scored from 0 to 3 depending on the severity of the symptoms. The total score is calculated by summing the scores of the items and can range from 0 to 30. Mothers scoring above the threshold of 13 suffer from different degrees of depression (23) According to Montazeri' study, Cronbach's alpha of the Persian version of EPDS was almost acceptable for all the women. Cronbach's alpha coefficient was 0.77 (for reliability testing) at time point 1 (6–8 weeks postpartum) and 0.86 at time point 2 (12–24 weeks postpartum) (24).
Beck’s Depression Inventory-II (BDI-II)
The new version of this self-report 21-item inventory aims to measure depression in adults and adolescents 13 years or above. The psychometric analysis of BDI-II in Iran showed that the items and components can diagnose and evaluate the severity and degree of depression well. The scores in this inventory range from 0 to 3 based on four options (0–3), indicating the absence of a symptom to the greatest severity of that symptom (25). In Iran, the intraclass correlation coefficient of this inventory was 0.81. Its internal consistency was 0.93 based on Cronbach's alpha and 0.64 based on the split-half method (26).
The ENhancing Assessment of Common Therapeutic Factors (ENACT): As part of a mental healthcare program in Nepal, ENACT was developed by Kohrt et al. to measure counselors' competenc (21). ENACT measures a set of common factors identified as therapeutic competencies and skills that seem to be necessary for proper counseling in any evidence-based intervention. This tool was first used in Nepal, Liberia, and Uganda (27–29). ENACT has 15 items with four levels: (1) Unhelpful or potentially harmful behaviors, (2) No basic skills or some but not all the skills, (3) All basic skills, and (4) All basic and advanced skills. Each level is a set of observable behaviors that help operationalize each level for each competence item (30).
The Ages & Stages Questionnaire (ASQ): ASQ contains questionnaires for children aged four to 60 months, which are filled out by the parents or caretakers and includes five domains: Communication, gross motor, fine motor, personal-social, and problem-solving. ASQ can be filled out by those with a low level of literacy as well. Each item has three options for response (yes = 10, sometimes = 5, not yet = 0) –only one of which should be selected (31).