Sleeping Pills

Feasibility and reliability were evaluated using data from the Monitoring study. Feasibility included the TiC-P response rate, respondent’s time of filling out the TiC-P and data completeness on the items of the questionnaire. Completeness is reported as proportions of missing values. Additionally, completeness on reported medication was evaluated including the medication name, the dose per intake, the number of doses per day, and the number of days that the medication was taken during the previous 4 weeks. For this evaluation a random sample (n=283) was taken from the questionnaires submitted by patients who actually reported use of medication. Completeness on medication name was checked manually and was defined missing if no name was reported or in cases that the medication was described in general terms (f.e. sleeping pill, antibiotic). Respondents’ time for filling out the TiC-P was assessed as follows. Patients in the Monitoring study filled out online a number of different questionnaires at the same time. Consequently, information was available of the time of filling out for successive submitted questionnaires. The average time for filling out the TiC-P was calculated by subtracting the times of these questionnaires according to the web-based dataset. Identically, we estimated the mean time for filling out the TiC-P of the first measurement and for the next measurements. Differences in time for filling out the TiC-P at baseline and during follow-up measurements were evaluated using a paired sample t-test.
Reliability was assessed using a test-retest design. Test-retest reliability analyses were performed to evaluate consistency of the data reported. For these analyses a subsample was invited to fill out the TiC-P again (retest) two weeks after submission of the original measurement. A cover letter explained the purpose of the retest and we offered a gift voucher of €10 if the retest questionnaire would be returned. Consistency of categorical (yes/no) variables was assessed with percentages of absolute agreements indicating the proportion of cases with the same value on the test and retest questionnaire. To adjust for the fact that a number of these agreements may arise by chance alone, chance-corrected agreements were assessed using Cohen’s kappa coefficients (κ values). The following values were attached to the coefficients: modest (0.21-0.40); moderate (0.41-0.60); satisfactory (0.61-0.80) and almost perfect (0.81-1.00)
[20 ]. Consistency of data on interval level was evaluated by computing intra class correlation coefficients (ICC) (two-way mixed models; absolute agreement).
The construct validity of the TiC-P was evaluated by assessing the agreement with reported and registered data for the items ‘contacts with a psychotherapist’ and ‘long-term absence from work’ including the percentage absolute agreement, absolute differences between reported data en registered data and Spearman rank correlation coefficient (rho). Reported data on contacts with therapists were compared with registration data of the therapists. Additionally, reported data on long-term absence from work was compared to registration data from the occupational health service. As registration data on absence from work of the Monitoring study were not accessible, the latter were derived from the Collaborative Care Study
[19 (link)]. All statistical analyses were performed in SPSS (V. 17.0; Chicago, IL). Significance was set at a p-value of 0.050.

The required sample size to study on pregnant women at 38 weeks of gestation was estimated to be 303 individuals (CI = 95%, P-value = 5%). For assessing the relationship between plasma vasopressin level and EPDS score at 6–8 weeks postpartum, the sample size was calculated to be 95 persons. All the 303 subjects were selected from among those who were referred to Urban and Rural Health Care Centers for prenatal care and were not depressed according to their EPDS score (< 13). They were first briefed about the study objectives and confidentiality of maternal and neonatal information, and then their informed consent was obtained.
The study inclusion criteria were singleton pregnancy, no systemic diseases such as lupus and diabetes mellitus, no pregnancy complications like diabetes, pre-eclampsia, etc., no previous history of psychological problems, Iranian nationality, no use of antidepressants, hormonal contraceptive pills, or sleeping pills within 2 weeks prior to venous blood sampling, good marital relationship with the spouse, no expressed significant economic problems, and no family history of depression or other mental illnesses. The study exclusion criteria were experiencing stressful conditions or using alcohol within 12 h before sampling, insufficient sleep and heavy physical activity the night before sampling, abnormal blood pressure during sampling or at postpartum period, instrumental vaginal delivery, congenital malformations of the newborn, and complications during childbirth (vaginal delivery or cesarean section) leading to treatments such as blood transfusion, resuscitation, hospitalization in the ICU or CCU, or transfer to the operating room. The mothers were controlled according to the routine prenatal care program until delivery. All participants (n = 303) were once again assessed with the Edinburgh Questionnaire during 6 to 8 weeks after delivery, and if they received a score of 13 or higher, they were referred to a psychiatrist to confirm their depression. Thirty-one of them scored 13 or more; of which, PPD of 29 subjects was confirmed by the psychiatrist. Sixteen non-depressed and five depressed subjects did not meet one of the inclusion criteria or were excluded from the study. Finally, the number of subjects in the depressed and non-depressed groups were 24 and 66, respectively.
Methods of data collection included observation, examination (weight, height, BMI, and other criteria in prenatal care forms such as blood pressure, fetal heart rate, fundal height, and warning signs during pregnancy), and patient interview. Gestational age was calculated from the first day of the last menstrual period (LMP), or the first trimester ultrasound (if uncertain about LMP). Weight, blood pressure, and heart rate of the fetus were measured by the same person using a digital scale, digital barometer, and fetal heart detector (Sonicaid), respectively.

An online questionnaire was used, consisting of questions developed by the study researchers, and belonging to the DSM-5 Level 1 Cross-sectional Symptom Scale [24 ]. The questionnaire contained 14 multiple-choice questions and a simple subjective question, referring to the age of the participants. The first two questions referred to accepting to participate in the research and being an adult with DM1; the other questions in the questionnaire were divided into three axes, namely:(a)

Sociodemographic: questions related to age, gender and region of Brazil in which they resided;

(b)

Mental health: the DSM-5 Level 1 Cross-sectional Symptom Scale [24 ] was used, adapted to assess only questions from the psychiatric domains related to anxiety, anger, depression, sleep disorders and substance use (considering only the medication use). In the question regarding the use of medications, the use of any of the following medications on their own was considered; that is, without a medical prescription, in larger amounts or for a longer period than prescribed (e.g., analgesics (such as paracetamol, codeine), high-stimulants (such as methylphenidate or amphetamines), sedatives or tranquilizers (such as sleeping pills or diazepam) or drugs such as marijuana, cocaine or crack, synthetic drugs (such as ecstasy), hallucinogens (such as LSD), heroin, inhalants or solvents (such as cola) or methamphetamine (or other stimulants)). The scale score ranged from zero to four, with zero corresponding to mild and four corresponding to severe;

(c)

Physical activity: questions regarding the practice of physical activity assessed the occurrence of physical activity before and during social isolation.