Bright light therapy in pregnant women with major depressive disorder: study protocol for a randomized, double-blind, controlled clinical trial.

BACKGROUND: Depression during pregnancy is a common and high impact disease. Generally, 5-10 % of pregnant women suffer from depression. Children who have been exposed to maternal depression during pregnancy have a higher risk of adverse birth outcomes and more often show cognitive, emotional and behavioural problems. Therefore, early detection and treatment of antepartum depression is necessary. Both psychotherapy and antidepressant medication, first choice treatments in a non-pregnant population, have limitations in treating depression during pregnancy. Therefore, it is urgent and relevant to investigate alternative treatments for antepartum depression. Bright light therapy (BLT) is a promising treatment for pregnant women with depressive disorder, for it combines direct availability, sufficient efficacy, low costs and high safety, taking the safety for the unborn child into account as well. METHODS: In this study, 150 pregnant women (12-18 weeks pregnant) with a DSM-V diagnosis of depressive disorder will be randomly allocated in a 1:1 ratio to one of the two treatment arms: treatment with BLT (9.000 lux) or treatment with dim red light therapy (100 lux). Both groups will be treated for 6 weeks at home on a daily basis for 30 min, within 30 min of habitual wake-up time. Follow-up will take place after 6 weeks of therapy, 3 and 10 weeks after end of therapy, at birth and 2, 6 and 18 months postpartum. Primary outcome will be the average change in depressive symptoms between the two groups, as measured by the Structured Interview Guide for the Hamilton Depression Scale - Seasonal Affective Disorder version and the Edinburg Postnatal Depression Scale. Changes in rating scale scores of these questionnaires over time will be analysed using generalized linear mixed models. Secondary outcomes will be the changes in maternal cortisol and melatonin levels, in maternal sleep quality and gestational age, birth weight, infant behaviour, infant cortisol exposure and infant cortisol stress response. DISCUSSION: If BLT reduces depressive symptoms in pregnant women, it will provide a safe, cheap, non-pharmacological and efficacious alternative treatment for psychotherapy and antidepressant medication in treating antepartum depression, without any expected adverse reactions for the unborn child. TRIAL REGISTRATION: Netherlands Trial Register NTR5476 . Registered 5 November 2015.

Feasibility and reliability of a newly developed antenatal risk score card in routine care.

OBJECTIVE: to study in routine care the feasibility and inter-rater reliability of the Rotterdam Reproductive Risk Reduction risk score card (R4U), a new semi-quantitative score card for use during the antenatal booking visit. The R4U covers clinical and non-clinical psychosocial factors and identifies overall high risk pregnancies, qualifying for intensified antenatal care. DESIGN: a population-based cross-sectional study (feasibility) and a cohort study (inter-rater reliability). SETTING: feasibility was studied in six midwifery practices and two hospitals; the reliability study was performed in one midwifery practice. PARTICIPANTS: 1096 pregnant women in the feasibility study and a subsample of 133 participants in the inter-rater reliability study. MEASUREMENTS: feasibility was expressed as (a) time needed to complete the R4U and (b) the missing rate at the item and client level. For inter-rater reliability (IRR) an independent, blinded, caregiver completed a re-test R4U during a second visit; inter-rater agreement for each item and all domain sum scores were computed. FINDINGS: completion of the R4U took 5 minutes or less in 63%; and between 5 and 10 minutes in another 33%. On the participant level 0.2% of women had >20% missing values (below 4% threshold, P<0.001). One of 77 items had a >10% missing rate. The per item IRR was 100% in 20% of the items, and below the predefined 80% threshold in 13% of the items (n=9). The domain sum scores universally differed less than the predetermined ±15% margin. KEY CONCLUSION: the R4U risk score card is a feasible and reliable instrument. IMPLICATION FOR PRACTICE: the R4U is suitable for the assessment of clinical and non-clinical risks during the antenatal booking visit in a heterogeneous urban setting in routine practice.