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.


CONCLUSIONS
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.


BACKGROUND
Netherlands Trial Register NTR5476 . Registered 5 November 2015.
Department of Psychiatry, Erasmus University Medical Centre Rotterdam, 's Gravendijkwal 230, 3015CE, Rotterdam, The Netherlands. b.bais@erasmusmc.nl.
Babette
B
Bais
Department of Psychiatry, Erasmus University Medical Centre Rotterdam, 's Gravendijkwal 230, 3015CE, Rotterdam, The Netherlands.|Epidemiological and Social Psychiatric Research Institute, Erasmus University Medical Centre Rotterdam, 's Gravendijkwal 230, 3015 CE, Rotterdam, The Netherlands.
Astrid M
AM
Kamperman
Philips Lighting Research, High Tech Campus 7, 5656 AE, Eindhoven, The Netherlands.
Marjolein D
MD
van der Zwaag
Department of Child and Adolescent Psychiatry, Erasmus University Medical Centre Rotterdam, 's Gravendijkwal 230, 3015 CE, Rotterdam, The Netherlands.
Gwen C
GC
Dieleman
Research Centre Innovations in Care, Rotterdam University of Applied Sciences, Rochussenstraat 198, 3015 EK, Rotterdam, The Netherlands.
Hanneke W
HW
Harmsen van der Vliet-Torij
Department of Obstetrics and Gynaecology, Erasmus University Medical Centre Rotterdam, 's Gravendijkwal 230, 3015 CE, Rotterdam, The Netherlands.
Hilmar H
HH
Bijma
Department of Psychiatry and Psychology, P. Debyelaan 25, 6229 HX, Maastricht, The Netherlands.
Ritsaert
R
Lieverse
Department of Psychiatry, Erasmus University Medical Centre Rotterdam, 's Gravendijkwal 230, 3015CE, Rotterdam, The Netherlands.
Witte J G
WJ
Hoogendijk
Department of Psychiatry, Erasmus University Medical Centre Rotterdam, 's Gravendijkwal 230, 3015CE, Rotterdam, The Netherlands.|Department of Child and Adolescent Psychiatry, Erasmus University Medical Centre Rotterdam, 's Gravendijkwal 230, 3015 CE, Rotterdam, The Netherlands.
Mijke P
MP
Lambregtse-van den Berg
D000328:Adult; D002940:Circadian Rhythm; D003865:Major Depressive Disorder / Q000523:psychology / Q000628:therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D009426:Netherlands; D010789:Phototherapy / Q000379:methods*; D011247:Pregnancy; D011248:Pregnancy Complications / Q000523:psychology / Q000628:therapy*; D037841:Pregnant People / Q000523:psychology*; D016574:Seasonal Affective Disorder / Q000628:therapy
Circadian rhythm; Clinical trial; Depression; Depressive disorder; Light therapy; Phototherapy; Pregnancy; Therapeutics