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Bright up! A randomized, double-blind, placebo-controlled study of light therapy for depression during pregnancy.


- candidate number23342
- NTR NumberNTR5476
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-nov-2015
- Secondary IDsNL55208.078.15 058-14-003 (NWO)
- Public TitleBright up! A randomized, double-blind, placebo-controlled study of light therapy for depression during pregnancy.
- Scientific TitleBright up! A randomized, double-blind, placebo-controlled study of light therapy for depression during pregnancy.
- ACRONYMBright up!
- hypothesisThis study investigates whether light therapy is an effective treatment for depression during pregnancy. Secondly, it investigates the late effects of bright light therapy on quality of sleep, endocrine function during pregnancy and birth outcome. Furthermore, it studies the effects on emotional and behavorial development of the child.
- Healt Condition(s) or Problem(s) studiedDepression, Pregnancy
- Inclusion criteriaWomen
18-45 years of age
Normal ocular function
12-18 weeks pregnant, as assessed by the gynaecologist or midwife
DSM diagnosis depressive disorder, as assessed by the researchers
- Exclusion criteriaInsufficient proficiency in Dutch or English
Multiple pregnancies (because of increased risk for adverse birth outcomes that might act as confounder and bias the results)
The use of selective serotonin reuptake inhibitors (SSRIís) shorter than 2 months before starting therapy
DSM diagnoses of bipolar I or II disorder
Seasonal affective disorder
Any psychotic episode
Substance abuse
Primary anxiety disorder
Recent history of suicide attempt
Habitual sleep disorders
Jetlag
Shift-work
Somatic and/or obstetric conditions that override study participation
Previous treatment with bright light therapy
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2015
- planned closingdate31-jul-2019
- Target number of participants150
- InterventionsTwo groups will be treated daily for 6 weeks with 30 minutes light therapy within 30 minutes of habitual wake-up time. In both groups, two different colours of light will be studied.
- Primary outcomeThe average change in depressive symptoms between the two groups, as measured by HAM-D and EPDS, after 6 weeks of treatment compared to baseline.
- Secondary outcome- Changes in depressive symptoms between the two groups, as measured by HAM-D and EPDS, measured at different time points (T2, T3 and T5);
- Changes in cortisol and melatonin levels between the two groups, measured at different time points (T0, T1, T2, T3 and T5);
- Changes in circadian rhythms between the two groups, such as total sleep time and sleep efficiency, measured at different time points (T0, T1, T2, T3, T5);
- Changes in birth outcome in the newborns between the two groups, such as birth weight and Apgar score;
- Changes in child behavior, as assessed by Mother and Baby Scales (MBAS), between the two groups, at the age of 2 months;
- Changes in cortisol stress response in infants between the two groups, at the age of 2 months.
- TimepointsT0: baseline
T1: after 6 weeks of treatment
T2: 3 weeks after end treatment
T3: 10 weeks after end treatment
T4: birth
T5: 2 months postpartum
- Trial web sitehttp://brightupstudie.nl
- statusplanned
- CONTACT FOR PUBLIC QUERIESMSc Babette Bais
- CONTACT for SCIENTIFIC QUERIESMD. PhD. M.P. Lambregtse - van den Berg
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Philips
- Publications
- Brief summaryAbout 5-10% of the pregnant women in the Netherlands suffer from depression. Children who are 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 depression during pregnancy is essential.
Psychotherapy, a first choice treatment for depression in non-pregnant women, shows limited relevance during pregnancy, for the direct availability of psychotherapists is poor. Since the window of opportunity is small during pregnancy and treatment bridges a long time span, the unborn child would not benefit from this treatment. A second treatment, the use of antidepressants, is controversial, for the effects to the (unborn) child are not entirely clear.
Therefore, it is relevant to investigate non-pharmalogical approaches to treat depression during pregnancy. Bright light therapy is a promising treatment for depression during pregnancy, for it has shown positive effects in other populations and for the little adverse reactions. Moreover, it is relatively cheap and easy to administer.
It has been shown that the effects of bright light therapy are associated with an improved circadian rhythm. This is expressed in improved sleep quality and the normalisation of stress hormones. This is relevant during pregnancy, for increased stress hormones, as a consequence of depression, might (partly) explain the unfavorable development of the unborn child.
This study investigates whether bright light therapy is an effective treatment for depression during pregnancy compared with low-intensity placebo light therapy (proof-of-principle). Secondly, it investigates the late effects of bright light therapy versus placebo on quality of sleep, endocrine function during pregnancy and birth outcome. Furthermore, it studies the effects on emotional and behavourial development of the child.
- Main changes (audit trail)6-aug-2017 -MT:
Inclusion criteria:
'12-18 weeks pregnant' replaced by '12-32 weeks pregnant'

Secondary outcome:
'Changes in depressive symptoms between the two groups, as measured by HAM-D and EPDS, measured at different time points (T2, T3 and T5)' replaced by 'Changes in depressive symptoms between the two groups, as measured by HAM-D and EPDS, measured at different time points (T2, T3, T5, T6 and T7)'

Additional secondary outcome:
- Changes in long-term cortisol exposure (hair sample) in infants between the two groups, at the age of 2 months

Additional timepoints:
T6: 6 months postpartum T7: 18 months postpartum
- RECORD2-nov-2015 - 6-aug-2017


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