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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20500

Enrollment

150

Registered

2015-11-02

Start date

2015-01-01

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression during pregnancy. Depressie tijdens de zwangerschap.

Interventions

Two 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.

Eligibility

Inclusion criteria

Inclusion criteria: Women 18-45 years of age Normal ocular function 12-32 weeks pregnant, as assessed by the gynaecologist or midwife DSM diagnosis depressive disorder, as assessed by the researchers

Exclusion criteria

Exclusion criteria: Insufficient 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 (SSRI’s) 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

Design outcomes

Primary

Measure	Time frame
The 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

Measure	Time frame
- 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); - 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 month; - Changes in long-term cortisol exposure (hair sample) in infants between the two groups, at the age of 2 months	—

Measure

Time frame

- 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); - 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 month; - Changes in long-term cortisol exposure (hair sample) in infants between the two groups, at the age of 2 months

—

Contacts

Public ContactBabette Bais

's Gravendijkwal 230

b.bais@erasmusmc.nl010-7031510

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)