To investigate whether bright light therapy is an effective treatment for depression during pregnancy compared with low-intensity placebo light therapy (proof-of-principle) and to investigate the late effects of bright light therapy versus placebo…
ID
Source
Brief title
Condition
- Other condition
- Pregnancy, labour, delivery and postpartum conditions
- Mood disorders and disturbances NEC
Synonym
Health condition
effecten op kind na de geboorte
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome will be the average change in depressive symptoms, as
measured by the Structured Interview Guide for the Hamilton Depression Rating
Scale - Seasonal Affective Disorder version (SIGH-SAD) and the Edinburgh
Depression Scale (EDS), 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 (baseline, after 6 weeks of treatment,
3 and 10 weeks after end of treatment, 2 months postpartum, 6 months
postpartum, 18 months postpartum).
Changes in cortisol and melatonin levels between the two groups, measured at
different time points (baseline, after 6 weeks of treatment, 3 weeks after end
of treatment, 2 months postpartum).
Changes in circadian rhythms between the two groups, such as total sleep time
and sleep efficiency, measured at different time points (baseline, after 6
weeks of treatment, 3 and 10 weeks after end of treatment, 2 months postpartum).
Changes in child behavior, as assessed by Mother and Baby Scales (MBAS),
between the two groups, at the age of 2 months, and by the Child Behaviour
Check List (CBCL) at the age of 18 months.
Changes in cortisol stress response in infants between the two groups, at the
age of 2 months.
Changes in long-term cortisol exposure in infants between the two groups, at
the age of 2 months.
Traumatic childhood experiences will be assessed, as they are a risk factor for
depressive symptoms and can affect endocrine outcome. Maternal traumatic
childhood experiences (Childhood Trauma Questionnaire, CTQ) will be assessed
3-6 yrs postpartum (amendement).
Background summary
About 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.
Study objective
To investigate whether bright light therapy is an effective treatment for
depression during pregnancy compared with low-intensity placebo light therapy
(proof-of-principle) and to investigate the late effects of bright light
therapy versus placebo on quality of sleep, endocrine function during pregnancy
and birth outcome. Furthermore, we will study the effects on emotional and
behavorial development of the child.
Study design
Randomized, double-blind, placebo-controlled study.
Intervention
Both groups will be treated daily for 6 weeks for 30 minutes within 30 minutes
of habitual wake-up time. In these groups, two different protocols will be
studied, in order to compare the efficacy.
Study burden and risks
Participants have to fill in different questionnaires at various time points in
this study. These can be filled in at home. Participants need to collect saliva
and urine samples at four moments in this study. At three moments, a hair
sample is needed. Researchers will collect these samples from the participants'
residence. A diary needs to be filled in, in which the quality of sleep needs
to be described. At three moments in this study, an actigraph needs to be worn,
which does not affect the daily activities.
There is a potential risk for side effects, these are however generally mild
and short-lived, such as headache and nausea. In studies studying
antidepressant therapy, the risk of a switch to (hypo)mania is present. In
order to minimize the risk of (hypo)mania, we will only include women with a
depressive disorder and exclude women with a bipolar disorder. In addition, we
will exclude women with a psychotic disorder and a history of suicide attempt.
Moreover, to reverse the (hypo)mania, we will manipulate the dosing of light,
in consultation with a psychiatrist.
's Gravendijkwal 230
Rotterdam 3015CE
NL
's Gravendijkwal 230
Rotterdam 3015CE
NL
Listed location countries
Age
Inclusion criteria
Women
18-45 years of age
12-18 weeks pregnant
DSM diagnosed depressive disorder
Exclusion criteria
DSM diagnosis of bipolar I or II disorder
Any psychotic episode
Substance abuse
Primary anxiety disorder
Recent history of suicide attempt
Shift-work
Somatic and/or obstetric conditions that override study participation
Insufficient proficiency in Dutch or English
Multiple pregnancy
The use of selective serotonin reuptake inhibitors (SSRI's) shorter than 2
months
Eye condition (macular degeneration, eye diseases, recent eye surgery)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL55208.078.15 |
| OMON | NL-OMON20500 |