The purpose of the present study is to investigate the effects of light therapy (with two different light boxes) on depression in people with intellectual disability (IQ *70 ) compared to standard care (care as usual).
ID
Source
Brief title
Condition
- Other condition
- Mood disorders and disturbances NEC
Synonym
Health condition
Verstandelijke beperking
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure in this study is the severity of depressive
symptoms as measured with the Depressive mood subscale of the Anxiety,
Depression and Mood Scale (ADESS). The depressive symptoms of participants in
both light therapy groups are compared with the depressive symptoms of
participants who don't get light therapy (care as usual).
Secondary outcome
Besides the primary study parameter we will also investigate whether there is a
significantly larger effect when light therapy is given with lamp model 1
compared to lamp model 2. And we examine whether any observed effect of light
therapy still exists after a period of 4 weeks (follow-up measurement). For
these two secondary study parameters we will also use the Depressive mood
subscale of the Anxiety, Depression and Mood Scale (ADESS).
Any existing diagnosis of major depressive disorder according to the criteria
of the DSM IV is made prior to the intervention. The researcher will (after
extensive training) decline a diagnostic interview for all participants. We use
the Dutch translation of the PAS-ADD (Psychiatric Assessment Schedule for
Adults with Developmental Disability, Clinical Interview).
Besides depressive symptoms we will also investigate the effect of lighttherapy
on the circadian rhythm (Actiwatch and DLMO) and stress level (cortisol level),
expectations of the caregiver (and, if possible, of the participant) over the
effect of light therapy on depressive symptoms of the participant and the
number of days the intervention is deployed (compliance). Personal and
environmental characteristics will be retrieved from the participants' medical
and psychological files and we investigate the number of life events of the
participant in the past year.
Background summary
In the general population a major depressive disorder is a common mental
disorder which has great influence on daily life. Depression can lead to
cognitive, social, emotional and physical problems and has a negative impact on
the quality of life. In the general population, depression may be associated
with the emergence of a number of physical illnesses and disrupted circadian
rhythms. Also in adults ( *18 years) with intellectual disabilities, depression
occurs frequently and this can have a negative impact on daily life. In older
adults with intellectual disabilities research has shown that both the
accumulation of life events as well as specific individual life events are
associated with depression. Regular treatments for depression, such as
cognitive behavioral therapy, can only be used among a small proportion of
people with intellectual disabilities. As a result, the current treatment
options for adults with intellectual disabilities are often limited to
lifestyle changes (keep good day-night rhythm and enough activities during the
day) and pharmacological treatment. In the general population light therapy is
an effective intervention for both seasonal and non-seasonal depression.
However, little is known about the effect of light therapy in people with an
intellectual disability. The research outcomes of the effect of bright light
therapy for depression in the general population cannot be generalized to
adults with intellectual disabilities. Bright light therapy can have a
different effect in this population because of brain injuries (prenatal,
perinatal or postnatal), congenital malformations, syndromes, genetic
abnormalities and environmental variables.
Study objective
The purpose of the present study is to investigate the effects of light therapy
(with two different light boxes) on depression in people with intellectual
disability (IQ *70 ) compared to standard care (care as usual).
Study design
Randomized controlled trial.
Intervention
Each individual participant from the two light therapy groups (the group with
the 10,000 lux light box and the group with the 100-499 lux light box) will
receive bright light therapy (in the morning before noon) for a period of 14
contiguous days. The bright light will be used for 30 minutes per day (20 cm)
or 60 minutes per day (at 30 cm distance).
Study burden and risks
The study question can only be studied in this group because people with
intellectual disabilites have specific characteristics. Participation requires
little effort from the participants. In this research there are negligible
risks for the participant.
Wytemaweg 80
Rotterdam 3015 CN
NL
Wytemaweg 80
Rotterdam 3015 CN
NL
Listed location countries
Age
Inclusion criteria
- Minimal age of 18 years.
- Intellectual disability (IQ*70).
- Informed consent.
- A depression or observable symptoms of depression.
Exclusion criteria
- Bipolar disorder type 1 or type 2 (because the risk of the occurrence of a manic episode).
- When the diagnosis 'dementia' is made **by a physician or behavioral scientist.
- If there is suicidal behavior or currently suicidal expressions.
- When an individual has or has had a hypomanic episode, manic episode or psychotic episode.
- When there is or has been a prepartum and/or postpartum depression.
- If the participant has a delirium.
- When the lens of the eye is missing (aphakia) .
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
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL51263.078.14 |