This explorative feasibility study will focus on developing a treatment protocol for light therapy in older adults with dementia and a depressive disorder. However, it is important to first consider whether the treatment is feasible at this target…
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
-Number of clients that fully completed the BLT treatment protocol
-Description of the way the protocol is executed
-Frequency and nature of the required adjustments to the protocol
-Frequency and nature of side effects
Secondary outcome
Change in level of depressive symptoms.
Background summary
Dementia is a disease characterized by cognitive impairment and
neuropsychiatric behavioral symptoms such as a depressive disorder. The
*Addendum ouderen bij de MultiDisciplinaire Richtlijn Depressie* shows that the
prevalence of depressive disorders in nursing homes is on average 15% and the
prevalence of a limited depression 25%. These percentages are significantly
higher than in other groups. In people with dementia the prevalence is even
higher: 25 to 35% of people with dementia have depressive symptoms. Less
treatment methods for depression are available for people with dementia than
for other target groups. Non-drug interventions such as psychotherapy and
psychoeducation are problematic as a result of the cognitive problems of the
clients. Pharmacotherapeutic interventions, such as antidepressants, have many
unwanted side effects, such as extrapyramidal effects and cognitive decline.
Moreover, it is clear from recent reviews that antidepressants are not proven
effective as a treatment for a depressive disorder in people with dementia. All
in all there is a need for an effective and safe treatment for people with
dementia and a depressive disorder.
BLT (Bright Light Therapy) is a treatment method that is used for depressive
disorders in adults for several decades. The method is known as effective,
safe, cheap and well tolerated. It is more attractive than antidepressants
because the effects show up earlier (usually within a week), it is more cost
efficient and there are significantly less side effects. In addition, the
treatment has been shown to have a durable effect after the end of the
treatment period. For older people with dementia, however, there is still no
protocol developed for this therapy, and in addition, the effectiveness has not
yet been reviewed. In "good clinical practice" there are positive effects found
when applying BLT in people with advanced dementia and a depressive disorder.
The latter is known by peer contact.
Hypotheses:
-We expect the protocol for this target group is feasible, i.e. 'be able to
complete the treatment according to the protocol'. However, there will be
differences between subgroups of clients with respect to the influence of
behavioral symptoms.
-Other client properties might also play a role in whether or not completing
the treatment. However, we expect that agitation is involved as an 'underlying
factor'.
-Possibly some adjustments to the protocol are needed for our target group or
for certain subgroups.
-There may be side effects, for example an increase in behavioral problems. It
could also happen that lamp is threatening or frightening for the clients. In
addition, physical side effects may occur.
-It is expected that the feasibility of the protocol will, to a large extent,
relate to the extent to which the health professionals support the treatment.
-Also the extent to which family members or other client representatives
support the treatment, is important for the feasibility of the treatment. We
expect many family members/client representatives will agree with the treatment.
-Contra-indications could be: increased rate of agitation/anxiety, too little
understanding of the treatment, fearfulness or a negative reaction to the lamp.
-Based on the literature, we expect that treatment with BLT will be an
effective treatment for clients with a Major Depressive Disorder or a limited
depressive disorder. In case of very mild depressive complaints we do not
expect the treatment to be effective. Not for all clients the effects will be
noticeable right after finishing the treatment; this may take several weeks.
Study objective
This explorative feasibility study will focus on developing a treatment
protocol for light therapy in older adults with dementia and a depressive
disorder. However, it is important to first consider whether the treatment is
feasible at this target group. After that, we will look at the preliminary
effectiveness on the basis of a number of individual treatments. The follow-up
study will look at the effectiveness with a larger sample size.
In summary, the following research questions are posed:
1) Is the treatment protocol for BLT as used for non-demented adults feasible
for institutionalized demented elderly with a depressive disorder?
a) What behavioral problems affect the feasibility of BLT?
b) Which client characteristics (such as gender, form and severity of dementia,
form and severity of depression) affect the feasibility of BLT?
c) What kind of adjustments are needed to make the protocol feasible for
institutionalised elderly people with dementia?
d) Are there any side effects during the treatment period, which compromise the
execution the protocol?
e) Is there sufficient support for BLT by the nurses? What are bottlenecks?
f) Is there sufficient support by the caregivers of the clients to give
permission for BLT?
2) What is the preliminary effectiveness of the customized BLT-protocol as a
treatment method for elderly people with dementia and a depressive disorder?
Study design
Exploratory feasibility study.
Study burden and risks
First there will be a preparatory phase in the study, which focuses on support
from the employees of the departments and caregivers of the clients. For the
first group mentioned, there will be asked for support in the form of a
clinical lesson and a focus group. The second group is informed and requested
permission through a permission letter. Next, 80 nursing home residents with
dementia will be screened through a short depression-observation list,
completed by the employees of the department. In case of an indication for a
depressive disorder, determined with a cut-off score, the diagnosis is
officially made by the psychologist. Also, the other in-and exclusion criteria
as stated in the research proposal, will be investigated. Given the prevalence
of depression in people with dementia (15%), the in-and exclusion criteria and
the permission procedure that is followed, it is expected that there are about
5 people left that could be treated with BLT. Within 2 weeks after finishing
the inclusion procedure therapy will start. Before treatment is started two
questionnaires about behavioral symptoms will be filled out by the employees of
the department. In addition, a questionnaire will be completed by the doctor,
which gives an indication about the severity of dementia. Patients will be
offered 10 days of BLT in 2 weeks with a Philips Energylight with a strength of
10,000 lux. At the end of week 2 and 3 the observer will fill out instruments
and questionnaires related to depressive symptoms and behavioral problems.
Three weeks after the last treatment session the same measurements will be
carried out again.
On the basis of previously performed research at other target groups it is
expected that there will be no or only mild side effects. The side effects that
could occur are headache, nausea, irritated eyes, disruption of the sleep-wake
rhythm, increased agitation and manic symptoms. The clients may quit the
treatment at any time, although at first the client will be motivated to
continue. If side effects occur, the researchers will determine if it is
necessary to stop the treatment in consultation with the doctor of the
department.
Aaltje Noordewierlaan 50
Leiden 2324 KS
NL
Aaltje Noordewierlaan 50
Leiden 2324 KS
NL
Listed location countries
Age
Inclusion criteria
* Age: 65 years and older
* Diagnosis of dementia. The patient must be diagnosed by a doctor (general practitioner, geriatrician, neurologist, geriatric specialist).
* Diagnosis of depression: either major depressive disorder, or limited depression. This diagnosis is made by the (GZ-) psychologist of the nursing home department, according to the Multidisciplinaire Richtlijn Depressie, addendum Ouderen, of Trimbos Instituut, from which the ' Provisional Diagnostic Criteria for Depression in Alzheimer's Disease ' (Olin et al., 2002) are used. The Cornell Scale for Depression in Dementia (CSDD) is used as a screening instrument.
Exclusion criteria
* Other neurological disorders (such as non-congenital brain damage or Korsakov's syndrome, Parkinson and Huntington), except for CVA belonging to vascular dementia.
* Other psychiatric disorders (such as bipolar disorder, anxiety disorder or psychosis)
* Serious eye conditions (for example, macular degeneration or eye conditions as a result of diabetes), where there is a contraindication to BLT
* Sensitivity to light (e.g. as a result of epilepsy)
* Highly elevated blood pressure syst > 200
For each participant the doctor of the nursing home department will determine whether BLT is medically justified.
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 |
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CCMO | NL50795.058.14 |