The key objective of the current field study is to test the effectiveness of an integrative lighting intervention to support sleep and increase self-control among AUD patients in ambulant care, and, in turn, stabilize and/or reduce alcohol…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
chronische alcoholafhankelijkheid
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are the differences in self-reported alcohol use and
alcohol craving (relative to measures at baseline).
Secondary outcome
Secondary parameters include sleep (timing, duration and quality), circadian
misalignment, self-control, mood, vitality, and quality of life, adherence to
the behavioural instructions, and experience with the lighting system as well
as the study protocol.
Background summary
Alcohol use disorder (AUD) patients often suffer from disturbed sleep-wake
patterns, and may experience challenges related to their self-control. As sleep
problems, circadian misalignment, and reduced self-control have been implicated
to increase alcohol consumption, this may lead to a negative spiral. As shown
by the relatively high relapse rates among AUD patients, this negative spiral
is difficult to break. Research has shown that light is an ambient and
unobtrusive tool which can support healthy sleep-wake patterns and benefit
daytime functioning. While chronotherapy (e.g., light interventions and/or
behavioral instructions) have been shown to benefit persons suffering from a
diverse range of clinical disorders (such as SAD, burnout, prenatal
depression), it hasn*t been tested among AUD patients in a placebo-controlled
study, despite clear indications for its potential to support these patients in
their fight against alcohol. We hypothesize that optimally tuned lighting can *
in addition to standard care - support AUD patients in their fight against
alcohol by facilitating sleep and self-control.
Study objective
The key objective of the current field study is to test the effectiveness of an
integrative lighting intervention to support sleep and increase self-control
among AUD patients in ambulant care, and, in turn, stabilize and/or reduce
alcohol consumption and craving.
Study design
A randomized, placebo-controlled trial will be performed in the field, in which
out-patients suffering from alcohol dependency are monitored over prolonged
time (baseline + 12-week treatment period). The lighting intervention
(user-tailored, dynamic lighting (UTDL) regime vs. control condition) will be
manipulated between subjects. All subjects will receive person-tailored
behavioural instructions with respect to sleep-wake timing.
Intervention
One group (intervention group; N=30) will receive behavioural instructions
(about sleep-wake timing) combined with a lighting intervention aimed to
facilitate adherence to these instructions and to increase self-control and
mood during daytime, while the other group (placebo group; N=30) will receive
behavioural instructions with standard light settings. The lighting
intervention will consist of dawn/dusk simulation (form of light therapy) in
the bedroom, combined with a higher intensity level in the living room during
daytime and gradual dimming in the evening.
Study burden and risks
The burden for participation is about 11.5 hours, distributed over 13 weeks. A
potential risk is a too large (unhealthy) reduction in alcohol consumption due
to participation in the study. Another potential risk related to the study
protocol is that subjects will complete questions about alcohol consumption,
craving, self-control, mood and sleep, which may inadvertently increase craving
or result in a negative mood. This may, in turn, make the subjects more prone
to relapse and increases in their alcohol consumption. Moreover, the light
intervention may lead to discomfort and headache. The change of these risks is
expected to be small due to the use of existing consumerproducts which is used
at a large scale, and byweekly monitoring of the caregiver.
Rondom 70
Eindhoven 5600 MB
NL
Rondom 70
Eindhoven 5600 MB
NL
Listed location countries
Age
Inclusion criteria
Patients should be under current, active treatment of an addiction clinic, with
primary alcohol dependence;
Capable of adherence to agreements with caregiver(s);
Aged 24-65 years old;
Fluent in Dutch language.
Exclusion criteria
Current florid psychosis;
Depression, prominent suicidal and/or homicidal ideation with active
intervention during the month prior to the moment of investigation and expected
active intervention during the actual research period;
Mentally incompetent;
Homelessness, or a housing condition that impedes participation;
Relatively high use of (pre-scribed) sleep mediation as reported by caregiver
or use of illegal sleep medication;
Two or more time zones trans-meridian flights one month prior to participation;
Shift work during the three months prior to participation;
Color blindness assessed with Ishihara test;
Visually impaired;
Recent eye surgery (last year), glaucoma or other eye disease
Design
Recruitment
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 |
|---|---|
| Other | 29732 |
| CCMO | NL67085.100.18 |
| OMON | NL-OMON24477 |