No registrations found.
ID
Source
Brief title
Health condition
chronic alcohol dependency
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are self-reported number of drinking days, number of alcoholic drinks consumed and alcohol craving
Secondary outcome
Sleep timing, duration, and quality, degree of circadian (mis)alignment, self-control with respect to resisting alcohol, vitality, mood, quality of life, and adherence to behavioral instructions
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 downwards spiral. As shown by the relatively high relapse rates among AUD patients, this negative spiral is difficult to break. 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. To this end, 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 intervention group 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 placebo group will only receive behavioural instructions with standard light settings. The lighting intervention will consist of dawn/dusk simulation, combined with a higher intensity level during daytime and gradual dimming in the evening in the living room and bedroom. We hypothesize that the user-tailored, dynamic lighting regime will – in addition to standard care - support AUD patients in their fight against alcohol by facilitating sleep and self-control.
Study objective
We hypothesize that exposure to the user-tailored, dynamic lighting condition will stabilize or reduce alcohol consumption and craving in comparison to a control condition with regular lighting.
Study design
Baseline + 12-week treatment period; repeated measures (experience sampling, diary) combined with wearable sensors (actigraphy and light sensors) and a (online) questionnaire during three relatively intensive sampling weeks (at baseline, in week 6 and week 12 of the treatment period). Weekly assessments during regular meetings with caregiver
Intervention
One group (intervention group) 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) will only receive behavioural instructions with standard light settings. The lighting intervention will consist of dawn/dusk simulation, combined with a higher intensity level during daytime and gradual dimming in the evening in the living room and bedroom.
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria: Patients should be under current, active treatment of the FACT team, with primary alcohol dependence, capable of adherence to agreements with FACT team (based on a maximum of 30% of not showing up for meetings at the clinic or being at home for home visits by caregiver), and are aged 24-65 years old. Moreover, they should be fluent in the Dutch language.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
• 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
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7457 |
| NTR-old | NTR7699 |
| CCMO | NL67085.100.18 |
| OMON | NL-OMON49511 |