The primary objective of the study is to assess whether or not physiological craving can be determined as different fluctuations prior to subjective craving or (re)lapse events when compared to non-events. The study has two secondary objectives: 1)…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
alcohol verslaving
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are self-reported alcohol craving, self-reported
(re)lapse, Blood alcohol concentration, Electrodermal activity, Blood volume
pulse.
Secondary outcome
The second study parameters are negative affect, stress, alcohol permitted,
alcohol available, severity of nicotine craving and social activities.
Background summary
Alcohol abuse is a major societal challenge. It is currently the fourth leading
unhealthy lifestyle behaviour contributing to morbidity and mortality and has
devastating effects on individuals and their families. Despite the availability
of different treatment options, many clients fall back into their addictive
behaviour. Such relapse is typically preceded by internal (e.g. stress) or
external influences such as exposure at a party. Unfortunately, these critical
moments typically occur in-between counselling sessions and when (online)
support is not readily available. Moreover, many clients do not recognize such
early responses in time and fail to take necessary precautions. As such, to
improve addiction treatment, the client would need to be supported at his/her
most vulnerable moments at whatever time and place. Therefore the aim of this
project is to research the possibility of a remote monitoring system that can
determine craving based on self-reported and physiological data. This system
unobtrusively monitors, with wearable bio-sensors, the clients physiological
craving responses in everyday life, jointly with an app to monitor
self-reported psychological craving thoughts.
Study objective
The primary objective of the study is to assess whether or not physiological
craving can be determined as different fluctuations prior to subjective craving
or (re)lapse events when compared to non-events. The study has two secondary
objectives: 1) to study the predictive value of self-reported alcohol craving
to (re)lapse and whether these relations are moderated by own believe in the
effectiveness of own coping skills; 2) to investigate whether negative affect,
stress, alcohol permitted, alcohol available, severity of nicotine craving
and/or social activities predicts subjective alcohol craving or (re)lapse.
Study design
An observational study, with an Intensive Repeated Measures in Naturalistic
Settings Case-study design where participants are monitored with wearable
bio-sensors and fill out questionnaires approximately six times a day for a
total of 100 days. Additionally, participants fill out questionnaires at the
baseline of the study and at the end of the study they take part in a
semi-structured interview.
Study burden and risks
A participant attends a briefing, which entails filling out a baseline
questionnaire and getting instructions on the experiment with an investment of
90 minutes, during the experiment they keep an Electronic diary were they fill
out 5 questionnaires with 4 questions which take 2-3 minutes and at the end of
the day the participant fills in a daily diary, which costs 8-15 minutes
depending on the amount of craving moments and drinking behaviour during that
day. Once a week a participant is asked to fill in an additional questionnaire
with five questions, with a time investment of 3-5 minutes. Expected effort is
21-35 minutes a day over the whole 3 month period. It is assumed that during
the course of the experiment the participant will get used to the questions and
therefore be able to answer the questions quicker. In a debriefing session of
90 minutes at end of the experiment the experiences of participant will be
discussed in a semi-structured interview.
Participants are free to collaborate in the study. They may quit the
study without reason and without consequences. At the end of the experiment a
participant can receive a short report of their personal data, showing them
insight into their craving, mood and the other parameters collected in this
experiment. This will not be a medical report, only a global overview of the
results of the individual participant. A possible side effect of the study, is
reactivity, the possibility that research methods themselves affect behaviour
under study (Shiffman, 2009a). The participant might become more aware of their
craving, mood and believe in own coping strategies during the day, causing them
to change behaviour which already might lead to less (re)lapse.
This awareness can also be a risk causing rumination, sadness or even
(re)lapse. However, throughout the entire study, participants are enrolled in a
treatment of Tactus addiction care meaning that they always have (online)
sessions with a therapist during the study.
Drienerlolaan 5
Enschede 7522 NB
NL
Drienerlolaan 5
Enschede 7522 NB
NL
Listed location countries
Age
Inclusion criteria
Moderate or sever alcohol use disorder according to de DSM-5 en under treatment at Tactus Addiction Care.
Exclusion criteria
Multiple user (except for nicotine)
Diagnosed with a psychiatric disease, suicidality, schizophrenia or panic disorder
Design
Recruitment
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 | NL58392.044.16 |