The main objective of this study is to investigate sex and gender differences in the prospective relationship between experienced stressors, craving and alcohol use during treatment and early recovery of AUD. The secondary objectives of this study…
ID
Source
Brief title
Condition
- Psychiatric disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Objective 1: The association between stressful events, craving and next day
drinking as assessed using ecological momentary assessment.
Secondary outcome
- Objective 2a: Subjective (craving) and physiological (heartrate variability)
changes following a short 10-minute alcohol exposure paradigm in the first two
weeks of treatment
- Objective 2b: sex and gender differences in clinical and social demographic
characteristics, including alcohol use characteristics, comorbid psychiatric
diagnosis, perceived social support and treatment satisfaction and positive
health outcomes.
Background summary
Alcohol use disorder (AUD) is one of the most prevalent psychiatric disorders
in the Netherlands and characterized by high relapse rates: 50-60% of patients
relapse within one year after detoxification. While the prevalence of AUD is
2-3 times higher in men (6.6%) than in women (2.3%), this gap is quickly
closing. Moreover, the prevalence of AUD is suggested to be 3 times as high
among gender minorities as compared to cisgender individuals. A central theory
in addiction research is that compulsive alcohol use results from a shift in
reward driven alcohol use to stress driven alcohol use. Recent studies suggest
that women (and gender minorities) are particularly prone to stress-related
relapse, whereas men are more prone to reward-related relapse, but empirical
evidence of this hypothesis is scarce.
Study objective
The main objective of this study is to investigate sex and gender differences
in the prospective relationship between experienced stressors, craving and
alcohol use during treatment and early recovery of AUD. The secondary
objectives of this study are to investigate sex and gender differences in the
clinical characteristics of AUD and to assess whether there are sex and gender
differences in subjective and physiological alcohol cue reactivity at the onset
of treatment and to explore how this is related to treatment outcome.
Study design
A longitudinal observational study
Study burden and risks
We will follow AUD patients during treatment as usual (cognitive behavioral
treatment or an online self-help program). The study will take place over a
period of 16 weeks. In those 16 weeks participants will come to the research
lab once, for a 90 minutes session, during which questionnaires are filled out
and the participants undergo a 10-minute alcohol cue exposure session. During
the exposure sessions participants will be exposed to pictures and videos of
alcohol during which heartrate variability is continuously measured using an
ambulatory monitoring system (VU-AMS). These exposure sessions may induce some
level of stress, but are not perceived as adverse when properly supervised by a
researcher. Additionally, participants are asked to fill out a short (6
questions) daily questionnaire on their smartphone to assess craving, affect,
arousal, the occurrence of stressful events and previous day drinking (maximum
duration of 2 minutes). Every four weeks an online questionnaire will be sent
to assess alcohol use in the past 28 days (to make up for potentially missing
data in the EMA assessment), treatment satisfaction and positive health
outcomes. While the participants themselves will not have direct beneficial
effects of the study, the knowledge resulting from this study has the potential
to pave the way for the development of sex- and gender specific treatment
strategies for alcohol use disorder. The overall nature and extent of the added
risk associated with participation in the current study is to be classified as
negligible and the burden can be considered minimal.
van der boechorstraat 7
Amsterdam 1081 BT
NL
van der boechorstraat 7
Amsterdam 1081 BT
NL
Listed location countries
Age
Inclusion criteria
Primary alcohol use disorder; starting treatment (either cognitive behavioral
treatment or an online self-help program) to control drinking; Having a
smartphone / tablet with internet access; Being between 18-64 years of age
Exclusion criteria
A current psychosis or history of psychosis
Acute suicidal ideation
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 | NL81985.018.22 |