Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02298751 |
| Other study ID # |
Cue Exposure Study, RESCueH |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 2015 |
| Est. completion date |
December 2019 |
Study information
| Verified date |
October 2021 |
| Source |
University of Southern Denmark |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Background: It is well documented that individuals with Alcohol Use Disorder (AUD) respond
well during evidence-based psychological treatment, but also that a large proportion relapse
when discharged from treatment and confronted with alcohol in real life. Cue Exposure Therapy
(CET) focuses on confronting alcohol cues in order to reduce cravings as well as the
likelihood of relapse. The aim of this study is to investigate whether CET as aftercare
increases the efficiency of Cognitive Behavioural Therapy (CBT) among AUD individuals.
Design and methods: The study is implemented as an investigator-blinded randomized controlled
trial. A total of 300 consecutively enrolled AUD patients, recruited from an alcohol
outpatient clinic will be randomized to one of the three following aftercare treatment
groups: (A) CET as a smartphone application (n = 100); (B) CET as group therapy (n = 100),
and (C) Aftercare as Usual (n = 100). It is hypothesized that the two experimental groups
((A) and (B)) will achieve better treatment outcomes as compared to the control group ((C)),
and It will be explored whether CET as smartphone application is as effective as CET as group
therapy. The groups will be compared in a number of parameters including alcohol intake,
cravings and copings-strategies.
Discussion: If the hypothesis, that CET increases the efficiency of CBT is verified, it will
make sense to supplement CBT with CET as aftercare, hence, reintegrating CET within a CBT
approach. Although, CET is most often regarded as one of the behavioral methods in CBT, there
appears to be segregation in the empirical literature when it comes to treatment of addictive
disorders. However, CET may allow the patient to practice and gain control over alcohol cue
reactivity and associated high-risk situations in an inter-mediating therapeutic context
before the patients inevitably are confronted by them. In this way, one might expect the
transition from treatment to daily life less overwhelming and CET may help prevent relapse in
the long term. Thus, CET may be particularly suitable as aftercare.
Description:
BACKGROUND It is well documented that individuals with Alcohol Use Disorders (AUD) respond
well during Cognitive Behavioural Therapy, but that a large proportion of individuals relapse
after treatment when confronted with alcohol in real life. Therefore, future treatment
interventions for long-term prevention of relapse should aim to teach how to apply coping
strategies and regain control over their alcohol cravings in their daily confrontations with
alcohol and associated stimuli.
Cue Exposure Treatment (CET) is a behavioural psychological approach that focuses on
confronting alcohol cues in order to reduce cravings as well as the likelihood of relapse.
During CET individuals are exposed to alcohol related stimuli whilst their usual drink
responses are hindered. Thus, they are given the opportunity to practice coping strategies
during exposure to alcohol. In this way, it is predicted that individual's learned automatic
responses will extinguish over time and that their cognitive control over cue reactivity
strengthens.
Mental health care applications, has the potential to improve alcohol treatment and
continuing care by offering psychological treatment anywhere and when the patient find it
convenient. Because, psychological treatment is a substantial socio-economic burden when
delivered in individual sessions, there has been a tendency to deliver the relevant treatment
through group sessions. However, mental healthcare applications, have even more potential in
order to reduce the burden on the health care system, in addition to increasing the
availability of evidence-based treatment. Whilst group sessions are documented effective,
behavioural healthcare applications targeting AUD needs further exploration.
OBJECTIVES
The objective of the study is three-fold:
1. To investigate whether manual-based CET delivered via a smartphone or in group sessions
increases the efficiency of CBT outpatient treatment in groups of AUD individuals.
2. To investigate whether CET as a smartphone application is as or more effective than CET
group therapy.
3. To investigate whether CET as smartphone intervention will show to be more
cost-effective than CET delivered in group sessions.
DESIGN AND METHODS The study is implemented as an investigator-blinded, randomized controlled
trial. A total of 300 consecutively enrolled AUD individuals, recruited from an alcohol
outpatient clinic will be randomized to one of the three following aftercare treatment
groups: (1) CET as a smartphone application; (2) CET as group therapy, and (3) Standard
aftercare treatment. Individuals in group 1 are required to use the smartphone application
five times a week for eight weeks. Individuals in group 2 are required to have CET group
therapy every other week for eight weeks. Individuals in group 3 will receive one individual
follow-up session eight weeks after the primary treatment has ended.
It is hypothesized a priori that the two experimental groups will achieve better treatment
outcomes as compared to the control group (3). No a priori hypotheses guides comparisons of
the effect of CET delivered via group sessions and smartphone application. Two-sided analyses
are conducted here, because there is no empirical literature in this specific area to
generate a priori hypotheses.
The groups will be compared pre- and post-aftercare treatment, according to the following
parameters:
1. Relapse and alcohol intake, as measured with the Time-Line-Follow-Back (TLFB) method;
2. Cravings, measured with Desires for Alcohol Questionnaire (DAQ), Obsessive-Compulsive
Drinking Scale (OCDS), and Visual Analogue Scale for Craving (VAS);
3. Coping skills, operationalized with Urge-Specific Strategies Questionnaire (USS)
Data will be collected at three different time-points: before entering aftercare
treatment (baseline), after eight weeks (follow-up), and again after six month
(follow-up). In addition, we will follow the patients through medical registers for one
year in order to measure relapse in the longer term, without the challenges associated
with getting contact one year after ended treatment.
4. Data from registers: The National Patient Register, The National Health Service
Register, The National Prescription Registry and The Psychiatric Central Research
Register.
Intention-to-treat analyses (ITT) will be carried out for all outpatients. With regard to
incomplete data, "last observation carried forward" (LOCF) and multiple imputations will be
used. Completer (on-treatment) analyses will be carried out for patients who have completed
the respective interventions.
Odense Patient data Explorative Network (OPEN) data manager develops electronic schemes for
data entry. Data will be imported and stored in OPEN Projects.
