Short summary

The aim of the present study is to examine the effect of Cue Exposure Therapy (CET) as aftercare on reduction of cravings and relapse-rates among AUD individuals. CET focuses on confronting alcohol cues in order to reduce alcohol-induced cravings. Hereby, preparing AUD individuals to navigate in the Danish society, where alcohol avoidance is impossible and prevent cue induced relapses after ended treatment and in the longer term. One of the CET aftercare interventions is delivered via a smartphone application which may be more cost-effective and enable treatment on a more regular basis regardless of time and space.

Rationale

Alcohol Use Disorder (AUD) is a widespread problem in Denmark and contributes to a substantial number of contacts with the treatment system, which constitutes a substantial burden on the health care system.

It is well documented that individuals with alcohol dependence respond relatively well during Cognitive Behavioural Therapy (CBT), 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 behavioral 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 AUD 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 apps, as smartphone application, 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 targeting AUD needs further exploration, despite promising preliminary results

The aims of the study are:

1.      To investigate whether manual-based CET delivered via a smartphone or in group sessions increases the efficiency of outpatient CBT treatment in AUD individuals

2.      To investigate whether CET as a smartphone application is as effective as CET group  aftercare and Aftercare as Usual

3.      To investigate whether CET as a smartphone application is more cost-effective than CET group aftercare and Aftercare as Usual

It is hypothesized that the two experimental groups will achieve better treatment outcomes as compared to the control group, and we will explore whether CET as a smartphone application is as effective/cost-effective as the CET group aftercare group.

Description of the cohort

The study is implemented as an investigator-blind randomized controlled trial.

The eligibility criteria for enrollment in the study are as follows:

Inclusion Criteria:

• Over 18 years
• Completed primary treatment with CBT
• Accept participating in the study

Exclusion Criteria:

• Not Danish speaking
• Psychotic disorders
• Severe cognitive impairment
• Terminal somatic illness

A total of 300 consecutively enrolled AUD individuals, fulfilling the eligibility criteria, 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
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.

Data and biological material

The groups will be compared pre- and post-aftercare treatment, according to the following parameters:

1. Relapse and alcohol intake: Measured with Addiction Severity Index (ASI), and Time-Line-Follow-Back (TLFB)
2. Cravings: Measured with Desires for Alcohol Questionnaire (DAQ), Obsessive-Compulsive Drinking Scale (OCDS), and Visual Analogue Scale for Craving (VAS) 
3. Coping skills and self-efficacy: Operationalized with Urge-Specific Strategies Questionnaire (USS), and Alcohol Abstinence Self-Efficacy Scale (AASE).

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). Intention-to-treat analyses (ITT) will be carried out for all outpatients.

OPEN's data manager develops electronic schemes for data entry. Data will be imported and stored in OPEN Projects.

Data from registers: The National Patient Register, The National Health Service Register, The National Prescription Registry and The Psychiatric Central Research Register. 

Collaborating researchers and departments

Department of Psychiatry, Odense University Hospital/ Reseach Unit of Psychiatry, University of Southern Denmark

• Professor, Chief Consultant and Head of Research Unit Bent Nielsen, MD, PhD
• Director and Assistant Professor Anette Søgaard Nielsen, PhD
• PhD-student Angelina Isabella Mellentin

Alcohol Treatment Center, Odense Municipal

• Manager Elizabeth Jessen

Department of Biostatistics, University of Southern Denmark

• Professor Claus Ekstrøm

Faculty of Health, Aalborg University/Institute of Organization and Industrial Sociology, Copenhagen Business School

• Professor Jes Søgaard

The Mads Clausen Institute, University of Southern Denmark

• Associate Professor Arne Bilberg
• Associate Professor Fei Yu

Institute of Regional Health Services Research, University of Southern Denmark

• Associate Professor Elsebeth Stenager