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Recent theoretical models emphasize the role of impulsive processes in alcohol addiction, which can be retrained with computerized Cognitive Bias Modification (CBM) training. In this study, the focus is on action tendencies that are activated relatively automatically.
The aim of the study is to examine the effectiveness of online CBM Alcohol Avoidance Training using an adapted Approach-Avoidance Task as a supplement to treatment as usual (TAU) in an outpatient treatment setting.
The effectiveness of 8 online sessions of CBM Alcohol Avoidance Training added to TAU is tested in a double-blind, randomized controlled trial with pre- and postassessments, plus follow-up assessments after 3 and 6 months. Participants are adult patients (age 18 years or over) currently following Web-based or face-to-face TAU to reduce or stop drinking. These patients are randomly assigned to a CBM Alcohol Avoidance or a placebo training. The primary outcome measure is a reduction in alcohol consumption. We hypothesize that TAU + CBM will result in up to a 13-percentage point incremental effect in the number of patients reaching the safe drinking guidelines compared to TAU + placebo CBM. Secondary outcome measures include an improvement in health status and a decrease in depression, anxiety, stress, and possible mediation by the change in approach bias. Finally, patients’ adherence, acceptability, and credibility will be examined.
The trial was funded in 2014 and is currently in the active participant recruitment phase (since May 2015). Enrolment will be completed in 2019. First results are expected to be submitted for publication in 2020.
The main purpose of this study is to increase our knowledge about the added value of online Alcohol Avoidance Training as a supplement to TAU in an outpatient treatment setting. If the added effectiveness of the training is proven, the next step could be to incorporate the intervention into current treatment.
Netherlands Trial Register NTR5087; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5087 (Archived at WebCite http://www.webcitation.org/6wuS4i1tH)
Alcohol misuse is a key public health concern and is associated with a high burden of disease, which in turn contributes to considerable economic costs for both individuals and society [
Recent research provides evidence that addictive behaviors are partly guided by relatively automatic processes that occur outside conscious control, making the individual respond impulsively to cues associated with the addictive substance, rather than displaying inhibitory control [
Cognitive behavioral therapy (CBT) is an evidence-based treatment for a variety of disorders including alcohol use disorders. Various meta-analyses show a large effect size in treatment outcomes of patients with alcohol disorders compared to no treatment and a small but clinically significant effect when compared to other active treatments [
The current study focuses on retraining the automatically triggered behavioral tendency to approach alcohol, by using online Alcohol Avoidance Training. In a preliminary test with this CBM training among heavily drinking students, it was shown to be successful in modifying the automatic action tendencies and related memory associations, and students who were successfully trained to avoid alcohol drank less alcohol in a taste test directly after the training [
More importantly, compared to patients in the placebo condition, patients in the training condition showed significantly less relapse after a year. A second study in the same clinic replicated the main findings and showed that the effects on relapse were mediated by change in approach bias [
Because TAU for alcohol use disorders often comprises of outpatient treatment, it is relevant to study the added value of CBM outside the clinical setting. Effectiveness of CBM in an outpatient setting may be attenuated by a lower adherence as compared to an inpatient setting. However, offering CBM online at home seems to generate high adherence rates. Combining Internet-based CBM with Internet-based CBT was found to be an acceptable form of treatment delivery for patients with depression, showing full adherence to the seven CBM sessions by 81% of participants [
We, therefore, are interested in whether the positive added effects found in clinical inpatient samples [
The aim of the current study is to investigate the effectiveness of online CBM Alcohol Avoidance Training as an adjunct to TAU in an outpatient treatment setting. Patients receive eight sessions of either the active or placebo version of the CBM Alcohol Avoidance Training during their TAU. The primary goal is to test the effects of this adjunct CBM on alcohol use immediately after finishing the intervention and three and six months later, by looking at the changes in the level of alcohol consumption over a week. The primary outcome measure is the percentage of the patients reaching the low-risk drinking level, defined as <22 standard units/week for men and <15 for women [
This study is a double-blind randomized placebo-controlled trial in a real-world setting. Patients receive TAU, consisting of outpatient personalized care
All patients with a primary alcohol problem enrolled for TAU are invited by their therapist to participate in the Alcohol Avoidance Training. After giving informed consent, patients are randomly assigned to one of the two training conditions: CBM Alcohol Avoidance Training or CBM placebo training. Patients begin the training simultaneously with the start of the behavioral change part of their treatment. Patients are recommended to follow a 15-minute CBM session twice a week for a period of five weeks. The CBM training includes eight sessions, preceded and followed by an assessment session, the preassessment and postassessment, respectively. Patients will be rewarded with a € 20 voucher if they complete all ten sessions. Three and six months after the TAU there will be follow-up assessments.
The study has been approved by the Ethics Committee of Amsterdam Academic Medical Centre in January 2015 (reference number 2014_154#C20141463) and has been registered at the Netherlands Trial Register (NTR5087).
The study population consists of patients aged 18 years or older with a primary alcohol problem, who are currently following TAU at Tactus Addiction Treatment Institute in the Netherlands. One general inclusion criterion is accessibility and ability to use the Internet, since patients will need to access CBM-training online. Two exclusion criteria apply for the TAU: (1) serious psychiatric illness with a risk to decompensate while decreasing alcohol consumption; and (2) the possibility of severe physical illness as a consequence of decreased alcohol consumption. There are no additional criteria for participation in this study.
Patients for the training are recruited by therapists at Tactus Addiction Treatment Institute. After the regular intake procedure, including baseline questionnaires, the TAU starts. Before the patient reaches the goal-setting assignment, the therapist will inform the patient about the CBM training and provide the patient with further information about the study. If the patient wants to participate, an informed consent form will be provided to patients by the therapist. After signing the form, the patient receives login credentials for the CBM training from the researcher.
After finishing registration, the patient is randomly assigned to the Alcohol Avoidance Training or to the placebo training, and receives an email with a link to the CBM training website. After logging in, the patient receives instructions about the training. At the start of each session, the patient is asked to complete the additional questionnaires for the purpose of this study, consisting of self-reported weekly alcohol consumption and desire for drinking. Each of the eight training session takes about 10-15 min. The first training session is preceded by an (online) preassessment and the final training session is followed by an (online) postassessment. Three and six months after the postassessment, each patient will receive online follow-up questionnaires. In case of nonresponse, the patient will be reminded by email or phone to complete the questionnaire.
TAU in this outpatient treatment setting is based on principles of CBT [
As we are interested in the effectiveness of online CBM Alcohol Avoidance Training as an adjunct to TAU, we do not differentiate between these four treatment “subgroups.” Due to the randomization, the experimental and control group are expected to be balanced concerning treatment modality and intensity.
Therapists have either a bachelor’s degree in social work or a master’s degree in psychology, and received a 2-day training on the treatment protocol of the TAU. Therapists can obtain expert advice from a multidisciplinary team consisting of treatment staff, an addiction physician specialized in addiction, a psychologist, and a supervisor. This multidisciplinary team also provides quality assurance through monitoring of client files and discussing treatment fidelity with counselors during weekly review of clients.
The intervention used in this study is the Alcohol Avoidance Training [
Participants flow chart. TAU: treatment as usual; CBM: Cognitive Bias Modification.
Overview of the main treatment ingredients in intensive and brief treatments.
Sessiona | Content | Intensive (face-to-face/Web) | Brief (face-to-face/Web) |
1 | Baseline assessment | ✓ | ✓ |
2 | Advantages and disadvantages | ✓ | |
3 | Daily drinking diary | ✓ | |
4 | Description of drinking moments | ✓ | |
5 | Analysing drinking situations | ✓ | |
6 | Goal setting | ✓ | ✓ |
7 | Helpful thoughts | ✓ | ✓ |
8 | Helpful behavior | ✓ | ✓ |
9 | Decision moments | ✓ | ✓ |
10 | Action plan | ✓ | ✓ |
aPart 1 is comprised of sessions 1-5 and part 2 is comprised of sessions 6-10.
The complete training program consists of eight sessions. Each session starts with a practice block of 12 trials with gray squared pictures followed by 160 trials divided into 4 blocks. The use of blocks was adopted to make the task less monotonous and to provide a short break. Two sets (A and B) of 40 stimuli each are used of which 20 are for alcoholic beverages and 20 for soft drinks [
An overview of all measurements instruments along with the randomized controlled trial measurement time-points are presented in
Demographic characteristics like gender, age, educational level, employment and clinical case history details (duration of alcohol dependence, previous detoxifications and treatments, duration of current abstinence and medication intake) will be collected during the baseline assessment of the TAU.
Weekly alcohol consumption will be assessed using the Alcohol Timeline Follow Back (TLFB) method [
The type and severity of alcohol dependence will be assessed by using the Diagnostic and Statistical Manual of Mental Disorders IV criteria, by means of the Substance Abuse Module (SAM) of the Composite International Diagnostic Interview (CIDI) [
The 5-item Obsessive Compulsive Drinking Scale (OCDS) [
Health status is evaluated using the Maudsley Addiction Profile, Health Symptom Scale (MAP-HSS). The MAP-HSS is a 10-item questionnaire that was adapted from the health scale of the Opiate Treatment Index [
The 21-item Depression Anxiety Stress Scale (DASS-21)[
The baseline drinking motives will be measured using the modified Drinking Motives Questionnaire Revised (mDMQ-R) [
Using eight items of the Drinking Refusal Self-efficacy Questionnaire (DRSEQ), participants will be asked whether they feel sure they can refuse alcohol on the three subdimensions of self-efficacy: social pressure, emotional relief and opportunism [
An example of Approach-Avoidance Training.
Measurement instruments: purpose, measures and time points.
Purpose and measurea | Baseline TAUb | Preassessment | Training | Postasssessment | Posttest TAU | Follow-up | ||||||
AAT | ✓ | ✓ | ✓ | |||||||||
Demographics | ✓ | |||||||||||
MAP-HSS | ✓ | ✓ | ✓ | |||||||||
DASS | ✓ | ✓ | ✓ | |||||||||
OCDS | ✓ | ✓ | ✓ | |||||||||
DMQ-R | ✓ | |||||||||||
CIDI | ✓ | |||||||||||
Drinking refusal self-efficacy | ✓ | |||||||||||
Weekly alcohol consumption | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||||||
✓ | ||||||||||||
CEQc | ✓ | |||||||||||
CSQ | ✓ |
aAAT: Approach-Avoidance Task; MAP-HSS: Maudsley Addiction Profile; DASS: Depression Anxiety Stress Scale; OCDS: Obsessive Compulsive Drinking Scale Depression; DMQ-R: Drinking Motives Questionnaire (Revised); CIDI: Composite International Diagnostic Interview; CEQ: Credibilty Expectancy Questionnaire; CSQ: Client Satisfaction Questionnaire.
bTAU: treatment as usual.
cCEQ will take place in session 2.
In the second training session intervention, credibility will be assessed using the Credibility and Expectancy Questionnaire (CEQ) [
The patient satisfaction regarding the CBM training will be assessed using the Client Satisfaction Questionnaire (CSQ) [
Approach-avoidance tendencies are assessed with the AAT pre- and posttraining [
The primary outcome measure for this study will be
Secondary outcome measures include changes in approach bias measured by an AAT in the preassessment and postassessment. An AAT bias index is calculated as the difference between the median reaction time scores for pushing pictures of one category (alcoholic beverages or soft drinks) and the median reaction time score for pulling pictures of that category. Median scores are used to minimize the influence of outliers. Positive scores indicate approach tendencies whereas negative scores indicate avoidance tendencies. Furthermore, it is investigated whether the added effect on treatment outcome is mediated by the amount of change in approach bias and who benefits most from training by identifying patient characteristics that moderate the outcome of the training. Other secondary outcome measures are general health condition, depression, anxiety and stress, intervention credibility and patient satisfaction.
Patients will be automatically assigned to one of the two conditions (Alcohol Avoidance Training or placebo training, as described in the Intervention section) with an equal likelihood, using the method of minimization [
The trial has a double-blind design because neither patients nor therapists know to which condition patients are assigned. To ensure anonymity, patients receive an email with a user ID to create their personal research account. If necessary, patients can contact the researcher for help. Patients complete the training at their own computer. To keep patients blind to their intervention condition, patients respond to an irrelevant feature (orientation of the picture) instead of the content of the picture (alcoholic beverage vs soft drink beverage) [
An a priori statistical power analysis (G-power) was conducted to determine the necessary number of participants. The primary outcome measure is a reduction in alcohol consumption. To obtain an estimate of the effect size to be expected, studies describing previous Alcohol Avoidance Training interventions were inspected [
Analyses will be conducted in agreement with intention-to-treat principle. Missing data points will be handled using multiple imputation [
Written informed consent to participate in the study will be obtained from all participants.
The study has been approved by the Ethics Committee of Amsterdam Academic Medical Centre in January 2015 (reference number 2014_154#C20141463) and has been registered at the Netherlands Trial Register (NTR5087).
The study was funded by Saxion University of Applied Sciences, Enschede.
The trial was funded in 2014 and is currently in the active participant recruitment phase (started on May 2015). Enrolment will be completed in 2019. First results are expected to be submitted for publication in 2020.
This study protocol design describes a double-blind randomized controlled trial to assess the added value of an online Alcohol Avoidance Training as adjunct to TAU for outpatient alcohol patients. Previous studies involving alcohol dependent patients in inpatient addiction treatment have shown promising results for Alcohol Avoidance Training in addition to TAU [
The online delivery of CBM training enables patients to conduct the sessions at a preferred location, which may entail some threats to treatment fidelity. The preferred environment might bring distractions like ambient sounds or the interaction with other people present, which could influence the concentration level and responsiveness to the training [
The strength of this study is the combination of online Alcohol Avoidance Training with TAU in an ambulatory setting. CBM training in an outpatient setting might be extra effective, because patients work on the training in their own relevant context with the presence of alcohol-related cues and challenges (eg, craving), that are not (or less) available in a clinical setting. So, patients can practice and apply their skills directly into the relevant setting. We are interested in investigating the impact of CBM training in the ambulatory setting. In addition, the ambulatory TAU is much less intensive than TAU in a clinical setting [
Approach-Avoidance Task
cognitive behavioral therapy
Cognitive Bias Modification
Depression Anxiety Stress Scale
Drinking Motives Questionnaire Revised
Maudsley Addiction Profile, Health Symptom Scale
modified Drinking Motives Questionnaire Revised
Obsessive Compulsive Drinking Scale Depression
treatment as usual
Time Line Follow Back
The authors would like to thank Marilisa Boffo for helping to create the Alcohol Avoidance Training, Tim de Jong and Bruno Boutin for their technical advice, and Abdullah Turhan for his help with references and figures.
MB-vdW, ES, MGP and MEP constructed the design. MB-vdW and MCL were responsible for the data collection and drafted the manuscript. ES, MGP, MEP, SBA, ETB and RW are supervisors and revised the manuscript. All authors have read and approved the final manuscript.
None declared.