Spaced Versus Massed Alcohol Avoidance Task

Summary

Rationale: Alcohol-Avoidance Training (AAT) has been used successfully to strengthen avoidance-tendencies in patients with alcohol use disorder (AUD). AAT is already recommended in German clinical treatment guidelines as an evidence-based treatment for AUD and may be incorporated in the next revision of the Dutch clinical guidelines on AUD. Studies in other fields (semantic learning) suggest that spaced learning may be superior to massed learning, but this has not been studied with regard to AAT.

Objectives:

To compare the effectiveness of spaced versus massed AAT sessions.

Study design: a two armed, randomised controlled trail. All participants will receive AAT in addition to routine clinical care in an inpatient setting (Treatment As Usual; TAU). AAT sessions in the experimental group (AAT-S) will be spaced out over four weeks following detoxification. Sessions in the control group (AAT-M) are massed within one week following detoxification. Assessments of alcohol consumption and craving take place before the start of AAT (baseline: T0, timeframe: last 30 days before admission (alcohol use) or past week (craving)) at three (T1) and six months follow-up (T2).

Study population: 200 patients with a primary DSM-5 diagnosis of AUD who receive TAU at three addiction care sites (clinical facilities 'Zevenaar', 'Tiel' and 'Wolfheze') of IrisZorg. Patients have finished alcohol detoxification, age ≥ 18, have good Dutch proficiency and have given written informed consent. During the follow-up assessments they are likely to have progressed to regular outpatient addiction treatment.

Intervention: During their four week (minimum) admission all participants receive TAU, which includes Community Reinforcement Approach (CRA) (Meyers \& Smith, 1995) grouptraining, AAT, sociotherapy and pharmacotherapy. AAT is a Cognitive Bias Modification paradigm that is used to retrain alcohol approach biases. In AAT participants must react to pictures of alcoholic and non-alcoholic beverages with a joystick to the tilt of the pictures which are presented on a computer screen.

In current routine clinical care AAT sessions are massed in the first week after detoxification (control condition: AAT-M). In the experimental condition AAT trails will be spaced out over four weekly sessions instead of one week (AAT-S).

Main study parameters/endpoints:

Changes from baseline to three and six month follow-up in:

1. Mean daily units of alcohol consumed (past 30 days); at baseline this refers to the 30 days directly pre-admission).
2. Mean ratings of mean alcohol craving (past seven days).

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participants in both conditions will receive the same amount of AAT sessions and trials. Sessions in the AAT-S condition will be spread out over four weeks. Participants in this condition will therefore be exposed to AAT alcohol pictures over a longer period. Given our current experience of AAT as part of TAU, we expect little risk of participants experiencing more sensations of craving. Alcohol (use) is discussed daily during admission as part of TAU. As an extra burden, participants will be asked to complete a questionnaire before the first AAT session. Participants will be approached for follow-up assessment three and six months following the first month of inpatient treatment. Participants receive an incentive (a voucher worth €15,-) after completing all FU assessments, as a compensation for the extra burden.

Conditions

• Alcohol Use Disorder

Interventions

BEHAVIORAL

Alcohol Avoidance Training

Participants are instructed to react with a joystick to the tilt of pictures, presented on a computer screen. For instance, participants make an approach movement (pull) with left-tilted pictures, and make an avoidance movement (push) with right-tilted pictures. After the correct movement is made, the pictures disappear, otherwise they do not, until the correct response is made.

Sponsors & Collaborators

• Radboud University Medical Center

  collaborator OTHER

• Behavioral Science Institute

  collaborator UNKNOWN

• Nijmegen Institute for Scientist-Practitioners in Addiction (NISPA)

  collaborator UNKNOWN

• W. Markus

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-10-08

Primary Completion

2025-01-01

Completion

2025-08-01

Countries

• Netherlands

Study Locations