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Recruiting NCT05631366

Spaced Versus Massed Alcohol Avoidance Task

Conditions: Alcohol Use Disorder

Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 234
Sponsor: W. Markus

Location: Netherlands

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 (Eberl et al., 2014). 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:Mean daily units of alcohol consumed (past 30 days); at baseline this refers to the 30 days directly pre-admission).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.

Eligibility Criteria

Inclusion Criteria:A primary diagnosis of alcohol use disorder (meeting the DSM-5 criteria (American Psychiatric Association, 2013);Age of at least 18 years or older;Good Dutch language proficiency;Written informed consent.Exclusion Criteria:Severe, current psychiatric symptoms (especially manic, psychotic, suicidal and aggressive symptoms) that may endanger participants or others and jeopardize study adherence (determined on a case-by-case basis. The staff member who will provide the AAT information, informed consent and instruction will always consult one of the principal investigators in that case).

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Source: ClinicalTrials.gov (NCT05631366). StuddyBuddy aggregates publicly available trial information.