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The effectiveness of spaced versus massed alcohol avoidance training in inpatient alcohol use disorder treatment: A multisite randomized trial

The effectiveness of spaced versus massed alcohol avoidance training in inpatient alcohol use disorder treatment: A multisite randomized trial - Spaced versus massed AAT

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON50788
Enrollment
234
Registered
2022-02-22
Start date
2022-03-02
Completion date
Unknown
Last updated
2024-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

alcohol gerelateerde stoornissen alcohol addiction

Interventions

Participant receive either AAT-M of AAT-S within a broader context of routine clinical care. AAT-M is an element of current routine care. The only difference in the AAT-S condition is that the AAT s

Sponsors

De Grift (verslavingszorg, Arnhem)
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion 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

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).

Design outcomes

Primary

MeasureTime frame
Main study parameter/endpoint To evaluate the effectiveness of spaced AAT compared to massed AAT in inpatient AUD treatment in terms of a possible reduction in alcohol consumption. o Changes in mean units of alcohol consumed in the past 30 days (MATE/MATE - Outcomes (Schippers, Broekman & Buchholz, 2007) section 1: number of regular drinking days x average number of drinks regular drinking day + number of heavy drinking days x average number of drinks heavy drinking day) (baseline vs. 6 month follow-up). Note that the baseline assessment will focus on alcohol use in the last 30 days preceding admission.

Secondary

MeasureTime frame
Secondary study parameters: To evaluate the effectiveness of spaced AAT compared to massed AAT in inpatient AUD treatment in terms of a possible increase in time-to-relapse, and decrease in craving and alcohol approach bias. o Duration of abstinence - estimated time-to-relapse following discharge (weeks), assessed at three month and six month follow-up. o Changes in mean craving score over the past 7 days (MATE/MATE - Outcomes section *Q1* from the OCDS-5 (Schippers et. al, 1997): thoughts and desires concerning wanting to use alcohol (baseline vs. three and six month follow-up). o Changes in alcohol approach bias (training effect) over the course of the four AAT sessions. Other study parameters: Other independent variables will be collected to describe the population and may be used to explore potential predictors.: o Age o Years problematic drinking (MATE section 1) o DSM-5 diagnosis (number of comorbid disorders) o Use of anti-craving medication during inpatient, AAT period (acamprosate, naltrexone, baclofen, topiramate, gabapentin) o Use of alcohol abstinence enforcing medication during inpatient, AAT period (antabuse, refusal). o Gender o Social-economic status o Marital status o Highest educational level attained o Ethnicity o Substance use (other than alcohol) last 30 days before detox (MATE section 1) o Years substance use (other than alcohol)(MATE section 1) o Time in treatment (total and last inpatient period) (patient files) o Addiction treatment history (MATE section 3) o Facility (Zevenaar, Tiel, Wolfheze) o Length of stay (hospitalisation) o Withdrawal severity (SIWA-Ar) o Trainer experience o Number of of relapses (any substance use during inpatient, AAT period) o Treatment drop out (against medical advice during inpatient, AAT period)

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)