The Effectiveness of Spaced Versus Massed Alcohol Avoidance Training in Inpatient Alcohol Use Disorder Treatment: A Multisite Randomized Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 234
- 试验地点
- 2
- 主要终点
- Alcohol consumption
研究概览
简要总结
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:
- 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.
详细描述
- INTRODUCTION AND RATIONALE
1.1. Dual Process Models in Addiction Dual-process models have provided more insight as to how individuals with an addiction can be 'drawn in' by alcohol-related cues at an implicit level, while at the same time more controlled, conscious cognitive processes may be invested in actively trying to avoid substances. Even when patients with substance abuse are made aware of long-term negative consequences, learn to seek alternatives, deal with group-pressure or craving, they are still susceptible to their immediate attention being subconsciously hijacked by substance related cues that trigger an automatic implicit approach-tendency towards the substance. Therapeutic interventions that aim to reduce these implicit approach tendencies have been developed.
1.2. Alcohol Avoidance Training Alcohol Avoidance Training (AAT), is one of several Cognitive Bias Modification paradigms that is used to retrain alcohol approach biases. Pictures of alcoholic and non-alcoholic beverages are used as stimulus material. 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. Pulling increases the size of the pictures whereas pushing decreases their size. After the correct movement is made, the pictures disappear, otherwise they do not, until the correct response is made. It has been demonstrated in lab studies, that a change in approach bias (increased avoidance of the targeted substance) predicts consumption behaviour of the targeted substance. Therefore, when a strong training effect can be demonstrated, a clinical effect is likely to ensue.
Research thus far indeed suggests that AAT provides a clinical effective add-on to TAU in the treatment of Alcohol Use Disorder (AUD). The first study on the effectiveness of AAT in problematic alcohol use was conducted in a non-clinical sample of 42 male students, classified as hazardous drinkers. The results showed that the automatic action tendencies to approach alcohol were reduced. In 2010, the first Randomized Controlled Trial (RCT) using AAT in patients with AUD was conducted. The sample consisted of 214 inpatients. When AAT was added to TAU, the total number of relapses after one year decreased by about 10% compared with patients who had received a sham or no training. Importantly, the clinical effect was replicated. In addition, analyses revealed four to six AAT sessions to be the mean optimum number of sessions needed. Although the effect sizes found are small to medium, the results are interesting given the high relapse rates in addiction treatment and minor burden related to the intervention.
Apart from the replicated clinical effectiveness, in our own clinical experience, AAT can be easily integrated with (inpatient) TAU. It does not require highly trained therapists as is the case in Cognitive Behavioral Therapy (CBT) or Community Reinforcement Approach (CRA). In addition, six AAT sessions will take the participant an average of 60 to 90 minutes total to complete. Therefore, the burden in time is low which may increase engagement and attendance and decrease drop-out. Finally, AAT can be provided as early as during detoxification and may even be more effective than when provided after detoxification. In comparison, traditional CBT and CRA interventions are thought to be less effective during detoxification as a result of dampened cognitive functioning in attention and often executive functioning as a result of prolonged abuse.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Spaced AAT
AAT-S participants will receive 4 AAT sessions totalling 1200 trails but spaced out over four weeks (one AAT session per week)
干预措施: Alcohol Avoidance Training (Behavioral)
Massed AAT
AAT-M participants will receive 4 AAT sessions (each with 300 trials) within the space of 8 days (which totals 1200 trails).
干预措施: Alcohol Avoidance Training (Behavioral)
结局指标
主要结局
Alcohol consumption
时间窗: baseline, three and six 6 month follow-up
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)
次要结局
- Duration of abstinence(assessed at three month and six month follow-up)
- Alcohol craving(baseline, three and six 6 month follow-up)
- Attentional bias or training effect (manipulation check(Baseline)
研究者
W. Markus
Dr. W. Markus, head of research department IrisZorg
IrisZorg
