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临床试验/NCT02634476
NCT02634476已完成不适用

Can Cognitive-bias Modification Training During Inpatient Alcohol Detoxification Reduce Relapse Rates Post-discharge?

Turning Point1 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2014年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
Turning Point
入组人数
83
试验地点
1
主要终点
Alcohol abstinence

研究概览

简要总结

It is well-established that many substance misusers experience impairment in cognition (thinking skills), particularly those needed to regulate and monitor behaviour and ensure that goals are achieved. According to the dual-process model, addiction arises from an imbalance in 'bottom-up' processing i.e., overactive automatic (impulsive) processes that drive behaviours and impaired 'top-down' controlling processes that stop behaviours associated with negative consequences. As a result, the individual becomes more sensitive to cues in their environment (e.g., alcohol images) that trigger the addictive behaviour. Cognitive-bias modification (CBM) is a novel, computer-based training paradigm that trains the brain to pay less attention to negative/harmful cues and more attention to positive or neutral cues. This approach minimizes the overactive 'bottom-up' processes and improves the 'top-down' control processes of unhealthy behaviors which enables the addicted individual to make better decisions. Recently, CBM has been used with addicted population to alter the tendency to approach alcohol, with one German study showing that a 4-session training programme was associated higher rates of abstinence at one-year (Wiers et al., 2011). The current study examines whether a novel computer based training programme alters cognitive biases (the tendency to approach alcohol related stimuli) in alcohol-dependent inpatients, and examine whether this enables them to be better at decision-making more generally, and its impact on craving and post-discharge abstinence rates. The study will also explore whether individual differences in impulsivity and sensitivity to reward and punishment determine response to the training programme. This will be achieved using a parallel-groups randomized superiority trial design involving approximately 80 patients attending inpatient withdrawal programmes in Victoria. The findings are likely to have implications for the design and delivery of psychosocial interventions delivered during early recovery from alcohol-dependence to optimise treatment effectiveness.

详细描述

Detailed Description:

According to the dual-process model of addiction (Gullo, Loxton, & Dawe, 2014), addictive behaviour is the result of an imbalance between a strong, impulsive processing system and a relatively weak, reflective processing system. Due to this imbalance, impulsive preferences are rewarded, reflected in an increased sensitivity to the stimuli of addiction (i.e., attentional bias) and an automatic tendency to engage with the stimuli of addiction (i.e., approach bias; Wiers et al., 2007). Clinical trials of CBM have begun to emerge for individuals with alcohol use disorders (Fadardi & Cox, 2009). Wiers et al. (2009) developed the alcohol approach/avoidance task (alcohol-AAT), where participants respond with an approach behaviour (pulling a joystick) or an avoidance behaviour (pushing a joystick) to pictures of addiction-related and neutral stimuli. Following four sessions of this training task patients displayed better treatment outcomes one-year later (Wiers et al., 2011). A study by Eberl et al. (2013) found that 12 sessions of approach-bias modification training was associated with higher rates of abstinence at one-year relative to controls.

Underlying the relationship between cognitive biases and addiction, within the dual-process model paradigm, are impulse-control processes. However, the relationship between impulsivity and cognitive biases remains unclear. Indeed, individuals with weak inhibition skills tend to have a bias toward automatic information processing (Gladwin et al., 2011) and impulsivity is thought to play a role in the degree to which cognitive biases influence outcomes (Peeters et al., 2012). The development of this understanding will benefit assessment of CBM treatments for addiction patients.

Rationale:

Despite intensive psychosocial interventions, most alcohol-dependent patients relapse within weeks if not days of leaving inpatient detoxification. The study therefore examines whether an alcohol approach-bias modification training programme during detox can reduce craving and relapse in alcohol-dependent inpatients. By dampening the automatic tendency to approach alcohol-related stimuli, individuals are allowing time to make more informed behaviour choices (i.e., improving their decision-making ability). Its impact will be examined through abstinence rates at 2-weeks and 3-months relative to those receiving sham training. The findings are likely to have implications for the design and delivery of psychosocial interventions delivered during early recovery from alcohol-dependence, aiming to optimise treatment effectiveness.

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 (Participant)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •At least weekly use of alcohol in the past month.
  • •Meet Diagnostic and Statistical Manual (DSM) criteria for alcohol use disorder
  • •Currently in treatment for alcohol withdrawal
  • •Able to understand English

排除标准

  • •Meet Diagnostic and Statistical Manual (DSM) criteria for a psychotic illness
  • •History of neurological illness
  • •History of brain injury involving loss of consciousness for >30 minutes
  • •Intellectual disability

研究组 & 干预措施

cognitive bias modification training

Experimental

Participants complete four sessions of the alcohol approach/avoidance task.

干预措施: Alcohol approach/avoidance task (Behavioral)

sham training

Sham Comparator

Participants complete four sessions of the sham approach/avoidance task.

干预措施: Sham approach/avoidance task (Behavioral)

结局指标

主要结局

Alcohol abstinence

时间窗: 2-week follow-up

We will assess whether the participant has consumed alcohol at any time between exiting the detoxification facility and completing the 2-week follow-up questionnaires.

次要结局

  • Abstinence at 3-months(3-month follow-up)
  • Days until relapse(2-week follow-up)
  • Number of heavy drinking days(2-week follow-up)
  • Decision-making(Immediately after the 4th training session (days 6 or 7 following admission))
  • Alcohol craving(2-week follow-up)
  • Alcohol craving(Immediately after the 4th training session (days 6 or 7 following admission))

研究者

发起方
Turning Point
申办方类型
Other
责任方
Sponsor

研究点 (1)

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