跳至主要内容
临床试验/NCT07178158
NCT07178158招募中不适用

Enhancing Addiction Treatment Through Psychoeducation: Evaluating the Feasibility and Acceptability of a Neuroscience-Informed Mobile App

Virginia Commonwealth University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年7月23日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Feasibility of recruiting for the Neuroscience-Informed Psychoeducation for Addiction (NIPA) intervention

研究概览

简要总结

Addiction is a brain disorder characterized by a broad range of both apparent and subtle cognitive impairments in attention, memory, executive functions, and decision-making. These cognitive problems are clinically significant and may contribute to poor treatment outcomes in people with Substance Use Disorders (SUDs), such as a high risk of dropout, low treatment compliance, and shorter periods of abstinence. Studies on cognitive function in SUDs reveal that chronic use of drugs and alcohol can also negatively affect another crucial component of cognition: awareness, or metacognition. Metacognition is defined as an individual's ability to perceive and understand their cognitive functions and use this understanding to regulate them. One of the key consequences of metacognitive impairments is the lack of insight in people with SUDs, which adversely affects treatment outcomes. Substance users with poor metacognition are more reluctant to initiate or continue treatment and are more likely to deny their cognitive problems. Therefore, improving metacognition may remove or reduce motivational barriers to invest time and effort in the recovery process in general, and in the brain recovery process specifically. Despite the importance of neurocognition and metacognition in the recovery process for substance users, there is a dearth of interventions designed to target these functions.

详细描述

To address this gap, the Neuroscience-Informed Psychoeducation for Addiction (NIPA) program was developed as one of the first initiatives in the field of SUDs to raise individuals' awareness about cognitive deficits (metacognition) associated with drug and alcohol use. NIPA is an app-based digital program that integrates neuroscience-based psychoeducation and game-based cognitive training. It consists of four 20-minute-long sessions covering neurocognitive functions commonly impaired in SUDs, such as attention, memory, cognitive flexibility, and impulsivity / decision-making. Each session includes videos, animations and cartoons depicting specific cognitive problems (e.g. in attention, decision-making, etc.), followed by games created by adapting common neurocognitive tasks (e.g. Stroop task, gambling task), designed to engage the specific cognitive function reviewed in the session and to raise individual's awareness of how they employ these cognitive functions to solve game-based puzzles and real-life problems. Each cognitive function is depicted in terms of the underlying brain network(s) (e.g. default mode network, salience network), which is followed by a set of brain training strategies and exercises that aim to improve resilience when exposed to substances and to motivate patients to invest time and effort in their treatment and to pursue cognitive rehabilitation interventions. The main goals of the proposed study are to determine whether the intervention is feasible and acceptable for patients with SUDs who are currently in treatment; and to obtain some preliminary data on its utility to increase metacognitive awareness, reduce depression and anxiety, and improve daily executive functioning and impulse control in patients with SUDs. We hypothesize that providing patients with the NIPA program may improve their metacognition, daily executive function, and mental health.

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
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • current DSM-5 opioid and/or stimulant use disorder
  • currently on medication treatment for SUD
  • owning a smartphone with sufficient functionality to download and utilize the NIPA app.

排除标准

  • current psychosis, mania, or suicidal/homicidal ideation
  • non-English speaking

研究组 & 干预措施

The intervention condition

Experimental

The intervention condition consists of TAU plus four ~20-minute long NIPA sessions, administered a week apart (NIPA+TAU). Participants in both intervention and control conditions would undergo two survey assessments on REDCap, one at baseline and one at the end of the intervention for the NIPA+TAU condition or at the end of week 4 for the TAU condition.

干预措施: Installing the Metacognium software app (Other)

Control condition

Placebo Comparator

The control condition consists of treatment as usual (TAU) consisting of medication treatment (buprenorphine) and group or individual behavior therapy. Participants in both intervention and control conditions would undergo two survey assessments on REDCap, one at baseline and one at the end of the intervention for the NIPA+TAU condition or at the end of week 4 for the TAU condition.

干预措施: Continue treatment as usual (Other)

结局指标

主要结局

Feasibility of recruiting for the Neuroscience-Informed Psychoeducation for Addiction (NIPA) intervention

时间窗: Baseline through 4 week intervention

The recruitment rate is quantified as the % of all participants who satisfy the inclusion criteria and agree to participate.

Retention/adherence rate for the Neuroscience-Informed Psychoeducation for Addiction (NIPA) Intervention

时间窗: Baseline through 4 week intervention

Retention/adherence rate is quantified as the % of participants who remain enrolled until the end of the study, completing all NIPA sessions and pre- and post-assessments.

Completion rate for the Neuroscience-Informed Psychoeducation for Addiction (NIPA) intervention

时间窗: Baseline through 4 week intervention

Completion rate, indexing the number of training sessions completed by each participant.

Measure acceptability of the Neuroscience-Informed Psychoeducation for Addiction (NIPA) intervention

时间窗: Baseline through 4 week intervention

Acceptability is measured with a 10-item questionnaire that uses a 10-point Likert scale, with higher scores indicating greater acceptability. Items include perceived enjoyment, convenience, informativeness, applicability, effectiveness, satisfaction, continued use, barriers to use, and most/least liked aspects.

次要结局

  • Assess Drug Knowledge(Baseline through 4 week intervention)
  • Measure attitudes towards drugs and alcohol(Baseline through 4 week intervention)
  • Intention for Substance Use(Baseline through 4 week intervention)
  • Metacognitive Awareness(Baseline through 4 week intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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