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NCT Number: NCT07178158

Enhancing Addiction Treatment Through Psychoeducation

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location contact

Jasmin Vassileva

PRINCIPAL_INVESTIGATOR

kayla McLean

CONTACT

804-828-8402

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Installing the Metacognium software app

Other

Participants in the NIPA+TAU group will be sent two, URL's (one for iOS and one for Android) for installing the Metacognium software app, which hosts the four NIPA sessions. Participants will be provided with unique ID for registering and using the program on the Metacognium app. The NIPA sessions will be locked until participants have completed their baseline assessment. Once participants complete each NIPA session, they will receive an email and/or text notifying them that the next session is unlocked and that they can proceed to complete it.

Continue treatment as usual

Other

Continue your treatment schedule as usual with the for 4 weeks.

Primary outcomes

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

    Time frame: Baseline through 4 week intervention

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

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

    Time frame: 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.

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

    Time frame: Baseline through 4 week intervention

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

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

    Time frame: 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.

Secondary outcomes

  1. Assess Drug Knowledge

    Time frame: Baseline through 4 week intervention

    Drug knowledge is assessed using a questionnaire developed by our team. The questionnaire consists of 12 true-or-false items adapted from the psychoeducational materials provided in the program. Participants will complete the questionnaire at baseline before the intervention, and again after the intervention ends. Drug knowledge scores will be calculated as the total number of true responses and reported as both numbers and percentages.

  2. Measure attitudes towards drugs and alcohol

    Time frame: Baseline through 4 week intervention

    The Attitudes Toward Alcohol Use Scale and the Attitudes Toward Drug Use Scale each consist of four items. Intentions for use will be measured by asking participants to rate their intention to use various substances in the next six months on a 7-point Likert scale. Higher scores indicate greater intention to use. The scales evaluate participants' consideration of being under the influence of the respective substances. Participants complete the questionnaire at baseline, prior to the intervention, and again after the intervention has concluded. Attitudes toward drugs and alcohol will be reported using the mean and standard deviation.

  3. Intention for Substance Use

    Time frame: Baseline through 4 week intervention

    Intention to use drugs and alcohol will be measured by asking participants to rate their intention to use various substances in the next month on a 7-point Likert scale, Higher scores indicate greater intention to use. Participants will complete the questionnaire at baseline prior to the intervention, and again after the intervention ends. Intentions to use will be reported using the mean and standard deviation.

  4. Metacognitive Awareness

    Time frame: Baseline through 4 week intervention

    The 15-item Mindful Attention Awareness Scale will measure metacognitive awareness. Each item is rated on a 6-point Likert scale, with higher total scores reflecting greater levels of mindfulness and awareness. Participants will complete the questionnaire at baseline before the intervention, and again after the intervention ends. The metacognitive awareness total score will be reported using the mean and standard deviation.

Other outcomes

  1. Negative Affect-Anxiety

    Time frame: Baseline through 4 week intervention

    Anxiety will be measured using the PROMIS Anxiety Scale, a 4-item measure of emotional distress related to fear, anxious misery, hyperarousal, and associated somatic symptoms experienced over the past 7 days. Each item is rated on a 5-point Likert scale, reflecting the frequency of the symptoms. Higher scores indicate more severe symptoms. Participants will complete the questionnaire at baseline, before the intervention, and again after the intervention ends. Anxiety total score will be reported using the mean and standard deviation.

  2. Negative Affect- Depression

    Time frame: Baseline through 4 week intervention

    Depression will be measured using the PROMIS Depression Scale, a 4-item measure of negative mood, self-perception, social cognition, and reduced positive affect and engagement. It measures the frequency of each symptom using a 5-point Likert scale. Higher scores indicate more severe symptoms. Participants will complete the questionnaire at baseline, before the intervention, and again after the intervention ends. Depression total score will be reported using the mean and standard deviation.

  3. Drug Abstinence Self-efficacy

    Time frame: Baseline through 4 week intervention

    The Drug Abstinence Self-Efficacy Scale is a 20-item scale that will be used to measure a participants confidence to remain abstinent from alcohol and drug use in situations that elicit drinking or substance use cues. It consists of four subscales measuring types of relapse precipitants such as negative affect, positive social, physical, and other concerns, and withdrawal and urges, measured on a 5-point Likert scale, with higher scores indicating greater self-efficacy to resist substance use in challenging situations. Participants will complete the questionnaire at baseline prior to the intervention, and again after the intervention ends. Self-efficacy total score will be reported using the mean and standard deviation.

  4. Barkley Deficits in executive functioning

    Time frame: Baseline through 4 week intervention

    The Barkley Deficits in Executive Function Scale will be used to measure subjective deficits in executive functioning as they manifest in daily life, using a 4-point Likert scale. Higher scores indicate greater executive function deficits. Participants will complete the questionnaire at baseline, prior to the intervention, and again after the intervention ends. Deficits in executive functioning total score will be reported using the mean and standard deviation

  5. Delay Discounting

    Time frame: Baseline through 4 week intervention

    The Monetary-Choice Questionnaire, consisting of 27 items, will be used to assess delay discounting. The participant chooses between a smaller, immediate (hypothetical) monetary reward and a larger, delayed monetary reward. These choices are used to calculate a discounting rate parameter (k). Higher k values indicate a stronger preference for immediate rewards and thus greater impulsivity. Participants will complete the questionnaire at baseline before the intervention, and again after the intervention ends. Discounting rate (K) score will be reported using the mean and standard deviation. Parametric t-test or nonparametric Mann-Whitney U test to examine between-group differences, and paired t-test or non-parametric Wilcoxon signed-rank test to determine if the within-individual change in the group is statistically significant. Pre-existing differences in all measures collected at baseline will be controlled in subsequent analyses, using baseline scores as covariates.

Study contacts

Contact information is provided by the study sponsor or research team.

Kayla McLean

CONTACT

[email protected]

(804) 828-8402

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 17, 2025
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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