- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07178158
- Original Trial
Enhancing Addiction Treatment Through Psychoeducation
August 4, 2026 updated by: Virginia Commonwealth University
Enhancing Addiction Treatment Through Psychoeducation: Evaluating the Feasibility and Acceptability of a Neuroscience-Informed Mobile App
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kayla McLean
- Phone Number: (804) 828-8402
- Email: mcleankl@vcu.edu
Study Locations
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Virginia
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Richmond, Virginia, United States, 23298
- Recruiting
- Virginia Commonwealth University
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Contact:
- kayla McLean
- Phone Number: 804-828-8402
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Principal Investigator:
- Jasmin Vassileva
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: The intervention condition
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.
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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.
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Placebo Comparator: Control condition
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.
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Continue your treatment schedule as usual with the for 4 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Feasibility of recruiting for the Neuroscience-Informed Psychoeducation for Addiction (NIPA) intervention
Time Frame: Baseline through 4 week intervention
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The recruitment rate is quantified as the % of all participants who satisfy the inclusion criteria and agree to participate.
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Baseline through 4 week intervention
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Retention/adherence rate for the Neuroscience-Informed Psychoeducation for Addiction (NIPA) Intervention
Time Frame: Baseline through 4 week intervention
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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.
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Baseline through 4 week intervention
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Completion rate for the Neuroscience-Informed Psychoeducation for Addiction (NIPA) intervention
Time Frame: Baseline through 4 week intervention
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Completion rate, indexing the number of training sessions completed by each participant.
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Baseline through 4 week intervention
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Measure acceptability of the Neuroscience-Informed Psychoeducation for Addiction (NIPA) intervention
Time Frame: Baseline through 4 week intervention
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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.
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Baseline through 4 week intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Assess Drug Knowledge
Time Frame: Baseline through 4 week intervention
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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.
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Baseline through 4 week intervention
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Measure attitudes towards drugs and alcohol
Time Frame: Baseline through 4 week intervention
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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.
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Baseline through 4 week intervention
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Intention for Substance Use
Time Frame: Baseline through 4 week intervention
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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.
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Baseline through 4 week intervention
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Metacognitive Awareness
Time Frame: Baseline through 4 week intervention
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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.
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Baseline through 4 week intervention
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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Baseline through 4 week intervention
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Negative Affect- Depression
Time Frame: Baseline through 4 week intervention
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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.
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Baseline through 4 week intervention
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Drug Abstinence Self-efficacy
Time Frame: Baseline through 4 week intervention
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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.
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Baseline through 4 week intervention
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Barkley Deficits in executive functioning
Time Frame: Baseline through 4 week intervention
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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
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Baseline through 4 week intervention
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Delay Discounting
Time Frame: Baseline through 4 week intervention
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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.
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Baseline through 4 week intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jasmin Vassileva, Ph.D., Virginia Commonwealth University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Schalet BD, Pilkonis PA, Yu L, Dodds N, Johnston KL, Yount S, Riley W, Cella D. Clinical validity of PROMIS Depression, Anxiety, and Anger across diverse clinical samples. J Clin Epidemiol. 2016 May;73:119-27. doi: 10.1016/j.jclinepi.2015.08.036. Epub 2016 Feb 27.
- Brown KW, Ryan RM. The benefits of being present: mindfulness and its role in psychological well-being. J Pers Soc Psychol. 2003 Apr;84(4):822-48. doi: 10.1037/0022-3514.84.4.822.
- Rezapour T, McLean KL, Psederska E, Maleki KN, Ekhtiari H, Vassileva J. Neuroscience-informed psychoeducation for addiction: a conceptual and feasibility study. Front Psychiatry. 2025 Feb 12;16:1527828. doi: 10.3389/fpsyt.2025.1527828. eCollection 2025.
- Barkley, RA. Barkley Deficits in Executive Functioning Scale (BDEFS) New York, NY: The Guilford Press; 2011.
- Heckman CJ, Dykstra JL, Collins BN. Substance-Related Knowledge, Attitude, and Behavior among College Students: Opportunities for Health Education. Health Educ J. 2011 Dec;70(4):383-399. doi: 10.1177/0017896910379694.
- Hiller ML, Broome KM, Knight K, Simpson DD. Measuring self-efficacy among drug-involved probationers. Psychol Rep. 2000 Apr;86(2):529-38. doi: 10.2466/pr0.2000.86.2.529.
- Khazaee-Pool M, Naghibi SA, Pashaei T, Chaleshgar-Kordasiabi M, Daneshnia M, Ponnet K. Drug Abstinence Self-Efficacy Scale (DASES): psychometric properties of the Farsi version. Subst Abuse Treat Prev Policy. 2021 Jan 3;16(1):1. doi: 10.1186/s13011-020-00336-9.
- Kirby, K. N., Petry, N. M., & Bickel, W. K. (2012). Monetary Choice Questionnaire [Dataset]. https://doi.org/10.1037/t10044-000
- Lins de Holanda Coelho G, H P Hanel P, Vilar R, P Monteiro R, Gouveia VV, R Maio G. Need for Affect and Attitudes Toward Drugs: The Mediating Role of Values. Subst Use Misuse. 2018 Nov 10;53(13):2232-2239. doi: 10.1080/10826084.2018.1467454. Epub 2018 May 4.
- Manser P, Poikonen H, de Bruin ED. Feasibility, usability, and acceptance of "Brain-IT"-A newly developed exergame-based training concept for the secondary prevention of mild neurocognitive disorder: a pilot randomized controlled trial. Front Aging Neurosci. 2023 Sep 21;15:1163388. doi: 10.3389/fnagi.2023.1163388. eCollection 2023.
- Meredith LR, Maralit AM, Thomas SE, Rivers SL, Salazar CA, Anton RF, Tomko RL, Squeglia LM. Piloting of the Just Say Know prevention program: a psychoeducational approach to translating the neuroscience of addiction to youth. Am J Drug Alcohol Abuse. 2021 Jan 2;47(1):16-25. doi: 10.1080/00952990.2020.1770777. Epub 2020 Jul 20.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 23, 2026
Primary Completion (Estimated)
April 30, 2027
Study Completion (Estimated)
April 30, 2027
Study Registration Dates
First Submitted
July 25, 2025
First Submitted That Met QC Criteria
September 15, 2025
First Posted (Actual)
September 17, 2025
Study Record Updates
Last Update Posted (Actual)
August 7, 2026
Last Update Submitted That Met QC Criteria
August 4, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HM300000090
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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