Substance Use DisordersNCT07178158
Enhancing Addiction Treatment Through Psychoeducation
A study testing Installing the Metacognium software app and Continue treatment as usual in people with Substance Use Disorders, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
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)… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Substance Use Disorders
- What is being tested?
- Installing the Metacognium software app and Continue treatment as usual
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2026to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- current psychosis, mania, or suicidal/homicidal ideation
- non-English speaking
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Virginia Commonwealth University
Richmond, Virginia, 23298
kayla McLean, 804-828-8402
Jasmin Vassileva
About this study
Official title: 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.
Read the 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.
- Conditions
- Substance Use Disorders
- Being tested
- Installing the Metacognium software app, Continue treatment as usual
- Keywords
- tES/TMA: Transcranial electrical stimulation, CT: Cognitive Training, DASES: Drug Abstinence Self-Efficacy Scale
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Installing the Metacognium software appOther
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 usualOther
Continue your treatment schedule as usual with the for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Installing the Metacognium software app |
| 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. Receives: Other: Continue treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of recruiting for the Neuroscience-Informed Psychoeducation for Addiction (NIPA) intervention
The recruitment rate is quantified as the % of all participants who satisfy the inclusion criteria and agree to participate.
Measured: Baseline through 4 week intervention
Retention/adherence rate for the Neuroscience-Informed Psychoeducation for Addiction (NIPA) 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.
Measured: Baseline through 4 week intervention
Completion rate for the Neuroscience-Informed Psychoeducation for Addiction (NIPA) intervention
Completion rate, indexing the number of training sessions completed by each participant.
Measured: Baseline through 4 week intervention
Measure acceptability of the Neuroscience-Informed Psychoeducation for Addiction (NIPA) 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.
Measured: Baseline through 4 week intervention
Secondary outcomes (4)
Assess Drug Knowledge
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.
Measured: Baseline through 4 week intervention
Measure attitudes towards drugs and alcohol
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.
Measured: Baseline through 4 week intervention
Intention for Substance Use
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.
Measured: Baseline through 4 week intervention
Metacognitive Awareness
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.
Measured: Baseline through 4 week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start23 Jul 2026
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a pilot feasibility two-arm, randomized controlled study with parallel assignment and 1:1 allocation of individuals with SUDs who are currently in treatment to either (1) Intervention condition: NIPA + treatment as usual (TAU); or (2) Control condition: TAU only. The control condition (TAU) consists of medication treatment (buprenorphine) and group or individual behavior therapy. The intervention condition (NIPA+TAU) consists of TAU plus four \~20-minute long NIPA sessions, administered a week apart. Participants in both intervention and control conditions would undergo two phenotypic 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jasmin Vassileva, Ph.D., Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07178158
- Sponsor's protocol ID
- HM300000090
- Status last verified
- Aug 2026
- First submitted
- 25 Jul 2025
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40012711Barkley, RA. Barkley Deficits in Executive Functioning Scale (BDEFS) New York, NY: The Guilford Press; 2011.
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.
PubMed 12703651Heckman 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.
PubMed 22303033Hiller 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.
PubMed 10840908Khazaee-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.
PubMed 33388062Kirby, 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.
PubMed 29727251Manser 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.
PubMed 37810620Meredith 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.
PubMed 32687415Schalet 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.
PubMed 26931289
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Addiction Treatment Through Psychoeducation: Evaluating the Feasibility and Acceptability of a Neuroscience-Informed Mobile App
- ClinicalTrials.gov ID
- NCT07178158
- Acronym / sponsor ID
- HM300000090
- Conditions
- Substance Use Disorders
- Keywords
- tES/TMA: Transcranial electrical stimulation, CT: Cognitive Training, DASES: Drug Abstinence Self-Efficacy Scale
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 23 Jul 2026 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 17 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a pilot feasibility two-arm, randomized controlled study with parallel assignment and 1:1 allocation of individuals with SUDs who are currently in treatment to either (1) Intervention condition: NIPA + treatment as usual (TAU); or (2) Control condition: TAU only. The control condition (TAU) consists of medication treatment (buprenorphine) and group or individual behavior therapy. The intervention condition (NIPA+TAU) consists of TAU plus four ~20-minute long NIPA sessions, administered a week apart. Participants in both intervention and control conditions would undergo two phenotypic 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.
| Arm | Type | Receives |
|---|---|---|
| The intervention condition | Experimental | Other: Installing the Metacognium software appThe 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. |
| Control condition | Placebo comparator | Other: Continue treatment as usualThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- current psychosis, mania, or suicidal/homicidal ideation
- non-English speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Installing the Metacognium software appParticipants 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. | Other | The intervention condition |
| Continue treatment as usualContinue your treatment schedule as usual with the for 4 weeks. | Other | Control condition |
Primary outcome
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.
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.
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.
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.
4 secondary outcomes
Assess Drug Knowledge
Time frame: Baseline through 4 week intervention
Measure attitudes towards drugs and alcohol
Time frame: Baseline through 4 week intervention
Intention for Substance Use
Time frame: Baseline through 4 week intervention
Metacognitive Awareness
Time frame: Baseline through 4 week intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Background: PubMed 40012711Rezapour 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.
- BackgroundBarkley, RA. Barkley Deficits in Executive Functioning Scale (BDEFS) New York, NY: The Guilford Press; 2011.
- Background: PubMed 12703651Brown 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.
- Background: PubMed 22303033Heckman 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.
- Background: PubMed 10840908Hiller 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.
- Background: PubMed 33388062Khazaee-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.
- BackgroundKirby, K. N., Petry, N. M., & Bickel, W. K. (2012). Monetary Choice Questionnaire [Dataset]. https://doi.org/10.1037/t10044-000
- Background: PubMed 29727251Lins 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.
- Background: PubMed 37810620Manser 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.
- Background: PubMed 32687415Meredith 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.
- Background: PubMed 26931289Schalet 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.
- Article full textLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jasmin Vassileva, Ph.D. principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Installing the Metacognium software app and Continue treatment as usual in people with Substance Use Disorders, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kayla McLean ((804) 828-8402, mcleankl@vcu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of recruiting for the Neuroscience-Informed Psychoeducation for Addiction (NIPA) intervention (time frame: Baseline through 4 week intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07178158, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.