Enhancing Addiction Treatment Through Psychoeducation

NCT07178158 | Not Yet Recruiting

• 1 other identifier: HM20032752
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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), 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.

Conditions

Substance Use Disorders

Keywords

tES/TMA: Transcranial electrical stimulation; CT: Cognitive Training; DASES: Drug Abstinence Self-Efficacy Scale

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Baseline through 4 week intervention

Secondary Outcomes (4)

• 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

Other Outcomes (5)

• Negative Affect-Anxiety

  Baseline through 4 week intervention

• Negative Affect- Depression

  Baseline through 4 week intervention

• Drug Abstinence Self-efficacy

  Baseline through 4 week intervention

Study Arms (2)

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.

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.

Other: Continue treatment as usual

Interventions

Continue treatment as usual OTHER

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

Control condition

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.

The intervention condition

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (11)

• 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.

  PMID: 40012711 BACKGROUND

• Barkley, RA. Barkley Deficits in Executive Functioning Scale (BDEFS) New York, NY: The Guilford Press; 2011.

  BACKGROUND

• 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.

  PMID: 12703651 BACKGROUND

• 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.

  PMID: 22303033 BACKGROUND

• 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.

  PMID: 10840908 BACKGROUND

• 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.

  PMID: 33388062 BACKGROUND

• Kirby, K. N., Petry, N. M., & Bickel, W. K. (2012). Monetary Choice Questionnaire [Dataset]. https://doi.org/10.1037/t10044-000

  BACKGROUND

• 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.

  PMID: 29727251 BACKGROUND

• 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.

  PMID: 37810620 BACKGROUND

• 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.

  PMID: 32687415 BACKGROUND

• 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.

  PMID: 26931289 BACKGROUND

Related Links

• Article full text

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Jasmin Vassileva, Ph.D.

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kayla McLean

CONTACT

(804) 828-8402; mcleankl@vcu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: September 17, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)