Enhancing Addiction Treatment Through Psychoeducation

NCT ID: NCT07178158

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2026-05-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Installing the Metacognium software app

Intervention Type: 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.

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.

Group Type: PLACEBO_COMPARATOR

Continue treatment as usual

Intervention Type: OTHER

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

Interventions

Installing the Metacognium software app

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.

Intervention Type: OTHER

Continue treatment as usual

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jasmin Vassileva, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

Central Contacts

Kayla McLean

Role: CONTACT

mcleankl@vcu.edu

(804) 828-8402

Facility Contacts

kayla McLean

Role: primary

804-828-8402

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Related Links

https://doi.org/10.3389/fpsyt.2025.1527828

Article full text

Other Identifiers

HM20032752

Identifier Type: -

Identifier Source: org_study_id