Enhancing Addiction Treatment Through Psychoeducation

Not Applicable

Not yet recruiting

• Conditions: Substance Use Disorders

• Registration Number: NCT07178158
• Lead Sponsor: Virginia Commonwealth University

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.

Study Timeline

• Study First Submitted: 2025-07-25
• Status Verified: 2025-09
• Study Start: 2025-09-01
• Study First Submitted QC: 2025-09-15
• Last Update Submitted: 2025-09-15
• Study First Posted: 2025-09-17
• Last Update Posted: 2025-09-17
• Primary Completion: 2026-05
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Feasibility of recruiting for the Neuroscience-Informed Psychoeducation for Addiction (NIPA) intervention	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	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	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	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 Outcome Measures

Name	Time	Method
Assess Drug Knowledge	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.
Measure attitudes towards drugs and alcohol	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.
Intention for Substance Use	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.
Metacognitive Awareness	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.

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States