Enhancing Addiction Treatment Through Psychoeducation

Virginia Commonwealth University (VCU)

Status: Not yet enrolling

Conditions: Substance Use Disorders

Treatments: Other: Continue treatment as usual; Other: Installing the Metacognium software app

Study type: Interventional

Funder types: Other

Identifiers

NCT07178158

HM20032752

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups, including a placebo group

The intervention condition

Experimental group

Description:

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.

Treatment:

Other: Installing the Metacognium software app

Control condition

Placebo Comparator group

Description:

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.

Treatment:

Other: Continue treatment as usual