Enhancing Addiction Treatment Through Psychoeducation
ConditionSubstance Use Disorders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorVirginia Commonwealth University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
current psychosis, mania, or suicidal/homicidal ideation
non-English speaking
Trial design
Design model
Parallel
Treatments tested in this trial
Installing the Metacognium software app
Other interventionParticipants 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 usual
Other interventionContinue your treatment schedule as usual with the for 4 weeks.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: The intervention conditionExperimental treatment 1 intervention
Group B: Control conditionPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline through 4 week intervention2
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.
Time frame
Baseline through 4 week intervention3
Completion rate for the Neuroscience-Informed Psychoeducation for Addiction (NIPA) intervention
Completion rate, indexing the number of training sessions completed by each participant.
Time frame
Baseline through 4 week intervention4
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.
Time frame
Baseline through 4 week interventionSecondary outcomes
1
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.
Time frame
Baseline through 4 week intervention2
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.
Time frame
Baseline through 4 week intervention3
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.
Time frame
Baseline through 4 week intervention4
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.
Time frame
Baseline through 4 week interventionOther outcomes
1
Negative Affect-Anxiety
Anxiety will be measured using the PROMIS Anxiety Scale, a 4-item measure of emotional distress related to fear, anxious misery, hyperarousal, and associated somatic symptoms experienced over the past 7 days. Each item is rated on a 5-point Likert scale, reflecting the frequency of the symptoms. Higher scores indicate more severe symptoms. Participants will complete the questionnaire at baseline, before the intervention, and again after the intervention ends. Anxiety total score will be reported using the mean and standard deviation.
Time frame
Baseline through 4 week intervention2
Negative Affect- Depression
Depression will be measured using the PROMIS Depression Scale, a 4-item measure of negative mood, self-perception, social cognition, and reduced positive affect and engagement. It measures the frequency of each symptom using a 5-point Likert scale. Higher scores indicate more severe symptoms. Participants will complete the questionnaire at baseline, before the intervention, and again after the intervention ends. Depression total score will be reported using the mean and standard deviation.
Time frame
Baseline through 4 week intervention3
Drug Abstinence Self-efficacy
The Drug Abstinence Self-Efficacy Scale is a 20-item scale that will be used to measure a participants confidence to remain abstinent from alcohol and drug use in situations that elicit drinking or substance use cues. It consists of four subscales measuring types of relapse precipitants such as negative affect, positive social, physical, and other concerns, and withdrawal and urges, measured on a 5-point Likert scale, with higher scores indicating greater self-efficacy to resist substance use in challenging situations. Participants will complete the questionnaire at baseline prior to the intervention, and again after the intervention ends. Self-efficacy total score will be reported using the mean and standard deviation.
Time frame
Baseline through 4 week intervention4
Barkley Deficits in executive functioning
The Barkley Deficits in Executive Function Scale will be used to measure subjective deficits in executive functioning as they manifest in daily life, using a 4-point Likert scale. Higher scores indicate greater executive function deficits. Participants will complete the questionnaire at baseline, prior to the intervention, and again after the intervention ends. Deficits in executive functioning total score will be reported using the mean and standard deviation
Time frame
Baseline through 4 week interventionSponsors and contacts
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Source ClinicalTrials.gov