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Enhancing Addiction Treatment Through Psychoeducation 40

Ainda não recrutando
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT07178158 é um estudo intervencionista para Transtornos por uso de substâncias. Seu status atual é: ainda não recrutando. O recrutamento está programado para iniciar em 1 de maio de 2026, com o objetivo de incluir 40 participantes. Coordenado por a Universidade da Commonwealth da Virgínia e deve ser concluído em 30 de abril de 2027. Essas informações foram atualizadas no ClinicalTrials.gov em 23 de fevereiro de 2026.
Resumo
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...Mostrar mais
Descrição detalhada
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-minu...Mostrar mais
Título oficial

Enhancing Addiction Treatment Through Psychoeducation: Evaluating the Feasibility and Acceptability of a Neuroscience-Informed Mobile App

Condições médicas
Transtornos por uso de substâncias
Publicações
Artigos científicos e trabalhos de pesquisa publicados sobre este estudo clínico:
Outros IDs do estudo
  • HM20032752
Número NCT
Data de início (real)
2026-05-01
Última atualização postada
2026-02-23
Data de conclusão (estimada)
2027-04-30
Inscrição (estimada)
40
Tipo de estudo
Intervencionista
FASE
N/A
Status
Ainda não recrutando
Palavras-chave
tES/TMA: Transcranial electrical stimulation
CT: Cognitive Training
DASES: Drug Abstinence Self-Efficacy Scale
Propósito principal
Tratamento
Alocação do design
Randomizado
Modelo de intervenção
Paralelo
Cegamento (Mascaramento)
Nenhum (Aberto)
Braços / Intervenções
Grupo de participantes/BraçoIntervenção/Tratamento
ExperimentalThe 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.
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,...Mostrar mais
Comparador placeboControl 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.
Continue treatment as usual
Continue your treatment schedule as usual with the for 4 weeks.
Desfecho primário
Medida de desfechoDescrição da medidaPrazo
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
Desfecho secundário
Medida de desfechoDescrição da medidaPrazo
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.
Baseline through 4 week intervention
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.
Baseline through 4 week intervention
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.
Baseline through 4 week intervention
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.
Baseline through 4 week intervention
Assistente de participação
Critérios de elegibilidade

Idades elegíveis
Adulto, Idoso
Idade mínima
18 Years
Sexos elegíveis
Todos
  • 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.

  • current psychosis, mania, or suicidal/homicidal ideation
  • non-English speaking
Virginia Commonwealth University logoUniversidade da Commonwealth da Virgínia
Contato central do estudo
Contato: Kayla McLean, (804) 828-8402, [email protected]
1 Locais do estudo em 1 países

Virginia

Virginia Commonwealth University, Richmond, Virginia, 23298, United States
kayla McLean, Contato, 804-828-8402
Jasmin Vassileva, Investigador principal