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Integrated Digital Health Approach to Reduce Hazardous Alcohol Use and Chronic Pain Among Rural Populations

31 de agosto de 2026 atualizado por: Tibor Palfai, Boston University Charles River Campus

Alcohol Use and Pain in Rural Populations

The current proposal seeks to test the benefit of a brief intervention combined with a digital program delivered though a smartphone app for reducing chronic pain and hazardous drinking among those in rural settings. Participants are recruited through social media and complete an online pre-screener and telephone screener to determine eligibility. All subsequent study assessment procedures are conducted through videoconferencing online. Participants complete 3 assessments over the course of 8 months. Following the first (baseline assessment) participants are randomized to either the INTERVENTION (INTV) or a treatment-as-usual CONTROL (CTL) condition. Those in the INTV condition meet with a health counselor for up to 50 minutes and then complete an 8-week smartphone-based intervention with weekly SMS based brief coaching. This in the CTL group meet with the health counselor only. Participants complete additional assessments at 3-months and 8-months post -baseline. Measures of alcohol use and pain are assessed after the intervention at 3 months and at the final outcome period at 8-months post-baseline.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

The current proposal represents an extension of previous research on the use of a smartphone-based intervention to reduce chronic pain and hazardous drinking among those in rural settings. The study is a randomized controlled trial that tests the efficacy of digital intervention for reducing pain intensity and interference and the quantity of alcohol consumption. Participants are recruited through social media and complete an online pre-screener to determine eligibility. This is followed by a telephone screener to confirm eligibility before scheduling baseline. All subsequent study assessment procedures are conducted through videoconferencing online. Following baseline assessment guided by an RA, participants are randomized to the INTERVENTION (INTV) or a treatment-as-usual CONTROL (CTL). Those in the INTV condition meet with a health counselor for up to 50 minutes and then complete an 8-week smartphone-based intervention with weekly SMS based brief coaching. This in the CTL group meet with the health counselor only. Participants complete additional assessments at 3-months and 8-months post -baseline. The 8-month assessment is the primary timepoint and assesses pain experience and alcohol use as measured by self-report and phosphatidylethanol (PEth) from a participant administered, RA supervised, finger stick. It is hypothesized that those in the INTV condition will show lower ratings of pain and less alcohol consumption at 8-months post-baseline.

Tipo de estudo

Intervencional

Inscrição (Estimado)

260

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Tibor P Palfai, PhD
  • Número de telefone: 617-353-9345
  • E-mail: palfai@bu.edu

Estude backup de contato

Locais de estudo

  • Estados Unidos
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02215
        • Boston University
        • Contato:
          • Tibor Palfai, PhD
          • Número de telefone: 617-353-9345
          • E-mail: palfai@bu.edu
        • Contato:
          • Sarah Fraher, BA
          • Número de telefone: 617353-0962
          • E-mail: sfraher@bu.edu
        • Investigador principal:
          • Tibor Palfai, PhD

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

  • Reside in a US rural area (non-metropolitan country) as defined by the Rural-Urban Commuting Codes from US Dept. of Agriculture
  • At least 18 years of age
  • Engage in hazardous drinking (either by exceeding weekly NIAAA guidelines of 7 standard drinks for women [>7] and those > 65 and older or 14 for men [>14] <65, and/or having at least one heavy drinking episode in the past month as measured by >3 drinks for women and those > 65 and >4 drinks for men < 65), - - Experience chronic pain (at least 3 months in duration) of at least moderate severity (4 or greater on the Numerical Pain Rating Scale)
  • Fluent in English
  • Use of a personal smartphone
  • Able to provide the name and contact information for one or more individuals who may be contacted in case the participant cannot be reached at follow-up.

Exclusion Criteria:

  • History of bipolar disorder, schizophrenia, or other psychotic disorders
  • Prior history of serious alcohol-related withdrawal symptoms (i.e., withdrawal-related seizures or delirium tremens)
  • Current psychological/behavioral treatment for alcohol use disorder
  • Current psychological/behavioral treatment for chronic pain
  • Cancer-related pain
  • Intent to have surgery for a pain-related condition in the next 8-months
  • If using psychoactive medications for pain management or alcohol use must be using a stable medication dose (same dose for at least 2 months).

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: Control (CTL) arm refers to a treatment-as-usual condition.
Participants in the CTL condition receive psychoeducation about pain and alcohol and referral resources should they wish to obtain additional treatment from a health counselor
Comportamental: Control Intervention
Participants are provided with psychoeducation about the reciprocal influences of hazardous drinking and chronic pain and their joint effects on health outcomes. In addition, they are provided with information about free web-based national resources should they wish to receive more information or additional help with pain or drinking
Experimental: Intervention (INTV)
The Intervention (INTV) condition consists of a brief intervention with a health counselor followed by an 8-week smartphone-based program to provide cognitive behavioral and self-management skills to reduce hazardous drinking and chronic pain
Comportamental: Mobile Intervention for Alcohol and Pain
The Intervention (INTV) is a brief motivational intervention with a health counselor followed by an 8-week smartphone-based program in which participants are provided with cognitive behavioral and self-management skills to reduce hazardous drinking and chronic pain. They practice skills using the app and have weekly contact with the health counselor through instant messaging

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Pain, Enjoyment of Life, and General Activity Scale (PEG)
Prazo: rating in the past week taken at (1) Baseline (2) 12-weeks post baseline, (3) 32-weeks post baseline. Note that 12-week and 32-week measures have up to 1 month window [i.e., 1 month post scheduled date for assessment] for completion
3-item, 0-10 numerical scale measure of pain
rating in the past week taken at (1) Baseline (2) 12-weeks post baseline, (3) 32-weeks post baseline. Note that 12-week and 32-week measures have up to 1 month window [i.e., 1 month post scheduled date for assessment] for completion
Average number of alcohol-containing drinks consumed per week: Time-Line Followback-30
Prazo: past 30 day drinking report taken at (1) Baseline (2) 12-weeks post baseline, (3) 32-weeks post baseline. Note that 12-week and 32-week measures have up to 1 month window [i.e., 1 month post scheduled date for assessment] for completion
Calendar-based measure of alcohol consumption in the past 30 days
past 30 day drinking report taken at (1) Baseline (2) 12-weeks post baseline, (3) 32-weeks post baseline. Note that 12-week and 32-week measures have up to 1 month window [i.e., 1 month post scheduled date for assessment] for completion
Number of heavy drinking days in past month: Time-Line Followback-30 [TLFB-30]
Prazo: number of days in the past 30. drinking report taken at (1) Baseline (2) 12-weeks post baseline, (3) 32-weeks post baseline.. Note that 12-week and 32-week measures have up to 1 month window [i.e., 1 month post scheduled date for assessment] for comple
From the TLFB-30, the number of days in the past month in which a participant engaged in heavy drinking [defined as 4+ for women and 5+ for men], 4 or more for those 65 and over.
number of days in the past 30. drinking report taken at (1) Baseline (2) 12-weeks post baseline, (3) 32-weeks post baseline.. Note that 12-week and 32-week measures have up to 1 month window [i.e., 1 month post scheduled date for assessment] for comple

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Short Inventory of Problems - Revised
Prazo: consequences in past 90 days....measure taken at baseline, 12-weeks post-baseline, and 32-weeks post-baseline. Note that 12-week and 32-week measures have up to 1 month window [i.e., 1 month post scheduled date for assessment] for completion
Seventeen, 4-category Likert scale item (from never to daily/almost daily) that assesses 17 common alcohol-related consequences
consequences in past 90 days....measure taken at baseline, 12-weeks post-baseline, and 32-weeks post-baseline. Note that 12-week and 32-week measures have up to 1 month window [i.e., 1 month post scheduled date for assessment] for completion

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Boston University Charles River Campus

Investigadores

  • Investigador principal: Tibor P Palfai, PhD, Boston University

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de fevereiro de 2027

Conclusão Primária (Estimado)

1 de novembro de 2030

Conclusão do estudo (Estimado)

1 de dezembro de 2030

Datas de inscrição no estudo

Enviado pela primeira vez

28 de agosto de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

31 de agosto de 2026

Primeira postagem (Real)

4 de setembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

4 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

31 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 8707E

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

Data will be shared following release within one year of the trial project period to investigators who make specific requests in writing regarding analysis plans. Plans will be reviewed with co-investigators to ensure that there is no overlap with planned analyses. A specific de-identified data set with IPD relevant to analyses will be provided to other researchers after this review. All IPD collected and deindentified will be eligible upon request

In addition, data will be shared according to the guidelines for the National Institute of Mental Health Data Archive (NDA).

Prazo de Compartilhamento de IPD

IPD and supporting information will be available by June 2032 which is 1 year following the end of the project period. Information will be available for a minimum of 2 years

Critérios de acesso de compartilhamento IPD

Investigators will request data and submit a data analysis plan for the project investigators to review. Deidentified data will be shared after a data sharing agreement is signed with the project institution and transferred through IT-approved data sharing processes.

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • CIF

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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