Desenvolvimento de uma intervenção de medicina comportamental do sono mHealth para uso durante o tratamento assistido por medicação para MOUD
Desenvolvimento de uma intervenção de medicina comportamental do sono mHealth para uso durante o tratamento assistido por medicamentos para transtorno por uso de opióides
This study is to develop and test a medical health application based on cognitive behavioral therapy for insomnia and augmented with other evidence-based sleep interventions that address common sleep-related problems in opioid use disorder. An initial program will be built utilizing input from persons beginning medications for opioid use disorders.
Visão geral do estudo
Status
Descrição detalhada
This pilot randomized controlled trial will assess the feasibility and acceptability of an evidence-based behavioral sleep intervention delivered via a mHealth app to individuals initiating treatment with medications for opioid use disorder. Additional outcomes include changes in sleep disturbance over the course of the 6-week intervention. Participants (N=40, 20 per group) will be randomized to download the mHealth app to their smartphones and complete the intervention within 6 weeks. The control group will receive a simplified version of the app with sleep hygiene instructions. Both groups will complete daily electronic sleep diaries for the following 6 weeks. Each week, they will be asked to complete a short assessment of their experiences from the previous week and their current insomnia severity. At the end of the 6th week, they will complete an online series of questionnaires, including validated feasibility/acceptability measures and measures of insomnia severity.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Allison K Willkerson, Ph.D.
- Número de telefone: 843-792-4636
- E-mail: wilkersa@musc.edu
Estude backup de contato
- Nome: Jacelyn Lane
- E-mail: lanejac@musc.edu
Locais de estudo
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South Carolina
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Charleston, South Carolina, Estados Unidos, 29464
- Recrutamento
- Medical University of South Carolina
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Contato:
- Allison Wilkerson, PhD
- Número de telefone: 843-792-4636
- E-mail: wilkersa@musc.edu
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
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No experience of withdrawal symptoms in past 2 weeks
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Being stabilized on buprenorphine
- Initiated buprenorphine in past 3 months
- Modified buprenorphine dose in past 3 months (e.g., reducing dose with goal of transitioning to vivitrol)
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Currently experiencing clinically significant sleep disturbance (PSQI > 5)
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Able to read and understand English
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Owns an Android or iOS smartphone
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At least 18 years of age
Exclusion Criteria:
- Current psychotic symptoms
- Current active suicidal ideation
- Severe visual impairment
- Current use of benzodiazepines
- Current severe SUD other than OUD (i.e., > 5 criteria met for any other SUD type per DSM-5)
- Peripartum women
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: mHealth application
Study participants, while being stabilized on buprenorphine, will download and engage with the developed mHealth application, completing daily electronic sleep diaries for the next 6 weeks. Each week, they will be asked to complete a short assessment of their experiences from the previous week and their current insomnia severity. |
Study participants will download the mHealth app to their smartphones and complete the intervention within 6 weeks. They will be required to complete daily electronic sleep diaries for the following 6 weeks. Each week, they will be asked to complete a short assessment of their experiences from the previous week and their current insomnia severity |
|
Experimental: Control Group
Participants in the control group will receive a simplified version of the app with sleep hygiene (SH) instructions and will be required to complete daily electronic sleep diaries for the next 6 weeks. The SH condition will utilize the same application and entail the same daily and weekly logs, but with the didactic material replaced by detailed education about SH strategies. Each week, participants will be asked to complete a brief assessment of their experiences from the previous week and their current insomnia severity. |
Study participants will download the mHealth app to their smartphones and complete the intervention within 6 weeks. They will receive a simplified version of the app with sleep hygiene instructions and will be required to complete daily electronic sleep diaries for the following 6 weeks. Each week, they will be asked to complete a short assessment of their experiences from the previous week and their current insomnia severity. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Enrollment feasibility/acceptability benchmark of at least 30 persons completing entire study period - Enrollment and retention percentages
Prazo: 6 weeks following enrollment
|
To achieve a minimum enrollment and retention percentage of 75% throughout the 6-week investigation period. |
6 weeks following enrollment
|
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Protocol adherence feasibility/acceptability benchmarks of participants completing modules and sleep diaries each week - Engagement
Prazo: 6 weeks following enrollment
|
Completing at least one module per week, submitting a minimum of four sleep diaries per week, and implementing stimulus control and sleep restriction on at least 90% of nights. |
6 weeks following enrollment
|
|
mHealth App Usability Questionnaire
Prazo: 6 weeks following enrollment
|
Validated measure of mobile app usability with 3 sections: Ease of use/satisfaction, system information arrangement, and usefulness |
6 weeks following enrollment
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Pittsburgh Sleep Quality Index
Prazo: At enrollment and 6 weeks following enrollment
|
Validated measure of difficulty falling and staying asleep and subsequent daytime function |
At enrollment and 6 weeks following enrollment
|
|
Structured Clinical Interview for Sleep Disorders - Revised Edition
Prazo: At enrollment and 6 weeks following enrollment
|
Assessment for sleep disorders based on the DSM-5 |
At enrollment and 6 weeks following enrollment
|
|
Insomnia Severity Index
Prazo: At enrollment and 6 weeks following enrollment
|
Global sleep quality; the most common self-reported sleep measure |
At enrollment and 6 weeks following enrollment
|
|
Daily Sleep Diary - Sleep Onset Latency
Prazo: Through study completion of 6 weeks
|
Subjective sleep onset latency (time to fall asleep) |
Through study completion of 6 weeks
|
|
Daily Sleep Diary - Wake-time After Sleep
Prazo: Through study completion of 6 weeks
|
Subjective time awake after sleep onset |
Through study completion of 6 weeks
|
|
Daily Sleep Diary - Total Sleep Time
Prazo: Through study completion of 6 weeks
|
Subjective total sleep time |
Through study completion of 6 weeks
|
|
Daily Sleep Diary - Sleep Efficiency
Prazo: Through study completion of 6 weeks
|
Subjective sleep efficiency |
Through study completion of 6 weeks
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
MOUD and drug use
Prazo: Through study completion of 6 weeks
|
Self-reported checklist |
Through study completion of 6 weeks
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Allison K Wilkerson, Ph.D., Medical University of South Carolina
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Pro128158
- 1R34DA058511 (Concessão/Contrato do NIH dos EUA)
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