Desarrollo de una intervención de medicina conductual del sueño de mHealth para su uso durante el tratamiento asistido por medicamentos para MOUD
Desarrollo de una intervención de medicina conductual del sueño de mHealth para su uso durante el tratamiento asistido por medicamentos para el trastorno por consumo de opioides
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.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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 estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Allison K Willkerson, Ph.D.
- Número de teléfono: 843-792-4636
- Correo electrónico: wilkersa@musc.edu
Copia de seguridad de contactos de estudio
- Nombre: Jacelyn Lane
- Correo electrónico: lanejac@musc.edu
Ubicaciones de estudio
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South Carolina
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Charleston, South Carolina, Estados Unidos, 29464
- Reclutamiento
- Medical University of South Carolina
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Contacto:
- Allison Wilkerson, PhD
- Número de teléfono: 843-792-4636
- Correo electrónico: wilkersa@musc.edu
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Enrollment feasibility/acceptability benchmark of at least 30 persons completing entire study period - Enrollment and retention percentages
Periodo de tiempo: 6 weeks following enrollment
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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
Periodo de tiempo: 6 weeks following enrollment
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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
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mHealth App Usability Questionnaire
Periodo de tiempo: 6 weeks following enrollment
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Validated measure of mobile app usability with 3 sections: Ease of use/satisfaction, system information arrangement, and usefulness |
6 weeks following enrollment
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Pittsburgh Sleep Quality Index
Periodo de tiempo: 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
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Structured Clinical Interview for Sleep Disorders - Revised Edition
Periodo de tiempo: At enrollment and 6 weeks following enrollment
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Assessment for sleep disorders based on the DSM-5 |
At enrollment and 6 weeks following enrollment
|
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Insomnia Severity Index
Periodo de tiempo: At enrollment and 6 weeks following enrollment
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Global sleep quality; the most common self-reported sleep measure |
At enrollment and 6 weeks following enrollment
|
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Daily Sleep Diary - Sleep Onset Latency
Periodo de tiempo: Through study completion of 6 weeks
|
Subjective sleep onset latency (time to fall asleep) |
Through study completion of 6 weeks
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Daily Sleep Diary - Wake-time After Sleep
Periodo de tiempo: Through study completion of 6 weeks
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Subjective time awake after sleep onset |
Through study completion of 6 weeks
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|
Daily Sleep Diary - Total Sleep Time
Periodo de tiempo: Through study completion of 6 weeks
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Subjective total sleep time |
Through study completion of 6 weeks
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Daily Sleep Diary - Sleep Efficiency
Periodo de tiempo: Through study completion of 6 weeks
|
Subjective sleep efficiency |
Through study completion of 6 weeks
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
MOUD and drug use
Periodo de tiempo: 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
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Pro128158
- 1R34DA058511 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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