A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
A Micro-Randomized Trial to Optimize a Just-in-Time Adaptive Intervention for Alcohol Craving and Suicide Ideation
This study will develop and evaluate a brief, personalized, single-session telehealth intervention combined with a four-week just-in-time adaptive intervention (JITAI) delivered via text messaging for adults with alcohol use disorder (AUD) and suicidal thoughts and behaviors. The study includes qualitative interviews, pilot testing, and a 28-day micro-randomized trial (MRT). In the MRT phase, participants (N=75) will be repeatedly randomized multiple times per day to receive text messages targeting craving and suicide ideation or to receive no message. Outcomes include alcohol craving, suicide ideation, alcohol consumption, and engagement with intervention strategies
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Margaret M Baer, PhD
- Número de teléfono: 567-218-3067
- Correo electrónico: baerm@musc.edu
Ubicaciones de estudio
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South Carolina
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Charleston, South Carolina, Estados Unidos, 29401
- Medical University of South Carolina
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Contacto:
- Margaret M Baer, PhD
- Número de teléfono: 567-218-3067
- Correo electrónico: baerm@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:
- Age 18 years or older
- Meets DSM-5 criteria for current (past 6 months) Alcohol Use Disorder (mild, moderate, or severe)
- Reports at least one episode of suicidal ideation in the past 6 months
- Currently engaged in alcohol use treatment (at least monthly participation in outpatient or intensive outpatient individual or group treatment)
- Alcohol identified as primary substance of use
- Resides in the United States
- Owns a personal smartphone
- Able and willing to provide informed consent
- Co-occurring mood disorders (excluding bipolar disorder), anxiety disorders, or other substance use disorders are permitted
Exclusion Criteria:
- Current suicidal or homicidal intent
- Suicide attempt within the past 3 months
- Psychiatric hospitalization within the past 3 months
- Current or past psychotic disorder or bipolar disorder
- Alcohol withdrawal requiring medical management (e.g., CIWA-Ar score > 8)
- Inability or unwillingness to provide informed consent
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Single arm. Groups of people are not randomized. Each person is repeated randomized.
Groups of people are not randomized. Each person is repeated randomized 112 times over 28 days to text message vs no text message. Within the text message condition, there is additional randomization to text message choice and text message language conditions. |
At four time points each day (112 time points across the 28-day study), each participant will be randomized to text message or no text message. Within the text message condition, there will be further randomization to Text Message Choice and Text Message Language conditions. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Integrated Plan Engagement
Periodo de tiempo: 28-day MRT period
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Participants will complete the following yes/no EMA item four times a day: "Since the last survey, I completed a strategy from my Integrated Plan." This item, created by the study team for this study, will assess the completion of any intervention strategy from the patient's individualized Integrated Plan during the 28 day period. |
28-day MRT period
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Alcohol Craving
Periodo de tiempo: 28-day MRT period
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Participants will complete the following EMA item (on a 0-10 Likert scale) four times a day: "Since the last survey, I thought about drinking or how good a drink would make me feel." This item, drawn from a well-established measure of alcohol craving (Penn Alcohol Craving Scale) will assess craving during the 28 day period. |
28-day MRT period
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Suicide Ideation
Periodo de tiempo: 28-day MRT period
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Participants will complete the following EMA item (on a 0-10 Likert scale) four times a day: "Since the last survey, I thought about killing myself." This item, drawn from a well-established interview that has also been used as a self-report measure to assess varied self-injurious thoughts and behaviors (Self-Injurious Thoughts and Behaviors Interview-Revised) will assess thoughts of suicide during the 28 day period. This item has been used previously by the PI in EMA studies. |
28-day MRT period
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Alcohol Consumption
Periodo de tiempo: 28-day MRT period
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Participants will complete the following EMA item to assess alcohol consumption four times a day: "Since the last survey, I drank __ drinks". |
28-day MRT period
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Margaret M Baer, PhD, Medical University of South Carolina
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Pro00151349
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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