Telehealth Cognitive Behavioral Stress Management for Adults With Cystic Fibrosis
8 de septiembre de 2020 actualizado por: Christina Bathgate, National Jewish Health
The purpose of this study to to assess the feasibility, acceptability, and satisfaction of a telehealth cognitive behavioral stress management (CBSM) intervention among adults with cystic fibrosis (CF) who exhibit elevated anxiety and/or depression symptoms.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
31
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Colorado
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Denver, Colorado, Estados Unidos, 80206
- National Jewish Health
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 80 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- At least 18 years old
- Fluent in English
- Diagnosed with Cystic Fibrosis
- Colorado resident
- Access to personal device (smart phone, computer, tablet) with 1) reliable internet connection, and 2) a built-in web camera and microphone or the capability to install a study-provided web camera and microphone
- Regular access to a private location with sufficient lighting that is free from distractions or intrusions to use during telehealth sessions
- Access to private email to complete surveys
- Mild anxiety and/or depression symptoms (i.e., a score of 5 or higher on the Generalized Anxiety Disorder 7 Item Scale (GAD-7) and/or the Patient Health Questionnaire 9 Item Scale (PHQ-9))
Exclusion Criteria:
- Currently receiving therapy or counseling with an outside provider for a mental health condition
- Currently in treatment for alcohol or substance abuse
- Unstable medical condition (not including cystic fibrosis)
- Neurological disease
- Pregnant women
- Active suicidal intent or plan (a score of 1 or higher on the Suicide Severity Scale)
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Telehealth
Participants randomized into the telehealth arm will receive up to 7 one-hour telehealth visits with the study psychologist.
The first six sessions will focus on cognitive behavioral stress management topics and the seventh session is optional, focusing on lung transplant readiness.
Participants will fill out questionnaires every other week (baseline, week 2, week 4, week 6, week 8) and during a 3-month follow-up (week 20).
Participants will wear an actigraphy watch to track sleep and movement for one week at a time during baseline, week 8, and week 20.
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Cognitive behavioral stress management is a well-established, practical intervention that combines elements of cognitive behavioral therapy with techniques designed to improve coping skills, social support, communication, and relaxation/mindfulness.
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Sin intervención: Treatment-As-Usual (TAU)
Participants randomized into the TAU arm will not receive any telehealth visits during the 8-week intervention phase. Participants will fill out questionnaires every other week (baseline, week 2, week 4, week 6, week 8) and during a 3-month follow-up (week 20). Participants will wear an actigraphy watch to track sleep and movement for one week at a time during baseline, week 8, and week 20. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Feasibility (patient perspective)
Periodo de tiempo: Week 0 (baseline)
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Assess the feasibility of telehealth-delivered Cognitive Behavioral Stress Management from the patient perspective using participation rates (i.e., number of people interested and consented into the study).
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Week 0 (baseline)
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Feasibility (clinician perspective)
Periodo de tiempo: Week 8
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Assess the feasibility of telehealth-delivered Cognitive Behavioral Stress Management from the clinician perspective using the Structured Assessment of Feasibility (SAFE; 16 items).
The first 8 items provide information about barriers to implementation and the second 8 items provide information about enablers to implementation.
It is recommended that no overall summary score be used, as this scale is designed to highlight barriers and facilitators that future programs should consider if they decide to continue or begin implementing this intervention.
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Week 8
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Acceptability (patient perspective 1 of 2)
Periodo de tiempo: Week 8
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Assess the acceptability of telehealth-delivered Cognitive Behavioral Stress Management from the patient perspective using participation rates (i.e., telehealth sessions completed, dropouts).
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Week 8
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Acceptability (patient perspective 2 of 2)
Periodo de tiempo: Week 8
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Assess the acceptability of telehealth-delivered Cognitive Behavioral Stress Management from the patient perspective using the Acceptability Scale (12 items; 5 = strongly agree, 1 = strongly disagree), which was adapted specifically for this study.
A mean acceptability score will be computed from these 12 items.
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Week 8
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Satisfaction (patient perspective 1 of 2)
Periodo de tiempo: Week 8
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Assess the satisfaction of telehealth-delivered Cognitive Behavioral Stress Management from the patient perspective.
Satisfaction measured using the Satisfaction Scale (8 items; 5 = strongly agree, 1 = strongly disagree), which was adapted specifically for this study.
A mean satisfaction score will be computed from the 8 items.
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Week 8
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Satisfaction (patient perspective 2 of 2)
Periodo de tiempo: Week 8
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Assess the satisfaction of telehealth-delivered Cognitive Behavioral Stress Management from the patient perspective using 4 open-ended questions designed specifically for this study.
A qualitative summary will be provided based on responses to the open ended questions.
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Week 8
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Anxiety symptom improvement
Periodo de tiempo: Week 0, 2, 4, 6, 8, 20
|
Assess changes in anxiety throughout study using the Generalized Anxiety Disorder 7-item Scale (GAD-7), which asks participants to rate how much they have been bothered by anxiety symptoms over the past 2 weeks (7 items, 0 = not at all, 1= several days, 2= more than half the days 3 = nearly every day).
A total score will be created by summing the scores of the 7 items.
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Week 0, 2, 4, 6, 8, 20
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Depression symptom improvement
Periodo de tiempo: Week 0, 2, 4, 6, 8, 20
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Assess changes in depression throughout study using the Patient Health Questionnaire 9-item Scale (PHQ-9), which asks participants to rate how much they have been bothered by depression symptoms over the past 2 weeks (9 items, 0 = not at all, 1= several days, 2= more than half the days 3 = nearly every day).
A total score will be created by summing the scores of the 9 items.
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Week 0, 2, 4, 6, 8, 20
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: CJ Bathgate, PhD, National Jewish Health
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
4 de junio de 2018
Finalización primaria (Actual)
1 de junio de 2020
Finalización del estudio (Actual)
1 de junio de 2020
Fechas de registro del estudio
Enviado por primera vez
3 de mayo de 2018
Primero enviado que cumplió con los criterios de control de calidad
6 de junio de 2018
Publicado por primera vez (Actual)
18 de junio de 2018
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
9 de septiembre de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
8 de septiembre de 2020
Última verificación
1 de septiembre de 2020
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 3143
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
No
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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