- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04035577
IntelliCare in College Students (ICCS)
Expanding College Student Mental Health With Stress Management Mobile Technologies - Extended Usability Trial
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Illinois
-
Chicago, Illinois, Estados Unidos, 60611
- Northwestern University
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
Participant is a student at the University of Illinois in Chicago or Northern Illinois University. Participant owns a smartphone capable of running Android 7 (or higher) or iOS11 (or higher).
Participant is 18 years of age or older
Exclusion Criteria:
None
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Extended usability of a mobile self-help intervention
Participants will have open access to the Intellicare Hub app for 8-weeks and be surveyed at Baseline, 4-weeks, and 8-weeks
|
During the trial, participants will use Intellicare apps for up to 8 weeks and will be invited to provide feedback about their experience at two follow-up time points: weeks 4 and 8.
All participants will first undergo initial assessments that will include a series of online questionnaires about their mood.
Eligible participants will receive up to 8 weeks of access to the IntelliCare system, which consists of apps with a variety of resources, including lessons and tools designed to teach skills for mood management.
It is suggested that participants utilize the mobile phone tools every day
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Patient Health Questionnaire - 8 (PHQ-8) - Depression Severity Module
Periodo de tiempo: Week 4
|
The PHQ-8 measures degree of depression severity. Possible range of scores for the PHQ-8 is 0-24. Higher values represent a worse outcome. Specifically, scores of 0-4 indicate minimal or no depression; 5-9 is mild; 10-14 is moderate; 15-19 is moderately severe; and 20-24 is severe. |
Week 4
|
Patient Health Questionnaire - 8 (PHQ-8) - Depression Severity Module
Periodo de tiempo: Week 8
|
The PHQ-8 measures degree of depression severity. Possible range of scores for the PHQ-9 is 0-24. Higher values represent a worse outcome. Specifically, scores of 0-4 indicate minimal or no depression; 5-9 is mild; 10-14 is moderate; 15-19 is moderately severe; and 20-24 is severe. |
Week 8
|
GAD-7 (Generalized Anxiety Disorder Scale-7)
Periodo de tiempo: Week 4
|
The GAD-7 is a self-administered 7 item instrument that uses some of the DSM-V criteria for GAD (General Anxiety Disorder) to identify probable cases of GAD along with measuring anxiety symptom severity.
GAD-7 total score for the seven items ranges from 0 to 21.
Higher values represent a worse outcome.
Specifically, scores of 1-4 indicate minimal anxiety symptoms; 5-9 is mild anxiety symptoms; 10-14 is moderate anxiety symptoms; and 15-21 is severe anxiety symptoms.
|
Week 4
|
GAD-7 (Generalized Anxiety Disorder Scale-7)
Periodo de tiempo: Week 8
|
The GAD-7 is a self-administered 7 item instrument that uses some of the DSM-V criteria for GAD (General Anxiety Disorder) to identify probable cases of GAD along with measuring anxiety symptom severity.
GAD-7 total score for the seven items ranges from 0 to 21.
Higher values represent a worse outcome.
Specifically, scores of 1-4 indicate minimal anxiety symptoms; 5-9 is mild anxiety symptoms; 10-14 is moderate anxiety symptoms; and 15-21 is severe anxiety symptoms.
|
Week 8
|
Anxiety Literacy Questionnaire
Periodo de tiempo: Week 4
|
This questionnaire is designed to assess anxiety specific mental health literacy by presenting 22 true or false statements regarding anxiety (e.g., "Being easily fatigued may be a symptom of anxiety disorder.")
Participants receive a score of 1 for each statement they correctly assign as either true or false.
Scores for each questionnaire can range from 0-22, with higher scores indicating greater anxiety specific mental health literacy.
|
Week 4
|
Anxiety Literacy Questionnaire
Periodo de tiempo: Week 8
|
This questionnaire is designed to assess anxiety specific mental health literacy by presenting 22 true or false statements regarding anxiety (e.g., "Being easily fatigued may be a symptom of anxiety disorder.")
Participants receive a score of 1 for each statement they correctly assign as either true or false.
Scores for each questionnaire can range from 0-22, with higher scores indicating greater anxiety specific mental health literacy.
|
Week 8
|
Depression Literacy Questionnaire
Periodo de tiempo: Week 4
|
This questionnaire is designed to assess depression specific mental health literacy by presenting 22 true or false statements regarding anxiety and depression (e.g., "Loss of confidence and poor self-esteem may be a symptom of depression.")
Participants receive a score of 1 for each statement they correctly assign as either true or false.
Scores for each questionnaire can range from 0-22, with higher scores indicating greater depression specific mental health literacy
|
Week 4
|
Depression Literacy Questionnaire
Periodo de tiempo: Week 8
|
This questionnaire is designed to assess depression specific mental health literacy by presenting 22 true or false statements regarding anxiety and depression (e.g., "Loss of confidence and poor self-esteem may be a symptom of depression.")
Participants receive a score of 1 for each statement they correctly assign as either true or false.
Scores for each questionnaire can range from 0-22, with higher scores indicating greater depression specific mental health literacy
|
Week 8
|
Cognitive and Behavioral Response to Stress Scale
Periodo de tiempo: Week 4
|
This is an 18-item scale designed to measure the use and helpfulness of various cognitive and behavioral skills.
There are four subscales included: cognitive skill frequency, cognitive skill usefulness, behavioral skill frequency, and behavioral skill usefulness.
For each cognitive or behavioral skill, participants rate how often they used the skill and how helpful it was (e.g.
"During the past month, how often did you take a moment to notice things that made you feel good or grateful?
How helpful was this in making you feel better?").
Scores for cognitive subscales range from 0-24, and scores from behavioral subscales can range from 0-30.
Higher scores indicate better outcomes.
|
Week 4
|
The Cognitive and Behavioral Response to Stress Scale
Periodo de tiempo: Week 8
|
This is an 18-item scale designed to measure the use and helpfulness of various cognitive and behavioral skills.
There are four subscales included: cognitive skill frequency, cognitive skill usefulness, behavioral skill frequency, and behavioral skill usefulness.
For each cognitive or behavioral skill, participants rate how often they used the skill and how helpful it was (e.g.
"During the past month, how often did you take a moment to notice things that made you feel good or grateful?
How helpful was this in making you feel better?").
Scores for cognitive subscales range from 0-24, and scores from behavioral subscales can range from 0-30.
Higher scores indicate better outcomes.
|
Week 8
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Mean Number of Treatment App Use Sessions
Periodo de tiempo: Daily for two months
|
Daily for two months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
- K08MH112878-EUT
- K08MH112878 (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.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Mobile self-help intervention
-
IWK Health CentreMcGill University; Canadian Institutes of Health Research (CIHR); University of... y otros colaboradoresActivo, no reclutandoTrastornos del neurodesarrollo | Trastornos del ComportamientoCanadá
-
IWK Health CentreCanadian Institutes of Health Research (CIHR)TerminadoTrastorno de oposición desafiante | Trastorno de conductaCanadá