- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03859180
Self-Managed Intervention for Anxiety in Parkinson's Disease
A Pilot Study for a Self-Managed Intervention for Anxiety in Parkinson's Disease
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Virginia
-
Richmond, Virginia, Estados Unidos, 23298
- Virginia Commonwealth University
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Clinical diagnosis of Parkinson's disease
- Hoehn & Yahr I, II, & III
- Self report or clinical diagnosis of anxiety
- Ability to speak and read English
Exclusion Criteria:
- Montreal Cognitive Assessment scores less than 26, indicating cognitive impairment
- Persons under the age of 18 are excluded from this study
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Focused breathing intervention group
Participants randomized to this group will be taught how to perform focused breathing for the self-management of anxiety and asked to practice for 4 minutes each day during a six week period.
They may practice focused breathing in addition to the twice daily practices if they experience anxiety.
They will be asked to document in a diary each time they practice focused breathing.
|
Focused breathing is a series of focused, controlled breaths that aid in relaxation.
Each participation in this group will be taught how to do focused breathing by the study investigator.
Once determined to be able to perform focused breathing, participants will be asked to practice it for 4 minutes, twice a day, for 6 weeks.
If they choose to do so, they may practice focused breathing if they become anxious at other times.
They will be asked to keep a diary of each time they practice and/or use focused breathing.
|
Sin intervención: Control group
The participants randomized to this group with not be required to perform any additional behaviors for the six week period of the study.
After completing post-tests they will be taught how to perform focused breathing for the self-management of anxiety.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Parkinson Anxiety Scale (PAS)
Periodo de tiempo: 6 weeks following onset of focused breathing twice daily practice.
|
This is an 11 question, Likert scale which includes the following responses: Not at all or never Very mild or rarely Mild, or sometimes Moderate, or often Severe, or (nearly) always. The tool is has 3 sub-scales designed to measure persistent anxiety, episodic anxiety, and avoidance behavior in Parkinson's disease. It will be administered pre and post intervention for the experimental group and pre and post enrollment for the control group. Scores from 36-48 could indicate the possibility of an anxiety disorder and the need for a clinical evaluation. |
6 weeks following onset of focused breathing twice daily practice.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Geriatric Depression Scale
Periodo de tiempo: 6 weeks
|
This is a 25 item, yes/no scale used to measure depressive symptoms.
!1 point is scored for each bolded answer (see copy of tool).
A score of 0-4 is considered normal; 5-8 suggests mild depressive symptoms; 8-1 moderate depressive symptoms, and 12-15 severe depressive symptoms.
Scores of 5 or greater with will be communicated to the patient's Parkinson's provider.
It will be administered pre and post intervention for the experimental group and pre and post enrollment for the control group.
|
6 weeks
|
Parkinson Sleep Scale - 2 (PSS-2)
Periodo de tiempo: 6 weeks
|
This is 12 item Likert scale tool used to measure the experience and quality of sleep in individuals with Parkinson's disease.
It is a 5 point scale ranging from 0 (very often) to 4 (never).
three domains are measured: Motor symptoms at night, Parkinson's disease symptoms at night, and disturbed sleep.
Each domain has 5 questions.
Range of the domain scores is 0-20; total score range is 0-60.
Participants are asked to answer the questions with referral to the past 7 days.
Higher scores indicate greater nocturnal disturbance.
It will be administered pre and post intervention for the experimental group and pre and post enrollment for the control group.
|
6 weeks
|
General Self Efficacy Scale (GSES)
Periodo de tiempo: 6 weeks
|
This is a 10 question Likert style tool designed to measure self-efficacy, and has the following options: Not true at all (1 point) Hardly true (2 points) Moderately true (3 points) Exactly true.(4 points) Responses are made on a 4-point scale; final composite score range from 10 - 40. Higher scores reflect an optimistic self-belief that one can perform a novel or difficult task or cope with adversity. It will be administered pre and post intervention for the experimental group and pre and post enrollment for the control group. |
6 weeks
|
Parkinson's Quality Scale-8 (PDQ-8)
Periodo de tiempo: 6 weeks
|
This is an eight item Likert response tool designed to measure quality of life in those with Parkinson's disease and has the following options: Never Occasionally Sometimes Often Always or cannot do at all It will be administered pre and post intervention for the experimental group and pre and post enrollment for the control group. Answers of the eight items are summed; a score of 0 (0=never) indicates good health; as the score increases (maximum score is 1000 the higher the score the poorer health). |
6 weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jo Lynne Robins, PhD, Virginia Commonwealth University
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
- Desordenes mentales
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Trastornos Parkinsonianos
- Enfermedades de los ganglios basales
- Trastornos del movimiento
- Sinucleinopatías
- Enfermedades neurodegenerativas
- Enfermedad de Parkinson
- Desórdenes de ansiedad
Otros números de identificación del estudio
- HM20014147
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 Enfermedad de Parkinson
-
ProgenaBiomeReclutamientoEnfermedad de Parkinson | Enfermedad de Parkinson con demencia | Síndrome de Parkinson-Demencia | Enfermedad de Parkinson 2 | Enfermedad de Parkinson 3 | Enfermedad de Parkinson 4Estados Unidos
-
National Heart, Lung, and Blood Institute (NHLBI)TerminadoEnfermedad de Parkinson 6, inicio temprano | Enfermedad de Parkinson (autosómica recesiva, aparición temprana) 7, humana | Enfermedad de Parkinson Autosómica Recesiva, Inicio Temprano | Enfermedad de Parkinson, autosómica recesiva de aparición temprana, digénica, Pink1/Dj1Estados Unidos
-
Assiut UniversityAún no reclutandoMri en Parkinson
-
Medical College of WisconsinRetirado
-
Hacettepe UniversityTerminadoEnfermedad de Parkinson idiopáticaPavo
-
Pôle Saint HélierRennes University Hospital; Réseau Parkinson BretagneTerminadoEnfermedad de Parkinson | Síndrome de ParkinsonFrancia
-
UCB PharmaTerminadoEnfermedad de Parkinson idiopáticaAlemania
-
AbbVie (prior sponsor, Abbott)Quintiles, Inc.TerminadoEnfermedad de Parkinson avanzadaEstados Unidos, Nueva Zelanda
-
UCB BIOSCIENCES GmbHOtsuka Pharmaceutical Co., Ltd.TerminadoEnfermedad de Parkinson Idiopática AvanzadaCorea, república de, Estados Unidos, Malasia, Singapur, Taiwán
-
Samuel Vilchez, PhDNational Autonomous University of Nicaragua; Wake Forest University; GID BIO, Inc. y otros colaboradoresTerminadoEnfermedad de Parkinson y parkinsonismo | Enfermedad de Parkinson idiopáticaNicaragua