- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03384953
Chronic Pain Skills Study - Vanderbilt University Medical Center
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The purpose of this pilot project is to test the efficacy and mechanisms of clinical hypnosis on chronic pain. Primary (characteristic pain intensity) and secondary (mood, quality of life) outcomes will be assessed at pre-treatment, three times during treatment, post-treatment, and at 3- and 6-month follow-up. Potential treatment moderators and mediators will also be assessed. The study will address two aims:
Aim 1: Determine the efficacy of 8 sessions of group delivered HYP training for reducing characteristic pain intensity in patients. The hypothesis associated with Aim 1 is:
Hypothesis 1: Primary Study Hypothesis. Patients receiving 8 sessions of HYP training will report significantly reduced pre- to post-treatment decreases in average pain intensity.
Aim 2 : To evaluate potential moderators (hypnotizability) associated with treatment outcomes following intervention. The hypothesis associated with Aim 2 is:
Hypothesis 2a: Hypnotizability will augment treatment outcomes such that those with higher hypnotizability will experience significantly greater treatment gains.
In addition to testing the above specific hypotheses, we will use the data obtained in this study to further explore (1) the longer-term (up to 6 months) effects of HYP and (2) additional potential moderators (e.g., treatment outcome expectancies, treatment motivation, demographic variables, pain type [neuropathic vs. nociceptive]) and mediators (pain acceptance, catastrophizing, mindfulness, therapeutic alliance, amount of skill practice between sessions) of treatment outcome.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Tennessee
-
Nashville, Tennessee, Estados Unidos, 37203
- Osher Center for Integrative Medicine at Vanderbilt
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- 18 years of age or older; *
- Self-reported presence of chronic pain;**
- Average pain intensity rating of ≥ 3 on a 0-10 Numerical Rating Scale (NRS) of pain intensity in the last week; **
- Worst pain intensity rating of ≥ 5 on a 0-10 Numerical Rating Scale (NRS) of pain intensity in the last week;**
- Duration of chronic pain 3 months or more; **
Experiences pain at least 75% of the time in the past 3 months; Those who have a hard time answering this question will be asked the following question: "Which statement best describes your pain?"
- Pain all the time, but the pain intensity varies;
- Pain most of the time with only occasional periods of being pain-free;
- Pain that comes and goes;
- Occasional pain; Participants must report experiencing pain that matches one of the first two options;**
- Able to read, speak, and understand English.**
Exclusion Criteria:
- Cognitive impairment or limitations (i.e. history of moderate to severe Traumatic Brain Injury (TBI), unresolved TBI, or other medical condition) that would interfere with a patient's ability to participate in a group involving focused attention*.
- Current or history of diagnosis of primary psychotic or major thought disorder as listed in participant's medical record or self-reported within the past five years;*
- Hospitalization for psychiatric reasons other than suicidal ideation, homicidal ideation, and/or PTSD self-reported or noted in chart (within the past 5 years);*
- Psychiatric or behavioral conditions in which symptoms are unstable or severe (e.g. current delirium, mania, psychosis, suicidal ideation, homicidal ideation, substance abuse dependency) as listed in participant's medical record or self-reported within the past six months;*
- Any behavioral issues as noted in the medical record or by a provider that would indicate the participant may be inappropriate in a group setting;***
- Presenting symptoms at time of screening that would interfere with participation, specifically active suicidal ideation with intent to harm oneself or active delusional or psychotic thinking;**
- Difficulties or limitations communicating over the telephone;**
- Any planned life events that would interfere with participating in the key elements of the study.**
Reported average daily use of >120mg morphine equivalent dose (MED). **
- also verified via medical record review, as described below. **verified solely via self-report, as described below; there is no medical record
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Clinical Hypnosis - Group Treatment
Subjects will receive 8 weeks of a manualized clinical hypnosis for chronic pain treatment in a group setting.
Assessments will be completed before, immediately after, and at 3- and 6- months post-treatment to assess for treatment gains.
|
group treatment
|
Experimental: Clinical Hypnosis - Individual Treatment
Subjects will receive 8 weeks of a manualized clinical hypnosis for chronic pain treatment in an individual, 1:1 setting.
Assessments will be completed before, immediately after, and at 3- and 6- months post-treatment to assess for treatment gains.
|
individual treatment
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in Pain Intensity
Periodo de tiempo: baseline and 6 months
|
Brief Pain Inventory (severity scale only) is a 4-item subscale of the Brief Pain Inventory assessing the severity of pain over the past week.
Questions inquire into an individual's worst, least, average, and current levels of pain on an 11-point likert scale, with 0 being no pain.
It has been validated and is considered the gold standard to utilize in patient-reported outcomes studies.
It takes <1 minute to complete.
|
baseline and 6 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Lindsey C McKernan, Ph.D., Vanderbilt University Medical Center
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 170652
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. .