Brief Behavioral Treatment of Insomnia in Military Veterans: Phase 2 (BBTIMVII) (BBTIMVII)
Treatment of Insomnia in Military Veterans:Phase 2
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Tipo de estudio
Inscripción (Actual)
Inscripción
Fase
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Pennsylvania
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Pittsburgh, Pennsylvania, Estados Unidos, 15237
- Western Psychiatric Institute & Clinic
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Age is 18 years old and older
- Military returnees from OIF/OEF
Meet diagnostic criteria for chronic insomnia as defined by:
a. Complaint of sleep latency >30 minutes, or wake time after sleep onset >30 minutes, or Sleep Efficiency <85%, or a complaint of non-restorative sleep
- Frequency of insomnia complaint >3 times per week;
- Duration of insomnia complaint >1 month
- Associated with at least one daytime consequences
- If using sleep medications, medication and dosage have not been changed in the past month, and will remain unchanged for the duration of the acute treatment phase of the study (i.e., 4 weeks)
- If using other psychotropic medications, medication and dosage have not been changed in the past 2 months, and will remain unchanged for the duration of the acute treatment phase of the study (i.e., 4 weeks)
Exclusion Criteria:
- Active duty personnel, or reservists/national guards scheduled to re-deploy if their departure date is < 2 months from the consent date
- Untreated, current, and severe PTSD as determined on the SCID.
- Untreated, current, and severe Major Depressive Disorder as determined by the Structured Clinical Interview for DSM-IV and a score > 30 on the Beck Depression Inventory
- Psychotic or bipolar disorder
- Current substance or alcohol use disorder as determined by the SCID or by positive drug toxicology results
- Unstable medical condition
- Hospitalization in the previous 2 weeks for a medical condition or surgery for which recovery overlaps with the study onset and duration
- Seizure disorder or open skull brain injury.
- Current sleep disorders such as nightmare disorder, restless legs syndrome, or suspected sleep disorder requiring polysomnographic assessment, such as obstructive sleep apnea or periodic leg movements.
- Sleep apnea revealed during the screening sleep study.
- Pregnancy.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
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Comparador activo: Breif Behavioral Treatment of Insomnia
Effective behavioral insomnia treatments are typically delivered over an 8-week period.
This format may not be easily exportable to primary and community care settings where military returnees and veterans seek help.
The goal here is to test the effects of a 4-week behavioral treatment that targets chronic insomnia (lasting >1 month) in service members returning from Operation Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF), and who present with the typical psychiatric comorbidities associated of combat-related anxiety and mood disorders and stress reactions.
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Twenty participants will be randomized to BBTI-MV.
As previously described, the intervention will be delivered over 4 consecutive weeks, which include individual face-to-face visits on Weeks 1 and 3, and telephone appointments on Weeks 2 and 4. Interventions will be delivered at Western Psychiatric Institutes and Clinic.
If possible, (according to space availability), the face-to-face sessions may also be conducted at the VAPHS clinics or at Reserve and Veterans Centers locally and regionally to strengthen our relations with local care and services providers and centers, and to facilitate future collaborative efforts.
The duration of the first treatment visit is 45-minutes, and the follow-up visit on Week 3 will last no more than 30 minutes.
Brief (<20 minutes) telephone sessions will be conducted on Weeks 2 and 4.
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Otro: Information Control
This arm of the study does not receive the Brief Behavioral Treatment for Insomnia.
This arm will act as the control arm.
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Participants will receive two brochures from the American Academy on Sleep Medicine of Sleep Hygiene and on Insomnia.
The therapists will read the content of the 2 brochures with participants, and discuss how the information provide relates to individual participants' sleep experiences.
No recommendations for altering sleep schedules will be made by the assigned therapist.
Participants will be instructed to read these two brochures over the course of the following week, and to consider how the information provided in the brochures related to their own sleep patterns
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¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Pittsburgh Sleep Quality Index (PSQI)
Periodo de tiempo: Baseline and Post Intervention
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Baseline and Post Intervention
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Pittsburgh Sleep Diary
Periodo de tiempo: Weekly
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Weekly
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PSQI Addendum for PTSD (PSQIA)
Periodo de tiempo: Baseline and Post
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Baseline and Post
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Sleep Quality defined by: PIRS-20 and ISI
Periodo de tiempo: Screening,Baseline, and Post
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Screening,Baseline, and Post
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Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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PTSD symptom severity as measured by the CAPS
Periodo de tiempo: Screening
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Screening
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Post Sleep Self Report: PSEQ-SV and POST
Periodo de tiempo: Screening
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Screening
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Depression: BDI
Periodo de tiempo: Baseline and Post
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Baseline and Post
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Anxiety: BAI
Periodo de tiempo: Baseline and Post
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Baseline and Post
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Medical History: MHQ, MEDHIST_2WK, MOS
Periodo de tiempo: Screening, Baseline, and Post
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Screening, Baseline, and Post
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Trauma History: THQ,CES,PCL-C,ICG
Periodo de tiempo: Screening, Baseline, and Post
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Screening, Baseline, and Post
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Sleepiness: EPWORTH, BASS
Periodo de tiempo: Screening, Baseline, and Post
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Screening, Baseline, and Post
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Mood and Behavior: BIS/BAS, SMITH, PANAS
Periodo de tiempo: Screening, Baseline, and Post
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Screening, Baseline, and Post
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Expectations and Satisfaction: TEQ-94, Client Satisfaction Survey
Periodo de tiempo: Baseline and Post
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Baseline and Post
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Colaboradores e Investigadores
Patrocinador
Patrocinador
Colaboradores
Colaboradores
Investigadores
Investigadores
- Investigador principal: Anne Germain, PhD, University of Pittsburgh, Department of Psychiatry
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización primaria
Finalización del estudio (Actual)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- PRO08070327
- NIMH: 1 R34 MH080696
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