- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01648049
Treatment of Insomnia and Depression in Elders (TIDE) (TIDE)
Insomnia and depression are two of the most prevalent mental health disorders and often co-occur.
Health disparities in rural America and among African-Americans are well documented. The investigators propose an R34 exploratory project to test the feasibility of delivering high-fidelity insomnia and depression psychological services to an underserved population. Treatment of Insomnia and Depression in Elders (TIDE) is a pilot study that will treat rural, predominantly African-American older adults who present to their primary care physician with co-occurring insomnia/depression. Stage 1 will be an uncontrolled case study series (n = 10) focusing on treatment development/refinement and patient acceptability. In stage 2, feasibility will be experimentally tested with 46 participants randomized to integrated cognitive-behavior therapy (CBT) + usual care or to usual care only in an effectiveness pilot study. The treatment will combine/integrate compact CBT for insomnia (including relaxation, sleep restriction, and stimulus control) and for depression (including cognitive therapy and behavioral activation). The experimental intervention comprises delivering CBT services by videoconferencing to patients in primary care settings who live in rural areas. Treatment will be evaluated by pre, post, and follow-up self report instruments on insomnia, depression, and quality of life. In addition, the stage 1 pilot will use investigator designed quantitative and qualitative measures to evaluate critical process variables including patient acceptability of the video format, patient acceptability of the treatments, and obstacles to adherence. Depending on stage 1 data, these measures may be incorporated into stage 2 as well. Several innovative features of this exploratory project include: intervening with CBT on both disorders hoping to gain a synergy by their combined presentation; use of telehealth to deliver treatment to distant locations; translation of efficacy findings to an effectiveness trial; treatment will be delivered in the primary care setting, the preferred locale of rural, older adults; the study will extend knowledge of the range of CBT applications by enrolling under-represented groups with respect to ethnicity, literacy, and financial resources.
The primary aims of this project are (1) to determine the feasibility and maximal therapy characteristics of integrated CBT for co-occurring insomnia/depression in both the case study series (stage 1) and the experimental investigation (stage 2), (2) collect pilot data on whether participants receiving integrated CBT + usual care show comparable or greater reductions in insomnia symptoms compared to participants receiving usual care at posttreatment and follow-up, and (3) collect pilot data on whether participants receiving integrated CBT + usual care show comparable or greater reductions in depression symptoms compared to participants receiving usual care at posttreatment and follow-up.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Alabama
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Tuscaloosa, Alabama, Estados Unidos, 35487
- UATuscaloosa
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- 50 years of age or older,
- resident of the Black Belt or adjacent counties and receiving services from one of our primary care collaborators
- absence of significant cognitive impairment as indicated by a score of 24 or higher (17 or higher for those with only an eighth grade education) on the Mini-Mental Status Examination (MMSE; Folstein, Folstein, & McHugh, 1975
- not currently receiving psychological treatment,
- absence of serious suicidality
- concurrent psychiatric/medical disorders are not automatic disqualifiers unless they prevent participants from attending CBT therapy sessions or impede data collection,
- a referral from their primary care physician indicating presence of both insomnia and depression symptoms of sufficient significance to warrant initiation or continuance of primary care treatment for newly emergent or residual symptoms. Persons who are currently receiving pharmacotherapy for insomnia and/or depression must evidence residual symptoms of both disorders of sufficient magnitude to be evaluated as clinically significant and warranting further treatment by their primary care physician.
Exclusion Criteria:
- age is below 50
- not receiving services from one of our primary care collaborators
- significant cognitive impairment is present as indicated by a score of 23 or lower (16 or lower for those with only an eighth grade education) on the MMSE
- currently receiving psychological treatment
- presence of serious suicidality
- intrusive and unstable concurrent psychiatric/medical disorders
- primary care physician declines to refer
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: CBT
Cognitive behavior therapy for both insomnia and depression featuring stimulus control and cognitive therapy.
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CBT treatment is an abbreviated protocol based on manualized, evidence-based treatments for geriatric insomnia (Lichstein & Morin, 2000) and geriatric depression (Thompson, Gallagher-Thompson, & Dick, 1995).
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Comparador activo: Treatment as Usual
No additional treatment besides regular care.
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Standard Care - Treatment as usual
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Insomnia Severity Index
Periodo de tiempo: 3-month follow-up (23weeks post-treatment)
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Insomnia Measure
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3-month follow-up (23weeks post-treatment)
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Hamilton Depression Scale
Periodo de tiempo: 10 weeks Post-treatment
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Depression measure
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10 weeks Post-treatment
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Hamilton Depression Scale
Periodo de tiempo: 3 Month follow-up (23 weeks post treatment)
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Depression Measure
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3 Month follow-up (23 weeks post treatment)
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|
Insomnia Severity Index
Periodo de tiempo: 10 weeks Post-treatment
|
Insomnia Measure
|
10 weeks Post-treatment
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
GDS
Periodo de tiempo: Pre-Treatment (Baseline/Week 0)
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Self-reported Geriatric Depression Scale
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Pre-Treatment (Baseline/Week 0)
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SOL
Periodo de tiempo: Pre-Treatment (Baseline/Week 0)
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self-reported Sleep Onset Latency
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Pre-Treatment (Baseline/Week 0)
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WASO
Periodo de tiempo: Pre-Treatment (Baseline/Week 0)
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Wake-time After Sleep Onset
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Pre-Treatment (Baseline/Week 0)
|
|
SOL
Periodo de tiempo: 10 weeks Post-treatment
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Self-reported Sleep onset latency
|
10 weeks Post-treatment
|
|
SOL
Periodo de tiempo: 3-month follow-up (23weeks post-treatment)
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Self-reported Sleep onset latency
|
3-month follow-up (23weeks post-treatment)
|
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GDS
Periodo de tiempo: 10 weeks Post-treatment
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Self Reported Geriatric Depression Scale
|
10 weeks Post-treatment
|
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GDS
Periodo de tiempo: 3-month follow-up (23weeks post-treatment)
|
Self-reported Geriatric Depression Scale
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3-month follow-up (23weeks post-treatment)
|
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WASO
Periodo de tiempo: 10 weeks Post-treatment
|
Wake-time After Sleep Onset
|
10 weeks Post-treatment
|
|
WASO
Periodo de tiempo: 3-month follow-up (23weeks post-treatment)
|
Wake-time After Sleep Onset
|
3-month follow-up (23weeks post-treatment)
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Kenneth L. Lichstein, Ph.D., University of Alabama, Tuscaloosa
- Investigador principal: Forrest Scogin, Ph.D., University of Alabama, Tuscaloosa
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (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 (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
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
- 10-0309
- 1R34MH086643-01A2 (Subvención/contrato del NIH de EE. UU.)
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