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Treatment of Insomnia and Depression in Elders (TIDE) (TIDE)

30 de noviembre de 2015 actualizado por: University of Alabama, Tuscaloosa

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

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

46

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Alabama
      • Tuscaloosa, Alabama, Estados Unidos, 35487
        • UATuscaloosa

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

50 años a 100 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

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

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿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
Experimental: CBT
Cognitive behavior therapy for both insomnia and depression featuring stimulus control and cognitive therapy.
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).
Comparador activo: Treatment as Usual
No additional treatment besides regular care.
Standard Care - Treatment as usual

¿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)
Insomnia Measure
3-month follow-up (23weeks post-treatment)
Hamilton Depression Scale
Periodo de tiempo: 10 weeks Post-treatment
Depression measure
10 weeks Post-treatment
Hamilton Depression Scale
Periodo de tiempo: 3 Month follow-up (23 weeks post treatment)
Depression Measure
3 Month follow-up (23 weeks post treatment)
Insomnia Severity Index
Periodo de tiempo: 10 weeks Post-treatment
Insomnia Measure
10 weeks Post-treatment

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
GDS
Periodo de tiempo: Pre-Treatment (Baseline/Week 0)
Self-reported Geriatric Depression Scale
Pre-Treatment (Baseline/Week 0)
SOL
Periodo de tiempo: Pre-Treatment (Baseline/Week 0)
self-reported Sleep Onset Latency
Pre-Treatment (Baseline/Week 0)
WASO
Periodo de tiempo: Pre-Treatment (Baseline/Week 0)
Wake-time After Sleep Onset
Pre-Treatment (Baseline/Week 0)
SOL
Periodo de tiempo: 10 weeks Post-treatment
Self-reported Sleep onset latency
10 weeks Post-treatment
SOL
Periodo de tiempo: 3-month follow-up (23weeks post-treatment)
Self-reported Sleep onset latency
3-month follow-up (23weeks post-treatment)
GDS
Periodo de tiempo: 10 weeks Post-treatment
Self Reported Geriatric Depression Scale
10 weeks Post-treatment
GDS
Periodo de tiempo: 3-month follow-up (23weeks post-treatment)
Self-reported Geriatric Depression Scale
3-month follow-up (23weeks post-treatment)
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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

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

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de junio de 2012

Finalización primaria (Actual)

1 de marzo de 2015

Fechas de registro del estudio

Enviado por primera vez

26 de junio de 2012

Primero enviado que cumplió con los criterios de control de calidad

19 de julio de 2012

Publicado por primera vez (Estimar)

24 de julio de 2012

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

2 de diciembre de 2015

Última actualización enviada que cumplió con los criterios de control de calidad

30 de noviembre de 2015

Última verificación

1 de noviembre de 2015

Más información

Términos relacionados con este estudio

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