Cognitive Therapy for Suicidal Older Men
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Older adult males have the highest suicide rate of any age group in the U.S. However, most research concerning treatments for suicide ideation and behavior has focused on adolescents and young adults. Very few treatments have been developed to reduce suicide ideation and behavior in men aged 50 and above. This study will assess the effectiveness of specialized cognitive therapy versus enhanced usual care in treating older men with suicide ideation.
Participants in this five-year study will be randomly assigned to receive either cognitive therapy or enhanced usual care. Participants will be identified within the VA Medical Center and the University of Pennsylvania Health System (UPHS) as having experienced suicide ideation in the past month. Cognitive therapy will be provided by Ph.D.-level therapists and will be geared specifically toward older men with suicidal tendencies. The enhanced usual care condition will consist of the usual care that individuals receive for suicide prevention, plus assessment and referral services provided by independent evaluators and study case managers. In addition, patients in the enhanced usual care condition will receive weekly telephone calls from the study therapists. These phone calls will be approximately 15-30 minutes in duration and their purpose will be to ensure patient safety and to provide some support. All participants will be assessed pre-treatment to attain baseline measures of suicide ideation, hopelessness, and depression. Study visits will occur at baseline and Months 1, 3, 6, 9, and 12 to assess suicide ideation. Self-report and clinician-administered measures will be used to assess participants' progress.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- Aaron T. Beck Psychopathology Research Center - University of Pennsylvania
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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:
- Suicidal intent or desire during the past month prior to the baseline interview as indicated by a score of 1 or higher on items 4 or 5 of the Scale for Suicide Ideation.
- Male
- 50 years of age or older
- Able to speak English
- Able to provide written informed consent
- Able to attend study assessment and therapy sessions
- Able to provide at least two verifiable contacts for tracking purposes
- Able to function at an intellectual level to allow for the reliable completion of study assessments and participate in psychotherapy as indicated by a Mini-Mental Status Exam (MMSE) total score of 24 or higher and an Executive Interview (EXIT-25) total score of 14 or lower.
Exclusion Criteria:
- Needed priority treatment for a substance use disorder as determined by the referring clinician.
- Needed priority treatment for PTSD as determined by the referring clinician.
- Taking antidepressant medication for less than one month, or if antidepressant medication has been changed in the last month as indicated by the Alexopolous "Composite Antidepressant Score" Scale.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Cognitive Therapy
A cognitive therapy protocol specifically designed to target suicidal ideation in older adults.
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Cognitive therapy (CT) will consist of 12 to 16 individual CT sessions on a weekly basis plus 3 booster sessions.
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Comparador activo: Enhanced Usual Care
Enhanced usual care consists of the usual care that individuals receive for suicide prevention, plus assessment and referral services provided by project staff, and weekly phone calls provided by study therapists.
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Enhanced usual care (EUC) will consist of the usual care that individuals receive for suicide prevention in the community, assessment and referral services provided by study staff, and weekly telephone calls lasting 15-30 minutes provided by study therapists to ensure patient safety and to provide some support.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Change in baseline suicidal ideation
Periodo de tiempo: baseline, 1, 3, 6, 9, 12 months
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baseline, 1, 3, 6, 9, 12 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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depression
Periodo de tiempo: baseline, 1, 3, 6, 9, 12 months
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baseline, 1, 3, 6, 9, 12 months
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hopelessness
Periodo de tiempo: baseline, 1, 3, 6, 9, 12 months
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baseline, 1, 3, 6, 9, 12 months
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quality of life
Periodo de tiempo: baseline, 1, 3, 6, 9, 12 months
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baseline, 1, 3, 6, 9, 12 months
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social problem solving skills
Periodo de tiempo: baseline, 1, 3, 6, 9, 12 months
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baseline, 1, 3, 6, 9, 12 months
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complicated grief
Periodo de tiempo: baseline, 1, 3, 6, 9, 12 months
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baseline, 1, 3, 6, 9, 12 months
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reasons for living and dying
Periodo de tiempo: baseline, 1, 3, 6, 9, 12 months
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baseline, 1, 3, 6, 9, 12 months
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perceived social support
Periodo de tiempo: baseline, 1, 3, 6, 9, 12 months
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baseline, 1, 3, 6, 9, 12 months
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Cognitive Executive Functioning
Periodo de tiempo: baseline, 1, 3, 6, 9, 12 months
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Executive functioning will be measured by scores on an Executive Functioning Interview, which measures skills such as planning, working memory, attention, inhibition, and mental flexibility.
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baseline, 1, 3, 6, 9, 12 months
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
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
Otros números de identificación del estudio
- R01MH086572-01A2 (Subvención/contrato del NIH de EE. UU.)
- 1R01MH086572-01A2 (Subvención/contrato del NIH de EE. UU.)
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