Computerized Cognitive Behavioral Therapy and Electroconvulsive Therapy
Evaluating the Feasibility and Efficacy of Computerized Cognitive Behavioral Therapy in Prolonging the Antidepressant Effects of Electroconvulsive Therapy
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Connecticut
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New Haven, Connecticut, Estados Unidos, 06519
- Yale University
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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:
- 18-75 years old
- meet DSM-5 criteria for depressive episodes
- able to use a computer
Exclusion Criteria:
- diagnosis of an axis II (personality disorder)
- active suicidal thoughts with a plan
- current substance use disorder
- non-affective psychosis
- prior treatment with ECT in the past 6 months
- CBT treatment in the past 12 months
- dementia
- delirium or another other neurological or mental disease that might affect cognition or the ability to meaningfully participate in computerized CBT
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Computerized Cognitive Behavioral Therapy
A computerized version of CBT has been developed in an effort to more widely disseminate the powerful effects of this psychotherapy modality, with studies showing efficacy comparable to that of traditional CBT.8
The present study aims to further investigate the feasibility of combining ECT and computerized CBT (c-CBT).
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The c-CBT software focuses on the same principles of traditional CBT, namely, "identifying, labeling, and modifying automatic thoughts; the link between thought and action; identifying and modifying schemas; and identifying and correcting cognitive errors."9
C-CBT is delivered in 9 online lessons, each designed to take 30-45 minutes to complete.
The software provides modeling of CBT principles (in the form of short videos), enables an interactive forum by giving users feedback based on responses to questions, and encourages participants to employ the skills learned in CBT to their situations.
A 9-minute video demonstrating the functionality of Good Days Ahead can be found at: http://www.empower-interactive.com/solutions/good-days-ahead/.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Beck Depression Inventory
Periodo de tiempo: Baseline
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The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression . The treatment group will undergo depression rating scales (as well as cognitive screening) at baseline, at 2 weeks during their index course of ECT, following the completion of the ECT phase, and then every 5 weeks for a total of 25 weeks total after the completion of the ECT phase. Depression rating scales will include the BDI, QIDS-SR, MADRS, CGI, and MOCA. During the 10 weeks of their c-CBT course, they will also complete self-rating scales on a more frequent basis (every 2.5 weeks); these scales are the BDI and QIDS-SR. |
Baseline
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Beck Depression Inventory
Periodo de tiempo: week 2
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The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression . The treatment group will undergo depression rating scales (as well as cognitive screening) at baseline, at 2 weeks during their index course of ECT, following the completion of the ECT phase, and then every 5 weeks for a total of 25 weeks total after the completion of the ECT phase. Depression rating scales will include the BDI, QIDS-SR, MADRS, CGI, and MOCA. During the 10 weeks of their c-CBT course, they will also complete self-rating scales on a more frequent basis (every 2.5 weeks); these scales are the BDI and QIDS-SR. |
week 2
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Beck Depression Inventory
Periodo de tiempo: Week 5 through week 15
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The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression . The treatment group will undergo depression rating scales (as well as cognitive screening) at baseline, at 2 weeks during their index course of ECT, following the completion of the ECT phase, and then every 5 weeks for a total of 25 weeks total after the completion of the ECT phase. Depression rating scales will include the BDI, QIDS-SR, MADRS, CGI, and MOCA. During the 10 weeks of their c-CBT course, they will also complete self-rating scales on a more frequent basis (every 2.5 weeks); these scales are the BDI and QIDS-SR. |
Week 5 through week 15
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Quick Inventory of Depressive Symptomology (QIDS)
Periodo de tiempo: Baseline, Week 2, week 5, week 10, week 15
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The16 item Quick Inventory of Depressive Symptomatology (QIDS) (an abbreviated version of the 30 item Inventory of Depressive Symptomatology (IDS) is designed to assess the severity of depressive symptoms. The treatment group will undergo the same depression rating scales (as well as cognitive screening) at baseline, at 2 weeks during their index course of ECT, following the completion of the ECT phase, and then every 5 weeks for a total of 25 weeks total after the completion of the ECT phase. During the 10 weeks of their c-CBT course, they will also complete self-rating scales on a more frequent basis (every 2.5 weeks); these scales are the BDI and QIDS-SR. |
Baseline, Week 2, week 5, week 10, week 15
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Montgomery-Åsberg Depression Rating Scale ( MADRS)
Periodo de tiempo: Baseline, Week 2, week 5, week 10, week 15
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The Montgomery-Åsberg Depression Rating Scale ( MADRS) is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. The treatment group will undergo the same depression rating scales (as well as cognitive screening) at baseline, at 2 weeks during their index course of ECT, following the completion of the ECT phase, and then every 5 weeks for a total of 25 weeks total after the completion of the ECT phase. During the 10 weeks of their c-CBT course, they will also complete self-rating scales on a more frequent basis (every 2.5 weeks); these scales are the BDI and QIDS-SR. |
Baseline, Week 2, week 5, week 10, week 15
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Clinical Global Impression (CGI)
Periodo de tiempo: Baseline, Week 2, week 5, week 10, week 15
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The Clinical Global Impression rating scales are commonly used measures of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders. The treatment group will undergo the same depression rating scales (as well as cognitive screening) at baseline, at 2 weeks during their index course of ECT, following the completion of the ECT phase, and then every 5 weeks for a total of 25 weeks total after the completion of the ECT phase. During the 10 weeks of their c-CBT course, they will also complete self-rating scales on a more frequent basis (every 2.5 weeks); these scales are the BDI and QIDS-SR. |
Baseline, Week 2, week 5, week 10, week 15
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Montreal Cognitive Assessment (MoCA)
Periodo de tiempo: Baseline, Week 2, week 5, week 10, week 15
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The Montreal Cognitive Assessment (MoCA) measures mild cognitive impairment. The treatment group will undergo the same depression rating scales (as well as cognitive screening) at baseline, at 2 weeks during their index course of ECT, following the completion of the ECT phase, and then every 5 weeks for a total of 25 weeks total after the completion of the ECT phase. During the 10 weeks of their c-CBT course, they will also complete self-rating scales on a more frequent basis (every 2.5 weeks); these scales are the BDI and QIDS-SR. |
Baseline, Week 2, week 5, week 10, week 15
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Samule Wilkonson, MD, Yale School of Medicine
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 (Estimar)
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
- 1404013837
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