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Optimizing CBSST With Executive Function Training for Schizophrenia (R33) (ECBSST R33)

18 de junio de 2026 actualizado por: Eric Granholm, University of California, San Diego

Optimizing Cognitive Behavioral Social Skills Training With Executive Function Training for Older Adults With Schizophrenia

This randomized controlled clinical trial will test a blended intervention that combines Executive Function Training with Cognitive-Behavioral Skills Training (E-CBSST). E-CBSST will be delivered to adults with late-life schizophrenia to determine if it increases Cognitive Behavioral Social Skills Training skills learning more than a supportive contact control condition and leads to improved functioning.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

Older adults with schizophrenia are at risk for cognitive and functional decline leading to premature institutionalization. A large and increasing number of older people with schizophrenia will need more effective services. The investigators previously tested a blended intervention that combines Executive Function Training (EFT) with Cognitive-Behavioral Skills Training (E-CBSST) and determined its efficacy for improving Cognitive Behavioral Social Skills Training (CBSST) learning and preventing functional decline in people with schizophrenia. CBSST combines Cognitive Behavioral Therapy (CBT), Social Skills Training (SST), and problem-solving intervention modules in an 18-session, group-delivered intervention that is repeated to practice the skills for a total of 36 sessions. In an open trial, 54 participants with schizophrenia or schizoaffective disorder age 60 or older were enrolled to receive E-CBSST for 20 weeks. E-CBSST included an initial 2-week course of EFT that included 3 sessions per week of computerized exercises and strategy monitoring using a worksheet and assistance from a therapist. Participants then completed 2 cycles of E-CBSST with 18 sessions each cycle, delivered twice a week, during which participants received brief EFT at the start of CBSST group sessions. Results from this open trial showed that E-CBSST was feasible with acceptable retention and increased CBSST skills learning.

The current study will compare E-CBSST to a control condition combining supportive contact with EFT (E-SC) in a randomized clinical trial. The study aims include confirming target engagement by showing that E-CBSST enhances CBSST skills learning to a greater extent than E-SC and to determine whether functioning improves significantly in E-CBSST and to a greater extent than E-SC. The same 2-cycle dose of E-CBSST from the open trial will be used and E-SC will deliver the same number of EFT and supportive contact sessions. Outcome assessments will be administered at baseline, after the Executive Function Training course (Week 3), after the first cycle of E-CBSST (Week 13; mid-trial), after the end of the second cycle (Week 23; end-trial), and following a 9-month post-treatment follow-up period.

E-CBSST could become an evidence-based intervention that enhances and not only maintains function and, in turn, reduces personal and societal burden. If successful, the next logical step would be a confirmatory effectiveness trial in a larger sample.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

106

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.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • Estados Unidos
    • California
      • San Diego, California, Estados Unidos, 92093
        • University of California, San Diego
        • Contacto:
        • Contacto:
        • Investigador principal:
          • Eric Granholm, PhD
    • Texas

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

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  1. Voluntary informed consent to participate;
  2. Age 60 years or older;
  3. DSM-5 diagnosis of schizophrenia or schizoaffective disorder based on the SCID;
  4. Be clinically stable as operationalized by (1) not having been admitted to a psychiatric hospital within the three months prior to assessment, (2) having had no change in antipsychotic medication dosage within four weeks prior to the baseline assessment, and (3) and ascertained to be clinically and medically stable by one the study investigators;
  5. Be willing and able to speak English;
  6. Be able to read and converse (with corrected vision or hearing if needed).

Exclusion Criteria:

  1. Meets criteria for a cognitive disorder or for a neurological or other medical disorder affecting the ability to participate in Executive Function Training or CBSST;
  2. Meets diagnostic criteria for bipolar disorder, current major depressive episode, or substance abuse or dependence within the six months prior to the baseline assessment except for caffeine or nicotine;
  3. Received electroconvulsive therapy within six months of the baseline assessment.

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: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: E-CBSST
E-CBSST es el brazo experimental de este estudio.
Conductual: E-CBSST
E-CBSST is a blended, in-person intervention that combines components of Executive Function Training (EFT) with Cognitive Behavioral Social Skills Training (CBSST). Participants complete 6 sessions of EFT and then 36 sessions of combined EFT and CBSST. CBSST techniques are based on cognitive behavioral therapy and social skills training developed for adult patients with schizophrenia. Participants set meaningful recovery goals and then learn skills to achieve their goals.
Comparador activo: E-SC
E-SC is the comparator condition in this study.
Conductual: E-SC
E-SC is a goal-focused supportive contact group therapy intervention that provides the same frequency and amount of therapist and other group member contact as E-CBSST. Participants will complete the same number of EFT sessions and then continue with semi-structured supportive contact sessions of the same number and duration as participants in the E-CBSST arm. The SC intervention will have a primary focus on setting and achieving recovery goals (e.g., living, learning, and socializing).

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Independent Living Skills Survey
Periodo de tiempo: Baseline, End of Executive Function Training (Week 3), Mid-Trial (Week 13), End-Trial (Week 23), and Follow-Up (9 months)
The Independent Living Skills Survey (ILSS) assesses whether specific functioning behaviors have been performed over the past month in multiple areas: Personal Hygiene, Appearance and Care of Clothing, Care of Personal Possessions (everyday household chores), Food Preparation, Health Maintenance, Money Management, Transportation, and Leisure and Community (including socialization). Each item is rated from 0 (No) to 1 (Yes). Scales are summed to yield a total score. Higher scores represent a higher level of functioning.
Baseline, End of Executive Function Training (Week 3), Mid-Trial (Week 13), End-Trial (Week 23), and Follow-Up (9 months)
Comprehensive Modules Test
Periodo de tiempo: Baseline, End of Executive Function Training (Week 3), Mid-Trial (Week 13), End-Trial (Week 23), and Follow-Up (9 months)
The Comprehensive Module Test (CMT) is an assessment of CBSST skills acquisition in three domains: Communication Skills Test, Problem Solving Test, and Thought Challenging Test. The total CMT score ranges from 0-33. Higher total scores represent higher level of CBSST skills acquisition.
Baseline, End of Executive Function Training (Week 3), Mid-Trial (Week 13), End-Trial (Week 23), and Follow-Up (9 months)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Executive Interview
Periodo de tiempo: Baseline, End of Executive Function Training (Week 3), Mid-Trial (Week 13), End-Trial (Week 23), and Follow-Up (9 months)
The Executive Interview (EXIT) is a bedside assessment of executive function scored from 0-50. Higher scores indicate greater executive dyscontrol.
Baseline, End of Executive Function Training (Week 3), Mid-Trial (Week 13), End-Trial (Week 23), and Follow-Up (9 months)
Positive and Negative Syndrome Scale
Periodo de tiempo: Baseline, End of Executive Function Training (Week 3), Mid-Trial (Week 13), End-Trial (Week 23), and Follow-Up (9 months)
The Positive and Negative Syndrome Scale (PANSS) is 30 item semi-structured clinical interview designed to assess positive and negative symptoms. The PANSS consists of 7 items on the positive symptom subscale, 7 items on the negative symptom subscale, and 16 items on the general psychopathology subscale. Each item in the subscale is rated from 0 (absence of symptom) to 7 (extreme symptom severity). Scores of each subscale are summed to yield a total score range of 30 (Absence of symptoms) to 210, where higher scores represent more severe symptoms.
Baseline, End of Executive Function Training (Week 3), Mid-Trial (Week 13), End-Trial (Week 23), and Follow-Up (9 months)

Colaboradores e Investigadores

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

Patrocinador

University of California, San Diego

Colaboradores

University of Texas Southwestern Medical Center

Investigadores

  • Investigador principal: Eric Granholm, PhD, University of California, San Diego
  • Investigador principal: Tarek Rajji, MD, Ut Southwestern

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 (Estimado)

1 de octubre de 2026

Finalización primaria (Estimado)

1 de junio de 2029

Finalización del estudio (Estimado)

1 de junio de 2029

Fechas de registro del estudio

Enviado por primera vez

11 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

11 de junio de 2026

Publicado por primera vez (Actual)

22 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

23 de junio de 2026

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

18 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • R33MH132859

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

Per terms of the award, participant-level data will be uploaded to the NIMH Data Archive (NDA).

Marco de tiempo para compartir IPD

Data will be uploaded according to NDA standard data submission periods. These periods are currently twice each year.

Criterios de acceso compartido de IPD

Data access is outlined in the current NDA Policy.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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