Optimizing CBSST With Executive Function Training for Schizophrenia (R33)

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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).

Первичные конечные точки

• Independent Living Skills Survey [Срок оценки: Baseline, End of Executive Function Training (Week 3), Mid-Trial (Week 13), End-Trial (Week 23), and Follow-Up (9 months)]
• Comprehensive Modules Test [Срок оценки: Baseline, End of Executive Function Training (Week 3), Mid-Trial (Week 13), End-Trial (Week 23), and Follow-Up (9 months)]

Вторичные конечные точки (2)

• Executive Interview [Срок оценки: 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 [Срок оценки: Baseline, End of Executive Function Training (Week 3), Mid-Trial (Week 13), End-Trial (Week 23), and Follow-Up (9 months)]

Критерии участия

Критерии включения

• Voluntary informed consent to participate;
• Age 60 years or older;
• DSM-5 diagnosis of schizophrenia or schizoaffective disorder based on the SCID;
• 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;
• Be willing and able to speak English;
• Be able to read and converse (with corrected vision or hearing if needed).

Критерии исключения

• 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;
• 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;
• Received electroconvulsive therapy within six months of the baseline assessment.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 2 центра

• University of California, San Diego — San Diego
• UT Southwestern Medical Center — Dallas

Идентификаторы

NCT: NCT07658391 · R33MH132859

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗