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

18. juni 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

106

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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Studiekontakt

Studer Kontakt Backup

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: E-CBSST
E-CBSST er den eksperimentelle armen i denne studien.
Atferdsmessig: 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.
Aktiv komparator: E-SC
E-SC is the comparator condition in this study.
Atferdsmessig: 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).

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Independent Living Skills Survey
Tidsramme: 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
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Executive Interview
Tidsramme: 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
Tidsramme: 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)

Samarbeidspartnere og etterforskere

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Sponsor

University of California, San Diego

Samarbeidspartnere

University of Texas Southwestern Medical Center

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. oktober 2026

Primær fullføring (Antatt)

1. juni 2029

Studiet fullført (Antatt)

1. juni 2029

Datoer for studieregistrering

Først innsendt

11. juni 2026

Først innsendt som oppfylte QC-kriteriene

11. juni 2026

Først lagt ut (Faktiske)

22. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

23. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

18. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • R33MH132859

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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

IPD-delingstidsramme

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

Tilgangskriterier for IPD-deling

Data access is outlined in the current NDA Policy.

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Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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