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

11. juni 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

106

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

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Ingen

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: E-CBSST
E-CBSST er den eksperimentelle arm i denne undersøgelse.
Adfærdsmæssigt: 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.
Adfærdsmæssigt: 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).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of California, San Diego

Samarbejdspartnere

University of Texas Southwestern Medical Center

Efterforskere

  • Ledende efterforsker: Eric Granholm, PhD, University of California, San Diego
  • Ledende efterforsker: Tarek Rajji, MD, UT Southwestern

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. oktober 2026

Primær færdiggørelse (Anslået)

1. juni 2029

Studieafslutning (Anslået)

1. juni 2029

Datoer for studieregistrering

Først indsendt

11. juni 2026

Først indsendt, der opfyldte QC-kriterier

11. juni 2026

Først opslået (Faktiske)

22. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • R33MH132859

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (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.

IPD-delingsadgangskriterier

Data access is outlined in the current NDA Policy.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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