Comparative Effectiveness of CET vs. SST in SMI (Serious Mental Illness)

  • STATUS
    Recruiting
  • End date
    Jan 31, 2026
  • participants needed
    378
  • sponsor
    Beth Israel Deaconess Medical Center
Updated on 19 April 2022

Summary

To compare two evidence-based treatments, Cognitive Enhancement Therapy (CET) and Social Skills Training (SST) that have been shown in meta-analyses and in our own research to be effective to improve community functioning. The investigators will test the impact of CET and SST on community functioning, with special attention to their relative effectiveness for patients differing in baseline cognitive skills and age. The research uses a cluster design in which different mental health service centers are randomized to one of the two treatments.

Description

Aim 1. We will test our hypothesis that CET will be associated with greater improvements than SST in both the primary outcome: community functioning (SAS, QLS), and the secondary outcomes of neuro- and social cognition (NIH Toolbox, PennCNB, and MSCEIT) and social skills (SSPA). For study Aim 1, we hypothesized that CET will be associated with greater improvements than SST in both the primary outcome: community functioning (SAS, QLS), and the secondary outcomes of neuro- and social cognition (selected NIH Toolbox and Penn CNB measures, and MSCEIT) and social skills (SSPA). Aim 2: We will explore differential effectiveness of the two interventions by baseline cognitive functioning and age. For Aim 2, we hypothesize that patients with less impairment in cognitive functioning at baseline will demonstrate relatively larger treatment gains in SST compared to those in CET than those who are initially more cognitively impaired, and that younger patients will benefit more from CET compared to those in SST than those who are older. The results of this study will address a key knowledge gap in the field and a decisional dilemma for clinicians. A pilot study at four treatment sites will be used to test the feasibility and acceptability of telementalhealth delivery of these two treatments, as compared to in-person delivery.

Details
Condition Schizophrenia and Related Disorders
Treatment Social Skills Training, Cognitive Enhancement Therapy
Clinical Study IdentifierNCT04321759
SponsorBeth Israel Deaconess Medical Center
Last Modified on19 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

age 18 to 65
DSM-5 diagnosis of schizophrenia or schizoaffective or schizophreniform disorder (confirmed via the MINI diagnostic interview)
estimated IQ of > 70 (established via WTAR)

Exclusion Criteria

the presence of a current organic brain syndrome
intellectual disability (DSM-5)
participation in either CET or SST within the prior year
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