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

Not Applicable

Recruiting

• Conditions: Schizophrenia and Related Disorders

• Registration Number: NCT04321759
• Lead Sponsor: Beth Israel Deaconess Medical Center

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-03-18
• Study First Submitted QC: 2020-03-24
• Study First Posted: 2020-03-25
• Study Start: 2021-06-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-13
• Last Update Posted: 2023-11-14
• Primary Completion: 2026-01-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 378

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Social Adjustment Scale II	Measurement at 0, 6, 12, 18, 24 months	Measure of social functioning
Change in Social Skills Performance Assessment	Measurement at 0, 6, 12, 18, 24 months	Measure of social functioning using role played scenarios
Change in Heinrich Quality of Life Scale	Measurement at 0, 6, 12, 18, 24 months	Measure of social functioning

Secondary Outcome Measures

Name	Time	Method
Change in Picture Sequence Memory	Measurement at 0, 6, 12, 18, 24 months	Neurocognition measure of visual/episodic memory \& learning in NIH Toolbox
Change in Auditory Verbal Learning Test	Measurement at 0, 6, 12, 18, 24 months	Neurocognition measure of verbal ability in NIH Toolbox
Change in Picture Vocabulary	Measurement at 0, 6, 12, 18, 24 months	Neurocognition measure of language in NIH Toolbox
Change in Penn Digit Symbol Test	Measurement at 0, 6, 12, 18, 24 months	Neurocognition measure of speed of processing in PennCNB
Change in List Sorting Working Memory	Measurement at 0, 6, 12, 18, 24 months	Neurocognition measure of working memory in NIH Toolbox
Change in Positive and Negative Syndrome Scale, PANSS-6	Measurement at 0, 6, 12, 18, 24 months	Short form of measure of positive and negative symptoms
Change in Oral Reading Recognition	Measurement at 0, 6, 12, 18, 24 months	Neurocognition measure of language in NIH Toolbox
Change in Penn Mouse Practice Test	Measurement at 0, 6, 12, 18, 24 months	Neurocognition measure of speed of processing in PennCNB
Change in Penn Conditional Exclusion Test	Measurement at 0, 6, 12, 18, 24 months	Neurocognition measure of reasoning \& problem solving in PennCNB
Change in Penn Continuous Performance Test	Measurement at 0, 6, 12, 18, 24 months	Neurocognition measure of reasoning \& problem solving in PennCNB
Change in Managing Emotions	Measurement at 0, 6, 12, 18, 24 months	Subscale of the Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT)

Trial Locations

Locations (5)

Hartford Hospital - Institute of Living; 🇺🇸 Hartford, Connecticut, United States

Maine Medical Center; 🇺🇸 Portland, Maine, United States

Massachusetts Mental Health Center; 🇺🇸 Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

UMass Medical School; 🇺🇸 Worcester, Massachusetts, United States