Comparative Effectiveness of CET vs. SST in SMI (Serious Mental Illness)
- Conditions
- Schizophrenia and Related Disorders
- Interventions
- Behavioral: Social Skills TrainingBehavioral: Cognitive Enhancement Therapy
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 378
- 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).
- the presence of a current organic brain syndrome;
- intellectual disability (DSM-5);
- participation in either CET or SST within the prior year.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Social Skills Training Social Skills Training The HOPES social rehabilitation program uses the principles of SST (modeling, role playing, positive and corrective feedback, homework assignments, in vivo skills practice), designed to improve both psychosocial functioning and preventive health.. Cognitive Enhancement Therapy Cognitive Enhancement Therapy CET is a comprehensive manualized cognitive remediation program designed to maximize gains in social functioning by integrating computer-based training to enhance neurocognition with group-based exercises to improve social cognition.
- 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)
Massachusetts Mental Health Center
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Hartford Hospital - Institute of Living
🇺🇸Hartford, Connecticut, United States
UMass Medical School
🇺🇸Worcester, Massachusetts, United States
Maine Medical Center
🇺🇸Portland, Maine, United States