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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparative Effectiveness of Cognitive Enhancement Therapy vs. Social Skills Training in Serious Mental Illness

Conditions
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Schizophrenia and Related Disorders

Intervention / Treatment
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* Behavioral: Cognitive Enhancement Therapy
* Behavioral: Social Skills Training


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized cluster design with 19 service centers assigned to one of the two treatments.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Enhancement Therapy<br>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. | Behavioral: Cognitive Enhancement Therapy<br>* CET's group-based exercises are delivered for 1.5 hours each week in a group of 6-8 participants led by a clinician and an assistant, for one year. During each of three modules (basic concepts, social cognition, CET applications), the groups focus on acquisition of adult social milestones in perspective-taking, social context appraisal, and other aspects of social cognition, with psychoeducational lectures, homework assignments, and in-group exercises. Weekly supervision sessions for the clinician trainers will include review of how patients respond to the different demands of computer-based training and group-based exercises and guidance about improving engagement in both.<br>|
| Active Comparator: Social Skills Training<br>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.. | Behavioral: Social Skills Training<br>* The psychosocial component involves weekly skills training classes delivered over one year, with modules including Communicating Effectively, Making and Keeping Friends, Making the Most of Leisure Time, Healthy Living, Using Medications Effectively, and Making the Most of a Health Care Visit (Pratt et al., 2008). Participants attend two sessions each week (normally morning and afternoon of the same day): a 90-minute session focused on a specific skill and a 60-minute session in which the specific skill is used in role-play exercises.<br>* Other names: HOPES;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive functioning, Social skills, Community functioning