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

Overview

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.

Full Title of Study: “Comparative Effectiveness of Cognitive Enhancement Therapy vs. Social Skills Training in Serious Mental Illness”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 31, 2023

Detailed Description

Aim 1. The investigators 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 (BACS and MSCEIT) and social skills (SSPA). . For study Aim 1,the investigators 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 (NIH Toolbox and MSCEIT) and social skills (SSPA). Aim 2: The investigators will explore differential effectiveness of the two interventions by baseline cognitive functioning and age. For Aim 2, the investigators 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.

Interventions

  • Behavioral: Cognitive Enhancement Therapy
    • 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.
  • Behavioral: Social Skills Training
    • 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.

Arms, Groups and Cohorts

  • Experimental: 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.
  • Active Comparator: 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..

Clinical Trial Outcome Measures

Primary Measures

  • Change in Social Adjustment Scale II
    • Time Frame: Measurement at 0, 6, 12, 18, 24 months
    • Measure of ability to engage socially in community settings
  • Change in Heinrich Quality of Life Scale
    • Time Frame: Measurement at 0, 6, 12, 18, 24 months
    • Measure of negative symptoms in schizophrenia
  • Change in Social Skills Performance Assessment
    • Time Frame: Measurement at 0, 6, 12, 18, 24 months
    • Social skills measure using role plays

Secondary Measures

  • Change in Auditory Verbal Learning Test
    • Time Frame: Measurement at 0, 6, 12, 18, 24 months
    • Neurocognition measure of verbal ability in NIH Toolbox
  • Change in List Sorting Working Memory
    • Time Frame: Measurement at 0, 6, 12, 18, 24 months
    • Neurocognition measure of working memory in NIH Toolbox
  • Change in Managing Emotions
    • Time Frame: Measurement at 0, 6, 12, 18, 24 months
    • Subscale of the Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT)
  • Change in Positive and Negative Syndrome Scale, PANSS-6
    • Time Frame: Measurement at 0, 6, 12, 18, 24 months
    • Short form of measure of positive and negative symptoms
  • Change in 9-Hole Pegboard Dexterity
    • Time Frame: Measurement at 0, 6, 12, 18, 24 months
    • Neurocognition measure of motor skills in NIH Toolbox
  • Change in Pattern Comparison Processing Speed
    • Time Frame: Measurement at 0, 6, 12, 18, 24 months
    • Neurocognition measure of processing speed in NIH Toolbox
  • Change in Oral Digit Symbol Test (Speed of Processing)
    • Time Frame: Measurement at 0, 6, 12, 18, 24 months
    • Neurocognition measure of processing speed in NIH Toolbox
  • Change in Flanker Inhibitory Control and Attention
    • Time Frame: Measurement at 0, 6, 12, 18, 24 months
    • Neurocognition measure of control and attention in NIH Toolbox
  • Change in Dimensional Change Card
    • Time Frame: Measurement at 0, 6, 12, 18, 24 months
    • Neurocognition measure of executive functioning in NIH Toolbox

Participating in This Clinical Trial

Inclusion Criteria

  • 1) age 18 to 65; 2) DSM-5 diagnosis of schizophrenia or schizoaffective or schizophreniform disorder;

Exclusion Criteria

  • 1) the presence of a current organic brain syndrome; 2) a current and severe substance use disorder (DSM-5); 3) intellectual disability (DSM-5)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Beth Israel Deaconess Medical Center
  • Collaborator
    • Patient-Centered Outcomes Research Institute
  • Provider of Information About this Clinical Study
    • Principal Investigator: Matcheri S. Keshavan MD, Stanley Cobb Professor and Academic Head of Psychiatry, Department of Psychiatry, – Beth Israel Deaconess Medical Center
  • Overall Official(s)
    • Matcheri S Keshavan, MD, Principal Investigator, Beth Israel Deaconess Medical Center
    • Russell K Schutt, PhD, Principal Investigator, Beth Israel Deaconess Medical Center
  • Overall Contact(s)
    • Jennifer Sabbagh, 617-975-8545, jsabbagh@bidmc.harvard.edu

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.